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  • Top Stories of 2023: #5 to #7

    By Donald Zuhn –-

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its 17th annual list of top patent stories.  For 2023, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  On Monday, we counted down stories #10 to #8, and today we count down stories #7 to #5, as we work our way towards the top four stories of 2023.  As with our other lists (2022, 2021, 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

    7.  University of California/Berkeley Appeals PTAB Ruling in CRISPR Interference; FDA Approves CRISPR Gene Editing Treatment

    In December 2022, the Patent Trial and Appeal Board rendered its decision on Preliminary Motions in Interference No. 106,133 between Senior Party Sigma-Aldrich and Junior Party The Broad Institute, Harvard University, and MIT (collectively, "Broad").  As with the priority phase in co-pending Interference Nos. 106,126, No. 106,127, and No. 106,132, the Board suspended the priority phase in Interference No. 106,133 until the appeal in Interference No. 106,115 has been decided by the Federal Circuit.  2022 and 2023 saw briefing in that appeal.

    Meanwhile, the significance of the final outcome in the CRISPR interferences was demonstrated last fall, when the U.S. Food and Drug Administration's Cellular, Tissue, and Gene Therapies Advisory Committee announced on October 27 that exagamglogene autotemcel (exa-cel), which was the subject of biologics license application (BLA) 125787 from Vertex Pharmaceuticals, Inc. in collaboration with CRISPR Therapeutics (Zug, Switzerland) and provides for the first time gene therapy for sickle cell anemia, was shown to be effective, having 29 of 30 patients stay pain-free for 18 months.  On October 31, the Advisory Committee issued its recommendation that exa-cel is safe for clinical use, and the FDA then approved the treatment on December 8.  The treatment, being marketed as CASGEVY, is the first CRISPR-based gene-editing therapy to be approved in the U.S.

    For information regarding this and other related topics, please see:

    • "FDA Signals Willingness to Approve CRISPR-Based Treatment for Sickle Cell Anemia," November 2, 2023
    • "Broad Files Reply Brief in Interference No. 106,115 Cross-Appeal," September 7, 2023
    • "CVC Files Response and Reply Brief in Interference No. 106,115 Appeal," August 27, 2023
    • "Amici Support Reversal of PTAB Decision in CRISPR Interference," July 25, 2023
    • "Broad Files Opening Brief and Cross-Appeal in CRISPR Interference," July 23, 2023
    • "CVC Appeals PTAB Decision in CRISPR Interference," July 12, 2023
    • "PTAB Rules on Preliminary Motions in Interference No. 106,133," January 22, 2023


    6.      Judicial Council of Federal Circuit Suspends Judge Newman

    Efforts to have Judge Pauline Newman, Circuit Judge on the Court of Appeals for the Federal Circuit, removed from the Federal Circuit for being unfit or guilty of misconduct were the subject of several reports in mid-2023.  In September, the Judicial Council of the Federal Circuit ordered Judge Newman to be suspended from the court for one year.  The Judicial Council's Order repeated allegations made previously against Judge Newman, supplemented with 16 (sometimes) heavily redacted Exhibits and notations and other supporting exhibits that were redacted in their entirety for confidentiality purposes.  The arguments and supporting exhibits were apparently provided to justify the grounds for the decision, which were Judge Newman's purported refusal to cooperate with the Special Committee's investigation into her competency (despite the Judge having provided medical and psychological results from her own doctors rather than the Committee's hand-picked ones).  The suspension remains subject to Judge Newman's on-going lawsuit in the D.C. District Court asserting that the Council's suspension is unconstitutional and a violation of Judge Newman's due process rights.

    For information regarding this and other related topics, please see:

    • "Judge Newman Suspended for One Year by Federal Circuit," September 20, 2023
    • "Federal Circuit Special Committee Recommends One-Year Suspension of Judge Newman," August 6, 2023
    • "Federal Circuit Special Committee Responds to Judge Newman's Counsel's Request for Clarification Regarding Misconduct Hearing," June 21, 2023
    • "Judge Newman Matter Continues," June 20, 2023
    • "Judge Newman and the On-Going Attempts to Remove Her from the Federal Circuit," May 21, 2023


    5.  Supreme Court Denies CareDx Petition; Senators Coon & Tillis Try to Fix Patent Eligibility (Again)

    In May, CareDx and Stanford University filed a petition for certiorari in CareDX, Inc. v. Natera, Inc. and CareDx, Inc. v. Eurofins Viracor, Inc.  At the time, we noted that the arguments in the petition threaded a very narrow needle in giving the Court a reason to grant certiorari and emphasize (as has been emphasized before) the need to do so.  In particular, the petition directed the Court's attention to the "heav[y] investment CareDx made in bringing this technology to market" and infringing behavior of both Natera and Eurofin in bringing their own "copycat" products to market.  Those hoping for a certiorari grant (and positive outcome), however, were frustrated (yet again) when the Court denied the patentees' petition in October.

    Given the refusal of the Supreme Court to wade back into the subject matter eligibility waters, Senators Coons and Tillis, who chaired a series of Congressional hearings on patent eligibility in 2019, who have asked the U.S. Patent and Trademark Office for its statistics and other information on patent eligibility, and who have proposed several bills providing various iterations of legislative solutions, proposed their latest attempt to provide a legislative solution in June when they introduced "The Patent Eligibility Restoration Act of 2023."  As we noted at the time, this proposal marks the third time that one or both of the Senators have proposed or introduced a bill to revise § 101.  The first two attempts garnered discussion but little tangible progress, leaving the patent community feeling like Charlie Brown repeatedly getting the football yanked away.

    In one bit of good news on the subject matter eligibility front, the storied case of American Axle v. Neapco Holdings entered a new chapter in July — not the final chapter, but the plot thickened considerably.  We provided a recap at the time, noting that Judge Stark, then of the District Court for the District of Delaware, had found all asserted claims of U.S. Patent No. 7,774,911 invalid under 35 U.S.C. § 101 as being directed to a law of nature implemented by well-understood, routine, and conventional means, a decision that was affirmed by the Federal Circuit, with the majority subsequently withdrawing its original opinion and handing down a revised opinion (finding claim 22 still ineligible but vacating and remanding the District Court's decision on claim 1) in response to a petition for en banc rehearing, and the Supreme ultimately denying American Axle's petition for certiorari.  On remand, Judge Williams (who had taken on the case given Judge Stark's promotion to the Federal Circuit), denied Neapco's motion for summary judgment of invalidity pursuant to § 101 and granted American Axle's motion for summary judgment of no invalidity.

    For information regarding this and other related topics, please see:

    • "American Axle's Claims Found Eligible on Remand," August 1, 2023
    • "Senators Tillis and Coons Once More Attempt to Fix Patent Eligibility," June 25, 2023
    • "Senate Bill Proposed to Provide Subject Matter Eligibility Solution," June 22, 2023
    • "Can Judge Michel and John Duffy Convince the Supreme Court to Revisit Subject Matter Eligibility?" May 31, 2023
    • "Stanford Asks Supreme Court to Revisit Subject Matter Eligibility on Diagnostic Claims," May 3, 2023
    • "Sequoia Technology LLC v. Dell Inc. (Fed. Cir. 2023)," April 23, 2023
    • "On Alice Rejections per USPTO Technical Center," March 6, 2023
    • "ITC Takes Section 101 to Its Illogical Extreme," March 1, 2023
    • "Chromadex, Inc. v. Elysium Health, Inc. (Fed. Cir. 2023)," February 15, 2023
    • "PTAB Remains Hostile to Section 101 Appeals," January 31, 2023
    • "The Mental Process Exception to Patent Eligibility is Remarkably Brainless," January 9, 2023

  • USPTO Further Transitions to DOCX Format

    By Donald Zuhn —

    USPTO SealIn an email News Brief distributed today, the U.S. Patent and Trademark Office reminded stakeholders that starting at 12:01 am (ET) on January 17, the filing of new, non-provisional utility patent applications with specification, claims, and abstract in a non-DOCX filing format will incur a surcharge of up to $400.  The Office noted that an Applicant will still have the option of providing a backup (or auxiliary) PDF version of a newly filed application with the DOCX version, and that there would be no fee associated with providing the backup PDF.

    The Office indicated that the transition to the DOCX format is intended "to modernize [the Office's] patent application systems to improve user experience, provide applicants a more streamlined process, harmonize across country borders, and strengthen [the Office's] ability to examine applications quickly and effectively."  The Office stated that it had "worked carefully with stakeholders to shape both the transition to DOCX as well as the timing," and that the Office's systems will "provide[] pre-prosecution checks that improve the robustness and reliability of patents."

    Further information regarding the DOCX format can be found on the Office's DOCX webpage, and a video explaining "How to file your patent application documents in DOCX" can be found here.  Questions regarding DOCX filing can be directed to the Patent Electronic Business Center at ebc@uspto.gov or 866-217-9197.

  • Top Stories of 2023: #8 to #10

    By Donald Zuhn –-

    FireworksAfter reflecting upon the events of the past twelve months, Patent Docs presents its 17th annual list of top patent stories.  For 2023, we identified ten stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants.  Today, we count down stories #10 to #8, and later this week we will count down the remaining top stories of 2023.  As with our other lists (2022, 2021, 2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.  In addition, we will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT).  Details regarding the webinar, which will focus on a few of the most important stories on this year's list, can be found here.

    10.  Debate on Expansion of COVID Waiver Continues; WHO Releases Draft Agreement on Pandemic Prevention, Preparedness, and Response

    The year began with the World Health Organization (WHO) releasing a draft agreement on pandemic prevention, preparedness, and response in February for consideration by the Intergovernmental Negotiating Body (INB), which is comprised of the 194 Member States of the WHO, and which was established in December 2021 at a special session of the WHO's World Health Assembly to draft and negotiate an agreement to strengthen global pandemic prevention, preparedness, and response.  The draft includes a 49-clause preamble, with at least ten of the clauses concerning intellectual property.  The agreement is expected to be agreed upon by the World Health Assembly in 2024.

    And the year ended with the International Trade Commission (ITC) issuing a Report, in response to a request by the U.S. Trade Representative, Ambassador Katherine Tai, in anticipation of negotiations over expansion of the World Trade Organization (WTO) IP waiver that applies to COVID-19 vaccines (but not yet to COVID-19 diagnostics and therapeutic drugs).  The mandate from the Trade Representative was that the ITC Report be a product of market and other research within the Commission's expertise and also reflect the views of stakeholders and the public, and that the Report would not have as a goal to "draw any policy conclusions."  Despite not drawing any policy conclusions, however, the ITC Report has renewed discussions in some quarters over expansion of the COVID-19 waiver, the deadline of which was extended indefinitely in December 2022 (see "Nine Countries Seek Extension of WTO Waiver to COVID-19 Therapeutics and Diagnostics" and "Top Four Stories of 2022").

    For information regarding this and other related topics, please see:

    • "International Trade Commission Issues Report of COVID-19 IP Waiver," November 8, 2023
    • ""Zero Draft" of WHO CA+ Released," February 7, 2023


    9.  Supreme Court Declines to Hear Teva Pharmaceuticals v. GlaxoSmithKline

    In May, the Supreme Court declined to grant certiorari in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, disregarding the views of the Solicitor General regarding whether to grant cert.  Perhaps the Justices felt that the Federal Circuit's backtracking in its second panel decision on the breadth of infringement inducement set forth in its first decision, in light of then Chief Judge Prost's strong dissent and the firestorm of protest (public and through amicus briefing regarding Teva's petition for rehearing), was enough to cabin the decision to the somewhat unique facts in the case.  The petition for cert. involved the Federal Circuit's decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020) and GlaxoSmithKline LLC v. Teva Pharmaceuticals USA (Fed. Cir. 2021), in both of which former Chief Judge Prost issued strong dissents, and which concerned whether a generic applicant filing a "skinny label" ANDA could properly be found liable for inducing infringement under 35 U.S.C. § 271(b).  The Court issued an Order to the Solicitor General soliciting the government's views and that brief advocated that the Court grant cert.

    For information regarding this and other related topics, please see:

    • "H. Lundbeck A/S v. Lupin Ltd. (Fed. Cir. 2023)*," December 18, 2023
    • "Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation," May 15, 2023


    8.  Patent Law under Attack (Again)

    The New York Times is (in)famous in this space for its attacks on the patent system (see "Top Stories of 2022: #8 to #10"; #9. New York Times Reopens Attack on U.S. Patent System).  And last year at this time, the Times was at it again in a front page piece on Humira, a drug used for a variety of ailments that has brought relief to millions of patients who otherwise suffered with earlier, less effective drugs.  The "problem" seems to be that Humira has made a pharma company a lot of money (purportedly $116 billion), that the drug is expensive (said to cost upwards of $50,000/year) and that the drug company has amassed a large number of patents to protect its intellectual property.  But as we noted in response to the Times article, the bigger problem is that the Times failed to recognize several important facts relating to the circumstances under which Humira's makers made this money and amassed its patent estate (or "thicket" as the anti-patent crowd likes to call it).

    In May, the U.S. Senate's Health, Education, Labor & Pensions (HELP) Committee passed out of committee five bills that attempted to address high drug prices:  the Ensuring Timely Access to Generics Act of 2023 (S. 1067); the Expanding Access to Low-Cost Generics Act of 2023 (S. 1114); the Retaining Access and Restoring Exclusivity Act (S. 1214); and the Increasing Transparency in Generic Drug Applications Act (S. 775).  And in September, a letter from 25 scholars, former judges, and former government officials sent to the Senate Health, Education, Labor and Pensions Committee, the Chair and Ranking Member of the House Ways and Means Committee, and the Secretary of Health and Human Services, Xavier Becerra, intended to "correct[] false claims that the federal government can use [the "march-in rights" provisions of] the Bayh-Dole Act . . . to impose price controls on prescription drugs."

    Attacks on the patent system are not confined to an asserted impact of patents on drug pricing, however.  Some attacking the patent system are also opposed to software patents, with such opposition seemingly being based on one or more of the false assumptions that all software patents are too broad, that it is obvious to invent software based processes, programming is an administrative activity that does not warrant patent protection, or that the patent system should not protect non-physical inventions.  As we noted in July, none of these positions have any legal or technical credibility.

    For information regarding this and other related topics, please see:

    • "Patent Luminaries Try to Set Congress Straight on Drug Price Controls," September 26, 2023
    • "FTC Announces Efforts to Police Pharmaceutical Companies' Patent Behavior," September 19, 2023
    • "Drugs May Cost Too Much, But Patents Are Not the Cause," July 18, 2023
    • "You Are Going to Hear A Lot More FUD about Patent Law, So Here Are Some Facts," July 5, 2023
    • "Senate Once Again Tries to Address Drug Pricing," May 16, 2023
    • "The New York Times Is at It Again Regarding Patents," January 29, 2023

  • Pacific Biosciences of California, Inc. v. Personal Genomics Taiwan, Inc. (Fed. Cir. 2024)

    By Kevin E. Noonan –

    Federal Circuit SealThe importance of claim construction, and how construing the same term facing a challenge based on different prior art in separate inter partes review proceedings can result in contrary findings on invalidity, was illustrated by the Federal Circuit's decision recently in Pacific Biosciences of California, Inc. v. Personal Genomics Taiwan, Inc.

    The case arose in Pacific Bioscience's IPR challenges to different combinations of claims* of U.S. Patent No. 7,767,441, owned by Personal Genomics Taiwan (PGI).  Claim 1, challenged in both IPRs, is representative:

    1.  An apparatus for identifying a single biomolecule, comprising:
        a substrate having a light detector; and
        a linker site formed over the light detector, the linker site being treated to affix the biomolecule to the linker site;
        wherein the linker site is proximate to the light detector and is spaced apart from the light detector by a distance of less than or equal to 100 micrometers.

    The two instituted IPRs were directed to claims 1, 2, 6, 7, 10–22, 24, and 27–36 ("the '1200 IPR") and claims 1–6, 9, and 43–58 ("the '1163 IPR").  Pacific Biosciences (PacBio) asserted U.S. Patent Application Publication No. 2004/0197793 A1 in the '1200 IPR, on anticipation and obviousness grounds, and International Publication No. WO 2007/045755 A1 in the '1163 IPR, also asserting anticipation or obviousness against the challenged claims.  The Board held in separate Final Written Decisions that PacBio failed to establish invalidity of the challenged claims in the '1200 IPR on either ground, but that the claims challenged in the '1163 IPR were invalid as being anticipated by the '755 published PCT application.  (The opinion notes that the FWD in the '1163 IPR also found invalidity on obviousness grounds that was not at issue in the appeal assessed below.)  As discussed in the Federal Circuit's opinion, both these determinations relied on the Board's construction of the term "identifying a single biomolecule" to have its plain and ordinary meaning encompassing identification of a single molecule and not multiple copies of the same molecule.  This appeal followed by each of the losing parties on each of the IPRs.

    The Federal Circuit affirmed the Board's determinations in each IPR, in an opinion by Judge Taranto, joined by Judges Prost and Hughes.  The opinion first addresses the Board's construction of the phrase "identifying a single biomolecule," which was given its plain and ordinary meaning of identifying a single biomolecule and not an amplified or multiplicity of the same biomolecule, or as stated in the opinion "requiring an apparatus capable of ascertaining the identity of one single, individual biomolecule by examining only that biomolecule."  The panel held that the plain and ordinary meaning, both on its face and in the context of the claims and specification supported the Board's construction that as a feature of the claimed apparatus the language recites "(a) ascertaining the identity of a biomolecule, i.e., what that biomolecule is, and (b) doing so by examining just that one biomolecule, not others (even copies)."  The Federal Circuit, reviewing the Board's construction without deference (because it was based solely on intrinsic evidence), nevertheless resorted to two dictionary definitions of "identify" to affirm the Board's construction with regard to the first portion of the definition, and the panel relied on the context of the claim to decide conformity with the second portion.  The "striking feature" the court stated that provided this context was the word "single," the panel stating that "[t]here is no apparent reason for the inclusion of the word 'single' in the phrase except to indicate that the capability required is to identify a molecule with just that one molecule in view."  The Federal Circuit was also persuaded by statements in the specification that the capability to identify singe biomolecules was "critical" to the invention, and that the "single molecule" feature avoided recognized problems in detecting "a population-level signal from an ensemble or cluster of amplified or copied biomolecules."  Finally, regarding claim construction the opinion uses comparisons with the language in other claims in the '441 patent that related to detecting more than one biomolecule to limit claim 1 to identifying a single biomolecule.

    Turning to the Board's factual predicates for its decisions on validity (challenged by both appellants), the panel held that the Board's conclusions in each case were supported by substantial evidence.  For the '1200 IPR, the "principal embodiment" disclosed in the cited art was using an assay having a sensitivity that permitted detection of biomolecules in amounts "as low as 0.1 attomoles."  This corresponds to detecting more than 60,000 molecules (according to PacBio's expert), and other portions of the prior art reference recited even higher amounts ("1 amol to 100 amol").  "This evidence," according to the opinion, "provides substantial-evidence support for the Board's finding that [the asserted prior art] does not disclose 'identifying a single biomolecule.'"  For the '1163 IPR, the "critical disclosure" was the capacity of the prior art apparatus to include openings in the detector sufficiently small to detect "individual chromophores" (emphasis in opinion).  In the Court's opinion, this disclosure provided substantial evidence supporting the Board's determination that the prior art was capable of detecting a single biomolecule, because such biomolecules were typically tagged with a single chromophore.  The panel found that the Board had sufficient basis for rejecting a contrary opinion from PGI's expert (that the sensitivity of the prior art detector was no less than 78 biomolecules) that included rebuttal evidence from PacBio that the disclosed improvement in detection provided by the cited prior art ("a factor of 400") could result in a sensitivity improvement permitted single biomolecule detection.  While the panel recognized that PacBio's expert asserted a lower estimate of improved sensitivity ("30 or 40 or 50 times better"), "[w]here the overall evidence reasonably allows the Board's factual finding on a point, we do not 'reweigh the evidence' to reject that finding," citing Regents of the University of California v. Broad Institute, Inc., 903 F.3d 1286, 1294 (Fed. Cir. 2018).  Accordingly, the Federal Circuit affirmed the Board's decisions in these IPRs.

    Pacific Biosciences of California, Inc. v. Personal Genomics Taiwan, Inc. (Fed. Cir. 2024)
    Panel: Circuit Judges Prost, Taranto, and Hughes
    Opinion by Circuit Judge Taranto

    * The challenged claims of the '441 patent:

    '1200 IPR

    '1163 IPR

    1. An apparatus for identifying a single biomolecule, comprising:

    a substrate having a light detector; and

    a linker site formed over the light detector, the linker site being treated to affix the biomolecule to the linker site;

    wherein the linker site is proximate to the light detector and is spaced apart from the light detector by a distance of less than or equal to 100 micrometers.

    2. The apparatus of claim 1, further comprising a blind sheet formed over the substrate, the blind sheet including a pinhole having a diameter, wherein the linker site is formed proximate to the pinhole.

    6. The apparatus of claim 2, further comprising a microlens formed between the substrate and the blind sheet.

    7. The apparatus of claim 1, wherein the distance is less than or equal to 25 micrometers.

    10. An optical detection system, comprising at least 10,000 apparatuses as recited in claim 1.

    11. A method of sequencing a plurality of nucleic acid molecules, the method comprising the steps of:

    affixing a plurality of nucleic acid molecules to the linker sites of the optical detection system of claim 10; and

    performing nucleic acid sequencing of the nucleic acid molecules in parallel on the optical detection system.

    12. A method of detecting a plurality of biomolecules, the method comprising the steps of:

    affixing a plurality of biomolecules to the linker sites of the optical detection system of claim 10; and

    detecting the biomolecules on the optical detection system in parallel.

    13. An optical detection system, comprising at least 250,000 apparatuses as recited in claim 1.

    14. An optical detection system, comprising at least 2,000,000 apparatuses as recited in claim 1.

    15. An optical detection system, comprising at least 10,000,000 apparatuses as recited in claim 1.

    16. A method of sequencing a nucleic acid, comprising the steps of:

    affixing one nucleic acid molecule to the linker site of the apparatus of claim 1; and

    performing nucleic acid sequencing of the nucleic acid molecule on the apparatus.

    17. The method of claim 16, wherein the nucleic acid is affixed to the linker site by binding to a polymerase molecule affixed to the linker site.

    18. The method of claim 16, wherein the nucleic acid sequencing comprises the step of adding labeled nucleotides to the apparatus.

    19. The method of claim 18, wherein the nucleotides are labeled fluorescently.

    20. The method of claim 19, wherein the nucleotides are labeled fluorescently on their terminal phosphate.

    21. The method of claim 16, wherein the nucleic acid sequencing is base extension sequencing and includes the step of adding blocked and labeled nucleotides to the apparatus.

    22. The method of claim 21, wherein the nucleotides are labeled fluorescently.

    24. The method of claim 22, wherein the nucleotides have distinct fluorescent labels and are added simultaneously.

    27. The method of claim 16, wherein the sequence of the nucleic acid is unknown.

    28. The method of claim 16, wherein the nucleic acid is detected with a label excited by Förster resonance energy transfer (FRET).

    29. The method of claim 16, wherein the nucleic acid is detected with a label by time-resolved fluorescence technology.

    30. A method of detecting a biomolecule, comprising the steps of:

    affixing one or more biomolecule to the linker site of the apparatus of claim 1; and

    detecting the biomolecule on the apparatus.

    31. The method of claim 30, wherein the biomolecule comprises a label.

    32. The method of claim 31, wherein the label is fluorescent.

    33. The method of claim 32, wherein the biomolecule comprises a moiety chosen from a polypeptide, antibody, lipid, vitamin, low molecular weight organic molecule, and polysaccharide.

    34. The method of claim 33, wherein the biomolecule is affixed to the linker site of the apparatus by a linking molecule.

    35. The method of claim 34, wherein the linking molecule comprises a capture molecule.

    36. The method of claim 35, wherein the capture molecule is a protein.

    1. An apparatus for identifying a single biomolecule, comprising:

    a substrate having a light detector; and

    a linker site formed over the light detector, the linker site being treated to affix the biomolecule to the linker site;

    wherein the linker site is proximate to the light detector and is spaced apart from the light detector by a distance of less than or equal to 100 micrometers.

    2. The apparatus of claim 1, further comprising a blind sheet formed over the substrate, the blind sheet including a pinhole having a diameter, wherein the linker site is formed proximate to the pinhole.

    3. The apparatus of claim 2, wherein the pinhole has a diameter of less than or equal to 1,000 nanometers.

    4. The apparatus of claim 2, wherein the pinhole has a diameter of less than or equal to 200 nanometers.

    5. The apparatus of claim 2, further comprising a filter layer formed between the substrate and the blind sheet.

    6. The apparatus of claim 2, further comprising a microlens formed between the substrate and the blind sheet.

    9. The apparatus of claim 1, wherein the light detector collects light from the biomolecule within a solid angle, the solid angle being greater than or equal to 0.8 SI steridian.

    43. A method of providing biomolecule analysis service, comprising the steps of:

    providing a sample comprising a biomolecule from a service requester to a service provider;

    the service requester receiving analytical results from the service provider, wherein the results are produced using the apparatus of claim 1.

    44. The method of claim 43, wherein the method is performed for remunerative consideration.

    45. The method of claim 44, wherein the service requester and the service provider are mediated by a vendor.

    46. The method of claim 43, wherein the analytical results are produced in another country.

    47. The method of claim 43, wherein the analytical results are produced in a country other than the United States of America.

    48. An apparatus for identifying a single biomolecule, comprising:

    a substrate having a light detector;

    a linker site formed over the light detector, the linker site being treated to affix the biomolecule to the linker site; and

    an excitation light source formed over the substrate;

    wherein the linker site is proximate to the light detector and is spaced apart from the light detector by a distance of less than or equal to 100 micrometers.

    49. The apparatus of claim 48, wherein the excitation light source includes a light emitting layer, the light emitting layer emitting excitation light to the linker site along a horizontal direction parallel to a surface of the light detector.

    50. The apparatus of claim 49, further comprising a filter layer formed between the substrate and the light emitting layer.

    51. The apparatus of claim 48, wherein the excitation light source is chosen from a light emitting diode (LED), an organic light emitting diode (OLED), a polymer light emitting diode (PLED), and a laser diode (LD).

    52. The apparatus of claim 48, wherein the excitation light source provides excitation light of a first wavelength range not overlapping with a second wavelength range of light emitted from the biomolecule.

    53. An apparatus for identifying a single biomolecule, comprising:

    a substrate having a light detector; and

    a linker site formed over the light detector, the linker site being treated to affix the biomolecule to the linker site;

    wherein the light detector collects light emitted from the biomolecule within a solid angle of greater than or equal to 0.8 SI steridian.

    54. An apparatus for identifying a single biomolecule, comprising:

    a substrate having a light detector;

    a linker site formed over the light detector, the linker site being treated to affix the biomolecule to it; and

    an excitation light source formed over the substrate;

    wherein the light detector collects light emitted from the biomolecule within a solid angle of greater than or equal to 0.8 SI steridian.

    55. A method for manufacturing an apparatus for identifying a single biomolecule, comprising:

    forming a light detector and a control circuit on a substrate;

    forming a blind sheet having a pinhole over the substrate; and

    forming a linker site over the light detector and proximate to the pinhole, the linker site being treated to affix the biomolecule to the linker site, wherein the linker site is proximate to the light detector and is spaced apart from the light detector by a distance of less than or equal to 100 micrometers.

    56. The method of claim 55, further comprising forming a filter layer between the substrate and the blind sheet.

    57. The method of claim 56, wherein forming the blind sheet comprises:

    forming an opaque layer on the filter layer;

    forming a photoresist layer on the opaque layer;

    patterning the photoresist layer to expose a portion of the opaque layer;

    etching the opaque layer using the patterned photoresist layer as a mask until the filter layer is exposed; and

    removing the photoresist layer.

    58. The method of claim 57, wherein the opaque layer comprises metal.

  • MBHB Webinar on Top Patent Law Stories of 2023

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "Top Patent Law Stories of 2023" on January 23, 2024 from 10:00 am to 11:15 am (CT).  Since 2007, the Patent Docs weblog has presented an annual, end-of-the-year review of the top stories in patent law.  In this presentation, Patent Docs co-authors Donald Zuhn, Kevin Noonan, and Michael Borella will take a look back at the top patent stories of 2023, many of which will likely impact patent applicants and practitioners in the coming year.

    While there is no fee to participate, attendees must register in advance.  Those wishing to register can do so here.  CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.

  • IPO Webinar: 2023 PTAB Year in Review

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "2023 PTAB Year in Review," on January 16, 2024 from 1:00 pm to 2:00 pm (ET).  Sendil Devadas of Corteva Agriscience; Joshua Goldberg of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP; and Kassandra Officer of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP will discuss some of the most significant developments in PTAB practice in 2023 and how those developments will impact future cases, and discuss important decisions promulgated last year, including several designated precedential, as well as court treatment of PTAB decisions with implications for PTAB practice.

    The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request).  Those interested in attending the webinar should register here.

  • Webinar on Unified Patent Court from a U.S. Perspective

    IPWatchdogIPWatchdog and Bardehle Pagenberg will be offering a webinar entitled "The State of Play at the UPC from a US-Perspective — Insights from a UPC Litigator" on January 17, 2024 at 12:00 pm (ET).  Gene Quinn of IPWatchdog, Inc. and Tobias Wuttke of Bardehle Pagenberg will discuss Unified Patent Court (UPC) developments from a U.S. perspective and how U.S. companies should adjust their enforcement and defense strategies in light of the emerging legal framework, and also cover how UPC litigation may complement U.S. patent enforcement as well as U.S. patent defense strategies.  The webinar will address the following topics:

    • Insights on how the UPC is operating, what the UPC time schedules and case management look like, and how internal workflows should be optimized
    • Clarity on the most relevant case law handed down by the UPC
    • Ways to improve defensive and offensive patent strategies involving this new forum
    • A better understanding of what the UPC really means from a U.S. perspective

    There is no registration fee for this webinar.  However, those interested in registering for the webinar, should do so here.

  • IPO Webinar: 2023 Case Law Year in Review

    IPO #2The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "2023 Case Law Year in Review," on January 17, 2024 from 1:00 pm to 2:00 pm (ET).  Paul Berghoff of McDonnell Boehnen Hulbert & Berghoff LLP, Gregory Castanias of Jones Day, and Wendy Larson of Pirkey Barber will attempt to distill down the past year's major decisions from the Supreme Court, Federal Circuit, PTAB, and TTAB, and discuss the ones that will affect IP practitioners in 2024 and beyond.

    The registration fee for the webinar is $150 for non-members or free for IPO members (government and academic rates are available upon request).  Those interested in attending the webinar should register here.

  • Webinar on Implementing Regulations of Chinese Patent Law

    Schwegman Lundberg WoessnerSchwegman Lundberg & Woessner will be offering a SLW Institute webinar entitled "Top 5 Changes in Chinese Patent Practice Based on the Amended Implementing Regulations of the Patent Law" on January 18, 2024 at 1:00 pm (CT).  Aaron Wininger of Schwegman Lundberg & Woessner will discuss the long-awaited amended Implementing Regulations of the Patent Law released by China's State Council in December 2023 that will take effect on January 20, 2024, and discuss the changes that have been made and how they will impact Chinese patent practice going forward.

    While there is no cost to participate in the program, those interested in attending the webinar can register here.

  • USPTO Provides Guidance on Standards for Enablement Requirement

    By Kevin E. Noonan –

    USPTO SealOn January 10th, the U.S. Patent and Trademark Office published a Notice in the Federal Register (89 Fed. Reg. 1563) regarding proposed Guidance on how the Office will apply the enablement requirement under 35 U.S.C. § 112(a) in light of the Supreme Court's decision last year in Amgen v. Sanofi.  In a nutshell, the Office announced that it will do so by continuing to use the rubrics established by the Federal Circuit in In re Wands.

    The Notice sets forth the Office's understanding of the Supreme Court's decision and its substantial adherence to existing law, particularly Wands.  But the Office is also cognizant (as the past 15-20 years has illustrated) that Supreme Court precedent is certainly (if not the only) the most relevant source of interpretation on how the patent statute should be understood and applied.  The Notice cites O'Reilly v. Morse, 56 U.S. 62 (1854); The Incandescent Lamp Patent, 159 U.S. 465 (1895); and Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928), in this regard.  The Office also recognizes more recent Federal Circuit precedent, including McRO, Inc. v. Bandai Namco Games Am. Inc., 959 F.3d 1091 (Fed. Cir. 2020); Wyeth & Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013); Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc., 928 F.3d 1340 (Fed. Cir. 2019); and Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 2019), and the Supreme Court's holding in Amgen, based on Wood v. Underhill, 46 U.S. 1 (1846), and Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916), that a "specification is not necessarily inadequate just because it leaves the skilled artisan to perform some measure of adaptation or testing."

    This is where the Wands factors come into play, in providing the framework for determining the "reasonableness of experimentation."  The Notice acknowledges that the Court did not expressly address or rely on the Wands factors but finds support for their continued analytical vitality in the Court's emphasis that "the specification may call for a reasonable amount of experimentation to make and use the full scope of the claimed invention," the Wands factors being probative thereof.  The Notice cites post-Amgen decisions, specifically Baxalta Inc. v. Genentech Inc., 2023 U.S. App. LEXIS 24863 (Fed. Cir. 2023); Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023); and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential), for reference to or reliance upon Wands.  Returning to the Federal Circuit's decision in Amgen (affirmed by the Supreme Court), the Notice cites the determination in that decision that "the scope of the claims was far broader in functional diversity than the disclosed examples, that the invention was in an unpredictable field of science with respect to satisfying the full scope of the functional limitations, and that there was not adequate guidance in the specification," all of which considerations track with the Wands factors.  Similar assessments are provided for the Baxalta (district court litigation), Medytox (PTAB decision in a PGR proceeding, and Starrett (PTAB decision in an ex parte appeal) Federal Circuit decisions.

    The Notice and proposed Guidance falls within the statutory interpretive protocol wherein the Supreme Court provides broad interpretation of the limits the statute imposes on what is patentable, the Federal Circuit applies those standards to individual cases cabined by their particular facts, and the Office, as an administrative agency, applies both layers of precedential interpretation in examining patent applications for compliance with the statutory standards as enacted by Congress and interpreted by the courts.  The Notice particularly specifies that it will apply the Wands factors "to ascertain whether the experimentation required to enable the full scope of the claimed invention is reasonable" "regardless of technology" under M.P.E.P § 2164.04.

    The Notice contains contact information for Office personnel from whom additional information can be obtained: Mary C. Till, Senior Legal Advisor, Office of Patent Legal Administration, at Mary.Till@uspto.gov or 571–272–7755; or Andrea S. Grossman, Legal Advisor, Office of Patent Legal Administration, at Andrea.Grossman@uspto.gov or 571–270–3314.