By Donald Zuhn —

Earlier today, David Boundy, the Vice President of Intellectual Property for Cantor Fitzgerald L.P., provided Patent Docs (and other members of the patent law blogging community) with a copy of a letter he sent to Susan Dudley of the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).  The letter, which criticizes the IDS rules proposed by the U.S. Patent and Trademark Office on July 10, 2006 (see "Changes to Information Disclosure Statement Requirements and Other Related Matters," 71 Fed. Reg. 38,808), was sent on behalf of twenty-five companies and organizations, including Amylin Pharmaceuticals, Beckman Coulter, BD, California Healthcare Institute, Mendel Biotechnology, Metabasis Therapeutics, Novo Nordisk, The Scripps Research Institute, Wyeth, and ZymoGenetics.

In the letter, Mr. Boundy concludes that "the proposed IDS Rule has no merit whatsoever, and it would cost patent applicants billions of dollars each year just to comply with onerous new paperwork burdens."  As a result, Mr. Boundy requests that the OMB "put an end to USPTO’s flagrant disregard for proper procedure and the exorbitant costs it imposes on its customers, and return this draft rule to USPTO for further consideration."

As with the new continuation and claims rules, Mr. Boundy accuses the Patent Office of "again misrepresent[ing] to OMB the breadth and depth of the effects likely to result," arguing that the proposed IDS rule "will impose billions of dollars of burden on patent applicants and owners."  To support this cost estimate, Mr. Boundy provides a letter from San Luis Obispo, CA patent attorney Philip Steiner, who determined that it would cost $1.9 billion to prepare patentability justification documents (at an estimated cost of $27,000 apiece) for the 480,000 applications per year that the Patent Office contends would require such documents under the proposed IDS rule.  In justifying these calculations, Mr. Steiner observes that:

Realistically, the business risk of preparing and filing a patentability justification document based on inequitable conduct considerations alone, places [a] patentability justification document in the same risk categories as patent infringement and patent validity opinions which range anywhere from $20,000 to over a $100,000.  I understand that several firms have decided that "examination support documents" ("ESD’s," provided under the "Continuations" rule that OMB evaluated in April-July 2007, which in turn are very similar to patentability justification documents in this IDS rule) are "opinions" that must be reviewed by two partners of the firm, adding considerable billable cost to preparing such a document.

Mr. Boundy argues that while the proposed IDS rule will impose significant costs upon applicants, the rule will yield only slight benefits for the Patent Office.  In particular, Mr. Boundy notes that "[i]f the proposed IDS Rule reduced examination time by 10% for the 15% of applications USPTO says would be affected – a generous estimate of the average cost of considering IDS documents affected by the Rule – the potential reduction in total workload is only 1.5%."

In addition to the costs associated with the proposed IDS rule, Mr. Boundy argues that the rule conflicts with case law that requires that applicants and their agents fully disclose all potentially relevant information to the Patent Office.  As Mr. Boundy explains, this conflict arises when an applicant is aware of more than twenty prior art references, and therefore, would be required under the rule to either "[d]eliberately withhold information" from the Patent Office because the proposed IDS rule "forces applicants to submit only the ‘most’ material information," or submit a (dreaded) patentability justification document describing each prior art reference in detail.  As to how the Patent Office could propose such a flawed rule, Mr. Boundy observes that the Office "has no experience in the area of inequitable conduct (which applies only after a patent issues) and has developed no agency expertise in any area that would enable it to understand the consequences of its proposed regulation."

While Mr. Boundy asserts that the proposed IDS rule would adversely affect many different industries, he argues that the biotechnology and life-sciences industries would be disproportionately affected.  In support of this assertion, Mr. Boundy provides a letter from ZymoGenetics Associate General Counsel Jennifer Johnson, in which Ms. Johnson includes a statistical analysis of patents issued to the top ten biotechnology companies for 2005.  As a result, Mr. Boundy writes that:

[The Patent Office] asserted that "a threshold of twenty documents" would exempt all but 15% of applications.  However, in 2005 in the biotechnology arts, the "20 document" threshold punitively affects 73% of biotech patents, and the "25 page" threshold affects 94% of biotech patents.  Because of the disparate impact on a single, highly-innovative industry, the proposed IDS rule should not be adopted without a careful regulatory impact analysis.

With respect to the "25 page" threshold, Ms. Johnson notes that "biotechnology-related patent applications are generally greater than twenty-five (25) pages in length.  Accordingly, an applicant citing a U.S. Patent document or Foreign Patent document in the biotechnological arts is almost assured of having to submit an explanation with the IDS."  Ms. Johnson also suggests that "it is highly likely that 100% of biotechnology businesses that file and prosecute patent applications would be affected [by the proposed IDS rule], as all of the companies surveyed had issued patents in 2005 that would have triggered the heightened disclosure requirements under the proposed rules."

In his letter to the OMB, Mr. Boundy is not content to merely point out the significant flaws in the Patent Office’s proposed IDS rule.  Instead, he also proposes several alternatives, including a restructuring of the fee schedule "so that applications that take more (or more specialized) examination time are charged proportionally higher fees," an allotment of examination time that recognizes differences in application size and complexity, the implementation of an "examination on request" system similar to that used in Europe, Japan, and Canada (which, Mr. Boundy notes, results in about 20% of applications simply being abandoned, with no expenditure of examination resources), and an expanded peer-to-patent program for public submission and comment on prior art references.

    By Kevin E. Noonan —

Last week, the U.S. Patent and Trademark Office promulgated its long-awaited guidelines for Examiners in making obviousness determinations in view of the U.S. Supreme Court’s decision in KSR Int’l Co. v. Teleflex Inc. (see "Patent Office Issues Examination Guidelines Regarding Obviousness after KSR").

As part of these guidelines, the Office provided various rationales available to Examiners to fulfill KSR’s requirement that the factfinder provide a reasoned basis for an obviousness determination.  One such rationale dealt with the "obvious to try" issue, as discussed by the Supreme Court in KSR:

When there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.

The guidelines with regard to the "obvious to try" standard are set forth in Rationale E:

(E) ”Obvious to try” – choosing from a finite number of
identified, predictable solutions, with a reasonable expectation of success;

(1) a finding that at the time of the invention, there
had been a recognized problem or need in the art, which may include a design
need or market pressure to solve a problem;

(2) a finding that there had been a finite number of
identified, predictable potential solutions to the recognized need or problem;

(3) a finding that one of ordinary skill in the art could
have pursued the known potential solutions with a reasonable expectation of
success; and

(4) whatever additional findings based on the Graham
factual inquiries may be necessary, in view of the facts of the case under
consideration, to explain a conclusion of obviousness.

Citing KSR, the Notice requires for this rationale that an Examiner articulate facts supporting the conclusion that ”a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.  In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."

The issue for biotechnology arises in Example 3 illustrating how an Examiner should apply this rationale; that Examiner relates to the Board’s decision in Ex parte Kubin (see Patent Docs post on this case):

Example 3:  The claimed invention in Ex parte Kubin, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007), was an isolated nucleic acid molecule.  The claim stated that the nucleic acid encoded a particular polypeptide.  The encoded polypeptide was identified in the claim by its partially specified sequence, and by its ability to bind to a specified protein.

A prior art patent to Valiante taught the polypeptide encoded by the claimed nucleic acid, but did not disclose either the sequence of the polypeptide, or the claimed isolated nucleic acid molecule.  However, Valiante did disclose that by employing conventional methods, such as those disclosed by a prior art laboratory manual by Sambrook, the sequence of the polypeptide could be determined, and the nucleic acid molecule could be isolated.  In view of Valiante’s  disclosure of the polypeptide, and of routine prior art methods for sequencing the polypeptide and isolating the nucleic acid molecule, the Board found that a person of ordinary skill in the art would have had a reasonable expectation that a nucleic acid molecule within the claimed scope could have been successfully obtained.

Relying on In re Deuel, Appellant argued that it was improper for the Office to use the polypeptide of the Valiante patent together with the methods described in Sambrook to reject a claim drawn to a specific nucleic acid molecule without providing a reference showing or suggesting a structurally similar nucleic acid molecule.  Citing KSR, the Board stated that ”when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.  If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”  The Board noted that the problem facing those in the art was to isolate a specific nucleic acid, and there were a limited number of methods available to do so.  The Board concluded that the skilled artisan would have had reason to try these methods with the reasonable expectation that at least one would be successful.  Thus, isolating the specific nucleic acid molecule claimed was ”the product not of innovation but of ordinary skill and common sense.”

This is nothing more, and nothing less, than a per se obviousness standard.  According to the guidelines, the existence of an isolated polypeptide in the prior art, without more, renders obvious a claim to a nucleic acid encoding the polypeptide.  Note that the guidelines do not require that even a partial amino acid sequence of the prior art polypeptide be known, nor does it require that a cell or tissue source of the protein be known, to raise a prima facie obviousness determination against a nucleic acid claim.  To put this in context, human blood clotting Factor VIII, which causes Hemophilia A, was "isolated" from fractionated blood components many years before the gene encoding the protein was isolated.  During that time, the cells producing the protein were not known; it has since been found to be produced by vascular endothelial cells.  Despite this inherent uncertainty, according to the Patent Office (no doubt having been "constantly advised by the patent examiners, who are highly skilled in this art, that cloning procedures are routine in the art"), the nucleic acid encoding Factor VIII would be prima facie obvious in view of the mere existence of a purified preparation of the protein in the art.  This rationale goes even further than the Board in Deuel, since there, the Board’s obviousness decision was based on "the examiners urg[ing] that when the sequence of a protein is placed into the public domain, the gene is also placed into the public domain because of the routine nature of cloning techniques."  Here, even this requirement has been dropped.

This result is not required by KSR, and is in fact contrary to it.  The Court did not abrogate In re Deuel in the KSR decision, and the portion of KSR dealing with the "obvious to try" standard is consistent with Federal Circuit precedent, including Deuel:

It is true that this court and its predecessors have repeatedly emphasized that "obvious to try" is not the standard under §103.  However, the meaning of this maxim is sometimes lost.  Any invention that would in fact have been obvious under §103 would also have been, in a sense, obvious to try.  The question is: when is an invention that was obvious to try nevertheless nonobvious?

The admonition that "obvious to try" is not the standard under § 103 has been directed mainly at two kinds of error.  In some cases, what would have been "obvious to try" would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.  In others, what was "obvious to try" was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.

Obviousness does not require absolute predictability of success.  Indeed, for many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice.  There is always at least a possibility of unexpected results, that would then provide an objective basis for showing that the invention, although apparently obvious, was in law nonobvious.  For obviousness under § 103, all that is required is a reasonable expectation of success.

In re O’Farrell (Fed. Cir. 1988) (citations omitted).  Neither of these situations apply per se to isolating a nucleic acid that encodes a known protein.

The guidelines are not even consistent with the Board’s decision in Kubin.  There, the Board cited several factual distinctions between the obviousness issue presented by Kubin and the facts in Deuel, including:

1.  In Kubin, a cell "unambiguously" (see below) expressing the gene was
known; in Deuel, a protein that the prior art taught was expressed in brain was
cloned from placenta.

2.  In Kubin, the nucleotide and amino acid sequence of
the mouse ortholog of human NAIL was known; in Deuel, the prior art disclosed
three different brain-specific proteins and a partial amino-terminal amino acid
sequence thereof.

3.  In Kubin, the art provided an isolated preparation of
the cognate protein and a monoclonal antibody that binds to the protein; in Deuel, the art
disclosed isolated preparations of three different brain-specific proteins but
no antibodies.

4.  In Kubin, the art provided a monoclonal antibody
specific for the gene product of the desired cDNA and thus providing a specific
probe; in Deuel, the probes were a plurality of degenerate oligonucleotides
prepared from the partial amino-terminal amino acid sequences.

5.  In Kubin, the art has developed expression cloning
technology and provided an antibody probe specific for the gene product of the
desired clone; in Deuel, the absence of a specific antibody precluded use of
expression cloning technology.

None of these factual issues are mentioned or required to be considered under the guidelines.

On the law, the Board conflated (and the guidelines set in stone) the issues of the obviousness of a composition of matter and the obviousness of producing it.  This is the same mistake that the Board made in Deuel:

The PTO’s focus on known methods for potentially
isolating the claimed DNA molecules is also misplaced because the claims at
issue define compounds, not methods.  See In re Bell, 991 F.2d 781, 785, 26
USPQ2d 1529, 1532 (Fed. Cir. 1993).  In Bell, the PTO asserted a rejection based
upon the combination of a primary reference disclosing a protein (and its
complete amino acid sequence) with a secondary reference describing a general
method of gene cloning.  We reversed the rejection, holding in part that
"the PTO’s focus on Bell’s method is misplaced.  Bell does not claim a
method.  Bell claims compositions, and the issue is the obviousness of the
claimed compositions, not of the method by which they are made."  Id.

We today reaffirm the principle, stated in
Bell, that the
existence of a general method of isolating cDNA or DNA molecules is
essentially
irrelevant to the question whether the specific molecules themselves
would have
been obvious, in the absence of other prior art that suggests the
claimed DNAs.  . . .  There must, however, still be prior art that
suggests the claimed
compound in order for a prima facie case of obviousness to be made out;
as we
have already indicated, that prior art was lacking here with respect to
claims
5 and 7.  Thus, even if, as the examiner stated, the existence of
general
cloning techniques, coupled with knowledge of a protein’s structure,
might have
provided motivation to prepare a cDNA or made it obvious to prepare a
cDNA,
that does not necessarily make obvious a particular claimed cDNA.
"Obvious
to try" has long been held not to constitute obviousness.  In re O’Farrell,
853 F.2d 894, 903, 7 USPQ2d 1673, 1680-81 (Fed. Cir. 1988).  A general incentive
does not make obvious a particular result, nor does the existence of techniques
by which those efforts can be carried out.  Thus, Maniatis’s teachings, even in
combination with Bohlen, fail to suggest the claimed invention.

The differences in the underlying technological sophistication in the art noted by the Board in Kubin could, under the appropriate circumstances,  render obvious a nucleic acid encoding, for example, a highly-conserved sequence where the art disclosed closely-related species orthologs, the cell or tissue of  origin was reliably known, and specific reagents, such as monoclonal antibodies to the protein, were readily available.  None of these factors are required under the Office’s KSR rationale to permit an Examiner to assert a prima facie case of obviousness against a nucleic acid claim.  Perhaps the Office is merely reflecting the current trend to pass as much of the examination burden as possible onto applicants, and expects that in instances where there are facts contrary to Kubin or the guidelines, applicants will provide sufficient rebuttal evidence to overcome the prima facie case.  This procedural avenue, however, does not address the analytical mistake of equating obviousness of the method of making with the obviousness of the thing made.  And by promulgating a per se rule of obviousness it is the Office, not the Federal Circuit, that runs directly afoul of Supreme Court precedent.

Unless Kubin has filed an appeal with a district court or the Federal Circuit, the only way that this guideline will be overturned will be after it has been improperly applied, appealed, affirmed by the Board, and then sent to the Federal Circuit for review.  Even then, the facts of that case will need to be sufficient for the CAFC to properly consider the issue.  It would be easier, and better for American innovation (in biotechnology, where the U.S. remains a leader) if the Office would be more preoccupied with allowing than rejecting patents.  On recent evidence, at least with regard to nucleic acid claiming, the Patent Office appears more interested in settling scores with the Federal Circuit.

    By Kevin E. Noonan —

The Patent Office has met the enemy, and it is the patent bar.  This has been evident since the original Notice of Proposed Rulemaking with regard to the continuation and claims limitations rules, where the Office blamed the bar for the proliferation of continuation applications and alleged prolixity of claiming.  According to the Office, patent attorneys are routinely guilty of incompetence, malfeasance, or misfeasance in representing their clients before the Office, and many if not all of the current Patent Office administration’s management problems would be solved if the bar would join the Office in a partnership to improve patent pendency and quality (to paraphrase the upbeat portion of Commissioner Doll’s stump speech).  Unfortunately for the bar, "partnering" means just following orders, a definition typical of the current administration’s views.

Just in case the bar hasn’t appreciated the message, the Office sent Harry Moatz (at left), Director of the Office of Enrollment and Discipline (OED), to reinforce the message at a recent Intellectual Property Owners (IPO) meeting in New York.  In only the second slide of his presentation, Mr. Moatz reminds us that the Office has the capacity to discipline registered practitioners who do not "comply with the regulations promulgated under [the Office’s rulemaking authority]."  In particular, this applies to the new rules published on August 21st and going into effect on November 1st.  Specifically, the OED is "considering" attorney conduct with regard to the duty to make a reasonable inquiry and the obligation to avoid submitting papers "for improper purpose or delay."  The Office will be monitoring compliance to detect any violations of these duties, as well as attorney "incompetence or neglect."

Mr. Moatz cited 37 C.F.R. § 10.18(b) as requiring that an attorney fulfill a duty to make an inquiry "reasonable under the circumstances" to avoid submitting papers for an "improper purpose" or delay.  This duty, as understood by the Office, includes an affirmative duty that an attorney read every paper submitted to the Office.  While on its face not an unreasonable requirement, in practice this duty applies to each and every prior art reference submitted in compliance with Rule 56.  Mr. Moatz affirmatively stated that this rule applied to each paper submitted to the Office regardless of its source, and that the paper must be read "in its entirety."  (This raises an interesting dilemma if a foreign patent office cites a reference that is not relevant to U.S. prosecution, such as a reference that is not prior art in the U.S. due to the one-year grace period.  If an attorney submits this reference in an Information Disclosure Statement, is it for an "improper purpose"?)  Moreover, while imposing the requirement that an attorney review a reference for its materiality, the need to perform this analysis does not excuse delay in submitting the reference; this requirement certainly appears to set up a classic Catch-22 situation.

A close reading of the rule indicates that this does not appear to be its purpose:  37 C.F.R. § 10.18(b)(1) states that submitting a paper certifies that any statement made therein does not "cover up" a material fact "by any trick, scheme or device," and 37 C.F.R. § 10.18(b)(2) imposes a duty to make reasonable inquiry that the paper is not filed for any "improper purpose."  The Office is interpreting these requirements to have the same attributes as Rule 11 of the Federal Rules of Civil Procedure, without any apparent justification (and in view of the differences between ex parte prosecution and inter partes litigation, without any logical underpinnings).  The Office clearly intends to apply these rules to require a prefiling inquiry, although the Office concedes that time constraints might demand that an application be filed before completion of the reasonable inquiry, resulting in a duty to file documents or amendments to comply.  Of course, this requirement may be in conflict with the well-established principle that an applicant (or his or her counsel) is under no obligation to perform a prefiling search (which could qualify as a "reasonable inquiry").

Mr. Moatz provided a number of examples of conduct that might run afoul of the Office’s ethical rules.  These include:

• filing a reference material to patentability "buried among a large number of cumulative references, where the buried reference anticipates one or more claims;" under these circumstances there cannot have been a "reasonable inquiry";
• filing an application with claims that are anticipated by at least one publication authored by one of the inventors;
• adding an "undue" number of claims with multiple dependent claims (where the fact that multiple dependencies can involve "thousands of claims" appears to be sufficient to establish that there could have been no reasonable inquiry); and
• filing a paper without the required fee, due to insufficient funds or stopped payment.

There are certainly ways in which the Office could apply these rules reasonably to stem actual abuses; however, the timing of this message from the Office does not suggest that reasonableness will be the watchword.

Mr. Moatz’s presentation also contained a discussion of inequitable conduct.  Again, the presentation emphasized an attorney’s continuing duty to make a reasonable inquiry.  The presentation cited Brasseler, U.S.A. LLP v. Styker Sales Corp., 267 F.3d 1370 (Fed. Cir. 2001) in this regard, a case where the CAFC characterized attorney conduct as constituting a "studied refusal to timely investigate" and failure to disclose material information.  This requirement is illustrated by the following scenario:

• A first practitioner advises applicant that prior art is material to patentability of the claimed invention and must be disclosed to the USPTO.
• The applicant refuses to follow this course of action and discharges the first practitioner.
• The applicant engages a second practitioner without telling the second practitioner of the potentially damaging prior art.
• Under § 10.85(b), the first practitioner would be required to disclose this situation to the Office.

(see Practice Before the Patent and Trademark Office, Final Rule 50, FR 5158, 5165 (Feb 8, 1985)).  While not unreasonable on its face, this example raises questions about the extent to which the first practitioner "knows" the applicant has filed the application without disclosing the "potentially damaging" prior art.  Is mere publication of an application enough, or does the rule require actual knowledge?  Does the duty of reasonable inquiry apply in this instance as well, where the first practitioner does not represent the applicant and is not involved in (and may have no reason to know about) filing or prosecution of the improper filing by the second practitioner?  The presentation does not make this clear, and application of the rule is thus fraught with undefined interpretations of the meaning of the "reasonable inquiry" requirement.

There is a perverse beauty to Mr. Moatz’s message.  The Office is not proposing any new rules; indeed, Mr. Moatz reminded his listeners that these rules were promulgated in 1997.  This warning from the Office merely threatens to apply the existing rules of conduct to force compliance inter alia with the new procedural rules.  The possibility exists that these rules of conduct will be applied fairly and that discipline will be applied only to those practitioners who affirmatively break the Office’s ethical rules or practice fraudulently in violation of their duties.  However, the timing and emphasis of Mr. Moatz’s presentation suggests otherwise.  Under these circumstances, the only thing that is certain is that the members of the patent bar have been warned.

For additional information regarding specific provisions of the New Rules, please see:

• "USPTO Issues Notice to ‘Clarify’ Certain Provisions of the New Rules," October 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(a)(2): Divisional Dilemma?" October 9, 2007
• "An
  Analysis of the New Rules: 37 C.F.R. § 1.142(c): Increasing the Chances
  of Submitting a Successful Suggested Restriction Requirement (SRR)," October 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.145: "Provoking a Restriction Requirement," October 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1)(i) & (vi): PCT Practice," September 23, 2007
• "An Analysis of the New Rules: USPTO Releases ESD Guidelines," September 17, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document," September 13, 2007
• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "USPTO News Briefs," October 18, 2007
• "PTO ‘Flagging’ Pending Applications that Exceed 5/25 Claim Limits," October 17, 2007
• "Hooray! – (Finally) the Big Dogs Have Joined the Hunt," October 11, 2007
• "Changes to New Rules to Be Published in Early November," October 11, 2007
• "‘Impact’ of New Continuation and Claims Rules," October 8, 2007
• "Is the Patent Office Starting to Blink," October 5, 2007
• "Breaking A Very Long Silence," October 1, 2007
• "It Ain’t Necessarily So," September 28, 2007
• "Commissioner Doll Addresses ACI Biotech Patents Conference," September 26, 2007
• "Rules Challenger Amends Complaint and Withdraws PI Motion," September 11, 2007
• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part II," August 24, 2007
• "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

    By Donald Zuhn —

The U.S. Patent and Trademark Office has added four new forms to its Claims and Continuations Practice webpage.  The new form likely to get the most use is PTO/SB/206, which can be used to identify commonly owned applications and patents pursuant to Rule 78(f)(1) and provide a rebuttal or terminal disclaimer/ explanation pursuant to Rule 78(f)(2) (see "An Aanlysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents").  Also provided is PTO/SB/201, which can be used to request streamlined docketing (see "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1) and 1.114: Streamlined Examination").  Two new forms which practitioners may find to be less useful are PTO/SB/211, for submitting a list of references in an Examination Support Document (ESD), and PTO/SB/216, which is a transmittal for submitting an ESD (see "An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document" and "USPTO Releases ESD Guidelines").

On Monday, the Patent Office announced that the latest version of the Manual of Patent Examining Procedure (M.P.E.P.) — 8th Edition, Revision 6 — is now available.  The parts of the latest version of the M.P.E.P. that have been updated are the Blue Pages (a complete list of changes to the latest version of the M.P.E.P.); the Title Page; Chapter 700 (Examination of Applications), Chapter 1800 (Patent Cooperation Treaty), and Chapter 2100 (Patentability); Appendix II (List of Decisions Cited), Appendix L (Patent Laws; Title 35), Appendix R (Patent Rules; 37 C.F.R.), Appendix T (Patent Cooperation Treaty), and Appendix AI (Administrative Instructions Under the PCT); and the Index.  None of the changes to the latest version of the M.P.E.P. concern the new continuation and claims rules.  Of particular interest to Patent Docs readers is the fact that, according to the Blue Pages, M.P.E.P. § 710.06 has only been changed to delete reference to a 1924 Commissioner’s Decision.  Thus, it appears that this section can still be used by applicants, as reported here previously (see "Procuring Patent Protection from the Present PTO" and "More on M.P.E.P. § 710.06"), to seek correction of errors in an Office action.

Finally, last Thursday, the Patent Office published corrections to its April 2007 Revision of Patent Cooperation Treaty Procedures notice, as previously reported here.