By Kevin E. Noonan —

As Patent Docs
reported on Wednesday, Patent Commissioner John Doll (at right) was the luncheon speaker at
the American Conference Institute’s Biotech Patents conference in Boston.  During the question-and-answer session, the Commissioner
was asked about information one participant had received from a Patent Office
official regarding divisional application practice.  Specifically, the question was about the
effect of filing a Chapter II Demand and receiving an International Preliminary
Examination in a PCT application claiming priority to a provisional application
that had also been converted to a U.S. non-provisional application.  In the scenario, the U.S. Examiner imposes a
restriction requirement in the non-provisional application, and the question
was whether the applicant had a right to file a divisional application on the
non-elected
claims.  The Patent Office
official had told the questioner that the Office would consider a divisional to
be precluded for any claims examined during the International phase, since the
new rules limited divisional application claims to claims that had not been
previously examined.  According to the
official, the International Preliminary Examination would qualify as a
"previous examination," and the divisional filing would be improper.

Commissioner
Doll stated at lunch that it was not the Office’s intention that an International
Preliminary Examination would preclude an applicant from filing divisional
applications in response to a U.S. Examiner-imposed restriction requirement in
a national phase application.  He also
promised to "get back to us" on the proper interpretation of the
rule.

It seems
that overnight Commissioner Doll either had a change of heart or was informed
that he was misinformed.  To clarify, if
a PCT application undergoes International Preliminary Examination, the Patent
Office will count that as a "previously-examined claim" and preclude
an applicant from filing a divisional application on any such claim in response
to a restriction requirement.  This
interpretation can be found in Frequently Asked Qustions (FAQ) Nos. C8 and C11
on the Patent Office website:

C8.  If applicant filed an initial application which is an
international application designating the U.S. and the international
application contains two inventions, can applicant file one continuation
application and submit a suggested restriction requirement (SRR) in the
continuation application rather than file two continuation applications?  Will
the Office count the withdrawn claims in determining whether the continuation
application exceeds the 5/25 claim threshold?  (Posted on 9/26/07)

Yes, an applicant may file a continuation application and
submit an SRR in the continuation application in lieu of filing two separate
continuation applications.  If the SRR is accepted and the examiner makes a
restriction requirement, applicant may file a divisional application for the
claims to the non-elected invention that has not been examined.  Note that
applicant may not file a divisional application to claim an invention that has
been examined in the international application designating the U.S. upon the
filing of a Demand.

The Office will not count the withdrawn claims in
determining whether an application exceeds the 5/25 claim threshold.  Therefore,
if the elected invention in the continuation application is drawn to 5/25 or
fewer claims, applicant is not required to file an ESD before the FAOM.

C11.  If applicant filed an initial application which is
an international application designating the U.S. and the International
Searching Authority determined that the international application lacks unity
of invention under PCT Rule 13, can the applicant file a divisional application
for the non-elected invention that was not examined in the international
application?  (Posted on 9/26/07)

Yes, applicant may file a divisional application for each
non-elected invention that was not examined in the international application.  However, if applicant filed a Demand and paid the additional examination fees
and all of the inventions were examined in the international application,
applicant may not file a divisional application.  This is because under PCT
Article 31, "examination" in the international phase is contingent
upon the filing of a Demand for international preliminary examination.  The
non-elected invention would be examined within the meaning of 37 CFR
1.78(d)(1)(ii) in the international application designating the U.S.

Thus, it is
now foolhardy to file a Chapter II Demand in any PCT application claiming
priority to the U.S.  In view of the
differences, long touted by the Patent Office and recognized in voluminous case
law, between the standards of an International Preliminary Examination and a
U.S. Patent Office examination, this interpretation exceeds the ironic and
borders on the nonsensical (and probably is contrary to U.S. law), but that
doesn’t seem to be a factor in the Office’s decision-making.

For additional articles in this series, please see:

• "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:

• "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 Kevin E. Noonan —

The American Conference Institute is holding its Biotech Patents conference this week in Boston, and the lunchtime speaker was John Doll, Commissioner for Patents.  Commissioner Doll (at right) is the happy face of the U.S. Patent and Trademark Office:  smiling, self-deprecating, and charming while he espouses the Patent Office mantra that the Office is willing to do everything possible to improve the patenting process in the United States.  And if his audience was skeptical, it was due in part to opposition to the recently-issued final rules for patent continuations and limitations on the number of claims.  Another factor is that Commissioner Doll’s numbers in support of his message don’t add up (like they didn’t in the infamous Town Hall meetings that accompanied the new rules when first proposed).

The Commissioner provided historical and recent evidence on patent "quality," which he explained was determined by reviewing applications allowed by the Examining Corps, and rejecting any application having at least one claim that "should not have been allowed."  The data show that this "allowance error rate" has ranged between 7.5% and 2.75% over the past thirty-two years, and is at about 3.5% for 2006 (the last year for which the statistics are available).  The Commissioner did not explain whether the "errors" calculated in this way were based on art, sufficiency of disclosure (i.e., under 35 U.S.C. § 112) or other sections of the rules or statutes (such as obviousness-type double patenting).  Also not addressed was the converse error rate:  the number of pending applications having at least one patentable claim the Office refuses to allow; he did indicate that this kind of review was done and had a conclusory slide claiming a 90% "in process compliance rate" for this metric (i.e., about 3-fold higher than the allowance error rate; the Office is obviously content when claims that should be allowed are not).  In view of the complexity of the issues that can be presented during patent prosecution, and the amount of time it takes for an examiner to properly understand the invention and its relationship to the art, it is likely that the "error rate" with which the Patent Office "allowance error rate" is determined is both high and the result of cursory and subjective determinations.

Also provided were statistics relating to the patent allowance rate (which the Commissioner explained was determined by dividing the number of allowed patents by the total of allowed patents, abandoned patents, and patents for which there was prepared an Examiner’s Answer on appeal, at which point the application was considered "disposed" to the Board of Patent Appeals and Interferences).  This rate has varied over the same 32-year time period from a high of a little more than 70% to the current low of less than 50%, and the Commissioner predicted that rate could be expected to further decrease in view of the new examination guidelines for applying the Supreme Court’s KSR decision.  (The post-KSR obviousness guidelines are supposed to be published in the Federal Register and posted on the Patent Office website some time in the next two weeks.)  Commissioner Doll overlayed the two graphs to show the error rate and allowance rates tended to trend together; however, the reduction in patent allowance rate cannot be explained by the decrease in the allowance error rate.  And the Commissioner had no explanation for the decrease in allowance rate over the past five years.

The Commissioner repeated the Patent Office statistics that the backlog of unexamined cases is growing and that patent examiner hiring could not overcome the increase.  (The census of the Patent Examining Corps stood at 5,150 examiners at the end of fiscal year 2006; although the hiring goal for FY2007 is 1,200 new examiners, only 127 have been hired to date and the Office has experienced attrition of 430 examiners.)  He also admitted that there are no longer sufficient numbers of supervisory patent examiners or primary examiners to train the new examiners, necessitating the "patent academy approach."  Thus, rather than being the result of a reasoned decision in favor of the academy approach, it appears that examiners are being trained this way out of necessity.  (The Commissioner also admitted that there were several examiners who "should be returned to the private sector" but refused to identify them.)  Pendency in the biotechnology art unit is at about 23 months to first action and 35 months overall.

The Commissioner is appropriately proud of the electronic filing system, which is now used to file more than 60% of the applications filed each week.  He also extolled the virtues of the Accelerated Examination (AE) program (which replaced the Petition to Make Special practice) and the pilot peer review program.  The AE program has been used by only a small number of applicants, in part because the Office set a significant number of hurdles for an application to qualify.  However, the Commissioner reported that one application in Technology Center 2800 issued within 97 days (and was allowed in 18 days).  Examiners in the program are reviewing unpublished applications (since these will qualify as prior art unavailable during the truncated prosecution of the AE program), and in instances where relevant unpublished patents are found, the application is withdrawn from the program and prosecution suspended until the application becomes available.

Regarding the peer review pilot program, which is being run for the Office by New York Law School, 35 applications have volunteered for the program and 18 applications posed on the peer review website (www.peertopatent.org).  Only applications in Technology Center 2100 (Computer Architecture Software and Information Security) are currently eligible for the program, although the Commissioner opined that biotechnology applications were a likely candidate for expanding the program once it has been evaluated after a one-year pilot period.  Commissioner Doll explained that the program would send an examiner up to ten prior art references submitted in the program, including any comments or annotations submitted with the art.  (It is ironic that the Office has typically given scant notice to determinations of prior art relevance from foreign patent offices, as evidenced for example in an International Search Report received in PCT applications, and is now providing examiners with the comments submitted by the public with these references.  As mentioned by the luncheon audience, the likelihood that a competitor will try to manipulate the system against an applicant is high, and the Office appears to be uninterested in the consequences of this possibility.)

The Commissioner "had a plane to catch" and so was unavailable to discuss the new continuation and claims rules.  However, he did acknowledge that some Patent Office personnel were providing incorrect information in response to inquiries; for example, he said it was not the Office’s intention that an International Preliminary Examination would preclude an applicant from filing divisional applications in response to a U.S. Examiner-imposed restriction requirement in a national phase application, but that the rules seemed to so indicate and some Office personnel were misinterpreting the rules in this way.

The continuing message was patent quality, but with a hint (as has been the case throughout) that the blame for any lack of quality lies with applicants and their attorneys.  He sweetened this message by inviting everyone (applicants, attorneys, and the public) to participate in the Patent Public Advisory Committee Outreach program which will occur over the next several months (although the Office’s performance in the continuation/claims rules does not inspire confidence).

Finally, Commissioner Doll invited anyone who has the experience that an examiner is not applying the rules properly, or is "churning" an application by reiterating rejections or not explaining why an applicant’s response is insufficient, or by citing additional art and/or rejections after an applicant has addressed and overcome previously-asserted grounds of rejection, should contact him directly so he can apply what he called some "one-on-one" training.  Although perhaps sincere, it is also naïve to think that an applicant would avail themselves of this opportunity, since it is almost certain to eliminate the possibility that the examiner would ever deign to allow an application submitted for examination by that applicant.  And the hollowness of the offer did little to dispel the impression that Commissioner Doll’s road show is intended more for appearance than substance and is largely irrelevant to the task of understanding the consequences of the violent changes his administration is making to the patent application process.

    By Christopher P. Singer —

As previously reported on Patent Docs, the biotechnology and chemical pharmaceuticals technology groups at the U.S. Patent Office held their most recent quarterly customer partnership meeting on September 12, 2007.  While we were unable to attend the webcast on the day of the meeting, we will summarize a couple of the presentations (available at http://www.cabic.com/bcp) based on the archived slideshows.

One presentation focused on restriction requirement practice as applied to inventions claiming nucleic acid molecules.  Julie E. Burke, QAS/PM, from Technology Center 1600 presented the slideshow (available here), which provided some background on how restriction practice relating to nucleic acids has evolved, basic restriction guidelines and tests for distinctness of invention/species and examples of proper restriction practice in seven common types of claims relating to nucleic acid technology, and in which of those types of claims Applicants will be restricted to a single sequence in an application.  These seven examples include inventions where: (1) different sequence identifiers (SEQ ID NOs) describe a single invention; (2) when sequences fully overlap; (3) practice for a combination claim; (4) distinct nucleic acid molecules; (5) a single sequence identifier may encompass two or more species; (6) a claim that depends upon, but does not link plural distinct inventions; and (7) a dependent claim that cannot be restricted from its independent and intervening claim(s).

1st Example:

1.  An isolated nucleic acid comprising SEQ ID NO: 1.
2.  An isolated nucleic acid encoding a protein having SEQ ID NO: 2.

— The specification discloses a nucleic acid comprising SEQ ID NO: 1 which contains the open reading frame for a protein having SEQ ID NO: 2.
— Claims 1 and 2 are not distinct from each other because the claims merely define the nucleic acid using different limitations.

Restriction between Claims 1 and 2 is NOT APPROPRIATE.

2nd Example:

1.  An isolated nucleic acid molecule comprising SEQ ID NO: 1.
2.  An isolated nucleic acid molecule comprising SEQ ID NO: 2.
3.  An isolated nucleic acid molecule comprising SEQ ID NO: 3.

— The term "comprising" permits additional nucleic acids at either end of the sequence.
— The sequence listing shows that SEQ ID NOs: 1, 2, and 3 fully overlap with each other.
— Assume that the sequences are:

SEQ ID NO: 1 = ATGTGCGATA
SEQ ID NO: 2 = ATGTGCGATA ATCTG
SEQ ID NO: 3 = ATGTGCGATA ATCTGTTATA

— The nucleic acid molecules comprising SEQ ID NO: 1, 2, and 3 are not distinct from each other, as claimed.
— As a practice tip, the PTO suggests using this claim format to refer to a single sequence in order to highlight the common region and avoid improper restriction:

1.  An isolated nucleic acid molecule comprising residues 1-10 of SEQ ID NO: 3.
2.  An isolated nucleic acid molecule comprising residues 1-15 of SEQ ID NO: 3.
3.  An isolated nucleic acid molecule comprising SEQ ID NO: 3.

Restriction to a single sequence of SEQ ID NOs: 1, 2, and 3 is NOT APPROPRIATE.

3rd Example:

1.  A kit comprising primers having SEQ ID NO: 1-100.

— The presence of one novel and nonobvious sequence within the combination will render the entire combination allowable.
— The combination will be searched until one nucleotide sequence is found to be allowable.
— The order of searching will be chosen by the examiner to maximize the identification of an allowable sequence.
— If no individual nucleotide sequence is found to be allowable, the examiner will consider whether the combination of sequences taken as a whole renders the claim allowable.

In general restriction of a combination of nucleotide molecules is NOT APPROPRIATE.

4th Example:

1.  An isolated nucleic acid comprising SEQ ID NO: 1.
2.  An isolated nucleic acid comprising SEQ ID NO: 2.

— The specification teaches that SEQ ID NO: 1 encodes a ribosomal protein and SEQ ID NO: 2 encodes an enzyme.
— Thus, claims 1 and 2 are distinct from each other because the mutually exclusive characteristic of SEQ ID NO: 1 is not encompassed by claim 2, and the mutually exclusive characteristic of SEQ ID NO: 2 is not encompassed by claim 1.
— Examination of Claim 1 and 2 would be burdensome because (a) each sequence requires a different search query, and (b) prior art for one sequence is not likely to teach the other sequence.

Restriction between the nucleic acid molecules comprising SEQ ID NO: 1 and SEQ ID NO: 2 is APPROPRIATE.

5th Example:

1.  An isolated nucleic acid consisting of SEQ ID NO: 1.

— Claim 1 refers to a single sequence identifier and uses closed transitional language "consisting of."
— The phrase "consisting of" followed by a single sequence identifier generally limits a claim to a single fully defined nucleic acid molecule.
— The sequence listing shows that SEQ ID NO: 1 is ATGSTAMATR, where S is G or C, M is A or C, and R is G or A.
— Therefore SEQ ID NO: 1 actually encompasses eight patentably distinct sequences:

ATGGTAAATG
ATGGTAAATA
ATGCTAAATG
ATGCTAAATA
ATGGTACATG
ATGGTACATA
ATGCTACATG
ATGCTACATA

Restriction in this situation can include an election of species because generic claim 1 reads upon all eight disclosed species.

6th Example:

1.  An isolated nucleic acid having SEQ ID NO: 1.
2.  An isolated nucleic acid having SEQ ID NO: 2.
3.  A vector comprising the nucleic acid of claim 1 or claim 2.
4.  A host cell comprising the vector of claim 3.

— SEQ ID NO: 1 and SEQ ID NO: 2 are distinct from each other as in the 4th Example (ribosomal protein and enzyme, respectively).
— A linking claim must be broader in scope than the linked claims.  Thus, claims 3 and 4 are NOT linking claims because claims 3 and 4 are narrower in scope that claims 1 and 2.
— The claims may be grouped as follows:

• Group I:  claim 1 and claims 3 and 4, in part, drawn to nucleic acid, vector, and host cell having SEQ ID NO: 1.
• Group II:  claim 2 and claims 3 and 4, in part, drawn to nucleic acid, vector and host cell having SEQ ID NO: 2.

Restriction between the two Groups is APPROPRIATE.

7th Example:

1.  An isolated nucleic acid comprising SEQ ID NO: 1.
2.  An isolated nucleic acid of claim 1, further comprising SEQ ID NO: 2 added to the 3′ end.
3.  An isolated nucleic acid of claim 2, further comprising SEQ ID NO: 3 added to the 3′ end.

— Alignment of the sequences shows that SEQ ID NOs: 1, 2, and 3 are distinct from each other:

SEQ ID NO: 1 = ATGTGCGATA
SEQ ID NO: 2 = TGGTACATGC
SEQ ID NO: 3 = ATTTAGCTATT

— Claims 1, 2, and 3 are not distinct from each other, because the claims could be alternatively presented as:

1.  A nucleic acid comprising ATGTGCGATA.
2.  A nucleic acid comprising ATGTGCGATA TGGTACATGC.
3.  A nucleic acid comprising ATGTGCGATA TGGTACATGC ATTTAGCTATT.

— A dependent claim must incorporate all the limitations of the independent and any intervening claims.

Restriction between the nucleic acids of claims 1, 2, and 3 is NOT APPROPRIATE.

Conclusion:

While many of the issues and questions surrounding restriction practice under the New Rules regarding Claims and Continuing Application Practice will not be answered or come to light until after November 1, 2007, this presentation at least provides some guidance to Applicants with inventions that relate to nucleic acid molecules.  This guidance allows for some degree of prospective planning in application and claim drafting strategies.