DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
In the response, dated 3/2/2026, the Applicant has provided claim and specification amendments, and arguments directed to the previous rejections of the claims. The amendments to the claims and specification has allowed for a withdrawal of the objection to the specification and the claims.
On pages 9 and 10 of the Applicant’s Arguments, the Applicant states why the claimed cell does not need to be deposited. The Applicant has provided a reasonable rationale as to why the cell does not need to be deposited, and the 35 USC 112(a) rejection of claims 1, 3-7, 9, 10, 12, 13, 15-18, and 21-24 is withdrawn.
On pages 10 and 11 of the Applicant’s Arguments, the Applicant contends that they have possession of the claimed recombinant sequences. First, the claims were not rejected under 35 USC 112(a) Written Description, but rather 35 USC 112(b); however, based upon the Applicant’s Arguments, it has become unclear whether the Applicant was in fact in possession of a reasonable number of sequences to suggest possession of the whole genus, since the claimed genus would necessarily include sequences that the Applicant never invented nor envisioned. Although this rejection will not be made in this office action, the provided arguments lead the Examiner to believe that there should certainly be a question regarding possession of the whole genus. It should be noted that the most recent 35 USC 112(a) Written Description guidance describes that defining polypeptides based upon their function, and not their sequence, can provide for written description issues. This is especially true when considering the 35 USC 112(a) Written Description examples provided on the USPTO website. Furthermore, by defining the inserted nucleic acids as “recombinant,” it can reasonably be assumed that this includes unnatural sequences that the Applicant neither possessed nor envisioned.
Since the claims were rejected under 35 USC 112(b), the Applicant is directed to MPEP 2422.02. By defining a “recombinant sequence,” the claim is suggesting that the sequence can include non-natural elements which would not be clear or definite to the artisan. By describing a “recombinant [gene]” that provides for a particular activity, there should be some recitation as to the identity of the gene. If the genes are limited to naturally occurring genes, wherein their recombinant insertion into S. cerevisiae is considered routine, this should be clearly claimed and the rejection would be withdrawn; however, if the Applicant is trying to further claim unnatural sequences that they neither envisioned nor invented, they should not be entitled to these cells. By claiming “one or more recombinant nucleic acids encoding a polypeptide having a heparosan synthase activity,” the Applicant is literally claiming every single nucleic acid that codes for anything that even has the smallest amount of heparosan synthase activity, as well as patented genes that provide for unexpectedly better heparosan synthase activity, compared to naturally occurring variants.
The Applicant has canceled claims 25-29, and as such, these rejections are considered moot.
The arguments and amendments have provided for a withdrawal of the objections to the claims and specification. Additionally, the 35 USC 101 and 102(a)(1) rejections of claims 24-29 are withdrawn, as these claims have been canceled. The 35 USC 112(b) rejections are maintained, since claims drawn to recombinant sequences should include sequence identifiers. Or, if the claims are drawn to only natural nucleic acid sequences that are conventionally available to the public-at-large, this should be more clearly claimed. No claim is allowed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-7, 9, 10, 12, 13, 17, 18, and 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 provides for “recombinant nucleic acids.” The term “recombinant” is generally used for sequences that are not naturally occurring. Since this is the case, it is unclear what recombinant sequences must be used to accomplish the claimed limitation. It is unclear if the Applicant is in possession of a particular sequence, or if any recombinant sequence would provide for the claimed limitation. Without providing the sequence in a SEQ ID No., it is unclear what recombinant sequence the Applicant is trying to limit the claims to. If the Applicant has created sequences, these should be clearly claimed with a SEQ ID No. If the Applicant creates a recombinant organism using naturally occurring nucleic acid sequences, this should be more clearly claimed, since, depending on how the claims are written, a naturally occurring sequences might not require the inclusion of a SEQ ID No.
Claims 3-7, 9, 10, 12, 13, 15-18, and 21-24 are indefinite insofar as they claim dependence on claim 1, and do not cure the above-described deficiency.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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