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 .
DETAILED ACTION
1. Claims 1-23, 25, 26 are amended. New claim 27 has been added. Claims 7, 8, 10, 15, 16, 22, 23, 25, 26 are withdrawn. Claims 1-6, 9, 11-14, 17-21, 24, 27 are under consideration.
Specification
2. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: the specification has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Objections
3. (previous objection, withdrawn) Claim 1 was objected to because of informalities. Applicant contends: the claim has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. (previous rejection, withdrawn as to claims 9, 12, 24; maintained as to claims 1-4, 11) Claims 1-4, 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 1-4, 11 as submitted 6/8/2026.
Applicant contends: claims 1-4, 9, 11, 12, 24 have been amended; the products as claimed cannot be found in nature; recombinant adenovirus has been defined as comprising heterologous polynucleotide and/or polypeptide sequence (p. 47); sequences as claimed and those in Wevers et al. differ; the products as claimed do not refer to a natural phenomenon and cannot be found in nature.
Upon further consideration, the rejection is withdrawn as to claims 12, 24 reciting inclusion of adjuvant. In view of applicant’s amendments and arguments, the rejection is withdrawn as to claim 9 reciting recombinant adenovirus according to applicant’s specification definition, but maintained as to claims 1-4, 11.
See the rejection as recited in the previous Office Action.
With respect to applicant’s amendments to claims 1-4 reciting “recombinant”, such language is not considered to distinguish the instantly claimed polynucleotides from naturally occurring genomic polynucleotides encoding the hexon, fiber and penton proteins, as absent further distinguishing claim language, such nucleotides are recite or read on the same nucleotide sequences (See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
Response to Arguments
Turning to applicant’s arguments, it noted the rejection is in view of the instant claims, and it is maintained that the instantly claimed polynucleotides are still considered to read upon naturally occurring products, or naturally occurring genomic nucleotide sequences encoding hexon protein, fiber protein, and penton protein as recited in claims 1-4, 11. As indicated above, whether the nucleotide sequences were recombinantly produced or merely isolated, the nucleotide sequences derived from genomic sequences still recite the nucleotide sequences encoding hexon protein, fiber protein, and penton protein (as instantly claimed, of GRAd32)(See MPEP 2113: I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
While the differences applicant points to with respect to Wevers et al. (previously cited) are noted and acknowledged, absent further distinguishing language, the instant claims still read upon genomic nucleotide sequences (as instantly claimed, of GRAd32) encoding hexon protein, fiber protein, and penton protein which were isolated from wild type adenovirus strains. It is noted that the specification teaches wherein: SEQ ID NO: 2 recites polynucleotide 18988..21870 of SEQ ID NO: 1 (genome of GRAd32) encoding hexon of GRAd32, SEQ ID NO: 3 recites 32338..33976 of SEQ ID NO: 1 (genome of GRAd32), SEQ ID NO: 4 recites 14025..15977 of SEQ ID NO: 1 (genome of GRAd32)(Table 1); wherein pGRAd32 vectors are derived from wild type Adenovirus strains isolated from stool samples obtained from healthy gorilla using standard procedures (Example 1); adenoviruses were purified (p. 51); genomes were extracted, and purified adenovirus DNA were cloned in a vector, further modified by deletions (outside of SEQ ID NO: 2 reciting polynucleotide 18988..21870 of SEQ ID NO: 1, 32338..33976 of SEQ ID NO: 1, and 14025..15977 of SEQ ID NO: 1). Further, the sequences as claimed together (claims 1-4) still read upon larger genomic sequence such as SEQ ID NO: 1; further vector comprising such sequences as recited in claim 11 still reads upon larger genomic sequence such as SEQ ID NO: 1 (GRAd32). Thus, as claimed, claims 1-4, 11 do not appear to recite additional structural features considered to further structurally distinguish genomic nucleotide sequences and read upon non-naturally occurring products.
Further it is noted that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejection is maintained for reasons of record.
Claim Rejections - 35 USC § 112
5. (previous rejection, withdrawn) Claims 1-6, 9, 11-14, 17-21, 24 were 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.
Applicant contends: claim 1 has been amended.
In view of applicant’s amendments, the rejection is withdrawn.
6. (previous rejection, withdrawn) Claims 14, 17, 18 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Applicant contends: claims 14, 17, 18 have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Conclusion
7. The elected species (species (A) in claim 1; A) in claim 3; SEQ ID NO: 3; A) in claim 4; SEQ ID NO: 4) are free of the prior art of record.
8. Claims 5, 6, 9, 12-14, 17-21, 24, 27 are objected to for depending on rejected claims.
9. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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