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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-9, in the reply filed on December 9, 2025 is acknowledged. The traversal is on the ground(s) that there would be no burden to consider all of the pending claims.
Applicant’s traversal has been fully considered, but is found unpersuasive because lack of search burden is only a criterion to consider under US restriction practice, see MPEP § 803. The instant application is a national stage of an international application filed under 35 U.S.C. 371 and is subject to unity of invention practice under 37 CFR 1.499, see the MPEP § 1893.03(d). The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13 and 19-25 are pending; claims 10-13 and 19-25 are withdrawn due to non-elected subject matter; and claims 1-9 are under consideration.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 1/20/2023 and 8/21/2023 have been considered by the examiner.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, i.e., Chinese application No. 2020106427453 filed on July 06, 2020 and Chinese application No. 202010945335.6 and filed on July 06, 2020, recited in the first paragraph of the instant specification, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The use of the term “GenBank” in paragraph [0026] in the instant published application (USPgPub 2025/0066740), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant' s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Applicant is required to properly annotate all trade names and/or marks present in the instant specification, if any additional trade names and/or marks are discovered.
The disclosure is objected to because the deposit information required is not in accordance with the requirements set forth in 37 CFR 1.809(d):
Acknowledgement is made with regard to the deposit information provided in paragraphs [0024 and 0120] of the instant published application, USPgPub 2025/0066740. However, the deposit information provided is found deficient because 37 CFR 1.809(d) states:
(d) For each deposit made pursuant to these regulations, the specification shall contain:
(1) The accession number for the deposit;
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(2) The date of the deposit;
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(3) A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
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(4) The name and address of the depository.
While (1), (3) and the name of the depository for (4) above have been satisfied, the date of deposit and the address of the depository, also required in (4) have not. In order for the deposit requirements to be satisfied, the address must be provided in the instant disclosure.
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37 CFR 1.809(e) further states:
Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of this section must be filed before or with the payment of the issue fee (see § 1.312).
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[Added, 54 FR 34882, Aug. 22, 1989, effective Jan. 1, 1990; paras. (b) and (c) revised and para. (e) added, 66 FR 21092, Apr. 27, 2001, effective May 29, 2001]
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.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature, without significantly more. Instant claim 1 recites a chimpanzee adenovirus (ChAd) comprising a hypervariable (HVR) having one or more nucleic acid sequences selected from SEQ ID NOs: 9-14. Instant claim 2 requires that HVR 7-9 has a nucleotide sequence of SEQ ID NO: 15. Instant claim 3 recites that HVR has a nucleotide sequence of at least 50% homology to SEQ ID NO: 7. Instant claim 4 states that the ChAd claimed possesses a conserved region. Claims 5 and 6 require the virus having a preservation number of CCTCC NO: V202120, with a strain of sAd-AY01 and has a nucleotide sequence represented by SEQ ID NO. 1. However, deposits of natural products do not distinguish naturally-occurring products.
Instant Example 1, paragraph [0118] of the instant published disclosure, USPgPub 2025/0066740, teaches that a novel chimpanzee strain was isolated from anal swabs. Example 2, bridging paragraphs [0120], states that the whole genome was sequenced and deposited “in China Typical Culture Collection Center, classified and named as orangutan adenovirus sAd-AY01, and the preservation number was CCTCC NO: V202120.” Paragraph [0122] states: “the chimpanzee adenovirus was a new adenovirus that had not been discovered. The sequence of HVR1-6 of the new chimpanzee adenovirus are…” SEQ ID NOs: 9-14, depicted in Table 1. Paragraphs [0023-0024] teach that the deposited ChAd genome comprises SEQ ID NO 1. The isolated ChAd naturally comprises the requisite conserved regions. Paragraph [0015] states, “[t]he adenovirus of the present invention at the position of HVR7-9 in the hypervariable region is not mutated, as shown in the sequence SEQ ID NO. 15.” Paragraphs [0019 and 0071] discusses the HRV antigen epitope hypermutant region, which comprises nucleic acid sequences having more than 50% homology to instant SEQ ID NO: 7.
There is no evidence in the instant disclosure that the deposited CCTCC NO: V202120, possessing genomic SEQ ID NO: 1 claimed has been recombinantly modified. Therefore, CCTCC NO: V202120, possessing genomic SEQ ID NOs: 1, 7, and 9-15 is naturally occurring. Similar to the fact pattern described in Myriad, the genetic information or genetic structure of the instant ChAd, CCTCC NO: V202120, possessing genomic SEQ ID NO: 1 is not created or altered upon isolation from its native environment. Finding or discovering an important structure does not satisfy the §101 inquiry. Isolation by severing chemical bonds naturally the genome from the remainder of the naturally-occurring virus components does not in itself provide a markedly different characteristic from any ChAd that is named CCTCC NO: V202120, possessing genomic SEQ ID NOs: 1, 7, and 9-15 found in nature since there are no chemical changes resulting from the isolation. Therefore, the instant claims recite a natural phenomenon according to Step 2A in MPEP § 2106.04(II).
The comparison between the material claimed and the ChAd that is named sAd-AY01, deposited as CCTCC NO: V202120, possessing genomic SEQ ID NOs: 1, 7, and 9-15, does not indicate a difference in structure, function, or other characteristics, as evidenced by instant paragraphs [0015, 0019, , 0071, 0118, 0120, and 0122]. Therefore, the claimed ChAd named sAd-AY01, deposited as CCTCC NO: V202120, possessing genomic SEQ ID NOs: 1, 7, and 9-15, are nature exception products. See Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are "products of nature" which cannot be patented). Accordingly, analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two requires eligibility analysis to evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. The instant claims recite no additional element that distinguishes the instantly claimed ChAd, sAd-AY01, possessing genomic SEQ ID NOs: 1, 7, and 9-15 from the naturally-occurring ChAd isolated from anal swabs in Example 1 of the instant published disclosure. The presence of a possible carrier, vehicle, and/or excipient does not change the nature or properties of the naturally-occurring the naturally-occurring ChAd claimed materials. Accordingly, possible additional carrier, vehicle, and/or excipients encompassed by the clams, do not integrate the recited judicial exception into a practical application that is patent eligible pursuant to the Supreme Court decision in Association for Molecular Pathology V. Myriad Genetics, Inc. -U.S.-(June 13, 2013).
(Please note that the ChAd with deletions in conserved regions, recited in instant claims 7-9 (not included in the instant rejection), would be patent-eligible subject matter since the ChAd is recombinantly changed, distinguishing it from the natural product instantly claimed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 4, and 7-9 are 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Instant claims 1 and 3 require a chimpanzee adenovirus (ChAd) comprising at least one hypervariable region (HVR) having at least 50% homology to any nucleotide sequence selected from SEQ ID NOs: 7 and 9-14. Paragraphs [0025-0030] of the instant published application, USPgPub 2025/0066740), discuss and review phylogenic lineage of HRVs of known chimpanzee, monkey, and human serotypes, showing that the range of homology between the different serotypes, with vast difference percent identity depicted in instant Figures 4 and 5.1 and homology ranging between 49-91% in Figure 5.2. The instant disclosure does not possess adequate written description for any and all ChAd comprising at least one hypervariable region (HVR) having at least 50% homology to any nucleotide sequence selected from SEQ ID NOs: 7 and 9-14. The broad structural genus encompassed by the instant claims does not adequately identify the infinite number of ChAd claimed. The skilled artisan would be unable to recognize a ChAd encompassed by the claims.
The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the specification is a ChAd corresponding to genomic sequence SEQ ID NO: 1. There is no disclosure of sufficient characteristics of the claimed genus of ChAd to allow persons of ordinary skill in the art to recognize that applicants were in possession of the claimed genus at the time the invention was filed. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not clearly allow persons of ordinary skill in the art to recognize that the inventors invented what is claimed. As discussed above, the skilled artisan cannot envision the distinguishing, identifying characteristics of the encompassed genus of ChAd viruses claimed. Given that the specification has only described ChAd SEQ ID NO: 1, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
Claims 5 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that the claimed ChAd, that is named sAd-AY01, deposited in the in China Typical Culture Collection Center, classified and named as orangutan adenovirus sAd-AY01, with preservation number: CCTCC NO: V202120, is required to practice the claimed invention since it is a recited limitation. As a required element it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a proper deposit of that the claimed ChAd named sAd-AY01, with preservation number: CCTCC NO: V202120, preserved at the Chinese Collection of Culture Collection. See 37 CFR 1.802.
The specification does not provide a repeatable method for obtaining that the claimed sAd-AY01, with preservation number: CCTCC NO: V202120, preserved at the Chinese Collection of Culture Collection and it is not apparent if it is readily available to the public. Applicant's deposit statement in paragraphs [0024 and 0120] of the specification does not indicate the extent of public availability. MPEP § 2404.01 states that: "A mere reference to a deposit of biological material itself does not necessarily mean that the biological material is readily available." If the deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, and 8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Colloca et al. (USPgPub 2012/0027788).
Colloca et al. anticipate a ChAd comprising HVR’s identical to instant SEQ ID NOs: 7 and 9-14, see the sequence alignments provided, anticipating instant claims 1 and 3. Paragraph [0046] of Colloca et al. anticipate one or more of conserved regions, E1, E2, E3, and E4, are deleted, anticipating instant claims 7 and 8, where conservation of any one remaining, i.e., not deleted, anticipates instant claim 4.
While Colloca et al. do not mention deposit number CCTCC NO: V202120, recited in claim 5, the instant deposit is not perfected since a promise of availability has not been provided as required by MPEP § 2404.01 and 37 CFR § 1.808. The instant material associated with the recited deposit number is therefore, not readily known or ascertainable to one of ordinary skill prior to the instant filing date. Therefore, the ChAd of Colloca et al. is indistinguishable from the instant ChAd claimed under In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Allowable Subject Matter
SEQ ID NO: 4 is free of the prior art.
Claim 9 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671