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
Election Restrictions
1. Applicant’s election without traverse of Group I and species (A) in claim 1; A) in claim 3; SEQ ID NO: 3; A) in claim 4; SEQ ID NO: 4) in the reply filed on 1/9/2026 is acknowledged.
Claims 7, 8, 10, 15, 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/9/2026.
Claims 1-6, 11 are under consideration. As newly added claims 22, 23, 25, 26 depend on linking claims 9, 12-14 and are not considered to read upon isolated polynucleotide as elected (Group I), rather proteins or peptide encoded by polynucleotide, claims 22, 23, 25, 26 are also considered withdrawn as being directed to non-elected Invention.
Thus, claims 1-6, 9, 11-14, 17-21, 24 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
3. The information disclosure statement (IDS) were submitted on 9/26/2025; 3/27/2025; 2/28/2025; 12/29/2022. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
4. The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on p. 43. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
5. Claim 1 is objected to because of the following informalities:
As to claim 1, for improved language, the claim should recite “positions” as opposed to “position”.
Appropriate correction is required.
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.
6. Claims 1-4, 9, 11, 12, 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 1-4, 9, 11, 12, 24 as submitted 1/9/2016.
In view of the 2019 PEG (“The 2019 Revised Patent Subject Matter Eligibility Guidance” (2019 PEG) found at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf ), based upon an analysis with respect to the claims as a whole, claims 1-4, 9, 11, 12, 24 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The claims are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more (these claims are interpreted in light of the most recent Guidelines (See “Subject Matter Eligibility” found at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility ; as well as Subject Matter Eligibility Examples: Life Sciences at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf )
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ), the claims are directed to an ineligible product as further detailed below.
In this case, claims 1-4, 9, 11, 12 recite, read on, or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, nucleic acid or polynucleotide) that is directed to a judicial exception (in this case, a natural phenomenon)(Step 2A).
Claim 1 recites an isolated polynucleotide encoding an adenovirus hexon protein comprising: A) (i) a HVR1 comprising an amino acid sequence according to position 136 to 168 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations, (ii) a HVR2 comprising an amino acid sequence according to position 187 to 201 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations, (iii) a HVR3 comprising an amino acid sequence according to position 219 to 225 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations, (iv) a HVR4 comprising an amino acid sequence according to position 257 to 268 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations, (v) a HVR5 comprising an amino acid sequence according to position 276 to 290 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations, (vi) a HVR6 comprising an amino acid sequence according to position 314 to 322 Y of SEQ ID NO: 2, or a variant thereof comprising up to two mutations, and (vii) a HVR7 comprising an amino acid sequence according to position 431 to 456 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations (elected species).
The specification teaches that SEQ ID NO: 2 is considered to correlate with hexon of genome GrAd32; SEQ ID NO: 3 correlates with fiber; SEQ ID NO: 4 correlates with penton (p. 10 of instant specification)(as recited in claims 1-4). It is noted the instant specification teaches pGrAd32 and wherein vectors are derived from wild type adenovirus strains isolated from stool samples obtained from healthy gorilla (p. 51). Further, Wevers et al. (“Novel adenoviruses in wild primates: a high level of genetic diversity and evidence of zoonotic transmissions,” Journal of Virology, Vol. 85, No. 20: 10774-10784 (2011))(See PTO-892: Notice of References Cited) also teaches: sequence from position 96-128 (no more than two mutations) that has 95.8% identity with HVR1 as recited in claim 1 A)(i) (See Result 1 of STIC Sequence Search Result 20260203_115130_us-18-003-858b-2_copy_136_138.align450.rup in Supplemental Content Tab). Claim 9 (ii) reads on naturally occurring adenovirus; claims 11, 12 read on polynucleotide.
Thus, the claimed product of polynucleotide (as recited in claims 1-4) is not markedly different from its naturally occurring counterpart (See Nature-Based Products, Example 4 (“Purified Proteins”) at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf ; see also Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Claims 1-4, 9, 11, 12 read on naturally occurring polynucleotide and does not show a difference in characteristics between the claimed polynucleotide and naturally occurring genomic polynucleotide. Thus the claims also read upon naturally occurring polynucleotide, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Thus the claimed product of polynucleotide is not markedly different from its naturally occurring counterpart (see Part I. A.3 of the Interim Eligibility Guidance, Example 2, p. 29). Thus the claims also read upon naturally occurring polynucleotide, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
The claims thus recite a nature-based product limitation that does not exhibit markedly different characteristics from its naturally occurring counterpart, or is directed to a “product of nature” exception.
Further as to Step 2A in view of the 2019 PEG, in view of Prong 1 of Revised Step 2A, the claims recite a natural phenomenon.
As to Prong 2 of Step 2A, the instant claims do not recite additional elements that integrate the judicial exception (natural phenomenon according to MPEP 2106.04(b)) into a practical application. “Integration into a practical application’ requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html )
Further, in view of Step 2B and the “No” pathway, the claims do not recite additional elements that amount to significantly more than the judicial exception.
As to claim 24 reciting “carrier”, as carrier, reads on, for example, water, there is no indication that mixing these components changes the structure, function, or other properties of the polynucleotide or water (See Subject Matter Eligibility Examples: Life Sciences, 28. Vaccines, Claim 3). Thus the claimed mixture does not display markedly different characteristics compared to the naturally occurring counterparts. Additionally, as solution is considered an additional element to the polynucleotide, mixing the polynucleotide with water does not markedly change the characteristics of either component, because each component is considered to have the same properties in the mixture as it had alone. In addition, using a solution carrier is well-understood, routine and convention when recited at this high level of generality and does not meaningfully limit that claim. Thus, the claim as a whole does not amount to significantly more than each component by itself.
Therefore, claims 1-4, 9, 11, 12, 24 do not recite eligible subject matter under 35 U.S.C.101 in view of the Subject Matter Eligibility Test for Products and Processes, and the claimed invention is directed to non-statutory subject matter.
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.
7. Claims 1-6, 9, 11-14, 17-21, 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.
See claims 1-6, 9, 11-14, 17-21, 24 as submitted 1/9/2026.
As to claim 1, claim 1 (vi) recites “322 Y”. It is not clear what such a recitation means within the context of the claim, as the other positions do not recite a letter.
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.
8. Claims 14, 17, 18 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.
See claims 14, 17, 18 as submitted 1/9/2026.
Each of the claims is drawn, inherently or explicitly, to method of treating or preventing disease by administering isolated polynucleotide encoding adenovirus hexon protein comprising HVRs 1-7 and variants thereof, including treating or preventing disease, infectious diseases, cancer, coronavirus disease. It is further noted method claim 14 depends on claim 1 which already does not recite a particular antigen or heterologous gene such as spike protein of SARS-CoV-2. Thus, the claims are drawn to methods comprising administering a genus of isolated polynucleotides encoding adenovirus hexon protein comprising HVRs 1-7 and variants thereof, including treating or preventing diseases, infectious disease, cancer, or coronavirus disease, including embodiments (as recited in claim 1) without an apparent coronavirus gene.
The following quotation from section 2163 of the Manual of Patent Examination.
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the application only teaches: using GrAd32 vectors (Example 1); with SARS-CoV-2 spike gene (Example 3).
However, in view of the breadth of the claims, the application does not teach a representative sample of methods of using isolated polynucleotides and variants thereof as claimed for therapeutic effect or treating disease or cancer or coronavirus disease or the breadth of infectious diseases as claimed. Further, there is no apparent common structure to the different claimed polynucleotides and variants thereof that distinguishes those that have therapeutic effect for disease or cancer or coronavirus disease or the breadth of infectious diseases from those that do not. There is therefore a high level of uncertainty as to which isolated polynucleotides encoding adenovirus hexon protein comprising HVRs 1-7 and variants thereof fall within the scope of the indicated genus.
In view of the fact that the examples provided do not demonstrate possession of the methods of treating disease or cancer or coronavirus disease or the breadth of infectious diseases using isolated polynucleotides encoding adenovirus hexon protein comprising HVRs 1-7 and variants thereof, including without coronavirus gene, and that the application has identified no structure correlating with said polynucleotides and variants thereof, there is insufficient written description support for the indicated methods and genus of isolated polynucleotides encoding adenovirus hexon protein comprising HVRs 1-7 and variants thereof, and therefore for the methods of using them.
In the present case, applicant has identified polynucleotides useful in the claimed methods only by function: the ability to treat disease or cancer or coronavirus disease or the breadth of infectious diseases.
However, while the application identifies spike proteins for coronavirus disease and for use with GrAD vector, it does not identify a representative sample of diseases. Further, as noted, claim 1 on which the method claims 14, 17, 18 depend does not even recite spike protein or coronavirus gene. Thus, the application does not identify species clearly within the claimed genus.
Nor does the application provide a specific structure of the isolated polynucleotides within the genus that correlates with the required function. Because there is no identification of structures common to each polynucleotide, nor sufficient representative examples by which such a structure may be determined, the application also fails to provide sufficient written description support for the identified genus of polynucleotides and variants thereof through identification of a structure and function. While all of the isolated polynucleotides are required to have a HVRs 1-7 or variants thereof, this is not alone sufficient structure to correlate with the function.
For the reasons above, and in view of the uncertainty as to which polynucleotides or variants thereof would be able to have therapeutic effect against disease or cancer or coronavirus disease or the breadth of infectious diseases, the application has not provided sufficient written description support for the methods identified in claims, 14, 17, 18.
Conclusion
9. HVR7 comprising an amino acid sequence according to position 431 to 456 of SEQ ID NO: 2, or a variant thereof comprising up to two mutations (as recited in claim 1 A)(vii)) is free of the prior art of record.
10. No claims are allowed.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672