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 Amendment
The Amendment filed 06/25/2025 in which claims 8, 11-13, 15, 16 and 20 were amended, claims 1-7, 9, 10, 14, 17-19 were canceled, has been entered. Claims 3-7, 10, 15-20 were previously withdrawn.
Claims 8, 11-13 are under examination on the merits.
Priority
Applicant’s claim for domestic benefit of prior-filed provisional application No. 63/105,478 filed on 10/26/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
As previously stated, the disclosure of the prior-filed application, Application No. 63/105,478 filed on 10/26/2020, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 8, 11 and 13. Therefore, claims 8, 11 and 13 do not receive domestic benefit to the provisional application No. 63/105,478 filed on 10/26/2020 because it does not disclose the elected species SEQ ID NO: 37, as recited in amended claims 8, 11-13 submitted on 06/25/2025. For purposes of applying prior art, the filing date for claims 8, 11- 13 is 10/26/2021.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 06/25/2025 after the mailing date of the nonfinal rejection on 02/27/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 06/25/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 02/27/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 06/25/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 02/27/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, withdrawn) Applicant’s amendments to the Specification concerning nucleotide and/or amino acid sequence disclosures submitted on 06/25/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 02/27/2025.
Claim Objections
(Previous objections, withdrawn as to claims 7, 8, 11, 12 and 18). The previous objections to claims 1, 2, 9, and 14 are moot in view of Applicant’s cancelation of those claims. Applicant’s amendments to claims 8, 11-13 have overcome previous objections to those claims.
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.
(Previous rejection, withdrawn as to claims 1, 2, 8, 9, 11-14) Claims 1, 2, 8, 9, 11-14 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.
See claims 1, 2, 8, 9, 11-14 as submitted 06/25/2025.
The previous rejections of claims 1, 2, 9 and 14 are moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to claims 8, 11-13 has overcome previous rejection to claims 8, 11-13.
(New rejection, necessitated by amendment as to claim 13) Claim 13 is 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 13 recites "said peptide”. There is insufficient antecedent basis for this recitation in the claim because claim 8 refers to “an immunogenic peptide”. It is unclear if the recitation of “said peptide” in claim 13 refers to the immunogenic peptide of claim 8 or an additional peptide. The claim language lacks consistency. Therefore, the claim is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(Previous rejection, withdrawn as to claims 2, 9, 12 and 14) Claims 2, 9, 12 and 14 were rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1.
See claims 2, 9, 12 and 14 as submitted 06/25/2025.
The previous rejections of claims 2, 9, and 14 are moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to claim 12 has overcome previous rejection to claim 12.
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.
(Previous rejection, withdrawn as to claims 1, 2, 8, 9, 11-14) Claims 1, 2, 8, 9, 11-14 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. 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 1, 2, 8, 9, 11-14 as submitted 06/25/2025.
The previous rejections of claims 1, 2, 9, and 14 are moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to claims 8, 11-13 has overcome previous rejection to those claims.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 8, 11-13) Claims 8, 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
See claims 8, 11-13 as submitted 06/25/2025.
It is noted that independent claim 8 was amended to recite “An immunogenic peptide derived from SARS-CoV-2 comprising SEQ ID NO: 37”. No new limitations were introduced in the amendment filed on 05/28/2025. Accordingly, the rejection under 35 U.S.C. 101 set forth in the previous Non-Final Office still applies to amended claim 8 and dependent claims 11-13.
As previously explained, 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, amended claims 8, 11-13 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is 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, amended claims 8, 11-13 recite, read on, or are directed to a composition of matter (Step 1) and recite natural phenomenon(s) (in this case, an immunogenic peptide derived from SARS-CoV-2) that is directed to a judicial exception (in this case, a natural phenomenon)(Step 2A).
Amended claims 8, 11-13 recite an immunogenic peptide derived from SARS-CoV-2. Such a recitation reads on genomic nucleic acid sequence encoding SARS-CoV-2 virus. Further, SEQ ID NO: 37 reads upon a genomic sequence of a SARS-CoV-2 virus isolate from dogs as taught by Sit et al. (prior art of record)(See Result 1 of STIC Sequence Search Result 20250131_133438_us-17-511-090-37.rup in SCORE), Sit et al. teaches a sequence encoding SARS-CoV-2 protein which shares 100% identity to instant SEQ ID NO: 37, and reads on the elected sequence as encompassed by amended claims 8 and 11-13. Alignment of record.
Thus, the claimed product of SARS-CoV-2 derived peptide as recited 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). Amended claims 8, 11-13 read on an amino acid encoding naturally occurring SARS-CoV-2 virus peptide and do not show a difference in characteristics between the claimed peptide and the amino acid encoding naturally occurring SARS-CoV-2 virus peptide. Thus the claims also read upon a naturally occurring amino acid, or a composition of matter as recited in Step 1 and a natural phenomenon as recited in Step 2A.
Thus the claimed product of amino acid encoding naturally occurring SARS-CoV-2 virus peptide 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 amino acid, 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, amended claim 8 does 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 )
As to claim 11 Prong 2 of Step 2A, instant claim 11 does not recite additional elements that integrate the judicial exception (natural phenomenon) 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).
Amended claim 11 recites “and a pharmaceutically acceptable adjuvant”. Amended claim 12 recites “wherein the pharmaceutical composition is in a pharmaceutical dosage form selected from the group consisting of solids, liquids, gels, and combinations thereof.” Amended claim 13 recites “wherein said peptide includes one or more L- or D amino acids, non-natural amino acids, isostere peptide bonds or posttranslational modifications including methyl, phosphate, mono and oligo saccharides, or fatty acids groups”. However, generally linking of the use of the judicial exception to a particular technological environment or field of use is not indicative of integration into a practical application – see MPEP 2106.05(h)”. Therefore, claims 11-13 does not recite additional elements that integrate the judicial exception into a practical application.
Further, in view of Step 2B and the “No” pathway, amended claim 8 does not recite additional elements that amount to significantly more than the judicial exception.
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. Amended claims 11-13 are recited at a high level of generality. Amended claims 11-13 merely adds insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g). Further, Amended claims 11-13 simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception - see MPEP 2106.05(d) and Berkheimer Memo. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well-understood, routine and conventional activity engaged in by scientists prior to applicant’s invention.
Therefore, amended claims 8, 11-13 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.
The rejection is maintained for reasons of record.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(Previous rejection, withdrawn as to claim 1, maintained as necessitated by amendment as to claims 8 and 13) Claim 8 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sit et al. (Prior art of record).
See claims 1, 8 and 13 as submitted 06/25/2025.
The previous rejection of claim 1 is moot in view of Applicant’s cancelation of this claim.
See also the 35 U.S.C. 112(b) rejections above.
Regarding amended claim 8, it is noted that the claim recites a single species “SEQ ID NO: 37” and the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph. No new limitations were introduced in the amendment filed on 06/25/2025. Accordingly, the rejection under 35 U.S.C. 102(a)(1) set forth in the previous Non-Final Office Action mailed on 02/27/2025 still applies to amended claim 8. As previously explained Sit et al. discloses a set of amino acid sequences derived from a SARS-CoV-2 virus isolated from dogs which were deposited in GenBank with Accession numbers: MT215193, MT215194, MT215195, MT270814, MT270815
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and MT276600 (Abstract, page 1, 3). As indicated above, one of such peptide shares 100% identity to instant SEQ ID NO: 37. See alignment below.
Accordingly, the teachings of Sit et al. anticipate amended claim 8.
Regarding amended claim 13, as indicated above the amino acid sequence of Sit et al. which shares 100% identity with instant SEQ ID NO:37 was isolated from dogs(Abstract, page 1, 3). Given that this is a naturally occurring amino acid sequence, it includes L- amino acids. Therefore, the teachings of Sit et al. anticipate amended claim 13.
Response to Arguments
Applicant's arguments filed 06/25/2025 have been fully considered but they are not persuasive.
Applicant contends on page 21 of the Remarks submitted on 06/25/2025: Applicant respectfully wishes to draw the Examiner's attention once again to the amendments introduced in claims 8, 11 and 13 mentioned above. Particularly, Claim 8 now refers to "a peptide derived from SARS-CoV-2 comprising SEQ ID NO: 37;" Claim 11 is directed to "a pharmaceutical composition for vaccination comprising the peptide of Claim 8 and a pharmaceutically acceptable adjuvant;" and Claim 13 now recites "the immunogenic peptide of Claim 8, wherein said peptide includes one or more L- or D-amino acids, non-natural amino acids, isostere peptide bonds or posttranslational modifications including methyl, phosphate, mono and oligo saccharides, or fatty acids groups." Now, in view of the foregoing, Applicant respectfully submits that the amended subject matter is eligible under the framework set forth in the 2019 Revised Patent Subject Matter Eligibility Guidance ("2019 PEG") and relevant sections of the MPЕР.
In response: As applicant asserts that amended claim 8 now refers to "a peptide derived from SARS-CoV-2 comprising SEQ ID NO: 37", which still reads on a naturally occurring product because this precise amino acid sequence was isolated from SARS-CoV-2 infected dogs by Sit et al., as indicated above and previously. The subject matter eligibility analysis presented above and previously clearly indicates that the claimed product of a peptide derived from SARS-CoV-2 comprising SEQ ID NO: 37 is not markedly different from its naturally occurring counterpart. As to dependent claims 11-13, as indicated above, these claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception - see MPEP 2106.05(d) and Berkheimer Memo. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from well-understood, routine and conventional activity engaged in by scientists prior to applicant’s invention.
Applicant contends on page 22 of the Remarks submitted on 06/25/2025: Now, even if for the sake of the argument Claim 8 referred to a naturally-occurring element (Step 2B), which is not true as explained, it is important to note that the peptide of SEQ ID NO: 37 exhibits markedly different characteristics that allow it to be used in a practical application. Specifically, and similarly to the other peptides referred in the application, the claimed peptide exhibited immunogenicity in an antigen presentation study conducted in the context of HLA class II antigen-presenting molecules.
In response: Applicant’s argument that the peptide of SEQ ID NO: 37 exhibits markedly different characteristics, specifically immunogenicity is not persuasive because immunogenicity of the amino acid sequence comprising SEQ ID NO: 37 was demonstrated by Sit et al. with antibody responses (Abstract, page 3). Further, immunogenicity does not constitute a markedly different characteristic because viral peptides, naturally occurring and non-naturally occurring, are known to elicit antibody responses.
Applicant contends on page 24 of the Remarks submitted on 06/25/2025: Although this document discloses several full or partial genome sequences SARS-CoV-2, it does not refer to the isolation of any specific peptide, much less an immunogenic peptide of SEQ ID NO: 37. Indeed, Sit et al. does not mention whether any particular protein fragment could be suitable as an immunogen. Thus, while the underlying viral genome may encode a sequence corresponding to SEQ ID NO: 37, Sit et al. fails to explicitly disclose an immunogenic peptide comprising such particular amino acid sequence. Furthermore, and even if for the sake of the argument one were to argue that Sit et al. inherently discloses a peptide comprising SEQ ID NO: 37 by virtue of providing full viral genome sequences, the reference would not enable the skilled artisan to arrive at the claimed subject-matter. Sit et al. does not describe any methodology for producing, synthesizing, or characterizing immunogenic peptides.
In response: As indicated above and previously, immunogenicity of the amino acid sequence comprising SEQ ID NO: 37 was demonstrated by Sit et al. with antibody responses (Abstract, page 3). Further, instant claims are directed to a peptide comprising SEQ ID NO: 37. Under BRI, the claims are interpreted as comprising any amino acid sequence of any length that matches a portion of SEQ ID NO: 37. Further, producing, synthesizing, or characterizing peptides for pharmaceutical formulations are activities routinely practiced by those of ordinary skill in the art.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1671
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1671