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 without traverse of Group I in the reply filed on 7/29/2026 is acknowledged. Applicant’s election without traverse of SEQ ID NO:2, SEQ ID NO: 21, and SEQ ID NO: 92 are acknowledged. Applicant recites that claims 1-3, 5-7, 16, and 18-23 read on the elected invention and species. Upon further consideration, SEQ ID NO: 78 and SEQ ID NO: 99 will be rejoined with the other elected sequences for examination, along with claims 8 and 24.
Claims 9-15 and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 7/29/2026.
Status of Claims
Claims 1-3, 5-16, and 18-27 were previously amended and claims 4, 17, and 28-30 were previously cancelled, in the amendment filed 10/24/2024. Claims 1-3, 5-16, and 18-27 are pending. Claims 9-15 and 25-27 are withdrawn. Claims 1-3, 5-8, 16, and 18-24 will be examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Foreign application IT102022000006785 is acknowledged as disclosing the claimed invention and the effective filing date is 04/06/2022.
Information Disclosure Statement
The Information Disclosure Statement filed on 10/04/2024 has been considered. Signed copies are enclosed.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. For example, see page 14, line 7, and page 15, line 30. 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.
The use of the term Sigma Aldrich, as recited on page 14, line 7, 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 is required to closely review the specification for additional occurrences of trade names and hyperlinks.
The disclosure is objected to because of the following informalities: Table 3 recites sequences disclosed in the Sequence listing not identified by their SEQ ID NO. If possible, Applicant should add appropriate SEQ ID NOs to Table 3 to make the disclose more transparent.
Appropriate correction is required.
Claim Objections
Claims 3 and 20 are objected to because of the following informalities: Claims 3 and 20 list SEQ ID NO: 82 twice. Appropriate correction is required.
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 3, 8, 20, and 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.
Claims 3, 8, 20, and 24 are indefinite due to the recitation of “preferably”. It is unclear if the further limitation that follows ‘preferably’ is required by the claim or not. Therefore, one of ordinary skill in the art would not be able to determine the scope of the claims.
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.
Claims 2, 3, 6-8, 16, 19, 20, and 22-24 are 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 2 is dependent on claim 1. Claim 1 recites that the peptide comprises a core sequence of 9 amino acids where 6, 7, or 8 amino acids are identical and in the same position with respect to SEQ ID NO: 1. Claim 2 recites the peptide is selected from the sequences with SEQ ID NOs: 13-90, and claim 3 recites the peptide is selected from a narrower list of SEQ ID NOs. However, several sequences recited by claim 2 and claim 3 only have 5 amino acids identical and in the same position as SEQ ID NO: 1 (see, for example, SEQ ID NO 87). Therefore, claim 2 and claim 3 expand the scope of claim 1, and do not further limit it.
Claims 6, 7, and 8 are dependent on claim 5, which recites the additional peptide comprises a core sequence of 9 amino acids where 6 or more amino acids are identical and in the same position with respect to SEQ ID NO: 2-12. Claim 6 recites that the peptide is selected from SEQ ID NOs: 91-631, claim 7 recites that the peptide is selected from SEQ ID NOs: 91-197, and claim 8 recites a subset of SEQ ID NOs. However, several sequences listed in claims 6, 7, and 8 have only 5 amino acids identical to and in the same position with respect to SEQ ID NO:2-12 (see, for example, SEQ ID NO: 139 as compared to SEQ ID NO: 2). Therefore, claims 6, 7, and 8 expand the scope of claim 5, and do not further limit it.
Claim 8 is dependent on claim 7. Claim 7 recites that the further peptide is selected from the group consisting of SEQ ID NO: 91-197. Claim 8 recites a more specific set of SEQ ID NOs, but includes SEQ ID NOs: 274, 276, and 282. Therefore, claim 8 expands the scope of claim 7, and does not further limit it.
Claim 16 recites “a vaccine or immunogenic composition comprising the composition of claim 1 and a pharmaceutically acceptable vehicle or excipient.” Claim 1 recites a composition comprising a peptide and a pharmaceutically acceptable excipient. There is no definition for vehicle or excipient provided in the specification, so the terms are interpreted as synonymous, as is common in the art. Thus, unless claim 16 is intended to include a more specific subset of excipient than claim 1 that is not defined by the claims or the specification, claim 16 does not further limit claim 1.
Claims 19 and 20 are dependent on claim 18. Claim 18 recites that the peptide comprises a core sequence of 9 amino acids where 6, 7, or 8 amino acids are identical and in the same position with respect to SEQ ID NO: 1. Claim 19 recites the peptide is selected from the sequences with SEQ ID NOs: 13-90, and claim 20 recites the peptide is selected from a narrower list of SEQ ID NOs. However, several sequences recited by claim 19 and claim 20 only have 5 amino acids identical and in the same position as SEQ ID NO: 1 (see, for example, SEQ ID NO 87). Therefore, claim 19 and claim 20 expand the scope of claim 18, and do not further limit it.
Claims 22, 23, and 24 are dependent on claim 21, which recites the additional peptide comprises a core sequence of 9 amino acids where 6 or more amino acids are identical and in the same position with respect to SEQ ID NO: 2-12. Claim 22 recites that the peptide is selected from SEQ ID NOs: 91-631, claim 23 recites that the peptide is selected from SEQ ID NOs: 91-197, and claim 24 recites a subset of SEQ ID NOs. However, several sequences listed in claims 22, 23, and 24 have only 5 amino acids identical to and in the same position with respect to SEQ ID NO: 2-12 (see, for example, SEQ ID NO: 139 as compared to SEQ ID NO: 2). Therefore, claims 22, 23, and 24 expand the scope of claim 21, and do not further limit it.
Claim 24 is dependent on claim 23. Claim 23 recites that the further peptide is selected from the group consisting of SEQ ID NO: 91-197. Claim 24 recites a more specific set of SEQ ID NOs, but includes SEQ ID NOs: 274, 276, and 282. Therefore, claim 24 expands the scope of claim 7, and does not further limit it.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 5-8, 16, and 18-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recites a . This judicial exception is not integrated into a practical application because the claims are not directed to a method. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis, laid out in accordance with MPEP 2106:
Applicant’s claims recite a composition comprising at least one peptide derived from the human microbiota and a pharmaceutically acceptable excipient. Therefore, the claim is directed to a composition of matter, which is one of the statutory categories of invention (Step 1: yes).
The claims are then analyzed to determine whether it is directed to any judicial exception. In this case, the claims are directed to a natural product. Claim 1 recites a composition comprising a peptide derived from the human microbiota, which comprises living, naturally occurring organisms. Therefore, any peptide made by the microbiota is a naturally occurring peptide, or natural product. The limitation of ‘a pharmaceutically acceptable excipient’ reads on water, as water is an excipient generally accepted in the art and the instant specification does not provide a specific definition for excipient. Therefore, the combination of water and a naturally occurring peptide is still a natural product.
Claim 5 recites that the composition further comprises a further peptide, limited by sequence identity to SEQ ID NOs: 2-12. The instant specification discloses, on page 49, second paragraph, that these sequences can be found in naturally occurring organisms (for example, SEQ ID NO:6 can be found in Clostridia bacterium). Therefore, these peptides are also considered natural products. Furthermore, the combination of the peptides and the excipient does not amount to significantly more, as there are multiple peptides in the specification that come from the same naturally occurring organism, and would therefore occur together in nature (see, for example, SEQ ID NOs: 64, 70, 71, 80, 133, 135, 140, 158, 248, 249, 266, 304, 316, 332, 382, 384, 437, 481, 483, 518, 521, 532, 538, 568, 569, 572, 572, and 621, which are all identified in the specification as being derived from Alistipes putredinis (see table 2)). Therefore, a naturally occurring A. putredinis bacterium would read on the instant claims, as it comprises at least two peptides that read on the instant claims and water. Thus, the instant claims are directed to a judicial exception of a natural phenomenon or natural product (Step 2A: Yes).
Next, the claims as a whole are analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
The dependent claims 2-3 and 6-8 further limit the sequences that may be present in the composition, but do not add any additional elements to the compositions of claims 1 and 5 that would amount to significantly more. Therefore, claims 2-3 and 6-8 do not overcome the judicial exception. For example, claim 2 recites that the peptide is selected from the group of SEQ ID NO: 13-90, which reads on the A. putredinis bacterium recited above. Claims 6 and 7 recite the second peptide is selected from the group of SEQ ID NO: 91-631, or SEQ ID NO: 91-197, which also read on the A. putredinis bacterium recited above. Claim 3 recites a subset of sequences, but as all are derived from the naturally occurring microbiota, all read on the judicial exception of a natural product. Claim 8 recites a second subset of SEQ ID NOs, but the list includes SEQ ID NOs that originate from the same bacteria as those in instant claims 1-3 (for example, Faecalibacterium prausnitzii comprises SEQ ID NO: 53, which meets the limitations of instant claims 1 and 2, and SEQ ID NO: 274, which meets the limitations of instant claim 5, 6, and 8, and “Clostridia bacterium” comprises SEQ ID NO: 39 and SEQ ID NO: 160, 162, and 169, which meet the limitations of instant claims 1-3 and 5-8, respectively (See table 2)). Therefore, the dependent claims of claim 1 do not amount to significantly more than the judicial exception.
Claim 16 recites a vaccine or an immunogenic composition that comprises the composition of claim 1 and a pharmaceutically acceptable excipient. Again, such an excipient is common in the art and reads on water, and therefore claim 16 does not amount to significantly more than the judicial exception.
Claims 18-24 recite the same peptide limitations as instant claims 1-3 and 5-8, but are drawn to a dietary supplement or replacement. There are no additional limitations imposed by the “dietary supplement or replacement” recitation in the preamble, and there is no definition in the specification that would indicate the dietary supplement would necessarily comprise anything other than the naturally occurring product. Therefore, as recited above, the bacteria listed in Table 2 as the source of these peptides read on instant claims 18-24 as well, and the claims are not drawn to significantly more than the judicial exception.
Therefore, claims 1-3, 5-8, 16, and 18-24 are not patent eligible.
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.
(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.
Claim(s) 1-3, 16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Border et al., OncoImmunology 8:2, e 1532759 (2019).
Border et al. teach a MAGE-A10 cancer antigen with sequence of GLYDGMEHL, identical to instant SEQ ID NO:1 (referred to as the MAGE-A10254–262 epitope; see page 2, left column, paragraph 2). Border et al. also teach MAGE-A10 epitope peptides that have mutations in each position to each amino acid (see Figure 5, Supplement figure S2, and page 3). This includes a peptide with sequence GLYDGMRHL, identical to SEQ ID NO: 78 of the instant application. Therefore, Border et al. describes a peptide with 8 amino acids identical and in the same location as SEQ ID NO: 1, anticipating claims 1-3, as the sequence is selected from SEQ ID NO: 13-90, and SEQ ID NO: 78 is listed in claim 3. Border et al. teach this peptide in a ELI-Spot assay, wherein the peptides were ordered in a lyophilized form and resuspended in water. Water reads on an excipient, and so Border et al. teach the composition of claim 1. Moreover, the instant specification and the instant claims do not provide any further limitations or any specific definition for “a vaccine or an immunogenic composition” or a “dietary supplement or replacement”. As such, both a vaccine and a dietary supplement could simply comprise water and a peptide. Therefore, Border et al. also teaches claims 16 and 18. Claims 19 and 20 recite the same limitation as claims 2 and 3, and thus Border et al. teaches claims 1-3, 16, and 18-20.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-8, 16, and 18-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Border et al., OncoImmunology 8:2, e 1532759 (2019), in view of US 11,464,842 B1 (Gifford et al., EFD 04/28/2021).
Border et al. teach a MAGE-A10 cancer antigen with sequence of GLYDGMEHL, identical to instant SEQ ID NO:1 (referred to as the MAGE-A10254–262 epitope; see page 2, left column, second paragraph). Border et al. also teach MAGE-A10 epitope peptides that have mutations in each position to each amino acid (see Figure 5, Supplement figure S2, and page 3). This includes sequences identical to SEQ ID NO: 78 of the instant application. Moreover, the information provided in Border et al. Figure 5 would make it obvious which amino acid substitutions could occur to protect binding of the antigen to the target HLA molecule, as it highlights the amino acids that can be swapped in at all 9 positions and still retain binding of the antigen. Using the information provided by Border et al., one would easily arrive at the instantly claimed sequence of SEQ ID NO:21, which substitutes G1K, M6L, and Y8S, all of which are disclosed in Border et al. Figure 5. Therefore, Border et al. teaches the peptide of SEQ ID NO: 78 (thereby teaching the peptide of instant claims 1-3), and the peptides of the instant application are obvious in view of Border et al.
Border et al. do not teach a vaccine comprising this peptide, or an additional peptide with 6, 7, 8, or 9 amino acids identical to SEQ ID NO: 2. However, a similar process to that of Border et al. could easily lead one of ordinary skill in the art to peptides that would reasonably fit the limitations of the instant claims.
Gifford et al. disclose immunogenic compositions comprising instant SEQ ID NO: 99 in several sequences, including SEQ ID NO: 57,649 and SEQ ID NO: 223,624, disclosed as immunogenic peptides in columns 164 and 64, respectively (see attached sequence alignments). This teaches the limitations of instant claims 5-8. Gifford et al. disclose using these compounds to increase immune responses to cancer (column 1, paragraph 5). Moreover, Gifford et al. generally disclose a method of optimization of peptide vaccines, including those against cancer antigens (see column 74), by iteratively substituting amino acids in known peptides and determining which will best fit an HLA allele. Thus, Gifford et al. teaches a method that solves the same problem as the instant invention, as does Border et al. Gifford et al. further teach this composition further comprising a vehicle or excipient, teaching the remaining limitations of instant claims 1 and 16.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the peptides taught by Border et al. and the peptides taught by Gifford et al. in an immunogenic composition, thereby teaching instant claims 1-3, 5-8, and 16. One would be motivated to do so, because the two peptides will allow for optimal antigen presentation of cancer antigens and can therefore be used for cancer treatments. One would have a reasonable expectation of success as Border et al. and Gifford et al. both teach that their peptides are successfully presented by HLAs and thus can be considered vaccine candidates. Therefore, the combination of Border et al. in view of Gifford et al. renders the instant invention obvious. Additionally, claims 18-24 are drawn to the same limitations as claims 1-3 and 5-8, but are drawn to a food supplement or replacement. The instant specification gives no definition for ‘a food supplement or replacement’, and only gives the examples of food products or drinking products. Therefore, any product that can be safe for consumption would read on a food supplement, including the vaccine composition recited above, or just the peptides as claimed suspended in water, as in Border et al. Therefore, claims 18-24 are also obvious over Border et al. and Gifford et al.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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/AMELIA STEPHENS/ Examiner, Art Unit 1645
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683
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