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
In response to the restriction requirement dated 8 May, 2026, Applicant elects, without
traverse Group II and species of compound of Formula (I):
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567
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Claims 29 and 34-57 are pending. Claims 39-54 and 57 are withdrawn since the Applicant elected a compound of Formula (I), not a mixture of peptides. Accordingly, claims 39-54 and 57 are withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Applicant's election in the reply filed on 7 August 2026 is acknowledged.
Claims 29, 34, 35, 36, 37 and 38 are hereby examined on the merits.
Priority
This application filed 10/25/2023 Claims Priority from Provisional Application 63380931, filed 10/25/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/07/2026 is in compliance with the
provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
Specification
The substitute specification filed 04/05/2024 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: a marked-up copy of the substitute specification has not been supplied (in addition to the clean copy).
Claim Objections
Claims 29, 34, 35, 36, 37 and 38 are objected to because of the following informalities: SEQ ID NO: 497 does not match the sequence listing. 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 29, 34, 35, 36, 37, 38 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.
Regarding claim 29, the structure of Formula (I) recites ‘wherein…..amino acid sequence selected from the group’ in lines 5-7. Here, it is unclear if R8 corresponds to amino acids in the structures represented by the recited sequences or if ‘(A)’ represents the sequences that encompass R8. For prior art purpose, Examiner interprets the “wherein…group’ to be directed to antigen (A) comprising the recited sequences.
Regarding claim 36, the ambiguity has been noted above. Accordingly, Examiner interprets ‘wherein….group’ to be directed to antigen (A) selected from the group consisting of the recited sequences.
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 29, 34, 35, 36, 37 and 38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treatment comprising administering a mixture of GLU peptide antigens [001052], does not reasonably provide enablement for a method of treatment comprising administering Formula (I) that is not a mixture with additional peptide antigens. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. This is a scope of enablement rejection. Examiner notes that a mixture of antigenic peptides in the method of treatment is not an elected species.
Claim 29 is directed to a method of inducing tolerance or immune suppression or treating an autoimmune disease, an allergy, an infectious disease, or a transplant rejection in a subject in need thereof. Claims 34 and 35 are dependent on claim 29.
Claim 36 is directed to a method of inducing tolerance or immune suppression or treating an autoimmune disease, an allergy, an infectious disease, or a transplant rejection in a subject in need thereof. Claims 37 and 38 are dependent on claim 36.
Embodiments of the specification disclose ‘subject’ as both human and non-human animals [00107]. In Example 5, the specification discloses vaccine compositions for treating autoimmunity in a murine EAE model [001000] wherein the peptide antigen (A) is a fragment of the MOG protein (see line 4). In [001005], embodiments of the specification disclose that mechanism of action for disease reversal (i.e. EAE model of disease), requires antigen MOG uptake and presentation by APC. Also see Fig 5, 6, 7A-B. The recited sequences in the claims, as disclosed in the specification [00707] includes amino acids selected from the celiac disease associated protein sequence. For instance, the elected peptide antigen SEQ ID NO: 488 is a gluten-derived (GLU) peptide antigen (see Example 9). Regarding treatment, embodiments of the specification disclose vaccines for inducing tolerance for treating celiac disease comprising 12 peptide antigen conjugates further comprising GLU peptide antigens [001052]. The specification fails to support a method of inducing tolerance or immune suppression or treating an autoimmune disease, an allergy, an infectious disease, or a transplant rejection comprising administering compound of Formula (I) with a specific peptide antigen (A). The specification supports a method of treatment comprising administering a mixture of GLU peptide antigens (see [001054]; Table 20, 21).
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether
there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement
requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5.The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the
disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands factors are applied to claims 29, 34, 35, 36, 37, 38 as follows:
The breadth of the claims and the nature of the invention
Claims 29, 34, 35, 36, 37, 38 are directed to a method of inducing tolerance or immune suppression or treating an autoimmune disease, an allergy, an infectious disease, or a transplant rejection in a subject in need thereof. The specification does not provide evidence for the method comprising administering compound of Formula (I). Embodiments of the specification provide a method comprising administering a composition comprising a mixture of GLU peptide antigens (see [001054]; Table 20, 21).
Accordingly, claims 29, 34, 35, 36, 37, 38 are unduly broad with respect to the method as claimed.
The State of the Prior Art
It is noted that there is no prior art that teaches the recited method for the diseases, as claimed.
The Level of Skill in the Art
Practitioners in this art (immunologists/medical professionals) would presumably be highly skilled in the art for administering compositions with the treatment properties as claimed.
The Level of Predictability in the Art
It is noted that the therapeutic art is unpredictable, requiring each embodiment to be individually assessed for clinical benefit. The amount of guidance or direction needed to enable
the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). This is because it is not obvious from the disclosure, of a specific method of treatment of subject and alleviation of symptoms comprising administering the claimed composition of Formula (I). In the instant case, the specification discloses vaccines for inducing tolerance for treating celiac disease comprising 12 peptide antigen conjugates further comprising GLU peptide antigens [001052]. The specification fails to support a method of inducing tolerance or immune suppression or treating an autoimmune disease, an allergy, an infectious disease, or a transplant rejection comprising administering compound of Formula (I) with a specific peptide antigen (A). The specification supports a method of treatment comprising administering a mixture of GLU peptide antigens (see [001054]; Table 20, 21). Without any experimentation demonstrating the claimed function of the compound, the level of unpredictability remains high. Therefore, it is unpredictable that the composition will function as claimed.
The amount of Direction Provided by the Inventor and The Presence or Absence of
Working Examples
The instant specification does not provide adequate guidance with regard to the method of treatment. Applicant’s limited disclosure is noted but is not sufficient to justify claiming the composition broadly. Absent a reasonable a priori expectation of success for using the compound of Formula (I), one skilled in the art would have to extensively test the compound, determine an effective dose on a subject suffering from an autoimmune disease, allergy, infectious disease or transplant rejection and evaluate immune tolerance or immune suppression. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is
claimed in its current scope, because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he
Level of Predictability in the Art” section supra, the specification teaches working examples with a mixture of GLU peptide antigens.
There is no prior art that teaches Formula (I) in the method of treatment in a subject as claimed. Also, as noted in the “Breadth of the Claims and Nature of Invention” section, the specification does not provide evidence that a subject suffering from autoimmune disease, allergy, infectious disease or transplant rejection is administered a therapeutically effective amount or the amelioration of symptoms. As such, the examples used in the specification are not indicative broadly of a method of treatment, with the desired result of amelioration of symptoms or of inducing tolerance or immune suppression. It is further noted that Applicant provides no data, examples, figures, etc. demonstrating a subject with the recited disease and effective amount of the claimed compound, for treatment. In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that,
based on the evidence regarding each of the above factors, the specification, at the time the application
was filed, would not have taught one skilled in the art how to make and/or use the full scope of the
claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d
1510,1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claims 29, 34, 35, 36, 37, 38, in view of the Applicant’s entire disclosure, it is concluded that the practice of the invention as claimed in claims 29, 34, 35, 36, 37, 38 would not be enabled by the written disclosure for a method of treatment. Therefore claims 29, 34, 35, 36, 37, 38 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to treat a subject as claimed using the compound.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 29, 34, 35, 36, 37, 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12642851. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 29, 34, 35, 36, 37 and 38, see claims 26-30 in reference patent ‘851.
2. Claims 29, 34, 35, 36, 37, 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 19/652, 580 in view of Patent No. 12642851. This is a provisional nonstatutory double patenting rejection.
Regarding claims 29, 34-38, reference application ‘580 teaches an amphiphilic block copolymer that reads on the instant claims. See embodiments of the instant specification [00264]. Reference application ‘580 does not teach the recited sequences of a peptide antigen and method of treatment.
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the amphiphilic block copolymer with the recited sequences, and use in the method of treatment. One motivated to do so would have a reasonable expectation of success as the method and sequences are provided in Patent No. 12642851.
Thus, one would have recognized that applying the teaching of the reference application ‘580 to the method of Patent No. 12642851, would have yielded predictable results and improved the utility of the composition (See MPEP § 2143 l(A)(D)).
3. Claims 29, 34, 35, 36, 37, 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-21, 47-51, 71-75, 76-78 and 83-90 of copending Application No. 19/246, 539 in view of Patent No. 12642851. This is a provisional nonstatutory double patenting rejection.
Regarding claims 29, 34-38, reference application ‘539 teaches a peptide antigen conjugate that reads on the instant claims. See embodiments of the instant specification [00264]. Specifically, reference application 539 teaches that B1 and B2 extensions (i.e. in the claimed peptide antigen) in some embodiments comprise PEG (page 32). Reference application ‘580 does not teach the recited sequences of a peptide antigen and method of treatment.
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide antigen conjugate with the recited sequences, and use in the method of treatment. One motivated to do so would have a reasonable expectation of success as the method and sequences are provided in Patent No. 12642851.
Thus, one would have recognized that applying the teaching of the reference application ‘539 to the method of Patent No. 12642851, would have yielded predictable results and improved the utility of the composition (See MPEP § 2143 l(A)(D)).
4. Claims 29, 34, 35, 36, 37, 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-65 of copending Application No. 19/242, 746 in view of Patent No. 12642851. This is a provisional nonstatutory double patenting rejection.
Regarding claims 29, 34, 35, 36, 37 and 38, see claims 41-65 in reference application ‘746.
Reference application does not teach the specific sequences of peptide antigen.
The recited sequences are disclosed in Patent No. 12642851.
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide antigen conjugate with the recited sequences, and use in the method of treatment. One motivated to do so would have a reasonable expectation of success as the sequences are provided in Patent No. 12642851.
Thus, one would have recognized that applying the teaching of the reference application ‘746 to the sequences of Patent No. 12642851, would have yielded predictable results and improved the utility of the composition (See MPEP § 2143 l(A)(D)).
5. Claims 29, 34, 35, 36, 37, 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 15, 16, 20, 22, 25, 26 of copending Application No. 19/183, 635 in view of Patent No. 12642851. This is a provisional nonstatutory double patenting rejection.
Regarding claims 29, 34, 35, 36, 37 and 38, the obviousness rationale has been set forth above.
6. Claims 29, 34, 35, 36, 37, 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 95, 253 of copending Application No. 18/277, 220 in view of Patent No. 12642851. This is a provisional nonstatutory double patenting rejection.
Regarding claims 29, 34, 35, 36, 37 and 38, see claims 95 and 253. The obviousness rationale has been set forth above.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights