DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
Claims 1-22, as originally filed 24 August 2023, are pending.
Claim Objections
Claims 21-22 are objected to because of the following informality: In line 2 of claim 21, the word “if” needs to be replaced with the word “of,” so the corresponding phrase states: “a therapeutically effective amount of a TRPV1 receptor antagonist.” Appropriate corrected is required.
Warning: Duplicate Claims
Applicant is advised that should claims 1-8 and 17-18 be found allowable, claims 9-16 and 19-20 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. MPEP § 608.01(m).
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventors regard as the invention.
Regarding claims 1 and 9, there is ambiguity as to whether the preamble actually requires administration of the vaccine. This ambiguity arises primarily from the fact that the administration of the vaccine is not recited as an active (manipulative) step in the body of the claim. Given that the vaccine is recited only in the preamble, it is possible that its administration merely refers to the intent or purpose of the claimed invention and, therefore, should not be afforded patentable weight. MPEP § 2111.02(II). Furthermore, if it is afforded patentable weight, does the phrase “is being administered” require that the vaccine and the TRPV1 receptor agonist are administered concurrently?
Regarding claims 2 and 10, the claim is replete with parentheses enclosing various alphanumeric identifiers, for example, “NE 19550.” This leads to confusion over the intended scope of the claim. Is the claim language contained within the parentheses merely exemplary and, therefore, not further limiting? Alternatively, does the claim language within the parentheses actually narrow the claim? MPEP § 2173.05(d) (“If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.”).
In further regard to claims 2 and 10, the following trademarks or tradenames are recited therein: NE 19550, MSK195, JYL79, SU200, NE-21610, NE-28345, and Novocaine. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. The trademarks/tradenames recited in claims 2 and 10 are used to identify or describe various TRPV1 receptor agonists and, consequently, cause confusion as to the scope of the claim. Therefore, claims 2 and 10 does not comply with the requirements of 35 U.S.C. 112(b). MPEP § 2173.05(u). Applicant is required to delete the trademarks/tradenames and, if desired, replace them with generic terminology describing the corresponding TRPV1 receptor agonist, if there is none already recited in the claim. In the interest of compact prosecution, the examiner notes that at least NE-21610 and NE-28345 do not appear to be accompanied by generic terminology, hence there is no clarity regarding their chemical structures.
In further regard to claims 2 and 10, the parentheses enclosing (i) “vannillotoxins,” (ii) the lengthy chemical name immediately preceding “(MSK195),” (iii) chinchocaine, (iv) larocaine, and (v) orocaine each lead to confusion over the intended scope of the claim. Is the claim language contained within the parentheses merely exemplary and, therefore, not further limiting? Alternatively, does the claim language within the parentheses actually narrow the claim? MPEP § 2173.05(d) (quoted above). If they are synonyms, then the examiner recommends deleting the parentheses.
In further regard to claims 2 and 10, the unmatched parenthesis immediately following “vanilloids” is confusing. The examiner recommends deleting it and adding a comma immediately after “vanilloids.”
In further regard to claims 2 and 10, the following phrase is unclear: “other pepper components.” Which chemical compounds are encompassed by the genus of other pepper components? MPEP § 2173.04 (“a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim)”).
Claim Rejections - 35 U.S.C. 112(d)
The following is a quotation of 35 U.S.C. 112(d):
[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 18 and 20 are rejected under 35 U.S.C. 112(d) as being of improper dependent form.
Claims 18 and 20 recite that “the TRPV1 receptor agonist is administered after administration of the vaccine.” Emphasis added. However, each of those claims depends on a claim requiring that “the TRPV1 receptor agonist is administered concurrently with the vaccine.” Claims 3 and 11 (emphasis added). Thus, claims 18 and 20 conflict respectively with claims 3 and 11 and, consequently, fail to comply with 35 U.S.C. 112(d).
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 U.S.C. 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esser-Kahn (WO 2020/118159 A1).
Esser-Kahn is directed to the use of NFkB inhibitors as innnune potentiators in vaccine compositions. Abstract.
Esser-Khan identifies capsaicin as a preferred NFkB inhibitor. Page 3 at lines 15-16 (“In some
embodiments, the NFkB inhibitor comprises capsaicin.”); see also page 67 at para. [0168] (“Of the molecules tested, honokiol and capsaicin proved to be effective at both limiting inflammation and potentiating the protective response.”).
Esser-Kahn discloses: “The primary in vivo target for capsaicin is the transient receptor potential cation channel subfamily V member 1 (TRPV1). TRPV1 modulates the immune response in a variety of ways, and importantly, has been implicated in dampening systemic inflammation associated with sepsis. However, it has never been explored in a vaccine setting. To understand how activation of TRPV1 may be modulating the effects of the adjuvant, the inventors compared the immediate inflammatory response of the vaccination in wild type mice (WT) and TRPV1 knockout mice. The inventors vaccinated WT and TRPV1 KO mice with 100 μg OVA and: 50μg CpG, 50 μg CpG + 20 μg capsaicin or PBS.” Page 69 at para. [0173] (emphasis added). In the interest of clarity, the examiner notes that OVA (ovalbumin) is a model antigen that is widely used in immunology and allergy research.
Esser-Kahn discloses: “Interestingly, the inventors found that anti-OVA antibody levels were increased in groups with capsaicin + CpG in both WT and KO mice. This implies that the antibody-boosting activity of capsaicin is separate from TRPV1-dependent decrease in inflammatory cytokines. This result demonstrates both that the decrease in inflammation is not responsible for the antibody-boosting activity of the NF-KB inhibitor a result that the inventors demonstrated previously, and also that the enhancement of the adaptive response is TRPV1 independent.” Page 70 at para. [0173] (emphasis added); see also page 71 at para. [0176] (“The inventors identified two such immune potentiators, honokiol and capsaicin that effectively decrease inflammation while increasing the adaptive response.”). Applicant is additionally referred to claims 1-3, 9, and 22 of Esser-Kahn, which are located on pages 79 and 81. Referring to claim 22 of Esser-Kahn, “at least 12 mg” of capsaicin (NFkB inhibitor) qualifies as an effective amount.
On the basis of the foregoing disclosure, claims 1-3, 7, 9-11, and 16 are anticipated by Esser-Kahn.
Regarding claims 4 and 12, Esser-Khan discloses “topical” administration on page 11 at paragraph [0025] and specifies that “[i]n some embodiments, NFkB inhibitor, the adjuvant, and/or the antigen are administered locally to the same site in the subject.” Page 8 at para. [0016]; see also page 81 at claims 20-21.
Regarding claims 5 and 13, Esser-Khan discloses systemic administration in paragraph [0173]. Applicant is additionally referred to paragraph [0016] of Esser-Khan, which discloses that “[i]n some embodiments, the NFkB inhibitor, antigen, and/or adjuvant is administered by intramucosal, intramuscular, parenteral, or subcutaneous administration.” See also page 81 at claim 16.
Regarding claims 6 and 15, Applicant is referred to claim 23 of Esser-Khan, which is on page 81. See also page 8 at para. [0018] (“In some embodiments, the subject is a human.”).
Regarding claims 8 and 14, Applicant is referred to claims 10-11 of Esser-Khan, which are on page 81. See also page 7 at para. [0015] (“In some embodiments, the method further comprises administration of inactivated virus, live attenuated virus, or antigenic fragments thereof. In some embodiments, the virus comprises influenza, dengue, or HIV.”).
Regarding claims 17-20, Applicant is referred to claim 18 of Esser-Khan, which is on page 81. See also page 7 at para. [0016] (“In some embodiments, the NFkB inhibitor is administered prior to the antigen. … In some embodiments, the NFkB inhibitor is administered after the antigen.”).
Claims 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimball (“Vanilloid receptor 1 antagonists attenuate disease severity in dextran sulphate sodium‐induced colitis in mice.” Neurogastroenterology & Motility 16.6 (2004): 811-818).
Kimball discloses: “Neurogenic mechanisms have been implicated in the induction of inflammatory bowel disease (IBD). Vanilloid receptor type 1 (TRPV1) has been visualized on nerve terminals of intrinsic and extrinsic afferent neurones innervating the gastrointestinal tract and local administration of a TRPV1 antagonist, capsazepine, reduces the severity of dextran sulphate sodium (DSS)-induced colitis in rats (Gut 2003; 52: 713–91). Our aim was to test whether systemically or orally administered TRPV1 antagonists attenuate experimental colitis induced by 5% DSS in Balb/c mice. Intraperitoneal capsazepine (2.5 mg kg-1, bid), significantly reduced the overall macroscopic damage severity compared with vehicle-treated animals (80% inhibition, P < 0.05); however, there was no effect on myeloperoxidase (MPO) levels. An experimental TRPV1 antagonist given orally was tested against DSS-induced colitis, and shown to reverse the macroscopic damage score at doses of 0.5 and 5.0 mg kg-1. Epithelial damage assessed microscopically was significantly reduced. MPO levels were attenuated by approximately 50%, and diarrhoea scores were reduced by as much as 70%. These results suggest that pharmacological modulation of TRPV1 attenuates indices of experimental colitis in mice, and that development of orally active TRPV1 antagonists might have therapeutic potential for the treatment of IBD.” (Emphasis added) Abstract.
The examiner notes that colitis and other IBDs (inflammatory bowel diseases) are defined as “autoimmune disorders” on page 7 of the specification of the present application (WO 2022/182940), as originally filed.
On the basis of the foregoing disclosure, claims 21-22 are anticipated by Kimball.
Conclusion
Claims 1-22 are rejected.
Claims 21-22 are also objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
07 March 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611