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 .
Applicant’s reply and amendment to the claims have cured most of the objections to the specification (see below), the rejection under 35 USC 112(a), written description, and the rejection under 35 USC 103.
Specification
The amendments to the specification received August 4, 2028 has been entered because the amendments appreciably ameliorate all of specifically noted objections of record, i.e., the title, removal of hyperlinks, and proper annotation of TRITON X-100™. However, it is noted that “Tween 80” in amended paragraph [0457] is a trade name or a mark used in commerce. 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 properly annotate all trade names and/or marks recited in the instant specification.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 36 remains rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention for reasons of record.
In reply to the rejection, applicant correctly states that enablement is assessed under factors set forth in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), and states that there is no requirement for demonstrated clinical efficacy. Applicant points to instant Example 19 demonstrating that IL-33-decorated HBc-Im7 virus-like particles administered to mice raise an anti-IL-33 antibody response, that the specification describes as persisting at “what would likely be a clinically effective level (1.12 gg/ml)” to at least 23 weeks after baseline (Figure 22; published paragraph [0652]). Applicant asserts that a skilled artisan would understand that antibodies raised against a pro-inflammatory cytokine such as IL-33 neutralize that cytokine and thereby reduce the associated inflammation. Applicant asserts that the specification provides working examples, a high level of ordinary skill, and predictable guidance sufficient to enable the amended claim.
Applicant’s arguments have been fully considered, but are found unpersuasive. MPEP § 2164.01(a) and in Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed, the Federal Circuit explicitly applied the Wands factors to assess whether the specification of Amgen’s patent provided sufficient enablement, for purposes of 35 U.S.C. 112(a), to make and use the full scope of the claimed invention. Claim 36 recites:
A method of treating a subject having an inflammatory disease or preventing an inflammatory disease from occurring in a subject predisposed for that disease, said method comprising administering an effective amount of the virus- like particle (VLP) of claim 1 or an effective amount of an immunogenic composition comprising the virus-like particle of claim 1.
Contrary to applicant’s assertion, the IL-33-decorated HBc-Im7 VLPs of Example 19 are not commensurate in scope with the Im7-HBc VLP’s of claim 1, requiring ColE7 bound to Im7 and any functional molecule. IL-33 is not designated as a functional molecule, selected from a list of alternatives, until claim 23. There is no evidence instantly provided that the claimed HBc-Im7-ColE7-functional molecule VLPs of claim 1 would be efficacious in treating any inflammatory disease, as asserted in claim 36. There is no data or evidence provided showing prophylactic efficacy against any inflammatory disease upon administration of IL-33-decorated HBc-Im7 VLPs or all possible HBc-Im7-ColE7-functional molecule VLPs of claim 1, as asserted.
Applicant criticizes the teachings of Guan et al. for using a different construct that does not establish that the instant VLPs fail to enable treatment of an inflammatory disease.
Applicant’s arguments and the teachings of Guan et al. have been fully considered, but are found unpersuasive because Guan et al. teach attaching IL-17, listed in claim 23 adjacent to IL-33, to the surface of an HBV VLP particle. The IL-17 HBV VLP of Guan et al. is shown to exacerbate intestinal inflammation in chronic murine colitis, see “Immunization of the vaccine exacerbates, rather than improves, intestinal inflammation in chronic murine colitis”, “Intestinal inflammation is exacerbated in association with enhanced production of IL‑17 & TNF”, and Figures 1, 3, and 4. Guan et al. also do not teach preventing inflammation with the IL-17 HBV VLP.
Regarding Oeda et al., applicant argues that the reference does not address surface decorated VLP’s of the instant claims and a skilled artisan would understand that the immune response to a decorated virus-like particle differs from the response to natural HBV infection.
Applicant’s arguments have been considered, but are found unpersuasive because claim 36 asserts that any inflammatory disease is treated and/or prevented, which would include pruritis due to HBV infection discussed by Oeda et al.
Applicant argues that Ma et al. not reducing airway inflammation with HBV VLP IL-13 does not establish that the claimed methods are not enabled, as enablement does not require success in every conceivable case.
Applicant’s arguments have been fully considered, but are found unpersuasive because the IL-33-decorated HBc-Im7 VLPs of instant Example 19 is not indicative of success in every conceivable case, or establish that IL-33-decorated HBc-Im7 VLPs of Example 19 treats or prevents any inflammatory disease in any subject. Ma et al. conclude that chronic inflammation and sustained airway hyperresponsiveness were not reversed upon administration with an HBV VLP-IL-13. See “Vaccine” and Figures 5 and 6. The skilled artisan would not predict success.
Inflammatory diseases listed in the instant published disclosure (USPgPub 20240093159) in paragraph [0482] include: arthritis, asthma, tuberculosis, periodontis, chronic ulcers, sinusitis, hepatitis, glomerulonephritis, inflammatory bowel syndrome/disease, preperfusion injury, transplant rejection, sickle cell disease, allergies, cardiovascular disease, psoriasis, cytokine-mediated pruritus, COPD, diabetes, bronchitis, Crohn's disease, atherosclerosis, dermatitis, arteritis, lupus. The title of Chavda et al. is: “Inflammation: the cause of all diseases” in (Cells. 2024 Nov 18; 13 (22): 1906), some of which are listed in section 3. In section 4, Chavda et al. opine, “Advancing the understanding of how inflammation drives various pathological conditions could pave the way for innovative therapeutic strategies, preventing the detrimental effects of chronic inflammation and ultimately improving health outcomes and quality of life.” The instant disclosure does not provide a nexus between the lack of knowledge in the current state of the art and the method claimed.
The skilled artisan would not predict that the instantly claimed HBV-toxin inhibitor-toxin-functional molecule complex would be efficacious in treating any subject having any inflammatory disease or preventing any inflammatory disease from occurring in any subject predisposed for that disease upon administration. For these reasons, it is determined that an undue quantity of experimentation would be required of the skilled artisan to make and use the instant invention.
Allowable Subject Matter
Claims 1, 3-6, 17-20, 23, and 35 are allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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