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 .
The amendments and remarks filed 10/17/25 are acknowledged. Claims 1 and 4 have been amended. Claims 2, 5, and 20 have been canceled. Claims 1, 2, 4, 6-19, and 21 are pending. Claims 16-19 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventio, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/2/25.
Claims 1, 2, 4, and 6-15 are under examination.
Withdrawn Objections and Rejections
The objection to the specification for trademarks and tradenames that are not properly identified. See paragraph 3, page 1 of the previous Office action.
The rejection of claims 1-15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first 5. paragraph, as failing to comply with the written description requirement, is withdrawn in light of Applicant’s amendment thereto. See paragraph 5, page 3 of the previous Office action.
The rejection of claims 1-15 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s amendment thereto. See paragraph 8, page 13 of the previous Office action.
The rejection of claims 1-15 under 35 U.S.C. 103 as being unpatentable over Nakamura 13. et al. (Journal of Controlled Release 176 (2014) 44-53) in view of Lim et al. (WO 2020/162705 A1, published August 13, 2020), is withdrawn in light of Applicant’s statement that the Lim et al. reference (‘705) was under an obligation of assignment to the same entity (common ownership) at the time of invention and filing. See paragraph 13, page 14 of the previous Office action.
New Rejection Necessitated by Applicant’s Amendment
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 1, 2, 4, and 6-15 are 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. This is a new matter rejection.
The newly amended claims recite “…the pathogen cell wall skeleton being substantially free of lipids and membrane protein…” However, the specification does not recite or describe a pathogen cell wall skeleton being substantially free of lipids and membrane protein, and therefore this newly added/amended claims constitute new matter.
Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
It is noted that Applicant did not point to support in the specification, by page and line number, for the new limitations recited in the amended claims. Accordingly, the newly added limitations in the claims constitute new matter.
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 1, 2, 4, and 6-15 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.
The instant claims are drawn to a live pathogen-mimetic nano-molecule comprising: a toll-like receptor 7 or 8 agonist, and a nanodispersion in a form of an aqueous dispersion of a pathogen cell wall skeleton, the pathogen cell wall skeleton being substantially free of lipids and membrane protein, wherein the toll-like receptor 7 or 8 agonist is in an inactive state by binding of a lipid to an activation site, wherein the toll-like receptor 7 or 8 agonist is any one or more selected from the group consisting of imidazoquinoline-, hydroxyadenine-, pteridine-, aminopyrimidine-, benzoazepine-, and thia-oxoguanosine-based compounds, and wherein the binding between the toll-like receptor 7 or 8 agonist and a lipid is cleavable.
The term “substantially free” in claim 1 is a relative term which renders the claim indefinite. The term “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although it is understood that the phrase “substantially free” relates to the pathogen cell wall skeleton component, the specification fails to provide one of ordinary skill in the art with any guidance to determine what degree or amount of lipids and membrane protein constitutes “substantially free”. Therefore, the metes and bounds of the claim are unclear because there is no way to distinguish the pathogen cell wall skeletons having substantially free of lipids or membrane protein from those without. That is, the claim does not provide a discernible boundary on the structure of the cell wall skeleton. Thus, the limitation is ambiguous, and one of skill in the art would not be apprised of the metes and bounds of the claims. Dependent claims 2, 4, and 6-15 do not cure the deficiencies of claim 1, and thus, are included in the rejection.
Claim Status
No claims are allowed.
Conclusion
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 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 SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa L. Ford can be reached at (571)272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANDRA CARTER/ Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674