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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's Request for Continued Examination (RCE) filed on June 8, 2026, with the submission filed on May 11, 2026, which includes a response to the Final Office Action mailed December 9, 2025, has been entered. Claims 2, 15, 17, 29, and 36 have been amended; claims 1, 3, 5, 7, 9, 13, 14, 16, 22, 23, 25, 27, and 30-33 have been canceled; and claim 39 has been newly added. Claims 6, 8, 10-12, 18-20, 34, 35, 37, and 38 have been withdrawn. Claims 2, 4, 15, 17, 21, 24, 26, 28, 29, 36, and 39 are under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 103
Applicant’s arguments are found sufficiently persuasive, and Applicant is being given the benefit of the doubt as to whether cationic liposomes would be reasonably expected to treat a respiratory tract infection. Therefore, the 35 USC 103 rejection presented in the Final Office Action mailed December 9, 2025 is hereby withdrawn.
Claim Objections
Claim 2 is objected to because of the following:
i). Claim 2, as now amended, stipulates that the liposome contains “at least one immunomodulator selected from a STING agonist”. The expression “at least one immunomodulator selected from a STING agonist” is awkward and appears to be in improper English grammatical form. The term “a STING agonist” appears to refer to one STING agonist. However, the expression “at least one immunomodulator” refers to one or more, and “is selected from” implies more than one option. To remedy this, Applicant is advised to amend the expression to e.g. “and one or more STING agonists”.
ii) In claim 2, there should be a semicolon rather than a comma between “STING agonist” and “wherein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 39 is 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.
Claim 39 stipulates in a wherein clause that “the STING agonist is…poly(I:C)”.
However, in the previous claim set, claim 2 stipulated that the liposome contained at least one immunomodulator selected from poly(I:C) and a STING agonist. Clearly, in the method previously presented, “poly(I:C)” and “a STING agonist” were two distinct elements. The original specification discloses “the liposomal composition may also comprise an immunomodulator, preferably poly (I:C) and more preferably STING agonists, such as cAMP, cGMP, c-di-AMP or c-di-GMP” (see paragraph 0011). Paragraph [0091] discloses “the immunomodulator may be selected from the group consisting of STING agonists such as cyclic-GMP-AMP (cGAMP), cAMP, c-di-AMP, cGMP and c-di-GMP”, and paragraph [0092] discloses “the immunomodulator is preferably a STING agonist selected from the group consisting of cGAMP, cAMP, cGMP, c-di-AMP and c-di-GMP, more preferably c-di-GMP”.
Hence, while Applicant has support in the original specification and claims for the immunomodulator being either poly(I:C) or a STING agonist, Applicant does not have adequate support for poly(I:C) being a STING agonist.
This constitutes new matter.
Claim Rejections - 35 USC § 112(b)
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 2, 4, 15, 17, 21, 24, 26, 28, 29, 36, and 39 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.
Claim 2, as now amended, stipulates that the liposome contains “at least one immunomodulator selected from a STING agonist”. The term “a STING agonist” appears to refer to one STING agonist. However, the expression “at least one immunomodulator” refers to one or more, and “is selected from” implies more than one option. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter, in particular whether the liposome requires one or more STING agonist, or is limited to merely one STING agonist.
Claim 26 stipulates that the method treats “the early infection of the respiratory tract”. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “the early infection”, and what duration or stage of an infection is “early” vs. “not early”. For example, if the infection has persisted for 1 day at the time treatment is commenced, does this constitute treating “the early infection”, or not? What if administration commences after the infection has persisted for 10 hours? How about 36 hours?
Claim 29, as now amended, stipulates in a wherein clause that the subject is “a mammal” or is selected from the group consisting of those recited, all of which are mammals. The claim thus recites a broad limitation, together with a narrower limitation that falls within the purview of the broad limitation, in the alternative in the same claim, which is indefinite.
Claim 39, which depends from claim 2, stipulates in a wherein clause that “the STING agonist is…poly(I:C)”. In the previous claim set, claim 2 stipulated that the liposome contained at least one immunomodulator selected from poly(I:C) and a STING agonist. Clearly, in the method previously claimed, “poly(I:C)” and “a STING agonist” were two distinct elements. In claim 39, however, poly(I:C) is a STING agonist. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 4, 15, 17, 21, 24, 26, 28, 29, 36, and 39 are (also) indefinite for depending from an indefinite claim.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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