DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 12/23/2025.
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 .
Status of the Claims
Claims 23-25, 28, 29, 31-34, 39, 41, 49 and 51have been amended. Claims 1-22, 26, 27, 37, 38 and 42-48 have been cancelled. Claims 54-71 are newly added. Accordingly, claims 23-25, 28-36, 39-41 and 49-71 remain pending in the application. New claims 62-69 are drawn to a nonelected method. See Restriction Requirement dated 3/17/2025 and subsequent Response dated 6/17/2025. Applicant elected Group I (composition) without traverse and, as such, claims 62-69 (method of using) are withdrawn without traverse. Claims 23-25, 28-36, 39-41 and 49-61 and 70-71 are under examination.
Information Disclosure Statement
The IDS dated 12/23/2025 has been considered. A signed copy is enclosed herewith.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claim 26 under 35 USC 112(b) moot. Specifically, the claim has been cancelled. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection under 35 USC 103 over Carnes in view of Moon moot. Specifically, the claims have been amended to include liposomes and applicant’s arguments are persuasive regarding “liposome” as it relates to the cited references. Thus, said rejection has been withdrawn.
Maintained Rejections
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 25, 28 and 33 stand 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 25 recites, “wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules comprise one or more phospholipids”. Claim 25 depends from claim 23. Claim 23 recites, “a plurality of pulmonary surfactant-biomimetic molecules, wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules comprise polyethylene glycol”. The claim is indefinite because it is unclear if the pulmonary surfactant-biomimetic molecules comprise the combination of polyethylene glycol and one or more phospholipids or if the polyethylene glycol and the phospholipids are separate populations of the pulmonary surfactant-biomimetic molecules.
Claim 28 recites, “wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules are 1,2-dipalmitoyl-sn-glycero-3- phosphocholine (DPPC), one or more of the pulmonary surfactant-biomimetic molecules are 1,2- dipalmitoyl-sn-glycero-3-phospho-(1'-rac-glycerol) (DPPG), and one or more of the pulmonary surfactant-biomimetic molecules are cholesterol”. Claim 28 depends from claim 23. Claim 23 recites, “a plurality of pulmonary surfactant-biomimetic molecules, wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules comprise polyethylene glycol”. The claim is indefinite because it is unclear if a population of pulmonary surfactant-biomimetic molecules contain only DPPC, DPPG, and cholesterol or if PEG is further permitted. If the latter is intended, “consisting of” language is suggested instead of the word “are”. Clarification is requested.
Claim 33 recites, “wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules are DPPC, one or more of the plurality of pulmonary surfactant-biomimetic molecules are DPPG, one or more of the plurality of pulmonary surfactant-biomimetic molecules are cholesterol, one or more of the plurality of pulmonary surfactant-biomimetic molecules are DPPE-PEG2000, one or more of the plurality of pulmonary surfactant-biomimetic molecules are phosphatidylethanolamine, one or more of the plurality of pulmonary surfactant-biomimetic molecules are phosphatidylinositol, one or more of the plurality of pulmonary surfactant-biomimetic molecules are phosphatidylserine, one or more of the plurality of pulmonary surfactant-biomimetic molecules are sphingomyelin, or one or more of the plurality of pulmonary surfactant-biomimetic molecules are lysophospholipid”. Claim 33 depends from claim 23. Claim 23 recites, “a plurality of pulmonary surfactant-biomimetic molecules, wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules comprise polyethylene glycol”. The claim is indefinite because only one of the species of surfactant-biomimetic molecules recited in claim 33 require PEG even though PEG is set out in claim 23 and, as such, it is unclear whether PEG is or is not required. Additionally, the use of the word “are” is unclear as to whether the limitations are intended to be “open-ended” or closed. If the formed is intended, “consisting of” language is suggested instead of the word “are”. Clarification is requested.
Response to Arguments
Applicant's arguments, filed 12/23/2025, regarding the 112(b) rejections have been fully considered but they are not persuasive.
Applicant argues that the amendments overcome the indefinite issues raised. Remarks, pages 2-3.
In response, it is respectfully submitted that after further consideration, the amendments do not remedy the indefinite issues of the affected claims. The rejections above have been modified to take into account the new claim language. Clarification is still needed.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejections are maintained.
New Rejections
In light of Applicant’s amendments and after further consideration, the following rejections have been newly added:
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 23-25, 29-36, 39-41, 49-54-56, 58-61, 70 and 71 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. The claims require a negatively charged liposome or nanoparticle. The liposome/nanoparticle comprises pulmonary surfactant biomimetic molecules, wherein one or more of the plurality of pulmonary surfactant biomimetic molecules comprise polyethylene glycol (non-ionic). Additional pulmonary surfactant biomimetic molecules claimed include DPPC (neutral), DPPG (anionic), cholesterol (neutral), DPPE (neutral), etc. The instant specification only names DPPG, phosphatidylinositol and phosphatidylserine as known anionic molecules. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species (MPEP 2163). A "representative number of species" means that the species which are adequately described are representative of the entire genus (MPEP 2163). In this case, three species is not a sufficient number of representative species of all pulmonary surfactant biomimetic molecules having a negative charge. The structures that correlate to the “negatively charged” liposomes/nanoparticles have not been sufficiently described. Thus, the claims contain 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, at the time the application was filed, had possession of the claimed invention.
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 23-25, 29-36, 39-41, 49-54-56, 58-61, 70 and 71 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the component that yields a negative charge of the liposome/nanoparticle. The claims require a negatively charged liposome or nanoparticle. The liposome/nanoparticle comprises pulmonary surfactant biomimetic molecules, wherein one or more of the plurality of pulmonary surfactant biomimetic molecules comprise polyethylene glycol (non-ionic). Additional pulmonary surfactant biomimetic molecules claimed include DPPC (neutral), DPPG (anionic), cholesterol (neutral), DPPE (neutral), etc. but are not required. The instant specification describes a limited number of negatively charged liposomal/nanoparticle components (see 112(a) rejection above). Thus, it is unclear what components are required in order to impart a negative charge on the liposome/nanoparticle.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 23-25, 33, 40, 41, 49 and 51 are rejected under 35 U.S.C. 102()(1) as being anticipated by Vance et al. (US 2014/0329889 A1, Nov. 6, 2014, hereafter as “Vance”).
The clamed invention is drawn to a composition comprising: a negatively charged liposome, comprising a plurality of pulmonary surfactant-biomimetic molecules, wherein one or more of the plurality of pulmonary surfactant-biomimetic molecules comprise polyethylene glycol (PEG); and one or more cargo molecules enveloped by the liposome, wherein the one or more cargo molecules are stimulator of interferon genes (STING) agonists that are natural or synthetic cyclic dinucleotides; and a method of making thereof.
Regarding instant claims 23, 24, 41 and 51, Vance teaches a method for increasing the production of a type I interferon (IFN) in a subject, the method includes the step of administering to the subject an amount of a 2'-5' phosphodiester linkage comprising cyclic-di-nucleotide active agent effective to increase the production of the type I interferon in the subject ([0016]). Vance teaches a method for increasing a stimulator of interferon genes (STING) mediated response in a subject, the method includes the step of administering to the subject an amount of a STING active agent effective to increase a STING mediated response in the subject, e.g., a cyclic-di-nucleotide ([0022]-[0024]). Vance teaches the cyclic dinucleotide or STING active agents may be encapsulated in a delivery vehicle comprising liposomes in the pharmaceutical composition and said liposomes may be modified to render their surface more hydrophilic by adding polyethylene glycol (“pegylated”) to the bilayer, which increases their circulation time in the bloodstream ([0187]). Vance incorporates by reference USPN 5,013,556 at [0187] which teach liposomes having enhanced circulation time (‘556 – title). ‘556 teaches PEG-PE liposomes, wherein PEG-PE is negatively charged and wherein PE is a lipid amine (col. 10, lines 1-12). ‘556 also teaches that total liposome charge may be varied to modulate liposome stability, to achieve desired interactions with or binding to drugs (col. 10, lines 3-16). ‘556 further teaches mixing liposome-forming lipids with an active agent (col. 10, lines 36-49).
Regarding instant claims 25, 33 and 49, ‘556 further teaches the inclusion of phospholipids such as phosphatidylethanolamine (col. 4, lines 44-53).
Regarding instant claim 40, Vance further teaches that the pharmaceutical composition comprises pharmaceutically acceptable carrier or diluents ([0093]).
Thus, the teachings of Vance render the instant claims anticipated.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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