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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 25, 27 – 28, 30, 34 – 35; amended claims 2, 4, 6, 9 – 12, 18, 20 and 23; and the species of a) transferrin and b) Fuchs endothelial corneal dystrophy the reply filed on March 30, 2026 is acknowledged. The traversal is on the grounds that restriction is optional, there is no burden to examine all groups, and that it should not incur additional cost to applicant. This is not found persuasive because as stated in the restriction requirement, the groups do not link so as to form a single inventive concept under PCT Rule 13.1. The groups lack unity of invention because even though the inventions of these groups require the technical feature of a composition comprising nanoparticles, a molecule and antioxidant, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US20200237925A1, cited on the ISR filed 11.21.2023 in the instant application. The reference teaches compositions comprising nanoparticles (0020, claim 5), peptides (molecules) that are cell penetrating (claim 1) in combination with antioxidants vitamin C, E and/or glutathione (claim 4).
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s request for rejoinder is acknowledged. Pursuant to the procedures set forth in the Official Gazette notice dated March 26, 1996 (1184 O.G. 86), claims directed to the process of making or using the patentable product, previously withdrawn from consideration as a result of a restriction requirement are subject to being rejoined if they include all the limitations of the allowable product.
In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim. A withdrawn claim that does not require all the limitations of an allowable claim will not be rejoined. Furthermore, where restriction was required between a product and a process of making and/or using the product, and the product invention was elected and subsequently found allowable, all claims to a nonelected process invention must depend from or otherwise require all the limitations of an allowable claim for the claims directed to that process invention to be eligible for rejoinder. See MPEP § 821.04(b). In order to retain the right to rejoinder, applicant is advised that the claims to the nonelected invention(s) should be amended during prosecution to require the limitations of the elected invention. Failure to do so may result in a loss of the right to rejoinder.
Claims 1 – 2, 4, 6, 9 – 12, 18, 20, 23, 25, 27 – 28, 30, 34 – 35, 37 – 39 are pending; claims 1, 37 – 39 are withdrawn; claims 2, 4, 6, 9 – 12, 18, 20, 23, 25, 27 – 28, 30, 34 – 35 have been considered insofar as the read on the elected species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 21, 2023; October 28, 2025; May 4, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, line 2, “CECs” should first be spelled out followed by the abbreviation.
Appropriate correction is required.
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 2, 4, 6, 9 – 12, 18, 20, 23, 25, 27, 28, 30 and 34 - 35 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.
Claim 25 and its dependents are drawn to a method of “preventing, inhibiting or treating a disease” comprising administering “an effective amount” of a composition to “a tissue.” These claims are considered genus claims that encompass a wide array of diseases, tissues and effective amounts. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of diseases that might be treated, tissues that might be administered the composition and effective amounts for all of the diseases that might be treated.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all diseases that might be treated, effective amounts administered and all of the tissues that might be treated. Examples of variations include but are not limited to neurodegenerative diseases, inflammatory bowel disease, atherosclerosis, cancer, psoriasis, kidney disease, hematologic diseases, COPD and metabolic diseases; all of these diseases would likely require different “effective amounts” and different tissue targeted for administration. Further, the claim recites “preventing, inhibiting or treating” which certainly indicates variability in the “effective amount.” Moreover, the possible variations of diseases, effective amounts and tissues are limitless with potentially millions of types of diseases, let alone the effective amounts to prevent, inhibit or treat said diseases and the various tissues to which the composition might be administered. The instant disclosure generically discloses treating only ocular diseases wherein the active composition is administered to the eye via ophthalmic solution (0006) or topical to the skin (0007). The single example is drawn to treating Fuchs endothelial corneal dystrophy (FECD) with ubiquinol cRGD-nanoparticles (example 4) with no disclosure of how treatment was carried out. The disclosure fails to identify any other tissue or any other ocular disease, let alone any other disease that exists (what is encompassed by the claim language).
Claim 27 recites the tissue may comprise “skin” however the disclosure fails to disclose applying any composition in any effective amount to the skin, such that any disease is prevented, inhibited or treated.
The purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by them. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." The specification lacks sufficient variety of species of disease, tissue or effective amount to reflect this variance in the genus since the specification does not provide any examples of such a genus of disease, tissue or effective amount. Accordingly, the specification fails to provide adequate written description for the genus “disease,” “tissue,” or “effective amount” and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these diseases, tissue and effective amounts, the specification does not describe the claimed methods in such full, clear, concise and exact terms so as to indicate that Applicant had possession of these methods at the time of filing of the present application.
Thus, the written description requirement has not been satisfied.
Claims 2, 4, 6, 9 – 12, 18, 20, 23, 25, 27, 28, 30 and 34 – 35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating Fuchs endothelial corneal dystrophy (FECD) with ubiquinol cRGD-nanoparticles, does not reasonably provide enablement for a) preventing, inhibiting FECD or preventing; or b) inhibiting or treating any disease in a mammal to any tissue in any effective amount. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The analysis of whether a claim is supported by the disclosure requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the art to make and use the claimed invention. The standards for determining whether this burden has been met, is by posing the question: is the experimentation needed to practice the invention undue or unreasonable? While a patent need not teach what is well known in the art, it must teach one in the art how to make and/use the claimed invention without undue experimentation. There are many factors to be considered when determining whether the disclosure satisfies the enablement requirement.
The claims are drawn to a method for preventing, inhibiting or treating any disease in a mammal by administering a composition to any tissue at any effective amount. The invention is drawn to treating FECD with ubiquinol cRGD-nanoparticles (see all examples). It is near impossible to predict what disease might be treated, let alone prevented or inhibited, with the claimed composition, and what the effective amount might be tied to every disease state that occur s in mammals. The disclosure teaches one in the art to treating FECD with ubiquinol cRGD-nanoparticles (see all examples), however is silent to the tissue to which the active is administered (e.g. topical to the eye, systemic or another tissue). The specification fails to exemplify or even correlate the treatment to any other condition of the eye in terms of similar diagnosis, etiology or progression of disease, let alone any disease that might occur in any mammal. In this regard, the specification fails to teach one how to make and use the active composition for preventing, inhibiting or treating any other disease. The specification lacks any disclosure for preventing or inhibiting FECD, let alone any disease, any tissue, and/or at any effective amount.
Therefore, at the time the application was filed, the specification would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
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, 6, 9 – 12, 18, 20, 23, 25, 27, 28, 30 and 34 – 35 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 25 and its dependents are drawn to a method of preventing, inhibiting or treating a disease, however are rendered indefinite for reciting “an effective amount” since the claim encompasses innumerous diseases, innumerous amounts to prevent those disease, innumerous amounts to inhibit the diseases, and innumerous amounts to treat the diseases. Moreover, the claims are indefinite because the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art (MPEP 2173.05(c)(III)).
Claim 25 and its dependents are further indefinite for reciting “nanoparticles having” as it is unclear how “having” intends to limit the claim. It is unclear if the nanoparticles comprise, consist essentially of, or consist of the molecules that follow, or if the molecules themselves are the nanoparticles. Clarification is required.
In claim 30, the phrase “candidate for ocular surgery” is not adequately defined by the claim language or specification, rending the claim indefinite. For purposes of examination, the phrase is interpreted to include any subject.
Claims 2, 4, 6, 9 – 12, 18, 20 and 23 are rendered indefinite for reciting “The composition” as the phrase lacks proper antecedent basis and does not specifically further define the method of claim 25.
Claim 2 is indefinite for reciting the composition is a sustained delivery composition because it merely states a function without limitations to achieve the function. It is unclear if the claim requires unrecited limitations to make the composition a “sustained delivery composition.” For purposes of examination, the claim is interpreted to have no additional limitations to the composition and does not specifically further limit the composition.
In claim 20, “the particles” lacks proper antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 2, 4, 6, 9 – 12, 18, 20 and 23 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
A dependent claim shall contain (i) a reference to a claim previously set forth, and (ii) then specify a further limitation of the subject matter claimed. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 4, 6, 9 – 12, 18, 20, 23, 25, 27, 28, 30 and 34 – 35 are rejected under 35 U.S.C. 103 as being unpatentable over Salem et al. (WO 2020/180985, cited by 371 document US 2022/0249399) in view of Asasutjarit et al. (2020).
Regarding claims 6, 9 – 12 (insofar as the read on the elected species), 18, 25 and 34 – 35, Salem teaches a method for treating humans with Fuchs endothelial corneal dystrophy (FECD) (a disease in a mammal) (0012) comprising administering to the eye (a tissue) an effective amount (claim 43) of a composition comprising lipid or polymer nanoparticle carriers (0010) and antioxidants such as ubiquinol, MitoQ, vitamin A, vitamin E, vitamin C, ascorbate-2-phosphate, idebenone, PQQ, NAC, palmitate, reduced glutathione, or a C14-C18 saturated fatty acid (0011).
Salem does not teach the method wherein the composition includes cell targeting or penetrating molecules on the lipid nanoparticles. However, Asasutjarit teaches targeted delivery of actives to the eye can increase efficacy of treatment and lessen side effects (abstract). Specifically, Asasutjarit teaches transferrin conjugated nano-liposomes (e.g. lipid nanoparticles) are effective drug delivery systems beyond topical eye drops in that the system improves physiochemical properties of the drug, facilitates drug absorption allowing for higher drug availability, controls a sustained release to target tissues leading to a decrease in administration frequency (abstract, p.2). Asasutjarit further teaches modifying the liposome with transferrin allows for targeted delivery to cells with transferrin receptors (e.g., corneal cells) (p.2). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated by Asasutjarit to modify the lipid nanoparticle carriers of Salem with transferrin for the advantages disclosed therein, and with a reasonable expectation for successfully treating FECD.
Regarding claims 27 - 28, Salem teaches administering to diseases of tissues including the corneal endothelium, corneal epithelium, corneal keratocytes, corneal stroma, or corneal nerves, conjunctival epithelium, conjunctival stroma, Tenon's capsule, trabecular meshwork, corneoscleral angle, lens epithelium, or lens (0013).
Regarding claim 30, the subject may be a mammal or human will undergo ocular surgery (candidate for surgery), had prior surgery, has ocular disease, exposure to ultraviolet light or oxidative stress (e.g. FECD) (0003, 0012, 0014).
Regarding claim 2, the composition may be in the form of drug eluting devices such as impregnated contact lens (or a sustained delivery) (0015).
Regarding claim 4, since the SOD2 mimetics are recited in the alternative to other antioxidants, these limitations are not required by the claim language.
Regarding claim 20, Salem teaches the antioxidant-carrier complex has a diameter of 200 – 400 nm, which falls in the claimed range of 50 – 500 nm (0010).
Regarding claim 23, the composition may further include a full or partial thickness cornea (0010).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 4, 6, 9 – 12, 18, 20, 23, 25, 27, 28, 30 and 34 – 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, 8, 10, 13, 18, 19, 26, 29, 35, 30, 40, 42, 43, 44 and 46 of copending Application No. 17/436 042 in view of Asasujarit et al. (2020).
The copending application claims a method of treating corneal endothelium, corneal epithelium, corneal keratocytes, corneal stroma, corneal nerves, conjunctival epithelium, conjunctival stroma, Tenon's capsule, trabecular meshwork, corneoscleral angle, lens epithelium, or lens tissue in a mammal, comprising administering to a mammal in need thereof an effective amount of a composition comprising an anti-oxidant comprising one or more of ubiquinol, MitoQ, vitamin E, vitamin C, ascorbate-2-phosphate, idebenone, pyrroloquinoline quinone (PQQ), N-Acetyl-L-cysteine (NAC), palmitate, reduced glutathione, or a C14-C18 saturated fatty acid (claims 1, 4, 5, 10, 35), lipid nanoparticles (claims 7, 8).
The application does not teach the method wherein the composition includes cell targeting or penetrating molecules on the lipid nanoparticles. However, Asasutjarit teaches targeted delivery of actives to the eye can increase efficacy of treatment and lessen side effects (abstract). Specifically, Asasutjarit teaches transferrin conjugated nano-liposomes (e.g. lipid nanoparticles) are effective drug delivery systems beyond topical eye drops in that the system improves physiochemical properties of the drug, facilitates drug absorption allowing for higher drug availability, controls a sustained release to target tissues leading to a decrease in administration frequency (abstract, p.2). Asasutjarit further teaches modifying the liposome with transferrin allows for targeted delivery to cells with transferrin receptors (e.g., corneal cells) (p.2). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated by Asasutjarit to modify the lipid nanoparticle carriers of the co-pending application with transferrin for the advantages disclosed therein, and with a reasonable expectation for successfully treating FECD.
The mammal has an ocular disease or is a candidate for surgery (claim 37) or FECD (claim 43).
The composition is delivered via intraocular device (or sustained delivery) (claim 44); forms particles having diameters of 100 – 500 nm (claim 18, 19); and includes full or partial thickness cornea (claim 13).
This is a provisional nonstatutory double patenting rejection.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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