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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 17 June 2026, have been entered in full. Claims 25-27 are canceled. Claims 1, 2, 4, 5, 11-14 and 24 are amended. Claims 1-24 are under examination.
Withdrawn Objections And/Or Rejections
The objection to the disclosure, as set forth at pages 2-3 of the previous Office Action (20 March 2026), is withdrawn in view of the amendment (17 June 2026).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 remains rejected under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Bernstein et al. (US 2022/0175844; published June 9, 2022). The basis for this rejection is set forth at pages 3-4 of the previous Office Action (20 March 2026).
APPLICANT’S ARGUMENTS: Applicant argues that claim 1 has been amended to specify treating NAION by intranasally administering "a pharmaceutical composition consisting of human nerve growth factor and one or more pharmaceutically acceptable carriers or excipients".
Applicant argues that Bernstein describes the identification of nerve lamina region neural progenitor cells ("ONLR-NPC") and lists at least 33 proteins produced by ONLR-NPC. Applicant directs the Examiner’s attention to Tables 1, 2 and paragraphs 0023, 0068-0079. Applicant cite case law. Applicant argues that arriving at the present claims would require at least, picking, choosing, and combining various disclosures in Bernstein, particularly since this reference never suggests that intranasal treatment with NGF alone is useful for treating any optic disorder, much less treating NAION.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
Bernstein et al. teach at the following paragraphs:
[0067] The invention is directed to methods of treating or preventing optic nerve diseases. Because ONLR-NPCs are thought to play a role in supporting glial cell growth and development, and by extension, myelination of axons as they emerge from the eye, ONLR-NPCs and the factors they secrete are likely to have activity in treating or preventing optic nerve hypoplasia, regional axonal dysfunction and hypomyelination. ONLR-NPCs and the factors they secrete may also enable glial cell replacement and remyelination.
[0068] The methods of treating or preventing optic nerve diseases of the invention comprise administering to a subject in need thereof a therapeutically effective amount of a composition comprising one or more of:
[0069] (i) a population of ONLR-NPCs,
[0070] (ii) ONLR-NPC conditioned media,
[0071] (iii) an ONLR-NPC lysate,
[0072] (iv) an ONLR-NPC extract, and
[0073] (v) one or more factors secreted by ONLR-NPCs,
thereby treating or preventing an optic nerve disease in the subject.
[0074] Optic nerve diseases that may be treated using the methods of the present invention include, but are not limited to, open-angle glaucoma, angle-closure glaucoma, optic nerve hypoplasia, optic nerve hypomyelination, regional axonal dysfunction, nonarteritic anterior ischemic optic neuropathy (NAION), and optic neuritis.
[0075] In one aspect, the composition comprises one or more factors secreted by ONLR-NPCs, wherein the factors are selected from the group consisting of Nerve Growth Factor (NGF), Latent Transforming Growth Factor-Beta 1 (TGF-β1), Fibroblast Growth Factor 1 (FGF1), Vascular Endothelial Growth Factor (VEGF), Mesenchymal Astrocyte Neurotrophic Factor (MANF), Connective Tissue Growth Factor (CTGF), and Insulin-like Growth Factors-1 and -2 (IGF-1 and IGF-2).
[0078] Administration of the composition may be via any of the means commonly known in the art. When administered to the eye, such routes include topical and intraocular, subconjunctival and retrobulbar injections. When administered to sites other than the eye, such routes include intravenous, intraperitoneal, intramuscular, subcutaneous and intradermal routes of administration, as well as topical, nasal application, by inhalation, orally, rectally, vaginally, or by any other suitable mode.
[0079] The pharmaceutical compositions of the present invention may be formulated, for example, for topical, intraocular, oral, sublingual, intranasal, rectal, transdermal, mucosal, pulmonary, or parenteral administration. [0081] In the methods of the invention, the composition administered to the subject may be in the form of a pharmaceutical formulation comprising (a) one or more of (i) a population of ONLR-NPCs, (ii) ONLR-NPC conditioned media, (iii) an ONLR-NPC lysate, (iv) an ONLR-NPC extract, and (v) one or more factors secreted by ONLR-NPCs and (b) a pharmaceutically acceptable carrier.
Contrary to the presented arguments, Bernstein teaches a Markush group of factors; i.e. composition comprises one or more factors secreted by ONLR-NPCs, wherein the factors are selected from the group consisting of Nerve Growth Factor (NGF), Latent Transforming Growth Factor-Beta 1 (TGF-β1), Fibroblast Growth Factor 1 (FGF1), Vascular Endothelial Growth Factor (VEGF), Mesenchymal Astrocyte Neurotrophic Factor (MANF), Connective Tissue Growth Factor (CTGF), and Insulin-like Growth Factors-1 and -2 (IGF-1 and IGF-2).
The teachings of Bernstein et al. encompasses a pharmaceutical composition having just one factor, such as NGF. Bernstein et al. teach treating NAION comprising intranasally administering a pharmaceutical composition comprising nerve growth factor (NGF) and a pharmaceutically acceptable carrier.
The scientific reasoning and evidence as a whole indicated that the rejection should be maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
1. Claims 1, 2, 5-8, 10-13, 15, 18-21, 23 and 24 remain are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein et al. (US 2022/0175844; published June 9, 2022) in view of Chen et al. (HUMAN CELL CO, WO 2022026468, published Feb 3, 2022).
APPLICANT’S ARGUMENTS: Applicant argues that the previous Office Action states that Berstein does not "explicitly teach that the daily administration occurs for at least one week" or "an amount of administered NGF” or “the SEQ ID Nos of NGF", but that Chen teaches "human NGF variants, compositions comprising human NGF variants and therapeutic uses for human NGF variants" and that “it would have been obvious to modify a method for treating NAOIN wherein the human NGF is intranasally administered to the human daily for at least one week in an amount between 15 ug and 2100 ug, wherein the human NGF comprises SEQ ID NO:1."
Applicant submits that even if one were to: 1) select a composition that only contained NGF from the least 33 proteins produced by ONLR-NPC suggested by Bernstein and not NGF in combination with one or more of the more than 33 factors suggested by Bernstein; 2) select NAION from among the various disorders suggested by Bernstein; and 3) select intranasal administration from among the various routes of administration suggested by Berstein, one would not have a reasonable expectation of success.
Applicant argues that there is no data or reasoning in Bernstein to suggest that NAION or any other disorder can be treated by intranasally administering human nerve growth factor. Applicant maintains that Chen adds nothing of significance regarding either intranasal administration of NGF to treat an optical disorder or use of NGF to treat NAION. Applicant maintains that given these teachings; one would not have a reasonable expectation of success in practicing the presently claimed invention. Applicant discusses the claimed invention and the instant specification.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
a. The Examiner has already discussed the Berstein reference above. Bernstein et al. teach treating NAION comprising intranasally administering a pharmaceutical composition comprising nerve growth factor (NGF) and a pharmaceutically acceptable carrier.
b. Regarding Applicant’s argument that there is no data or reasoning to in Bernstein to suggest that NAION or any other disorder can be treated by intranasally administering human nerve growth factor;
MPEP 2121 teaches the following: EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT. A prior art reference provides an enabling disclosure and thus anticipates a claimed invention if the reference describes the claimed invention in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention; "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm.Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006). See also MPEP § 2122.
c. As was stated in the previous Office Action, Bernstein et al. do not explicitly teach that the daily administration occurs for at least one week. Bernstein et al. do not teach an amount of administered NGF or the SEQ ID Nos of NGF.
Chen et al. teach a human NGF variant peptide that is 100% identical to instant SEQ ID NO:1. Chen et al. teach that the human NGF variants and pharmaceutical compositions thereof are useful for treating optic glioma and advanced optic nerve atrophy. Chen et al. teach that the pharmaceutical compositions of the present invention can be administered intranasally. Chen et al. teach the concentration of the invention components in the pharmaceutical formulations of 1 µg/ml, e.g., at or at least about 100 µg/ml to as much as 10 mg/ml. Chen et al. teach that administration comprises daily, weekly, or a plurality of times per week administration for greater than two weeks or for greater than two months.
d. Based on the teachings, it would have been obvious to combine Bernstein with Chen and expect success. Bernstein et al. teach treating non-arteritic anterior ischemic optic neuropathy (NAION) comprising intranasally administering NGF. NAION causes a loss of blood flow (i.e. ischemia) to the optic nerve in the eye resulting in atrophy. Chen et al. teach intranasally administering NGF to treat advanced optic nerve atrophy. Knowing the amino acid sequence of NGF, as taught by Chen, allows the skilled artisan to easily make large amounts of the NGF protein recombinantly.
The scientific reasoning and evidence as a whole indicated that the rejection should be maintained.
2. Claims 1-8, 10, 11, 13, 15-21 and 23 remain rejected under 35 U.S.C. 103 as being unpatentable over Bernstein et al. (US 2022/0175844; published June 9, 2022) in view of De Young et al. (WO 97/17087, GNENETECH, published May 15, 1997) and Frey, II (US 2002/0169102, published Nov. 14, 2002).
APPLICANT’S ARGUMENTS: Applicant argues that neither De Young nor Frey add anything of significance to the teachings of Berstein. Applicant argues that both references are entirely speculative regarding the dose of NGF that might be administered to treat a variety of disorders (De Young) or to support the development of donor cells in the CNS (Frey). Applicant argues that neither reference presents any data or reasoning suggesting that intranasally administered NGF at any dose or using any schedule, is effective for treating any disorder, much less an optic nerve disorder such as NAION. Applicant argues that given these teachings, one would not have a reasonable expectation of success in practicing the presently claimed invention.
Applicant’s arguments have been fully considered but are not found persuasive for reasons discussed above and reasons of record.
De Young teaches intranasally administering human recombinant NGF to induce nerve cell growth and repair. De Young teaches doses/dosages as recited in the instant claims. Fray teaches intermittent cycles for administering human recombinant NGF. Frey teaches intranasally administering NGF.
The scientific reasoning and evidence as a whole indicated that the rejection should be maintained.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Objections
Claims 12 and 24 are objected to because of the following informalities:
Claims 12 and 24 have a typo: “human growth factor” should be “human nerve growth factor”. See claim 12, lines 3-4 and claim 24, lines 3-4. Appropriate correction is required.
Claim 24, line 2 recites an extraneous phrase “(of “ that should be deleted.
Claim Rejections-35 USC § 112 First paragraph, Written description, New matter
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 1-24 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 specification as originally filed does not provide support for the invention as now claimed:
“..and one or more pharmaceutically acceptable….". (see claim 1).
Applicant's amendment, filed 17 June 2026, asserts that no new matter has been added, but does not provide sufficient direction for the written description for the above-mentioned “limitations”.
The Examiner has found the following teachings:
[0107] “A further object of the present invention relates to a pharmaceutical composition comprising nerve growth factor (NGF) and at least one pharmaceutically acceptable..”
The claim amendment results in New Matter for the following reasons.
The instant specification recites the teaching “..and at least one..”.
The limitation “at least one” encompasses a quantity of one or potentially two, three or any higher number of pharmaceutically acceptable carriers or excipients.
The claim has now been amended to recite, “..and one or more..”.
The new limitation “one or more” encompasses a limitation of ONLY one acceptable carrier or ONLY one acceptable excipient. The new limitation now has an upper limit (i.e. one).
The new claim amendment has eliminated a quantity of carriers or excipients that was not originally excluded, resulting in newly changing the scope of disclosure and the scope of that which was contemplated at the time of filing, resulting in new matter.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to provide specific written support for the “limitations” indicated above or rely upon the limitations set forth in the specification as filed.
Claims 2-24 are included in this rejection insofar as they ultimately depend from claim 1 and does not resolve the issue discussed above.
Conclusion
No claims are allowed.
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 REGINA M DEBERRY whose telephone number is (571)272-0882. The examiner can normally be reached M-F 9:00-6:30 pm (alt Fri).
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/R.M.D/Examiner, Art Unit 1647 7/7/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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