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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on December 23, 2025 has been entered.
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
3. Applicant’s amendment filed December 23, 2025 is acknowledged. Claims 6-20, 22-26, 28-32, 34-35, 39-40, 42-50, 52-65, 67-115 and 119-121 are canceled. Claims 1-2 are amended. Claims 1-5, 21, 27, 33, 36-38, 41, 51, 66 and 116-118 are pending in this application. Claims 21, 37, 66 and 116-118 are withdrawn without traverse (filed 3/9/2022) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 9, 2022.
4. Claims 1-5, 27, 33, 36, 38, 41 and 51 are under examination with respect to corneal dystrophy and a ROCK inhibitor in this office action.
5. Applicant’s arguments filed on December 23, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections/Objections Withdrawn
6. The objection to claim 2 is withdrawn in response to Applicant’s amendment to the claim.
The rejection of claims 1-5, 27, 33, 36, 38, 41, 51 and 120-121 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in response to Applicant’s amendment to the claims.
The rejection of claims 120-121 under 35 U.S.C. 103 as being unpatentable over Bevec (US2010/0204136) in view of Ru et al. (Sci. Rep. 20 5:18619. DOI:10.1038/srep18619), Hedley et al. (US7169603) and Yamaguchi et al. (US2016/0271224) is moot because the claims ae canceled.
Claim Rejections/Objections Maintained
In view of the amendment filed on December 23, 2025, the following rejections are maintained.
Claim Rejections - 35 USC § 103
7. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5, 27, 33, 36, 38, 41 and 51 stand rejected under 35 U.S.C. 103 as being unpatentable over Bevec (US2010/0204136) in view of Ru et al. (Sci. Rep. 20 5:18619. DOI:10.1038/srep18619), Hedley et al. (US7169603) and Yamaguchi et al. (US2016/0271224). The rejection is maintained for the reasons of record and the reasons set forth below.
Claims 1-5, 27, 33, 36, 38, 41 and 51 as amended are drawn to a method for enhancing survival and reducing cell death of corneal endothelial cell (CEC) in a subject, the method comprising locally administering to an eye of the subject via eye drop or injection a composition comprising -MSH at a concentration of 10-8 mg/mL, 10-5 mg/mL, 10-3 mg/mL, 10-2 mg/ml or 10-1 mg/mL, thereby enhancing survival and reducing cell death of CECs.
Response to Arguments
On p.8-15 of the response, Applicant argues that Bevec fails to teach or suggest the claimed method recited in instant claims because: i) Bevec teaches the use of peptide Ac-Ser-Tyr-Ser-Met-Glu-His-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2 [a-MSH] as a therapeutic agent for treating different diseases including inflammatory disease, neurodegenerative disease, infectious disease does not teach the claimed method for enhancing survival and reducing cell death of CECs in a subject comprising locally administering to an eye of the subject via eye drop or injection a composition comprising an a-MSH at a concentration of 10-8 mg/mL, 10-5 mg/mL, 10-3 mg/mL, 10-2 mg/ml or 10-1 mg/mL, thereby enhancing survival and reducing cell death of CECs”. The concentration of 10-1ug/ml disclosed by Bevec is a possible concentration. Bevec does not teach eye drop or injection; ii) Ru, Hedley, Yamaguchi and Okumura do not remedy the deficiencies of Bevec because none of the references teach or suggest locally administering to an eye of the subject via eye drop or injection a composition comprising an a-MSH at a concentration of 10-8 mg/mL, 10-5 mg/mL, 10-3 mg/mL, 10-2 mg/ml or 10-1 mg/mL, thereby enhancing survival and reducing cell death of CECs. Ru teaches application of a-MSH at different doses in a dry eye model, Hedley teaches the use of treating diseases characterized by inflammation and/or autoimmunity including uveitis or diabetes but does not teach enhancing survival and reducing cell death of CECs (Examples 5-8) and Yamaguchi teaches methods of reducing CEC loss including selecting a subject identified as having an eye with reduced numbers of corneal nerves compared to a reference eye by administering VIP or a nucleic acid encoding but does not teach a-MSH. Applicant further cites MPEP2141, In re Vaeck, Novatis Pharm. v. West-Ward Pharm., MPEP2144.05, KSR International Co. v. Teleflex Inc., MPEP 2121.01, Elan Pharm., Inc. v. Mayo Found. For Med. Educ. & Research, Raytheon Technologies v. General Electric Corp.in support of the arguments.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ru, Hedley and Yamaguchi are cited to support different doses and amounts recited in claims 1, 36 and the frequencies and regiments recited in claim 38.
In this case, Bevec teaches a method of using the same material (i.e. a composition comprising -MSH), the same active step (i.e. administering to an eye of the subject) in the same patent population as instant claims because the diseases treated in the Bevec’s method include corneal dystrophy and other diseases recited in dependent claims 2 and 5.
Bevec teaches a method of treating different eye diseases comprising locally administering a composition comprising -MSH to an eye of the subject with different eye diseases, wherein the different diseases include corneal dystrophy (see p. 16, line 42), Iridocorneal endothelial syndrome, endothelial syndrome (see p.19, line 23), glaucoma, neovascular glaucoma, cataract, retinopathy, diabetic retinopathy, diabetic maculopathy, corneal edema, occlusion of retinal artery, obstruction of central artery of retina, occlusion of retinal vein, ocular edema, ocular hypertension, macular edema, aged macular degeneration, aged disciform macular degeneration ([0062]; [0133]), cystoid macular edema….as recited in claims 2 and 5 (see [0133])) (see paragraphs [0136]; [0131]; [0133]; [0126]; [0140]).
The corneal dystrophy and other diseases recited in claims 2 and 5 disclosed by Bevec is also a non-inflammatory ocular disorder and non-autoimmune ocular disorder recited in claims 3-4 (see paragraphs [0136]; [0131]; [0133]; [0126]; [0118]; [0144]; [0147]-[0158]; [0169]; [0188]-[0191]; [0203]-[0211];[0244]-[0245], Examples 12-13; [0249]-[0251], Examples 16-17; [0252]-[0259], Examples 18-20, p. 39, claims 13-21).
Bevec teaches topical administration via injection recited in claim 1 (see paragraph [0140]) and different concentrations including 3-100g/100ml (i.e.0.03-1mg/ml), 5-70g/100ml (i.e.0.05-0.7mg/ml) or 10-40g/100ml (i.e.0.1-0.4mg/ml=10-1mg/ml-4x10-1mg/ml) (see paragraph [0169]). The concentration of 10mg/100ml disclosed by Bevec is equal to “10-1g/mL” recited in claim 1.
If the composition comprising -MSH used in the claimed method can enhance survival and reduce cell death of CECs in the subject, the same composition comprising -MSH disclosed by Bevec can enhance survival and reduce cell death of CECs in the subject because the material, the active step and the patient population disclosed by Bevec are identical to those recited in instant claims.
Thus, Bevec does teach a method of enhancing survival and reducing cell death of CECs wherein the subject have corneal dystrophy or other diseases recited in claims 2 and 5 because the Bevec’s method using the same material and the same administering step in the same patient population.
While Bevec does not teach -MSH in a form of eye drop or different concentrations including 10-8 mg/mL, 10-5 mg/mL, 10-3 mg/mL, 10-2 mg/ml in claim 1 or he effect amounts or concentrations that are exactly identical to claims 36 and 120-121, or different frequencies and regimens in claim 38, Ru, Hedley and Yamaguchi teach these limitations and provide motivation and an expectation of success in using -MSH in a form of eye drop, different concentrations and effective amounts of the claimed range and different frequencies and regimens the in the Bevec’s method because Ru, Hedley and Yamaguchi teach effective doses including the claimed doses and amounts recited in claims 1 and 36 and the frequencies and regiments recited in claim 38 are effective to treat different ocular diseases including ocular diseases because the doses disclosed by Bevec, Ru, Hedley and Yamaguchi are the effective amounts defined in the instant specification (see p. 6-8 of the instant specification).
In particular, Ru teaches topical administering -MSH to the ocular surface of an eye via injection -MSH at a dose of 10-4ug/ul or doses of 10-5, 10-4 and 10-3mg/ml on daily basis to inhibit cell loss of the ocular surface of the dry eye (abstract; p.2, results; p.2-11).
Hedley teaches locally administering an -MSH at a dose of 0.1 to 100 moles of the polypeptide, or of about 1 to 200 g of DNA per kg of body weight per dose is effective to treat uveitis or diabetes (see col. 25, lines 5-12; col. 25, lines 16-18; col. 26, lines 7-18).
Yamaguchi teaches topical administering to an eye via eye drop or local injection ([0077]) VIP (as in claim 51) at different dose ranges including 0.001 to 30 mg/kg body weight, about 0.01 to 25 mg/kg body weight, about 0.1 to 20 mg/kg body weight, about 1 to 10 mg/kg, 2 to 9 mg/kg, 3 to 8 mg/kg, 4 to 7 mg/kg, or 5 to 6 mg/kg body weight, and different regimens including administering to the eye of the subject (a) less than 1, 2, 3, 4, 5, or 6 times per day; (b) about 1, 2, 3, 4, 5, 6, or 7 times per week; or (c) once daily, which are effective to treat different ocular diseases including the ocular diseases recited in claims 2-5 (see paragraphs [0007]; [0069]-[0072];[0005]-[0007]; [0074]; [0077]-[0099]).
The doses disclosed by Ru, Hedley and Yamaguchi are the effective amounts to reduce apoptosis, increase the number, migration and proliferation of CECs or to slow a decrease in the number of CECs as in claim 27 or to prevent the density from decreasing by more than 50…or 500 cells/mm2 within the first 6 months as in claim 36 because the doses disclosed by Ru, Hedley and Yamaguchi are the effective amounts defined in the instant specification (see p. 6-8 of the instant specification).
A person of ordinary skill in the art would have recognized that selecting and applying the known topically or locally administering method via eye drop or injection, the known frequencies and regimens, the known effective amounts or concentrations and the known methods disclosed by Ru, Hedley and Yamaguchi to the Bevec’s method would have yielded the predictable result of enhancing survival and reducing cell death of CECs in a subject who has not had and does not have Descemet stripping, dry eye diseases or a transplant of Corneal tissues or CECs, and resulted in an improved method.
Using the known topically or locally administering method of administering -MSH via eye drop or injection, the known frequencies and regimens, the known effective amounts or concentrations used in the art in the Bevec’s method would enhance survival and reducing cell death of CECs in a subject, and expand application of the Bevec’s method in treating subjects with different ocular diseases including the ocular diseases recited in claims 2-5, and would increase patient’s satisfaction with recommended treatment regimens using -MSH in different ocular diseases including the ocular diseases recited in claims 2-5.
The claimed method recited in claim 1 requires a concentration of “10-8 mg/mL, 10-5 mg/mL, 10-3 mg/mL, 10-2 mg/ml or 10-1g/mL” or “10-8M” or “10-4M”, which overlaps with the range of Bevec, Ru, Hedley and Yamaguchi because Bevec teaches 3-100g/100ml, 5-70g/100ml or 10-40g/100ml, Ru teaches 10-4ug/ul or 10-5, 10-4 or 10-3mg/ml, Hedley teaches a dose of 0.1 to 100 moles of the polypeptide, or of about 1 to 200 g of DNA per kg of body weight per dose and Yamaguchi teaches 0.001 to 30 mg/kg body weight, about 0.01 to 25 mg/kg body weight, about 0.1 to 20 mg/kg body weight, about 1 to 10 mg/kg, 2 to 9 mg/kg, 3 to 8 mg/kg, 4 to 7 mg/kg, or 5 to 6 mg/kg body weight. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) and See MPEP §2144.05-I.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known topically or locally administering method via eye drop or injection, the known frequencies and regimens, the known effective amounts or concentrations and the known methods disclosed by Ru, Hedley and Yamaguchi to the Bevec’s method and yield the predictable result of enhancing survival and reducing cell death of CECs in a subject who has not had and does not have Descemet stripping, dry eye diseases or a transplant of Corneal tissues or CECs to expand application of the Bevec’s method in treating different ocular diseases including the ocular diseases recited in claims 2-5.
ii. Routine optimization of Bevec, Ru, Hedley and Yamaguchi’s dose ranges would have led to the claimed range of a concentration of “10-8g/mL”, “10-5g/mL”, “10-3g/mL”, “10-2g/mL” or “10-1g/mL” or “10-8M”, or “10-4M” because Bevec teaches 3-100g/100ml, 5-70g/100ml or 10-40g/100ml, Ru teaches 10-4ug/ul (M) or 10-5, 10-4 or 10-3mg/ml (M), Hedley teaches a dose of 0.1 to 100 moles of the polypeptide, or of about 1 to 200 g of DNA per kg of body weight per dose and Yamaguchi teaches 0.001 to 30 mg/kg body weight, about 0.01 to 25 mg/kg body weight, about 0.1 to 20 mg/kg body weight, about 1 to 10 mg/kg, 2 to 9 mg/kg, 3 to 8 mg/kg, 4 to 7 mg/kg, or 5 to 6 mg/kg body weight for treating different ocular diseases including the diseases recited in claims 2-5. The person of ordinary skill in the art would have found it obvious to optimize within the range taught by Bevec, Ru, Hedley and Yamaguchi because Bevec, Ru, Hedley and Yamaguchi teach that this entire range treats different ocular diseases including the diseases recited in claims 2-5 and also teach how to optimize the dose ranges. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”; Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert.denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). See MPEP § 2144.05.
Accordingly, the rejection of claims 1-5, 27, 33, 36, 38, 41 and 51 under 35 U.S.C. 103 as being unpatentable over Bevec in view of Ru, Hedley and Yamaguchi is maintained.
Claim Rejections - 35 USC § 103
8. Claim 51 stands rejected under 35 U.S.C. 103 as being unpatentable over Bevec (US2010/0204136) in view of Ru et al. (2015), Hedley et al. (US7169603) and Yamaguchi et al. (US2016/0271224) as applied to claims 1-5, 27, 33, 36, 38 and 41 above, and further in view of Okumura et al. (Am J. Pathol. 2012, 181: dx.doi.org/10.1016/jajpath.2012.03.033). The rejection is maintained for the reasons of record and the reasons set forth below.
Response to Arguments
On p.15-16 of the response, Applicant argues that Okumura does not remedy the deficiencies of Bevec in view of Ru, Hedley and Yamaguchi for the reasons set forth. Okumura describes a study suggesting that the selective ROCK inhibitor Y-27632 enables cultivated CEC-based therapy but Okumura does not teach or suggest the use of -MSH in a method for enhancing survival and reducing cell death of CECs.
Applicant's arguments have been fully considered but they are not found persuasive. Contrary to Applicant's arguments, the examiner asserts that based on MPEP §2141, MPEP2141-I, rationales identified by the Court in KSR (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)), MPEP2141-II, the basic factual inquires of Graham v. John Deere Co.(Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966)),and MPEP §2141.01-2147.03, the cited references do render the claimed invention obvious because:
i. Applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Okumura is cited to support the use of ROCK inhibitor recited in claim 51.
ii. For the reasons set forth above, Bevec, Ru, Hedley and Yamaguchi do teach the method recited in claims 1-5, 27, 33, 36, 38, 41 and 51.
ii. While Bevec, Ru, Hedley and Yamaguchi do not teach further administering a ROCK inhibitor to the subject as in claim 51, Okumura teaches this limitation and provides motivation and an expectation of success in further administering a ROCK inhibitor to the subject in the method of Bevec, Ru, Hedley and Yamaguchi because the ROCK inhibitor has been shown to convert CECs into a phenotype capable of regenerating in vivo endothelial tissue.
Okumura teaches that transplantation of CECs in combination with a ROCK inhibitor, Y-2763 successfully achieved the recovery of corneal transparency and injection of cultured CECs with the ROCK inhibitor enables regeneration of cornea in a primate model (see p.268, abstract; p.271-275).
A person of ordinary skill in the art would have recognized that selecting and applying the known ROCK inhibitor, Y-2763, and the known technique disclosed by Okumura to the method of Bevec, Ru, Hedley and Yamaguchi would have yielded the predictable result of enhancing survival and reducing cell death of CECs in a subject who has not had Descemet stripping, dry eye diseases or a transplant of Corneal tissues or CECs, and resulted in an improved method.
Using CECs in combination with a ROCK inhibitor, Y-2763 or with VIP would expand application of the method of Bevec, Ru, Hedley and Yamaguchi in treatment of different ocular diseases, and would increase patient’s satisfaction with recommended treatment regimens because the use of the combination of CECs with a ROCK inhibitor, Y-2763 has been shown to successfully achieve the recovery of corneal transparency, and injection of cultured CECs with the ROCK inhibitor enables regeneration of cornea in a primate model.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known ROCK inhibitor, Y-2763, and the known technique disclosed by Okumura to the Bevec, Ru, Hedley and Yamaguchi’s method to improve and expand application of the Bevec, Ru, Hedley and Yamaguchi’s method in treatment of different ocular diseases and yield the predictable result of enhancing survival and reducing cell death of CECs in a subject who has not had Descemet stripping, dry eye diseases or a transplant of Corneal tissues or CECs. See MPEP § 2143. 01-I, MPEP § 2144.06 and MPEP §2144.07.
Accordingly, the rejection of claim 51 under 35 U.S.C. 103 as being unpatentable over Bevecin view of Ru, Hedley and Yamaguchi as applied to claims 1-5, 27, 33, 36, 38, 41 and 51 above, and further in view of Okumura is maintained.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on December 23, 2025.
Claim Rejections - 35 USC § 102
9. 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.
Claims 1-5, 27, 36 and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bevec (US2010/0204136, published August 12, 2010, priority Sep 11, 2007, as in IDS).
Claims 1-5, 27, 36, and 41 as amended are drawn to a method for enhancing survival and reducing cell death of corneal endothelial cell (CEC) in a subject, the method comprising locally administering to an eye of the subject via eye drop or injection a composition comprising -MSH at a concentration of 10-8 mg/mL, 10-5 mg/mL, 10-3 mg/mL, 10-2 mg/ml or 10-1 mg/mL, thereby enhancing survival and reducing cell death of CECs.
Bevec teaches a method of treating different eye diseases comprising locally administering a composition comprising -MSH to an eye of the subject with different eye diseases, wherein the different diseases include corneal dystrophy (see p. 16, line 42), Iridocorneal endothelial syndrome, endothelial syndrome (see p.19, line 23), glaucoma, neovascular glaucoma, cataract, retinopathy, diabetic retinopathy, diabetic maculopathy, corneal edema, occlusion of retinal artery, obstruction of central artery of retina, occlusion of retinal vein, ocular edema, ocular hypertension, macular edema, aged macular degeneration, aged disciform macular degeneration ([0062]; [0133]), cystoid macular edema….as recited in claims 2 and 5 (see para. [0133]; [0136]; [0131]; [0133]; [0126]; [0140]).
The corneal dystrophy and other diseases recited in claims 2 and 5 disclosed by Bevec is also a non-inflammatory ocular disorder and non-autoimmune ocular disorder recited in claims 3-4 (see paragraphs [0136]; [0131]; [0133]; [0126]; [0118]; [0144]; [0147]-[0158]; [0169]; [0188]-[0191]; [0203]-[0211];[0244]-[0245], Examples 12-13; [0249]-[0251], Examples 16-17; [0252]-[0259], Examples 18-20, p. 39, claims 13-21).
Bevec teaches topical administration via injection recited in claim 1 (see paragraph [0140]) and different concentrations including 3-100g/100ml (i.e.0.03-1mg/ml), 5-70g/100ml (i.e.0.05-0.7mg/ml) or 10-40g/100ml (i.e.0.1-0.4mg/ml=10-1mg/ml-4x10-1mg/ml) (see paragraph [0169]). The concentration of 10mg/100ml disclosed by Bevec is equal to “10-1g/mL” recited in claim 1.
If the composition comprising -MSH used in the claimed method can enhance survival and reduce cell death of CECs in the subject, the same composition comprising -MSH disclosed by Bevec can enhance survival and reduce cell death of CECs in the subject as in claim 27 or effective to prevent density of CECs in the cornea of the subject from decreasing by more than about 50, 100…cells/mm2 within the first 6 months after surgery in claim 36 because the material, the active step and the patient population disclosed by Bevec are identical to those recited in instant claims.
Bevec also teaches detecting CECs before or after administration of -MSH as in claim 41 because the number of apoptotic cells, and the number of CECs and migration were examined and monitored to identify the effects of -MSH before and after treatment (see paragraphs [0244]-[0245], Examples 12-13; [0249]-[0251], Examples 16-17). Thus, claims 1-5, 27, 36 and 41 are anticipated by Bevec (US2010/0204136).
Conclusion
10. NO CLAIM IS ALLOWED.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached Monday-Thursday, 7:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Chang-Yu Wang
June 27, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675
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