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
Election/Restrictions
Applicant’s election without traverse of Group I and age-related macular degeneration in the reply filed on 7/21/2026 is acknowledged.
Claim 71 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/21/2026.
Status of the Claims
Claims 64-71 and 78-89 are pending in this application.
Claim 71 is withdrawn from consideration as being drawn to a non-elected species.
Claims 64-70 and 78-89 are presently under consideration as being drawn to the elected species/invention.
Claim Rejections - 35 USC § 112
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.
Claim 65-66 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. Claims 65-66 relate to inherent properties of SEQ ID NO: 1, which once administered would inherently inhibit deterioration and/or loss of visual acuity, and improve best corrected visual acuity. Therefore, claims 65-66 fail to further limit the subject matter of claim 64. 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
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.
Claims 64-70 and 78-89 are rejected under 35 U.S.C. 103 as being unpatentable over Besirli et al. (US 10508134) in view of Yu et al. (BioDrugs (2021) 35:303-323).
With respect to claims 64, 68, 70, 78 and 86-87, Besirli et al. teach a method of treating age-related macular degeneration comprising administering a composition for intravitreal administration comprising a polyacetate salt of the compound of Formula I (claims 19-20).
It is noted that the compound of Formula I is a MET12 analog which corresponds to instant SEQ ID NO: 1.
Besirli et al. also teach administering 10 ug (Fig. 8).
Besirli et al. do not teach that the individual has geographic atrophy.
Yu et al. teach that Investigational agents in development for the treatment of geographic atrophy secondary to age‑related macular degeneration include ONL1204; an analog of MET12 (title; page 316, right column, 1st para).
It would have been obvious to one of ordinary skill in the art to treat macular degeneration having geographic atrophy using the method of Besirli et al. because Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy.
Furthermore, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham, including the exemplary rationales: (A) Combining prior art elements according to known methods to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(B) Simple substitution of one known element for another to obtain predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143).
The presently claimed invention would have been obvious to one of ordinary skill in the art because Besirli et al. teach the treatment of age-related macular degeneration with a MET12 analog, and Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy, which is an advanced state of age-related macular degeneration, thus satisfying rationales (A)-(B) and (D)-(G).
With respect to claims 65-66, it is noted that these claims relate to inherent properties of SEQ ID NO: 1, which once administered to a patient with macular degeneration having geographic atrophy would inherently inhibit deterioration and/or loss of visual acuity, and improve best corrected visual acuity. Furthermore, Besirli et al. teach that administration of the compound of Formula I yields improved photoreceptor survival and prevents photoreceptor cell death (column 14, lines 39-49). Therefore, one of ordinary skill in the art would have reasonably expected inhibiting deterioration and/or loss of visual acuity, and improving best corrected visual acuity, all of which depend directly on preventing photoreceptor cell death.
With respect to claim 67, Besirli et al. teach that “[a] controlled population untreated with the inventive polypeptide can be observed to confirm the effect of the inventive polypeptide in reducing the inhibition of cell death or inflammation within a like population of cells” (column 20, lines 48-51). Therefore, it would have been obvious to one of ordinary skill in the art to compare visual function to a baseline visual function prior to administering the compound of Formula I, since this would indicate whether the method improves said visual function.
With respect to claims 69 and 79-85, Besirli et al. teach that “[T]he determination of a therapeutically effective dose is within the capability of practitioners in this art. In some embodiments, an effective human dose will be in the range of 5-10,000 μg/eye” (para bridging columns 14-15).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
Alternatively, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see 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)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum dosage by normal optimization procedures known in the pharmaceutical art.
With respect to claim 88, Besirli et al. teach pharmaceutical compositions comprising the compound of Formula I and one or more excipients (column 18, lines 14-19; column 19, lines 19-23; passim).
With respect to claim 89, Besirli et al. teach that the compound of Formula I is present in the composition at a concentration of 1 mg/ml, 2 mg/ml, 5 mg/ml, 10 mg/ml, or more (column 15, lines 5-11; passim).
Claims 64-67, 69-70 and 78-89 are rejected under 35 U.S.C. 103 as being unpatentable over Zacks (US 2010/0226878) in view of Yu et al. (BioDrugs (2021) 35:303-323).
With respect to claims 64 and 70, Zacks teaches administering a photoreceptor protective composition comprising MET12, which corresponds to instant SEQ ID NO: 1, to an eye of an individual having macular degeneration (claims 7 and 15; para [0088]), wherein the macular degeneration is age-related macular degeneration (para [0050]), and wherein said photoreceptor protective composition is administered in an amount sufficient to enhance photoreceptor survival (claims 11 and 18).
Zacks further teaches administering to the vitreous of the eye (para [0054]).
Zacks does not teach that the individual has geographic atrophy, or the concentration claimed (5-500mg).
Yu et al. teach that Investigational agents in development for the treatment of geographic atrophy secondary to age‑related macular degeneration include ONL1204; an analog of MET12 (title; page 316, right column, 1st para).
It would have been obvious to one of ordinary skill in the art to treat macular degeneration having geographic atrophy using the method of Zacks because Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy.
Furthermore, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham, including the exemplary rationales: (A) Combining prior art elements according to known methods to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(B) Simple substitution of one known element for another to obtain predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143).
The presently claimed invention would have been obvious to one of ordinary skill in the art because Zacks teaches the treatment of age-related macular degeneration with MET12, and Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy, which is an advanced state of age-related macular degeneration, thus satisfying rationales (A)-(B) and (D)-(G).
With respect to the claimed amount administered, Zacks teaches that “[i]t will be within the ordinary skill of the medical professional treating such patient to ascertain the most appropriate delivery route, time course, and dosage for treatment” (para [0057]).
Furthermore, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see 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)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum dosage by normal optimization procedures known in the pharmaceutical art.
With respect to claims 65-66, it is noted that these claims relate to inherent properties of SEQ ID NO: 1, which once administered to a patient with macular degeneration having geographic atrophy would inherently inhibit deterioration and/or loss of visual acuity, and improve best corrected visual acuity. Furthermore, Zacks teaches that administration of MET12 yields improved photoreceptor survival (para [0047]), and further teaches that the method prevents, inhibit, block, and/or reduce photoreceptor cell death (para [0050]). Therefore, one of ordinary skill in the art would have reasonably expected inhibiting deterioration and/or loss of visual acuity, and improving best corrected visual acuity, all of which depend directly on preventing photoreceptor cell death.
With respect to claim 67, Zacks teaches that “[I]t will be appreciated that application of the inventive method of treating a patient most preferably substantially alleviates or even eliminates such symptoms; however, as with many medical treatments, application of the inventive method is deemed successful if, during, following, or otherwise as a result of the inventive method, the symptoms of the disease or disorder in the patient subside to a degree ascertainable (para [0057]). Therefore, it would have been obvious to one of ordinary skill in the art to compare visual function to a baseline visual function prior to administering MET12, since this would indicate whether the method improves said visual function.
With respect to claims 69, 78-85, 87 and 89, as discussed above, it would have been obvious for one of ordinary skill to discover the optimum dosage by normal optimization procedures known in the pharmaceutical art.
With respect to claim 86, Zacks teaches that pharmaceutical salts can bbe made with acetic acid (para [0033]).
With respect to claim 88, Zacks teaches that “[T]he pharmaceutical compound may be administered in the form of a composition which is formulated with a pharmaceutically acceptable carrier and optional excipients, adjuvants, etc.” (para [0058]).
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 64-70 and 78-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10508134 in view of Yu et al. (BioDrugs (2021) 35:303-323).
With respect to claims 64, 68, 70, 78 and 86-87, ‘134 teaches a method of treating age-related macular degeneration comprising administering a composition for intravitreal administration comprising a polyacetate salt of the compound of Formula I (claims 19-20).
It is noted that the compound of Formula I is a MET12 analog which corresponds to instant SEQ ID NO: 1.
‘134 also teaches administering 10 ug (Fig. 8). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
‘134 does not teach that the individual has geographic atrophy.
Yu et al. teach that Investigational agents in development for the treatment of geographic atrophy secondary to age‑related macular degeneration include ONL1204; an analog of MET12 (title; page 316, right column, 1st para).
It would have been obvious to one of ordinary skill in the art to treat macular degeneration having geographic atrophy using the method of ‘134 because Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy.
Furthermore, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham, including the exemplary rationales: (A) Combining prior art elements according to known methods to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(B) Simple substitution of one known element for another to obtain predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143).
The presently claimed invention would have been obvious to one of ordinary skill in the art because ‘134 teaches the treatment of age-related macular degeneration with a MET12 analog, and Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy, which is an advanced state of age-related macular degeneration, thus satisfying rationales (A)-(B) and (D)-(G).
With respect to claims 65-66, it is noted that these claims relate to inherent properties of SEQ ID NO: 1, which once administered to a patient with macular degeneration having geographic atrophy would inherently inhibit deterioration and/or loss of visual acuity, and improve best corrected visual acuity. Furthermore, ‘134 teaches that administration of the compound of Formula I yields improved photoreceptor survival and prevents photoreceptor cell death (column 14, lines 39-49). Therefore, one of ordinary skill in the art would have reasonably expected inhibiting deterioration and/or loss of visual acuity, and improving best corrected visual acuity, all of which depend directly on preventing photoreceptor cell death.
With respect to claim 67, ‘134 teaches that “[a] controlled population untreated with the inventive polypeptide can be observed to confirm the effect of the inventive polypeptide in reducing the inhibition of cell death or inflammation within a like population of cells” (column 20, lines 48-51). Therefore, it would have been obvious to one of ordinary skill in the art to compare visual function to a baseline visual function prior to administering the compound of Formula I, since this would indicate whether the method improves said visual function.
With respect to claims 69 and 79-85, ‘134 teaches that “[T]he determination of a therapeutically effective dose is within the capability of practitioners in this art. In some embodiments, an effective human dose will be in the range of 5-10,000 μg/eye” (para bridging columns 14-15).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
Alternatively, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see 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)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum dosage by normal optimization procedures known in the pharmaceutical art.
With respect to claim 88, ‘134 teaches pharmaceutical compositions comprising the compound of Formula I and one or more excipients (column 18, lines 14-19; column 19, lines 19-23; passim).
With respect to claim 89, ‘134 teaches that the compound of Formula I is present in the composition at a concentration of 1 mg/ml, 2 mg/ml, 5 mg/ml, 10 mg/ml, or more (column 15, lines 5-11; passim).
Claims 64-70 and 78-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10829518 in view of Yu et al. (BioDrugs (2021) 35:303-323).
With respect to claims 64, 68-70, 78-85 and 87, ‘518 teaches a method of treating age-related macular degeneration comprising administering a composition for intravitreal administration comprising a compound of Formula I (claims 19-20).
It is noted that the compound of Formula I is a MET12 analog which corresponds to instant SEQ ID NO: 1.
‘518 also teaches administering 25 ug to 200 ug (claim 18).
‘518 does not teach that the individual has geographic atrophy.
Yu et al. teach that Investigational agents in development for the treatment of geographic atrophy secondary to age‑related macular degeneration include ONL1204; an analog of MET12 (title; page 316, right column, 1st para).
It would have been obvious to one of ordinary skill in the art to treat macular degeneration having geographic atrophy using the method of ‘518 because Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy.
Furthermore, the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham, including the exemplary rationales: (A) Combining prior art elements according to known methods to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(B) Simple substitution of one known element for another to obtain predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
PNG
media_image1.png
18
19
media_image1.png
Greyscale
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (MPEP 2143).
The presently claimed invention would have been obvious to one of ordinary skill in the art because ‘518 teaches the treatment of age-related macular degeneration with a MET12 analog, and Yu et al. teaches that MET12 analogs may be useful to treat macular degeneration with geographic atrophy, which is an advanced state of age-related macular degeneration, thus satisfying rationales (A)-(B) and (D)-(G).
With respect to claims 65-66, it is noted that these claims relate to inherent properties of SEQ ID NO: 1, which once administered to a patient with macular degeneration having geographic atrophy would inherently inhibit deterioration and/or loss of visual acuity, and improve best corrected visual acuity. Furthermore, ‘518 teaches that administration of the compound of Formula I yields improved photoreceptor survival and prevents photoreceptor cell death (column 14, lines 35-41). Therefore, one of ordinary skill in the art would have reasonably expected inhibiting deterioration and/or loss of visual acuity, and improving best corrected visual acuity, all of which depend directly on preventing photoreceptor cell death.
With respect to claim 67, ‘518 teaches that “[a] controlled population untreated with the inventive polypeptide can be observed to confirm the effect of the inventive polypeptide in reducing the inhibition of cell death or inflammation within a like population of cells” (column 20, lines 43-46). Therefore, it would have been obvious to one of ordinary skill in the art to compare visual function to a baseline visual function prior to administering the compound of Formula I, since this would indicate whether the method improves said visual function.
With respect to claim 86, ‘518 teaches a polyacetate salt of the compound of Formula I (column 5, lines 1-5; column 6, lines 11-14; passim).
With respect to claim 88, ‘518 teaches pharmaceutical compositions comprising the compound of Formula I and one or more excipients (column 10, lines 13-19; column 15, lines 36-38; passim).
With respect to claim 89, ‘518 teaches that the compound of Formula I is present in the composition at a concentration of 1 mg/ml, 2 mg/ml, 5 mg/ml, 10 mg/ml, or more (column 15, lines 1-7; passim).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
Prosecution Insights