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
Response to Amendments
The amendments made to the claims and specification 04/13/2026 have been entered.
Status of claims
Claims currently under examination are claims 7-10 and 12-16.
Withdrawn Objection and Rejections
In view of the amendments, the objection to the specification has been withdrawn.
In view of the amendments made to the claims, the objection over claim 11 is now moot and therefore withdrawn.
The 112(a) rejections made in the prior office action have been withdrawn.
Maintained Rejections
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(s) 7-10 and 12-16 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kim (US 9,750,743, published 2017, hereinafter Kim ‘743).
Kim’ 743 in its claim 1 claims “A method for inhibiting brain neuron apoptosis in a subject in need thereof comprising administering a composition containing a phosphodiesterase type 5 inhibitor that is mirodenafil…”.
Kim ‘743 in col. 1, l. 60-67 discusses administration of PDE5 inhibitors and specifically states “…the present inventors have confirmed that, as a result of administering a PDE5 inhibitor to an animal model induced with neuron apoptosis due to brain injury, the brain neuron apoptosis was significantly inhibited…”. Kim ‘743 in col. 8, l. 35-50, Table 1 discloses test groups of mice that received mirodenafil in various doses in a range of 0.5 mg/kg to 2 mg/kg.”
Regarding claims 8-10 and 12-16, the limitations of said claims are inherent features of administering mirodenafil. The properties do not materially change the method and, therefore, Kim’s disclosure of administering mirodenafil embraces the instant claims.
Further, the MPEP section 2112, subsections I and III state:
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
III. A REJECTION UNDER 35 U.S.C. 102 AND 103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
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.
Patent US 12,485,124 (Formerly application 18/906,967)
Claims 7-10 and 12-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,485,124. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 7 claims a method comprising administering a therapeutically effective dose of a compound from the group consisting of mirodenafil. The claim further requires that the therapeutically effective dose treat Alzheimer’s Disease and inhibits Wnt signaling through DKK-1 inhibition or inhibits Positive Feedback loop of Aβ production. The additional limitations do not change the method of administering and any method that comprises administering mirodenafil would read on the instant claims.
Reference claim 1 is shown below. The claim language is essentially identical to the instant claim 7 save for the addition of other PDE5 inhibitors.
Reference claim 1
PNG
media_image1.png
174
312
media_image1.png
Greyscale
Reference claim 2-7 are drawn to various limitations that are consequence of administering mirodenafil and include wherein the therapeutically effective dose “induce a change over time in at least one of a test for evaluating for cognitive ability…”, “inhibits formation of Aβ aggregation….”, “inhibits β-Amyloidogenic Processing through BASE-1 reduction”, etc. Essentially, the reference claim language is almost identical, if not identical, to the instant claim language.
Patent US 9,750,743
Claims 7-10 and 12-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,750,743. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 is drawn to a method of administering mirodenafil. Although the reference claim is drawn to a method for inhibiting brain neuron apoptosis, this is considered an intended use which does not significantly change the method claimed. Both the instant claim and the reference are drawn to a method of administering mirodenafil.
Co-pending applications
17/593,842
Claims 7-10 and 12-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-15 of copending Application No. 17/593,842 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 7 states “A method of reducing accumulation of amyloid beta (Aβ) in a hippocampal neuronal cell in a subject in need, the method comprising, administering to the subject a pharmaceutical composition comprising a therapeutically affective dose of a compound selected from the group consisting of mirodenafil, sildenafil, vardenafil, tadalafil, udenafil, dasantafil, and avanafil, or a pharmaceutically acceptable salt thereof, a solvate thereof, or a hydrate thereof, wherein the therapeutically effective dose reduces accumulation of Aβ in the hippocampal neuronal cell.”
Instant claim 7 is a near exact recitation of reference claim 7 except instant claim 7 specifies only one compound, mirodenafil.
Both claims require the administration of the PDE5 inhibitor mirodenafil.
Reference dependent claims are also drawn to similar limitations and include “inhibits formation of Aβ aggregation inhibition…” (instant claim 8), “inhibits β-amyloidogenic processing…” (instant claim 9), “reduces extracellular formation and accumulation” (instant claim 10), etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19/003,405
Claims 7-10 and 12-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-19 and 23-32 of copending Application No. 19/003,405. (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 23-32 are drawn to methods that comprise administering a pharmaceutical composition of reference claim 17. Reference claim 17 is drawn to a composition that comprises a phosphodiesterase 5 inhibitor. Reference claims 18-19 specify phosphodiesterase inhibitors and include mirodenafil.
Where the instant claims drawn to a method for reducing Aβ accumulation, the reference claims are drawn to methods which include “preventing and/or inhibiting formation and/or accumulation of beta-amyloid” (ref. claim 23), “treating a neurodegenerative disease” (ref. claim 24) which includes Alzheimer’s disease (claim 25), “inhibiting Aβ oligomer / Fibril formation” (claim 26), “inhibiting β-Amyloidogenic processing…” (claim 27), etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/492,734
Claims 7-10 and 12-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/492,734 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 6-16 are drawn to methods of administering a composition of reference claims 1-6. Reference claims 1-6 are drawn to compositions comprising phosphodiesterase 5 inhibitors which include mirodenafil (claims 2 and 4-5).
Similar in co-pending application 19/003,405 above, the method claims are also drawn to methods which include “preventing and/or inhibiting formation and/or accumulation of beta-amyloid”, “treating a neurodegenerative disease” which includes Alzheimer’s disease, “inhibiting Aβ oligomer / Fibril formation”, “inhibiting β-Amyloidogenic processing…”, etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
19/003,429
Claims 7-10 and 12-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21, 24, and 27-49 of copending Application No. 19/003,429 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Similar to the double patenting rejections, the reference claims are drawn to methods of administering compositions which comprise mirodenafil. Where the instant claims specify treating Alzheimer’s Disease, the reference claims are drawn to methods which are similar to instant claims 6-10 and 12-16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18/991,922
Claims 7-10 and 12-15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-45 of copending Application No. 18/991,922 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Similar to the double patenting rejections, the reference claims are drawn to methods of administering compositions which comprise mirodenafil. Where the instant claims specify treating Alzheimer’s Disease, the reference claims are drawn to methods which are similar to instant claims 6-15.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments have been considered but are not persuasive.
Applicant argues that “Kim does not disclose or suggest a method of reducing accumulation of amyloid beta (Aβ) in a hippocampal neuronal cell let alone administering to the subject a therapeutically effective dose of mirodenafil or a pharmaceutically effective salt, solvate, or hydrate thereof to reduce accumulation of Aβ in the subject’s hippocampal neuronal cell.”
The MPEP section 2112, subsections I and III state:
I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW PROPERTY
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
III. A REJECTION UNDER 35 U.S.C. 102 AND 103 CAN BE MADE WHEN THE PRIOR ART PRODUCT SEEMS TO BE IDENTICAL EXCEPT THAT THE PRIOR ART IS SILENT AS TO AN INHERENT CHARACTERISTIC
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.
Therefore, the 102 rejection is maintained.
Regarding the double patenting rejections, applicant holds the rejections in abeyance until allowable subject matter has been identified.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights