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 .
Applicant’s amendments filed 1/12/2026 have been entered.
Claims 1-4, 6, 8-12 are pending. The outstanding rejection under 35 USC 112b is withdrawn in view of the amendments filed 1/12/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 8-10 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.
For claims 1-4, 6, 8-10, the instant specification has support for the language of the claims, i.e., neuropilin antagonists, however, the court has held "generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed." Id. at 1171, citing Enzo Biochem, Inc. v. Gen-Probe Inc., 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). In the instant case, the functional characeteristic of inhibiting or blocking or antagonizing neuropilin has not been coupled with a known or disclosed correlation between function and structure of the composition. Furthermore, there are no tests to demonstrate the rate of release of exemplary dosages forms in the presence of alcohol, let alone that the rate of release is within the claimed ranges.
In University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927-28 (Fed. Cir. 2004), the court reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification's function description, the specification did not provide an adequate written description of the claimed invention. Ariad, 94 USPQ2d at 1173.
Therefore, instant Specification does not provide adequate written description support for the invention of Claim 5 because it does not describe enough species of pharmaceutical composition capable of achieving the claimed function. As such, the Specification would not reasonably convey to a person of ordinary skill in the art that Applicant had possession of the claimed invention as a whole. Applicant has not disclosed a sufficient number of species to support the claims as recited. Applicant has only disclosed limited number of examples of neuropilin antagonists. The claims, therefore, extend beyond what are disclosed.
Thus, while one of ordinary skill in the art would conclude that the Applicant would have been in possession of some neuropilin antagonist such as those recited in claim 8 at the time of filing, one of ordinary skill in the art would not conclude that the Applicant described a sufficient number of pharmaceutical compositions to be in possession of the claimed invention as a whole at the time of filing.
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.
Claim(s) 1-4, 6, 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2012/156289 (’289) in view of Andres et al., Arch Gynecol Obstet (2015) 292:523–529. ‘289 is of record in IDS filed 5/25/2022.
‘289 teaches the neuropilin antagonists NRPa-47 and NRPa-48 are effective in treating endometriosis by inhibiting angiogenesis (see claims 1 and 4; page 24, line 13 and claim 14 for example).
‘289 does not expressly teach the use of progesterone in the method. ‘289 does not expressly teach the type of endometriosis or non-human mammal.
Andres et al. teaches the use of dienogest as effective in treating endometriosis (see the abstract).
It would have been obvious to one of ordinary skill in the art at the time of filing to employ both NPRa-47 or NPRa-48 with dienogest together in a method of treating endometriosis.
One of ordinary skill in the art would have been motivated to employ both NPRa-47 or NPRa-48 with dienogest together in a method of treating endometriosis. Concomitantly employ both agents, which are known to be effective in treating endometriosis individually, in to a single method useful for the very same purpose is prima facie obvious (See In re Kerkhoven 205 USPQ 1069 (CCPA 1980)). Furthermore, with regards to different types of endometriosis recited in the claim, the inhibition of angiogenesis (thereby treating endometriosis) would be reasonably expected to be useful for all kinds of endometriosis, absent evidence to the contrary.
Furthermore, the limitations of the mechanism of action of the neuropilin antagonists being “inhibits the interaction between a neuropilin protein (e.g. NRP-1) and its partners, in particular VEGF-A165“ would be considered as the intrinsic in the neuropilin antagonists.
Response to Arguments
Applicant's arguments filed 1/12/2026 averring the specification not requiring to disclose what is being well-known in the art to fulfill the written description requirements, have been fully considered but they are not persuasive. The examiner notes that there is no evidences stating that neuropilin antagonists as well-known in the art. The three references (WO2012/156289, Powell et al., and Jarvis et al.) only discloses limited number of neuropilin antagonists. The instant specification does not describe enough species of pharmaceutical composition capable of performing as neuropilin antagonists. There is no pharmacophore known in the art. And yet, the claims encompass any and every neuropilin antagonists. The applicant fails to provide sufficient evidence showing the possession of the full scope of the invention.
Applicant’s arguments with regard to the rejection under 35 USC 103a that the cited prior art fails to teach the specific mechanism of action of how the endometriosis being treated, have been considered, but are not found persuasive. As discussed in the rejection, the examiner notes that ‘289 teaches the neuropilin antagonists NRPa-47 and NRPa-48 are effective in treating endometriosis by inhibiting angiogenesis. Although it is silent as to whether the neuropilin antagonist would cause apoptosis, the method of treating endometriosis employs the very same compounds. The examiner notes that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. It follows that the recited mechanism of action would be effected once the compound is administered in the body.
As for claim 12, the unexpected benefit is demonstrated. Therefore, the claim is in condition of allowance.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 SAN MING R HUI whose telephone number is (571)272-0626. The examiner can normally be reached Mon - Fri 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAN MING R HUI/Primary Examiner, Art Unit 1627
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