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 .
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.
Previously presented rejection of claims 11, 14-21 rejected under 35 U.S.C. 103 as being unpatentable over Imai WO 2017188365 and Werner WO 2018104305 is maintained for reasons of record.
Applicants argument centers on
1.
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2.Imai
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3.
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4.Amendments to claims.
Response:
With respect to
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Applicant is reminded of options such as those found in MPEP 1204 Notice of Appeal [R-01.2024] or contacting Examiner’s supervisors.
The pictured Imai compound at page 2 of office action falls under the scope of the instant claim 1 formula (A) and is the compound of dependent claim 14 A1,
and
it has antagonistic activity on P2X4 receptor.
Imai was/is invoked for the recited active ingredient and its inseparable inherent P2X4 receptor biological property.
That Werner does not disclose the instant core structure of the instant compound is irrelevant for the rationale for the rejection,
because,
Werner was/is invoked for the teaching that the above mentioned
inseparable inherent P2X4 receptor biological property is associated with, as acknowledged by the applicant Remarks at numbered page 22 of 25 third paragraph, to recited diseases state, for example colitis (see more on this below).
As to the argument that Werner discloses, broadly, the use for IBD etc., and Werner teaching are drawn to non-benzodiazepine compounds for use in the treatment of pain is not persuasive as further explained below:
Just as Werner, in spite of the large number of benzodiazepine compounds disclosed in the specification (PgPub pages 5-29), none of which is Applicant’s invention, relevant biological properties are disclosed for only two compounds:
one for recited formula
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, Compound A (A16 of dependent claim 14)
and
one for recited formula
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, Compound B.
Even though the position taken is that the instant claims are drawn to previously known use for previously known compound, as per the teachings in the cited references, Examination guidelines in this regard is summarized below:
New use for an old compound. The new use (if any) must account for the possibility that the underlying mechanism for the new therapy is the same mechanism that allows for a prior art treatment using the same compound (or its obvious version).
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use.
As MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[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."
As to the Applicant’s argument
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:
The relevant biological data for the compound A16 (=NP 1815PX) in the post filing date article (article was co-authored by the instant applicant) in
Inflammation (2022) 45(4) 1829-1847
in a Murine Model of Colitis
has been questioned by the Editor-in-Chief of the above journal in the disclosure
Inflammation (2025) 48:2841
as follows:
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OBJECTION:
Even though Applicant can be his/her own lexicographer, it is noted that the claimed formulae are defined in confusing manner given that each of the many of the variables in the claimed formulae are drawn to one single possibility. Thus the need for not presenting generic formulae (A) and (B!) only with variables is unclear. For example formula (A) could be pictured without any of the R groups
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.
Previously presented rejection of claims 11, 14-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8470814 further in view of Imai WO 2017188365 and Werner WO 2018104305 is maintained for reasons of record.
Previously presented rejection of claims 11, 14-21 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos. 8778933, 9115123 and 9561235 is maintained for reasons of record.
For both the above rejections, Applicant’s arguments are not persuasive. Examiner thanks Applicant for not ignoring that the entirety of arguments presented for rejection under Claim Rejections - 35 USC § 103 was used in obviousness analysis for double patenting rejections.
That said, given that not 35 USC § 103 is maintained, double patenting is also maintained.
Claim 11, 14-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 and 21 of copending Application No. 18694663 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims have overlapping subject matter.
Instant base claim is drawn to treating inflammatory bowel disease. This treatment is anticipated to treat the associated pain which is the subject matter of conflicting claims. The active ingredient and underlying disease treated are same in both cases.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625