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 Claim(s) 14-21 rejected under 35 U.S.C. 103 as being unpatentable over Imai WO2020050253 A1 2020-03-12 (equivalent to English US 20210205326), Imai WO2017188365, Werner WO 2018104305 (previously provided), Burnstock, Curr Opin Pharmacol. 2017 December ; 37: 131–141, Burnstock, Purinergic Signalling (2016) 12:59–67 (previously provided); Rani, Intest Res 2016;14(4):297-304 (previously provided), and Vuerich, Frontiers in Immunology, Purinergic Signaling, Front. Immunol. 11:1882, 2020 is maintained for reasons of record.
Applicants arguments are not persuasive:
Applicant arguments focus on teachings separately in the cited references.
Applicant in the conclusion acknowledged that the issue here is combination of the teachings.
According to Examination guidelines with respect to the Doctrine of Inherency, the discovery of a previously unappreciated property.of a prior art method, or of a scientific explanation for the prior art's functioning, does not render the old method new to the discoverer. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
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.
Note that claims to a method of using a known compound, which are often based on newly acquired knowledge of biochemical pathways, 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.
Abdominal pain and cramping are the defining symptoms of Irritable Bowel Syndrome (IBS). This pain is often accompanied by changes in bowel habits, such as diarrhea, constipation, or both. The cited reference, for example, the specifically pointed out
Werner teachings do include the biochemical property and treatment of disorders IBS and IBD (for example, previously pointed out Werner claim 12).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (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. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(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;
(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.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel. The cited references are good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
From previous action:
Imai, 20210205326 at page 18, [0284] teaches the specific compound of instant claim 14 as does Imai Japanese WO2017188365 at page 258, [0354] and at page 282 second listed. (RN1447803-11-3).
According to the above Imai(s), the compound has antagonistic activity on P2X4 receptors.
P2X4 receptor activity is inexorably linked to the inflammatory diseases is well-known in the art, for example,
Werner teaches P2X4 antagonist for use in the treatment of gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), diarrhea-dominant IBS and Crohn's disease. Based on the P2X4 antagonising activity, the compounds are useful for the relief of pain and inflammation of a variety of conditions including IBS and IBD (claims 12, 14; page 24, lines 22-23; page 24, line 34 - page 25, line 2; page 25, lines 25-28; page 26, lines 6-13; page 27, line 33 -
page 28, line 21; page 31, lines 13-16).
Burnstock 2016 teaches P2X4 receptors and Gut inflammation (Title and Abstract); Burnstock 2016 page 8 concludes that Antagonists of P2X receptors, and P2X7R and P2X3R, in particular, are potential therapeutic targets for treating IBD, IBS and motility disorders; Rani, teaches Irritable bowel syndrome and inflammatory bowel disease overlap syndrome: pieces of the puzzle are falling into place (Title and Abstract) and Vuerich, titled Control of Gut Inflammation by Modulation of Purinergic Signaling, concludes that Mounting clinical evidence and research data support the
involvement of purinergic signaling alterations in IBD pathogenesis. Note that these NPL documents are Review articles and correspond to the limitations of dependent claims 15-21 inexorably linked to IBS and IBD. Such linkages can be found, using word search technique in these Review articles.
As such the recited active ingredient, its inherent biological property and the linkage of the said biological property to the recited disease state are explicitly taught in the references cited here.
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.
Claim(s) 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18,-21 of copending Application No. 18694663 (reference application) further in view of Imai WO2020050253 A1 2020-03-12 (equivalent to English US 20210205326), Imai WO2017188365, Werner WO 2018104305 (previously provided), Burnstock, Curr Opin Pharmacol. 2017 December ; 37: 131–141, Burnstock, Purinergic Signalling (2016) 12:59–67 (previously provided); Rani, Intest Res 2016;14(4):297-304 (previously provided), and Vuerich, Frontiers in Immunology, Purinergic Signaling, Front. Immunol. 11:1882, 2020.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the claims contain overlapping subject matter as explained below:
Conflicting claims 18, 19, 20 and 21 of 18694663
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The above claims depend on claims 15-17 for their active ingredient and include the instant recited active ingredient.
Abdominal pain and cramping are the defining symptoms of Irritable Bowel Syndrome (IBS). This pain is often accompanied by changes in bowel habits, such as diarrhea, constipation, or both.
In the obviousness analysis, the following prior art teachings are considered.
Imai, 20210205326 at page 18, [0284] teaches the specific compound of instant claim 14 as does Imai Japanese WO2017188365 at page 258, [0354] and at page 282 second listed. (RN1447803-11-3).
According to the above Imai(s), the compound has antagonistic activity on P2X4 receptors.
P2X4 receptor activity is inexorably linked to the inflammatory diseases is well-known in the art, for example,
Werner teaches P2X4 antagonist for use in the treatment of gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), diarrhea-dominant IBS and Crohn's disease. Based on the P2X4 antagonising activity, the compounds are useful for the relief of pain and inflammation of a variety of conditions including IBS and IBD (claims 12, 14; page 24, lines 22-23; page 24, line 34 - page 25, line 2; page 25, lines 25-28; page 26, lines 6-13; page 27, line 33 -
page 28, line 21; page 31, lines 13-16).
Burnstock 2016 teaches P2X4 receptors and Gut inflammation (Title and Abstract); Burnstock 2016 page 8 concludes that Antagonists of P2X receptors, and P2X7R and P2X3R, in particular, are potential therapeutic targets for treating IBD, IBS and motility disorders; Rani, teaches Irritable bowel syndrome and inflammatory bowel disease overlap syndrome: pieces of the puzzle are falling into place (Title and Abstract) and Vuerich, titled Control of Gut Inflammation by Modulation of Purinergic Signaling, concludes that Mounting clinical evidence and research data support the
involvement of purinergic signaling alterations in IBD pathogenesis. Note that these NPL documents are Review articles and correspond to the limitations of dependent claims 15-21 inexorably linked to IBS and IBD. Such linkages can be found, using word search technique in these Review articles.
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
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