DETAILED ACTION
Claims 81-82 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant’s election without traverse of
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in the reply filed on 05/27/2025 is acknowledged.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Applicants' elected species of
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does not appear allowable, therefore the search and examination of the claims has not been extended beyond the elected species (see the following 35 USC 103(a) rejection).
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statements filed on 06/16/2022, 03/30/2023, 05/27/2025 have been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 81-82 is/are rejected under 35 U.S.C. 103 as being unpatentable over BARNES (see WIPO Pub No. 2007/067612, pub. 06/14/2007, cited in IDS filed 06/16/2022). BARNES teaches compound
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(see Example 30, p. 86-87) which corresponds to the elected species
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except that rather than a OCH3, there is a Br at the position. BARNES teaches broadly that in compounds
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in the position of R2a is selected from halogen or alkoxy (see p. 12). Further, the compounds are taught to be inhibitors of protein tyrosine phosphatases (PTPases) - see p. 2 and in pharmaceutical compositions (see p. 44).
The prior art compound of BARNES is disclosed to inhibit protein tyrosine phosphatases and useful in treating insulin resistance, glucose intolerance, obesity, diabetes, hypertension (see p. 2), which is the same effect that Applicant' s compound is found to have. BARNES describes a compound in which the 7-position of the instant compound claims is substituted with a Br rather than OCH3. However, BARNES teaches that the same position can be substituted with a halogen in addition to an alkoxy. One would be motivated to synthesize such compound since the compound of BARNES is described to inhibit protein tyrosine phosphatases and useful in treating insulin resistance, glucose intolerance, obesity, diabetes, hypertension. The motivation to make the claimed compound derives from the expectation that structurally similar compounds are generally expected to have similar properties and similar utilities.
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 motivation to substitute a methyl for hydrogen would derive from (B) from KSR. It is common in the chemical/pharmaceutical field for a skilled artisan to synthesize structurally related compounds in hopes of obtaining greater activity on the desired target – a process known as structure-activity relationship (SAR) in the chemical arts. In the instant case, substitution of halogen for an alkoxy would have been desirable in order to find compounds that inhibit protein tyrosine phosphatases to treat insulin resistance, glucose intolerance, obesity, diabetes, hypertension. The explicit teaching of BARNES together with the enabled examples would have motivated one skilled in the art to modify the known compounds with the expectation that that would have similar utility.
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 81-82 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,954,202. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘202 teaches compound
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. However, claim 71 teaches compound 5-(1-fluoro-3-hydroxy-6-methoxynaphthalen-2-yl)-1λ6,2,5-thiadiazolidine-1,1,3-trione which is a positional isomer (i.e. having the methoxy substituent at the 6-rather than the 7-position) of said compound. According to MPEP 2144.09, Section II compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious). Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” Regarding the pharmaceutical composition, it is obvious to add a carrier to an obvious compound – see Ex parte Douros, 163 USPQ 667 (P.T.O. Bd. App. 1968) in order to allow for administration of the compound in the treatment of disease (i.e. those related to inhibition of protein tyrosine phosphatase).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2019/246513, filed 06/21/2019 but has the same inventors as the instant application.
WO 2020/186199, filed 03/13/2020 and claims priority to US Prov Appl No. 62/818,447, filed 03/14/2019 teaches compounds that do not have the naphthalene-2-yl core or have differing substituents in the 6- rather than 7-position of the naphthalene core.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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