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 .
Claims 1-18 are pending in the instant application. Claims 1, 7-11 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 2-6, 12, and 14-18 are rejected.
Information Disclosure Statement
The information disclosure statement filed on January 17, 2025 has been considered and a signed copy of form 1449 is enclosed herewith.
Drawings
The drawings are objected to because some of the font in Figure 1B is difficult to read or appears to be missing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election of Group II, claims 2-12 and 14-18, and the species of SBI-993 in the response filed on July 21, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The restriction requirements are still deemed proper and are hereby made final.
The examiner will follow the guidelines of MPEP 803.02 wherein once a species is elected, it is examined for compliance with all applicable statutes for patentability and if compliance is found, then the examination is expanded to a reasonable number of elected species to determine whether they also comply with the statute. The examiner will determine whether the entire scope of the claims is patentable according to MPEP 803.02.
Applicant's elected species appears allowable over the prior art of record. Therefore, according to MPEP 803.02: should no prior art be found that anticipated or renders obvious the elected species, the search of the Markush-type claim will be extended. If prior art is found that anticipated or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The search of the Markush-type claim has been extended to the non-elected species wherein:
the compounds are of Formula VIII (see claim 6) wherein L1 is -C(O)NR’- wherein R’ is hydrogen and the rest of the variables are as defined in the claims.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 2-6, 12, and 14-18 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6 and 14-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 3, 4, 5, and 17 recite the broad recitation “halogen” and the claims also recite “(F, Cl, Br, I)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. This rejection can be overcome by deleting “(F, Cl, Br, I)” from the claims.
Regarding claim 15, the phrase "as seen for example” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome, for example, by deleting the phrase “as seen for example in endurance athletes” from the claim.
Also regarding claim 15, the word “including” renders the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d). This rejection can be overcome, for example, by deleting the phrase “including hepatic steatosis and nonalcoholic steatohepatitis” from the claim.
Also regarding claim 17, the phrase “administering to the subject the composition comprising” is confusing and renders the claim indefinite. The word “the” implies that the composition has been mentioned earlier in the claim and it has not. This rejection can be overcome by replacing the above-mentioned phrase with “administering to the subject a composition comprising.”
Claim Rejections - 35 USC § 102
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 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.
Claims 2-6, 14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2008/124000 A2.
WO 2008/124000 A2 discloses thiazole derivatives as androgen receptor modulator compounds, such as Compound 141 or
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(see Example 41 on page 131), and compositions thereof (see abstract). It is disclosed that the compounds can be administered in a form suitable for extended release (see page 93, lines 4 and 5). The reference also discloses that the compound can be used in a method for treating one or more androgen receptor mediated diseases or conditions, such as obesity (see page 7, line 2 and claim 44). Since treatment of obesity would result in a reduction of body weight, a method of reducing body weight in a subject who is obese (claim 18) comprising administering to the subject a composition comprising a compound represented by the general Formula I wherein the compound of Formula I is represented by the general Formula VIII wherein L1 is -C(O)NR’- wherein R’ is hydrogen; R19’ is substituted alkoxy; R18’ is hydrogen; R1’ and R2’ are hydrogen; and R3’ is unsubstituted alkoxy is anticipated by the reference.
Claims 2-6, 14, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/050984 A1.
WO 2015/050984 A1 discloses compounds, such as compound ID 220 or
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(see page 75), for example, and pharmaceutical compositions thereof. The reference also discloses that the compounds may be used for the prevention and treatment of obesity. See abstract. Since treatment of obesity would result in a reduction of body weight, a method of reducing body weight in a subject who is obese (claim 18) comprising administering to the subject a composition comprising a compound represented by the general Formula I wherein the compound of Formula I is represented by the general Formula VIII wherein L1 is -C(O)NR’- wherein R’ is hydrogen; R19’ is substituted amino; R18’ is hydrogen; R1’ and R2’ are hydrogen; and R3’ is unsubstituted alkoxy is anticipated by the reference.
Claims 2-6, 14, 17, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2016/131192 A1.
WO 2016/131192 A1 discloses compounds of formula I, such as compound No. 30 or
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(see page 22), and compositions thereof. The reference also discloses that the compounds may be used in a method to treat metabolic disorders, such as obesity. See abstract. Since treatment of obesity would result in a reduction of body weight, a method of reducing body weight in a subject who is obese (claim 18) comprising administering to the subject a composition comprising a compound represented by the general Formula I wherein the compound of Formula I is represented by the general Formula VIII wherein L1 is -C(O)NR’- wherein R’ is hydrogen; R19’ and R18’ are hydrogen; R1’ is hydrogen; and R2’ and R3’ are unsubstituted alkoxy is anticipated by the reference.
With respect to the art rejections above over claim 14, it is noted that the references do not teach that the compositions can be used in the manner instantly claimed (i.e., to promote at least one of tyrosine phosphorylation of insulin receptor substrate 1, nuclear translocation of MondoA, and cellular glycogen synthesis). However, the intended use of the claimed compositions does not patentably distinguish the compositions, per se, since such disclosed use is inherent in the reference compositions. In order to be limiting, the intended use must create a structural difference between the claimed compositions and the prior art compositions. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
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 2-6, 12 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 4-7, 11 and 12 of U.S. Patent No. 12,103,917. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 12,103,917 claims a method of reducing body weight in a subject comprising administering to the subject the composition comprising a compound represented by the general Formula IX which fits within the scope of the method of reducing body weight in a subject comprising administering to the subject a composition comprising a compound represented by the general Formula I of the instant claims. Specifically, the compound SBI-993 used in instant claim 12 fits within the scope of the compounds represented by the general Formula IX used in the pharmaceutical compositions claimed in claim 1 of the reference. Therefore, there is significant overlap of subject matter in the claims of the reference and the instant claims.
It would have been obvious to one of ordinary skill in the art at the time of the invention to carry out the method of reducing body weight in a subject comprising administering to the subject a composition comprising a compound represented by the general Formula IX of the reference and to arrive at a method of reducing body weight in a subject of the instant claims with a reasonable expectation of success. The motivation would have been to find additional compounds which can be used for the quoted purpose. Thus, a prima facie case of obviousness has been established.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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