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 .
This is a Final Office Action.
Election/Restrictions
Applicant's election without traverse of Group (III) in the reply filed on June 3, 2025 is acknowledged. Group (II), drawn to a method of attenuating or ameliorating ventricular remodeling in a subject having or having had a myocardial infarction (MI) or at risk of having a myocardial infarction comprising administering a retinoic acid receptor-beta (RARβ) agonist, embraced by claims 15-20 was elected by Applicant. Applicant has not pointed to any errors in the Examiner’s analysis of the classification of the different inventions. The requirement is still deemed proper and is therefore made FINAL.
Applicant elected the following species, AC261066 as the RARβ agonist:
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and indicated claims 15-20 read on said species.
Claims 15-20 are pending and under consideration.
Specification
The objection to the disclosure because of the blurry structures on pages 13-15 have blurry structures is withdrawn based on the amendments.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 15-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.’’ (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Applicant has not demonstrated that all RARβ agonist will function to attenuate or ameliorate ventricular remodeling in a subject having or having had a myocardial infarction or at risk of having a myocardial infarction, only two compounds were disclosed, 4’-octyl-4-biphenylcaroxylic acid (AC-55649) and AC-261066. Moreover, Applicant has not demonstrated that said two compounds can treat more than (I/R) injury in the heart, although the claims are for any and all ventricular remodeling. Thus, Applicant did not have possession of the full scope of attenuating or ameliorating ventricular remodeling in a subject having or having had a myocardial infarction or at risk of having a myocardial infarction by administering any RARβ agonist.
Applicant addressed the above rejection by stating, “[T]he claims have been amended to recite that the selective RARP2 agonist is AC261066 or AC55649, thereby rendering this rejection moot.”
This is unpersuasive. The written description rejection is based not only the genus of the compounds claimed, but also the umbrella term “ventricular remodeling.” Again, the application does not demonstrate that said two compounds can treat more than (I/R) injury in the heart, although the claims are for any and all ventricular remodeling. Moreover, the subject having or having an MI or at risk of having an MI is not the cause of the ventricular remodeling based on the language in the claim. Furthermore, the disclosure does not provide possession of “an ester, amide, prodrug, or combination thereof” for AC261066 or AC55649 for the presently claimed method.
Therefore, the rejection is maintained.
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 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.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 15-18 and 20 under 35 U.S.C. 102(a)(1) as being anticipated by Paiva (American Society for Nutrition, 2005, pages 2326-2328) is withdrawn based on the amendments.
Claim Rejections - 35 USC § 103
The rejection of claims 15-20 under AIA 35 U.S.C. 103(a) as being unpatentable over Paiva et al. (American Society for Nutrition, 2005, pages 2326-2328) in view of Lund et al. (J. Med. Chem, 2005, 48, pages 7517-7519) and Olsson et al. (WO 2007009083), is withdrawn based on the amendments.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 15-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11191755. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims method of attenuating or ameliorating ventricular remodeling in a subject having or having had a myocardial infarction (MI) or at risk of having a myocardial infarction with a RARβ agonist, e.g. compound AC261066. The claims in the ‘755 patent are drawn to a method of providing a cardioprotective effect on a heart of a subject, comprising administering therapeutically effective amount of a retinoic acid receptor-beta (RARβ) agonist, i.e. compound AC261066. The method in the ‘755 patent falls within the scope of the present claims.
Claims 15-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11160769 in view of in view of Hamasaki et al. (March 2000, 20(3), 737-743). Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims method of attenuating or ameliorating ventricular remodeling in a subject having or having had a myocardial infarction (MI) or at risk of having a myocardial infarction with a RARβ agonist, e.g. compound AC261066. The claims in the ‘769 patent are drawn to a method of lowering cholesterol and/or triglyceride levels in a subject, comprising administering therapeutically effective amount of a retinoic acid receptor-beta (RARβ) agonist, i.e. compound AC261066.
Hamasaki et al. teach a lowering cholesterol treatment is associated with improvement in coronary vascular remodeling, see title.
Claims 15-20 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 19, 20, 26 and 27 of copending Application No. 17542852 in view of Paiva et al. (American Society for Nutrition, 2005, pages 2326-2328).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present application claims method of attenuating or ameliorating ventricular remodeling in a subject having or having had a myocardial infarction (MI) or at risk of having a myocardial infarction with a RARβ agonist, e.g. compound AC261066. The currently claimed method would reduce myocardial injury to a heart.
The claims in the ‘852 application are drawn to a method for reducing myocardial injury to a heart in a subject by administering a RARβ agonist, i.e., compound AC261066, wherein the injury is an MI and reduced in size.
Paiva teaches that early after myocardial infarction (MI) left ventricular enlargement can occur as a result of infarct expansion, which increases the surface of the infarcted area by stretching and thinning the damaged region. Moreover, the rationale provided in the 102 rejection also applies here.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Applicant traverses by stating, “[T]he submission of a terminal disclaimer is premature prior to the indication of allowable subject matter in this application.”
Thus, the rejection is maintained.
Conclusion
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 SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624