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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 02/05/2025, claims 1-129 are canceled, and claims 130-150 are newly added. Currently, claims 130-150 are pending in the instant application.
Priority
The instant application is a CON of application 17/885,493 filed on 08/10/2022 and issued as US patent No. 12251385. The instant application claims priority to provisional applications 63/317,518, 63/249,568, and 63/232,154 filed on 03/07/2022, 09/08/2021, and 08/11/2021, respectively.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 – Second Paragraph
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 133, 137-139, and 146-148 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.
Claim 133 is indefinite for reciting “wherein the HbA1c is lowered by 1% and maintained at that level after the compound is withdrawn”, because a person of ordinary skill in the art would not reasonable be able to understand the metes and bounds of the claim. It is unclear from the recitation of the claim how the HbA1c is being lowered and maintained post-withdrawal. The instant claim does not provide any positive steps to the method claimed in parent claim 130. Accordingly, the instant claim is not further limiting of the parent claim.
Claim 137 is indefinite for reciting “lower than normal serum C-peptide levels”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. Firstly, the term “normal” does not appear to be defined in either the instant claim or the specification. Furthermore, what is considered “normal” serum peptide levels may vary between individuals based on various possible health factors. Secondly, the recitation of “lower than normal” does not provide definite structure to the claim as it cannot be determined what range of serum peptide level this would encompass. Applicant may overcome this rejection by amending the claim to recite a definitive range of serum peptide level in the patient being treated.
Claim 138 is indefinite for reciting “higher than normal cholesterol levels” and “higher than normal triglyceride levels”, because a person of would not reasonably be able to understand the metes and bounds of the claim. Firstly, the term “normal” does not appear to be defined in either the instant claim or the specification. Furthermore, what is considered “normal” cholesterol levels may vary between individuals based on various possible health factors. Secondly, the recitation of “lower than normal” does not provide definite structure to the claim as it cannot be determined what range of cholesterol level this would encompass. Applicant may overcome this rejection by amending the claim to recite a definitive range of serum peptide/triglyceride level in the patient being treated.
Claim 139 is indefinite for reciting “lower than normal serum insulin levels, and the serum insulin levels are increased on treatment”, because a person of would not reasonably be able to understand the metes and bounds of the claim. The instant claim suffers from the same deficiency as claims 137 and 138 in that the claim and specification do not appear to disclose what is considered “normal” levels of serum insulin. Furthermore, the recited “increase” in serum insulin would not be understandable for the same reasons.
Claim 146 is indefinite for reciting “lower than normal serum C-peptide levels”, because a person of ordinary skill in the art would not reasonably be able to understand the metes and bounds of the claim. The instant claim is indefinite for the same reasons as iterated in the rejection of claim 137 above.
Claim 147 is indefinite for reciting “higher than normal cholesterol levels” and “higher than normal triglyceride levels”, because a person of would not reasonably be able to understand the metes and bounds of the claim. The instant claim is indefinite for the same reasons as iterated in the rejection of claim 138 above.
Claim 148 is indefinite for reciting “lower than normal serum insulin levels, and the serum insulin levels are increased on treatment”, because a person of would not reasonably be able to understand the metes and bounds of the claim. The instant claim is indefinite for the same reasons as iterated in the rejection of claim 139 above.
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 130-150 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12251385 (herein the ‘385 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the issued patent are directed towards essentially the same subject matter.
Claim 130 of the instant application recites a method for reducing HbA1c in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of Compound 10:
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136
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Claim 142 recites a method for improving glycemic control in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of Compound 10:
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136
376
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Claim 1 of the ‘385 patent recites a method for reducing HbA1c in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a compound according to Formula (I):
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119
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Claim 13 of the ‘385 patent recites the method of claim 1 wherein the compound is Compound 10:
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191
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As can be seen above, both the claims of the instant application and the ‘385 patent are drawn to methods of reducing HbA1c in a patient. The compound of the instant application not only falls within the bounds of claim 1 of the ‘385 patent, but is explicitly recited in claim 13 of the ‘385 patent for the same method of use. Furthermore, the HbA1c is generally understood to be associated with measurement of blood glucose levels, and the lowering of HbA1c implicates modulation of glycemic control. Accordingly, the claims of the instant application and the claims of the issued patent cannot be considered as patentably distinct.
Conclusion
Claims 130-150 are rejected.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
