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 .
DETAILED ACTION
Claims 187-219 are pending in the application. Claims 187-196, 200-208 and 212-219 are rejected. Claims 188, 201 and 214 are objected to. Claims 197-199 and 209-211 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of “a GLP1 agonist” for a species of an additional therapeutic agent in the reply filed on May 5, 2026 is acknowledged.
Claims 197-199 and 209-211 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 5, 2026.
Priority
This application is a continuation of U.S. Application No. 17/052,791, filed on November 3, 2020, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2019/030723, filed on May 3, 2019, which claims benefit of Provisional Application No. 62/667,259, filed on May 4, 2018.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on February 7, 2024 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Drawings
The drawings are objected to because the Examiner is unable to ascertain the data points corresponding to “5008 Diet,” “Vehicle/Vehicle” and “0602/Vehicle” in FIG. 1A, FIG. 1B and FIG. 2. To further improve the clarity and reproducibility of the aforementioned figures, Applicant should submit replacement drawings. 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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 188, 201 and 214 are objected to because of the following informalities:
Claims 188, 201 and 214 should each be amended to cancel the expression “or a pharmaceutically acceptable salt thereof” for sake of clarity and consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 187-196, 200-208 and 212-219 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.
Claims 187, 188, 190, 191, 200, 201, 203, 204, 212 and 214-216 each recite the expression “compound having a structural formula” and is rejected as indefinite. The term “having” is open-ended; therefore, it is unclear what additional, unrecited elements- if any- Applicant intended each claim to encompass. It is suggested Applicant replace the aforementioned open-ended expression with a closed-ended transitional phrase which limits the claim to the recited structural formula. Dependent claims 189, 192-196, 202, 205-208, 213, and 217-219 do not correct this issue of indefiniteness and are hence rejected.
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.
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 187-196, 200-208 and 212-219 are rejected under 35 U.S.C. § 103 as being unpatentable over Colca et al. (PCT Publication No. WO 2011/084456 A1; July 14, 2011).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Colca et al. teach “a pharmaceutical composition comprising a compound of Formula I or an alkali earth metal salt thereof...and a GLP analogue.” See e.g., paragraph [0046]. Colca et al. further teach the following as a compound of Formula I (see e.g., paragraph [0037]):
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Colca et al. also teach “the GLP analogue comprises Exenatide.” See e.g., paragraph [0090]. Colca et al. also teach “potassium” as an alkali earth metal salt. See e.g., paragraph [0332]. Colca et al. also teach that “[s]olid dosage forms for oral administration include capsules, tablets, pills, powders, and granules...[wherein] the active compound is mixed with at least one inert, pharmaceutically acceptable excipient or carrier.” See e.g., paragraph [0343]. Colca et al. further teach administration “one or more times a day, to obtain the desired therapeutic effect.” See e.g., paragraph [0337].
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Colca et al. does not teach the instantly claimed dosage amounts/ranges. However, Colca et al. does teach “a single unit dosage form...between about 10 mg to about 120 mg, between about 10 mg to about 100 mg, or about 15 mg to about 60 mg” of the prior art Formula I. See e.g., paragraph [0224]. Therefore, the dosage ranges taught by Colca et al. overlap with the instantly required dosage limitations.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Therefore, it would have been obvious for a person of ordinary skill in the art to arrive at the instantly claimed dosage amounts/ranges based on the teachings of Colca et al. The optimization of result-effective variables, i.e., variables that achieve a recognized result, such as dosages, are considered to be within the ability of the skilled artisan. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438 (CCPA 1929). Therefore, a skilled artisan would have been motivated to optimize the aforementioned result effective parameters as part of a routine optimization process. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. 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 187-196, 200-208 and 212-219 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,931,345 B2 because claims 1-26 of the patent are drawn towards methods of administering to a subject in need thereof a daily dosage of from about 62.5 mg to about 250 mg of the instantly claimed compound (shown below) and a GLP1 agonist.
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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/D.M.S./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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