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 .
Status of the Claims
Claims 1-15 were originally filed April 4, 2023.
The amendment received September 6, 2023 canceled claims 1-15 and added new claims 16-35.
The amendment received February 10, 2026 amended claims 16-22, canceled claims 23-25, and added new claim 36.
The amendment received June 18, 2026 changed the status identifiers only.
Claims 16-22 and 26-36 are currently pending.
Claims 16-20 and 36 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 16-22 and 36) in the reply filed on June 18, 2026 is acknowledged.
Claims 26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 18, 2026.
Applicant’s election of nifedipine and semaglutide in the reply filed on June 18, 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 § 818.01(a)).
Claims 21 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 18, 2026.
Please note: claim 22 is withdrawn because the claim depends from withdrawn claim 21. The dependency appears to be in error. Liraglutide and semaglutide are incretin mimetics which are disclosed in claim 20. If the claim is amended, the claim may be rejoined. Please note: both the dependency and the indication that liraglutide and semaglutide may be incretin mimetics and/or incretin enhancers should be amended (see claim 20).
Applicant's election with traverse of a pharmaceutical excipient in the reply filed on June 18, 2026 is acknowledged. The traversal is on the grounds that (a) the species requirement did not specifically spell out which species are recited in the application via providing a definitive list, (b) the examiner of record did not provide any reason or evidence why the additional components are independent or patentably distinct, (c) the examiner of record did not indicate why an undue search burden was present, (d) a species requirement should not be imposed when the claims do not recite any species, and (e) applicants are of the opinion that the species requirement somehow forces the applicant to narrow what is presently claimed (i.e. comprising language). This is not found persuasive because (a) applicants and applicants’ representative should be well versed in what is present in the application as filed; (b) and (c) the present is a 371 (National Stage) application, therefore, Lack of Unity was utilized to break Unity of Invention; (d) species requirements are not dependent on what is claimed per se, but can be required for anything in the specification that is pertinent to the claims; and (e) the species requirement does not mean that applicants have to narrow the claim scope. See MPEP § 1893.03(d). An election of “nothing” would have also been acceptable. Please note: since a pharmaceutical excipient is not present in any of the claims, the rejections of record do not require a pharmaceutical excipient.
The requirement is still deemed proper and is therefore made FINAL.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a 371 (National Stage) of PCT/EP2021/077562 filed October 6, 2021 which claims foreign priority to EP 202000382.8 filed October 6, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted February 10, 2026 is being considered by the examiner (i.e. only English language portions were considered).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See pages 2, 13, and 28.
The disclosure is objected to because of the following informalities: page 22 should indicate that this section is a “Brief Description of the Drawings”.
Appropriate correction is required.
Content of Specification
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 16 is objected to because of the following informalities: “A” and “An” should read “a” and “an”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “of” should read “according to” to correlate with the other dependent claims. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “bepridil” is listed in the Markush group twice (see lines 8 and 9). Appropriate correction is required. Applicants are also respectfully requested to carefully review the entire Markush group for any other formalities.
Claim 36 is objected to because of the following informalities: “A” and “An” should read “a” and “an”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 16-20 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berger et al. U.S. Patent Application Publication 2016/0145272 published May 26, 2016.
For present claims 16-20 and 36, Berger et al. teach compositions comprising both a calcium channel blocker including nifedipine and GLP-1 receptor agonist including semaglutide (please refer to the entire specification particularly paragraph 444; claims).
Therefore, the teachings of Berger et al. anticipate the presently claimed composition.
Claims 16-18, 20, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadereit et al. WO 2015/086728 published June 18, 2015.
For present claims 16-18, 20, and 36, Kadereit et al. teach compositions comprising agonists of GLP-1 including semaglutide combined with other pharmaceutically active compounds including calcium channel blockers (i.e. diltiazem, benzothiazepine; please refer to the entire specification particularly pages 3, 19, 23-26; claims).
Therefore, the teachings of Kadereit et al. anticipate the presently claimed composition.
Claims 16-20 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spana et al. U.S. Patent Application Publication 2018/0153965 published June 7, 2018.
For present claims 16-20 and 36, Spana et al. teach compositions comprising incretin mimetics including exenatide liraglutide, and lixisenatide and calcium channel blockers including nifedipine (please refer to the entire specification particularly paragraphs 11, 88, 110, 138, 141, 149).
Therefore, the teachings of Spana et al. anticipate the presently claimed composition.
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.
Claims 16-20 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kadereit et al. WO 2015/086728 published June 18, 2015 and Spana et al. U.S. Patent Application Publication 2018/0153965 published June 7, 2018.
For present claims 16-18, 20, and 36, Kadereit et al. teach compositions comprising agonists of GLP-1 including semaglutide combined with other pharmaceutically active compounds including calcium channel blockers (i.e. diltiazem, benzothiazepine; please refer to the entire specification particularly pages 3, 19, 23-26; claims).
For present claims 16-20 and 36, Spana et al. teach compositions comprising incretin mimetics including exenatide liraglutide, and lixisenatide and calcium channel blockers including nifedipine (please refer to the entire specification particularly paragraphs 11, 88, 110, 138, 141, 149).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. combination of integrin mimetics/GLP-1 agonists with calcium channel blockers) and the combination would have yielded predictable results (i.e. combination therapy) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. one calcium channel blocker) for another (i.e. species of nifedipine) would have yielded predictable results (i.e. combination therapy with a specific calcium channel blocker) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. combining integrin mimetics/GLP-1 agonists with calcium channel blockers) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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