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 .
Claim Status
Applicant’s response and amendments to the claims, filed 11/12/2025, have been received and entered. Claims 6 and 23-24 were cancelled.
Claims 1-5, 7-9, 16-22, and 25-26 are pending.
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-5, 7-9, 16-22, and 25-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2019/081637 A1 (Published May 2, 2019) in view of WO 02/087545 (Published November 7, 2002) and WO 2011/107474 A1 (Published September 9, 2011).
The amended claims recite medical devices, e.g., stents, balloons, micocatheters, or bioabsorbably scaffolds, comprising means for administration of a TRPC6 inhibitor, wherein said means is a coating of the medical device (Claim 1 and claims dependent therefrom). The claims also recite a method of treating or preventing a disease associated with neointimal hyperplasia, e.g., stenosis or restenosis, comprising administering a TRPC6 inhibitor to a subject in need thereof, wherein the TRPC6 inhibitor is administered via a medical device, said medical device comprising means for administration of the TRPC6 inhibitor; and/or wherein the TRPC6 inhibitor is administered systemically (Claim 21 and claims dependent therefrom).
WO ‘637 teaches a method of treating a disease or disorder that can be alleviated TRPC6 inhibition comprising administering a therapeutically effective amount of a compound according to any one of claims 1 to 16, or a pharmaceutically acceptable salt thereof, to patient in need thereof (Claim 18; p.7; p.16-17). The compounds are taught as inhibitors of TRPC6 (Entire Disclosure) and have the same general formula (IV) as the compounds recited in instant claim 20 (Claims 1-16). The disease or disorder is, inter alia, restenosis (Claim 19; p.7; p.16-17). Restenosis is disclosed by Applicants as a disease associated with neointimal hyperplasia (Specification at [003], [00642]-[00643]; Claim 25). The TRPC6 inhibitors disclosed therein can be administered systematically as required by claim 21 (p.153, 4th full paragraph).
WO ‘637 differs from the instant claims in so far as it does not disclose medical devices, e.g., stents, balloons, microcatheters, or bioabsorbably scaffolds, comprising a coating comprising the TRPC6 inhibitors disclosed therein.
WO ‘545 teaches compositions and methods for the treatment of hyperplasia, e.g., for reducing neointimal hyperplasia, comprising proteins and at least one pharmaceutically active agent (Abstract; p.6, l.27-32). Specifically, they teach formulations useful for administration of suitable drugs in conjunction with procedures such as balloon angioplasty or stenting to reduce the level of restenosis (p.5, l.30-32). They teach that the combination of a biocompatible protein with drugs of interest greatly reduces the toxicity of such drugs (p.7, l.31-33). They teach the compositions can be administered systemically, e.g., intra-arterially or intravenously (p.9, l.20-24). In the treatment of restenosis, the drug may be administered locally through the stenting catheter at the time of the procedure and at the local region of the stent (Id.). Alternatively, compositions can be administered at the time of the vascular procedure by deploying a stent containing at least one drug coated thereon (p.11, l.25-28; Example 26).
The combined teachings of WO ‘637 and WO ‘545 differ from claims 8 and 19 in so far as they do not disclose TRPC6 inhibitors of formula (I), e.g., SAR7334.
WO ‘474 teaches numerous TRPC6 inhibitors that fall within the scope of the claimed genus of formula (I), including the claimed species SAR7334 (p.1, l.21-22; p.65, l.11 to p.66, l.16; Table spanning p.48-65). See especially Example 3, Compound 8.
It would have been obvious to a person of ordinary skill in the art to administer a known TRPC6 inhibitor such as those disclosed in WO ‘637 or WO ‘474 to a subject having restenosis as expressly suggested by the teachings of WO ‘637. Administering such a TRPC6 inhibitor systemically, e.g., intra-arterially or intravenously, locally through the stenting catheter at the time of the procedure and at the local region of the stent, or by a stent containing the TRPC6 inhibitor drug coated thereon would have been obvious in view of the teachings of WO ‘545.
One exemplary rationale for the Examiner’s finding of obviousness is the combining of prior art elements, e.g., the treatment of restenosis with TRPC6 inhibitors as taught in WO ‘637 with the administration of drugs for the treatment of restenosis via known methods of such administration as taught in WO ‘545, to yield predictable results. Here, the prior art teaches each element claimed: i) administration of a TRPC6 inhibitor to a subject in need of treatment of restenosis (WO ‘637) and ii) administration of drugs for the treatment of restenosis via any suitable means, e.g., intra-arterially or intravenously, locally through the stenting catheter at the time of the procedure and at the local region of the stent, or by a stent containing the drug coated thereon (WO ‘545). One of ordinary skill in the art could have combined these elements by known methods and each element would perform the same function it does separately. For example, the TRPC6 inhibitor would inhibit TRPC6 and therefore treat restenosis whether administered intra-arterially or intravenously, locally through the stenting catheter at the time of the procedure and at the local region of the stent, or by a stent containing the drug coated thereon. The results of the combination of these elements are predictable in so far as the TRPC6 inhibitors were already known in the art and methods of treating restenosis by administering drugs intra-arterially or intravenously, locally through the stenting catheter at the time of the procedure and at the local region of the stent, or by a stent containing the drug coated thereon were already known in the art. All Applicants have done is taken known TRPC6 inhibitors taught in WO ‘637 and/or WO ‘474 and predictably applied them to a medical device for administering them to subjects having restenosis as taught in WO ‘545.
Another exemplary rationale for the Examiner’s finding of obviousness is the use of a known technique to improve a similar product. Here, the prior art teaches a “base” method, i.e., TRPC6 inhibitors for use in the treatment of a disease or disorder that can be alleviated TRPC6 inhibition such as restenosis comprising administering a therapeutically effective amount of the TRPC6 inhibitor, or a pharmaceutically acceptable salt thereof, to patient in need thereof (WO ‘637). The prior art teaches a “comparable” method, i.e., administration of drugs for the treatment of restenosis that has been improved by combining the drug with a protein (WO ‘545). A person of ordinary skill in the art could have applied the known “improvement” taught in WO ‘545 in the same way to the TRPC6 inhibitors taught in WO ‘637 and administered such TRPC6 inhibitors in combination with a protein by any suitable means, e.g., intra-arterially or intravenously, locally through the stenting catheter at the time of the procedure and at the local region of the stent, or by a stent containing the drug coated thereon, to a person in need of treating restenosis with a reasonable expectation of success.
Accordingly, it would have been prima facie obvious to a person of ordinary skill in the art to use a medical device such as a stent or balloon to administer a known TRPC6 inhibitor to a subject in need of treating restenosis as suggested and motivated by the combined teachings of the cited prior art.
Response to Arguments
With respect to WO ‘637 (“Bouyssou”), Applicants argue that Bouyssou differs from the subject-matter of new claim 1 in that it does not mention or suggest to the skilled person to use an TCRP6 inhibitor for coating a medical device, does not teach or suggest that the TRCP6 inhibitor prevent restenosis by its control of the proliferation and migration of smooth muscle cells, and that there is no disclosure in Bouyssou that TRCP6 inhibitors may have a lower chance of side effects.
In response, the Examiner acknowledged in the rejection that WO ‘637 differs from the claims in so far as it does not disclose medical devices, e.g., stents, balloons, microcatheters, or bioabsorbably scaffolds, comprising a coating comprising the TRPC6 inhibitors disclosed therein. Additionally, in response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the TRCP6 inhibitor prevent restenosis by its control of the proliferation and migration of smooth muscle cells and TRCP6 inhibitors may have a lower chance of side effects) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants argue the skilled person starting from Bouyssou or Follmann finds therein no suggestion why he or she should coat a medical device with an TRCP6 inhibitor. Applicants assert that without the knowledge that the TRCP6 inhibitor acts on the migration of smooth muscle cells and, therefore, would have lower side effects compared to paclitaxel and rapamycin, which is disclosed only in the present application (see paragraph [0031]), the skilled person would not use a TRCP6 inhibitor for coating a stent for preventing or treatment of stenosis.
In response, the reason to coat a stent for preventing or treating restenosis is expressly found in WO ‘545 (“Desai”). Coating of stents with a therapeutic agent for the treatment of restenosis was known in the art as evidenced by WO ‘545. The art discloses TRPC6 inhibitors for the treatment of restenosis and discloses that such TRPC6 inhibitors can be administered by any “conventional” means, i.e., “…the compounds of the invention may be administered via a pharmaceutical composition in any conventional pharmaceutical dosage form in any conventional manner” (p.153). The coating of a stent with a therapeutic agent for the treatment of restenosis is one such “conventional manner” as evidenced by WO ‘545.
Applicants argue that a combination of known devices or methods needs a reason that leads the skilled person to the claimed combination. Here, Applicants admit, the coating of stents is known from Desai, and several TRCP6 inhibitors are known from Bouyssou and Follmann. Applicants argue, however, that none of the cited documents leads the skilled person to the coating of a medical device with an TRCP6 inhibitor with the present results, e.g. less side effects compared to rapamycin or paclitaxel (paragraph [0031], present application) used in Desai.
In response, while Desai (WO ‘545) focus on the use of paclitaxel and rapamycin for coating stents for the treatment of restenosis, specifically a means for reducing the toxicity thereof, such does not negate the known use of coating a medical device (e.g., stent) with a therapeutic agent for the treatment of restenosis as taught in Desai, which is precisely what the Examiner relies upon Desai for. That TRPC6 inhibitors are less toxic than paclitaxel is immaterial to the present rejection. The reason to combine the teachings of Desai with the teachings of Bouyssou and Follmann is the predictable use of coating a stent with a therapeutic agent for the treatment of restenosis.
It is readily apparent from the combined teachings of the cited prior art that Applicants did not invent TRPC6 inhibitors (WO ‘637 and WO ‘474), did not invent their administration for the treatment of restenosis (WO ‘637), and did not invent administration of a drug for the treatment of restenosis using coated stents (WO ‘545). Rather, Applicants have merely applied a known technique (coating of stents) as taught in Desai to known TRPC6 inhibitors as taught in WO ‘637 and WO ‘474 for the treatment of a disease (restenosis) that TRPC6 inhibitors are disclosed to be useful in treating (WO ‘637).
Applicants are not entitled to preclude the public from coating any and all medical devices with any and all TRPC6 inhibitors simply because they identified a potential mechanism through which inhibitors of TRPC6 might function (inhibition of migration of SMCs) as therapeutic agents for the treatment of restenosis.
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 JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached Monday-Friday, 7:30 am - 4:00 pm PST.
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/James D. Anderson/Primary Examiner, Art Unit 1629