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 .
Priority
The instant application is the national stage entry of PCT/JP2022/015625 filed 29 March 2022. Acknowledgement is made of the Applicant’s claim of foreign priority to application JP2021-061681 filed 31 March 2021. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. The effective filing date of the instant application is accordingly 29 March 2022.
Examiner's Note
Applicant's amendments and arguments filed 2 June 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 2 June 2026, it is noted that claim 1 has been amended and claims 3-4 newly added. Support can be found in the specification at [0016].
Status of the Claims
Claims 1-2 and 4 are pending.
Claims 1-2 and 4 are rejected.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites, “wherein the water-insoluble means that” (emphasis added). The word “the” appears to be extraneous and should be removed. Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kawakatsu et al. (JP 2009/261437; machine translation attached and cited) in view of Kuwahara et al. (US 6,166,168).
Kawakatsu relates to a catheter having a contact portion with a (meth)acrylate copolymer which is composed of a water-insoluble (meth)acrylate copolymer obtained by copolymerizing a hydrophilic (meth)acrylate monomer and a hydrophobic (meth)acrylate monomer [0001]. Kawakatsu provides a method for coating a medical device with an antithrombotic copolymer which achieves both suppression of complement activation and suppression of platelet activation and does not cause plasma leakage [0016]. The method comprises copolymerizing a hydrophobic (meth)acrylate with a hydrophilic (meth)acrylate wherein the hydrophobic (meth)acrylate comprises an alkyl (meth)acrylate and/or a silicone (meth)acrylate of formulae 1 and 2, below [0016-0017]. The ratio of hydrophobic to hydrophilic (meth)acrylate is preferably 50-95/50-5 [0033].
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The definitions of the various R groups overlap or encompass the ranges in the instant claims. The hydrophilic (meth)acrylate is represented by formula 3, below.
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The (meth)acrylate copolymers have an average molecular weight ranging from 2,000-200,000 and is soluble in alcohol having 1-6 carbon atoms [0020]. Regarding formula 2, the raw price of silicone (meth)acrylate is relatively high, thus using it alone can be disadvantageous in terms of cost effectiveness [0029]. As such, the upper amount of silicone (meth)acrylate can be 50% by weight or less, down to as low as 1% or 0.1% by weight, and may be mixed with other alkyl (meth)acrylate [0029]. The residual amount of unreacted monomers is about 0 [0071].
Kawakatsu does not teach wherein the reduced viscosity is from 0.18-3.00 dl/g.
Kuwahara teaches a copolymer useful as an agent for imparting antithrombogenic properties to medical polymers (col 10, lns 16-22). The polymer may be applied to a medical material such as a catheter (col 12, lns 1-2, 27-31). Kuwahara teaches that if the viscosity is less than 0.5 dl/g, the resulting copolymer will have insufficient mechanical strength, thus the preferred range for reduced viscosity is from 1.0-3.0 dl/g, whereas the overall taught range is a viscosity of “at least 0.5 dl/g” (col 6, lns 55-63).
It would have been prima facie obvious to prepare a medical device such as a catheter, and coat it with the antithrombogenic copolymer of Kawakatsu. Kawakatsu teaches all three of the claimed monomer units and teaches using them in combination with each other. The ranges of the variables of each monomer overlaps or encompasses that of instant claims 1-2 and 4. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I).
That being said, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of monomers from within Kawakatsu, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
The resulting copolymer coating would comprise a combination of formulae 1 and 2 in a 50/50 ratio with formula 3. Since the silicone monomer is preferably used in low amounts such as 1%, a ratio of 1/2/3 would have been obvious to be 49/1/49, which falls within the required ratio of instant claim 1. The resulting viscous liquid is taught as having the required alcohol solubility and residual monomer content. Regarding the reduced viscosity, Kawakatsu does not teach this property, however Kuwahara teaches that copolymers used as catheter coatings require a reduced viscosity to achieve a sufficient mechanical strength. The preferred range for reduced viscosity of “at least 0.5 dl/g,” as taught by Kuwahara, would have been obvious to apply to the copolymer of Kawakasu.
Regarding the claimed definition of water-insoluble which defines solubility based on mass reduction over time, this property is considered to be addressed by the composition in the prior art addressing all the limitations of the claimed invention. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Claims 1-2 and 4 are accordingly rejected as obvious over the prior art.
Response to Arguments
Applicant's arguments filed 2 June 2026 have been fully considered but they are not persuasive. The Applicant argues, on pages 4-7 of their remarks, that Kuwahara does not provide a reason to select the amended reduced viscosity range for the methacrylate copolymer of Kawakatsu.
Kuwahara teaches a copolymer useful as an agent for imparting antithrombogenic properties to medical polymers that may be applied to a medical material such as a catheter, wherein the reduced viscosity is “at least 0.5 dl/g.” In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I). As such, a value of 0.5 dl/g is obvious in view of the prior art and thus renders obvious instant claims 1-2 and 4.
The Applicant argues, on page 8 of their remarks, that new claim 3 teaches a range of viscosity from 0.18-0.35 dl/g which is not taught in the art.
In response, the Examiner agrees that this range is not taught and that Kuwahara actually teaches away from a viscosity this low.
Allowable Subject Matter
Claim 3 contains allowable subject matter. Kuwahara teaches that a copolymer with a reduced viscosity of less than 0.5 dl/g will have insufficient mechanical strength (col 6, lns 60-63). Kuwahara thus teaches away from a viscosity in the range of 0.18-0.35 dl/g.
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 ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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