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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/30/2025 and 10/17/2025 was filed after the mailing date of the application data sheet on 4/18/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the phrase “According to the present disclosure” can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the terms PLAXEL FM, BLEMMER PME-100, BLEMMER PME-200, BLEMMER PME-400, BLEMMER 50 POEP-800B, NLEMMER 20 ANEP-600, BLEMMER AME-100, BLEMMER AME-200, BLEMMER 50AOEP-800B, SILAPLANE FM-0711, SILAPLANE FM-0721, SILAPLANE FM-0725, SILAPLANE TM-0701, SILAPLANE TM-0701T, X-22-174ASX, X-22-174BX, KF-2012, X-22-2426, X-22-2404 METABLEN P-531A, METABLEN P-530A, METABLEN P-551A, METABLEN P-550A, METABLEN P-501A, METABLEN P-570A, ACRYESTER SEM-Na, V-50, PEROCTA O, V601, TK-1300, ADK STAB O-130P, ADK STAB 37, LOXIOL VPN233, TH-2500, ADK STAB SC-266, MC638, RYURON PASTE 860, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
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 16 and 17 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.
Regarding claim 16, the phrase “a mass average molecular weight of the (meth)acrylic polymer (P) is 100,000 or more” is indefinite because neither the claim nor the specification provides a measurement basis or units for the numerical limitation. For examination purposes, the units have been interpreted to be Daltons.
Regarding claim 17, the term “anti-blocking particles” is indefinite because neither the claim nor the specification provide a standard for ascertaining the requisite “anti-blocking” degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-9, 11-13, 15-16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kawakatsu et al (US 20150190551 A1, priority date 09/20/2012).
Regarding claims 1-5 and 16, Kawakatsu discloses a pellet-shaped composition for medical use and molded products comprising the same, the composition comprising:
100 parts by weight of polyvinyl chloride (Abstract),
1 to 120 parts by weight of a plasticizer (Abstract), and
0.01 to 5 parts by weight of a (meth)acrylate copolymer containing hydrophobic and hydrophilic (meth)acrylate units (Abstract).
Note that the limitation of 0.01 to 5 parts by weight of a (meth)acrylate copolymer containing hydrophobic and hydrophilic (meth)acrylate units reads on claims 2 and 3. A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Note that the open-ended language of Kamakatsu necessarily teaches embodiments wherein the proportion of a monomer unit (applicant’s b1) in a polymer of the copolymer unit (applicant’s B1) is 100% by mass, which reads on claims 4 and 5, as well as the inclusion of additional (meth)acrylic polymers, which reads on claim 16.
It is noted that Kawakatsu discloses a copolymer but does not particularly disclose a block or graft copolymer, nor does the specification teach away such configurations. In this instance, the genus of copolymers is sufficiently small that one of ordinary skill in the art would at once envisage the use of each member, including the use of the species of graft or block copolymers. It has been held that a prior art genus containing only 20 compounds and a limited number of variations in the generic chemical formula inherently anticipated a claimed species within the genus because “one skilled in [the] art would... envisage each member ” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962) (emphasis in original). A reference disclosure can anticipate a claim even if the reference does not describe "the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)).
Regarding claim 6, Kawakatsu additionally discloses that the hydrophilic (meth)acrylate units include methoxy polyethylene glycol (meth)acrylate units [0015].
Regarding claim 7, Kawakatsu does not particularly disclose the glass transition temperature of the polymer. However, 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. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 8 and 9, Kawakatsu discloses monomer units consisting of hydrocarbon-containing (meth)acrylates with hydrocarbon substituents from 6 to 14 carbons in length [0014-0015]. A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I).
Regarding claims 11, 12, and 13, Kawakatsu additionally discloses that the plasticizer is preferably di-2-ethylhexyl phthalate, tri-2-ethylhexyl trimellitate, or diisononyl cyclohexane-1,2-dicarboxylate [0067].
Regarding claim 15, Kawakatsu does not particularly disclose the haze value of the resin composition. However, the pellet-shaped composition exhibits excellent transparency [0001] and is therefore considered to satisfy the haze value specified by the present invention. In the alternative, 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. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 18 and 19, Kawakatsu discloses a process of kneading (mixing) 10 kg of a polyvinyl chloride resin, 1.0 kg of di-2-ethylhexyl phthalate and 0.1-300 g of one of the listed (meth)acrylate copolymers (examples 1-12, 14-15) at 155°C and producing pellets at 160°C [0054-0065, 0067-0068].
Regarding claims 20 and 21, Kawakatsu additionally discloses a medical tube produced by molding the composition set forth in the above rejection or claim 1 [0011].
Claims 10 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kawakatsu et al (US 20150190551 A1) as applied to claims 4 and 21 above, and further in view of Nishumura et al (US 20210206896 A1, priority date 09/26/2018). The above rejection with respect to Kawakatsu et al (US 20150190551 A1) is incorporated herein by reference in its entirety.
Regarding claim 10, Kawakatsu discloses all limitations of claim 4 but does not particularly disclose a macromonomer represented by instant Formula (2).
In the same field of endeavor, Nishimura discloses a copolymer for suppressing protein adsorption comprising constituent units (a) and (b), wherein unit (a) is derived from a polymerizable monomer such as a vinyl chloride [0137], unit (b) is derived from a monomer selected from the group containing methoxymethyl acrylate, methoxyethyl acrylate, methoxypropyl acrylate, methoxybutyl acrylate, methoxymethyl methacrylate, methoxyethyl methacrylate, methoxypropyl methacrylate, and methoxybutyl methacrylate, among others [0021], a plasticizer, a stabilizer, and other additives [0266]. The copolymer further contains a constituent (a) contains a unit derived from a macromonomer represented by Formula (4), below.
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In the above formula, R6's each independently represent a hydrogen atom, an alkyl group which is unsubstituted or has a substituent, an alicyclic group which is unsubstituted or has a substituent, an aryl group which is unsubstituted or has a substituent, a heteroaryl group which is unsubstituted or has a substituent, or a non-aromatic heterocyclic group which is unsubstituted or has a substituent, where a plurality of R6's may be the same or different from each other, R7’s represent a hydrogen atom or a methyl group, where a plurality of R7's may be the same or different from each other, Z is a terminal group, and n1 is a natural number of 2 to 10,000 [0019-0020]. Nishimura particularly discloses that macromonomers in this molecular weight range provide excellent coating film performance and moldability [0166].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the resin composition taught by Kawakatsu with the macromonomer-derived units taught by Nishimura with a reasonable expectation of success.
Regarding claim 22, Kawakatsu discloses all limitations of claim 21 but does not particularly disclose a method of using the article according to claim 21 comprising contacting the article with a plasma protein.
Nishimura discloses contacting molded articles comprised of the disclosed composition with a plasma protein [0029] and particularly discloses that such copolymer-containing molded articles suppress protein adsorption [0030]. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the resin composition disclosed by Kawakatsu in contact with plasma protein to suppress plasma proteins as taught by Nishimura with a reasonable expectation of success.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kawakatsu et al (US 20150190551 A1) as applied to claim 1 above, and further in view of Toshiharu et al (JP H02209150 A, English translation attached, priority date 02/08/1989). The above rejection with respect to Kawakatsu et al (US 20150190551 A1) is incorporated herein by reference in its entirety.
Regarding claim 14, Kawakatsu discloses all limitations of claim 1 but does not particularly disclose stabilizers selected from the group consisting of a calcium-zinc-based stabilizer and an epoxidized vegetable oil.
In the same field of endeavor, Toshiharu discloses a blood or transfusion treating member comprising a vinyl chloride resin, dioctyl phthalate as a plasticizer, epoxidized soybean oil (vegetable oil) (page 4, lines 14-15), and a combination of calcium stearate and zinc stearate as a stabilizer (page 3, lines 10-11). Toshiharu particularly discloses that stabilizers stabilize compositions (page 1, lines 19-20). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the composition taught by Kawakatsu with the stabilizers taught by Toshiharu, motivated by a desire to increase the stability of the resin composition, with a reasonable expectation of success.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kawakatsu et al (US 20150190551 A1) as applied to claim 1 above, and further in view of Kawai et al (JP H0951941 A, English translation attached, priority date 08/11/1995). The above rejection with respect to Kawakatsu et al (US 20150190551 A1) is incorporated herein by reference in its entirety.
Regarding claim 17, Kawakatsu discloses all limitations of claim 1 but does not particularly disclose the inclusion of anti-blocking particles.
In the same field of endeavor, Kawai discloses a medical catheter tube comprised of a soft polyvinyl chloride resin and an acrylic resin which further comprises a processing aid, being 0.5 to 5 parts by weight of a methyl methacrylate and alkyl acrylate copolymer [0013], corresponding to the instantly claimed resin particles, to prevent blocking (anti-blocking particles). Adjusting the blended quantity and particle diameter of said processing aid according to the desired properties is a matter which would be obvious to one of ordinary skill in the art. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the resin composition taught by Kawakatsu with the processing aid taught by Kawai, motivated by a desire to prevent blocking, with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Onishi et al (JP H04152952 A, English translation attached) discloses a biocompatible medical material having on a surface thereof a synthetic polymer comprising mainly an alkoxyalkyl (meth)acrylate represented by general formula (I), and indicates that a polymer of the alkoxyalkyl (meth)acrylate is an alkoxyalkyl (meth)acrylate homopolymer or copolymer which may be a random copolymer, block copolymer, or a graft copolymer (page 2, lines 34-38).
Tanaka et al (US 20100135852 A1) discloses a hollow fiber membrane-type blood oxygenator which is coated with a water-insoluble (meth)acrylate copolymer, in which a hydrophobic (meth)acrylate is copolymerized with a hydrophilic (meth)acrylate at a molar ratio of (50 to 90):(50 to 10) (Abstract). Tanaka discloses that copolymers of methyl methacrylate with methoxy polyethylene oxide methacrylate are suitable coating materials for suppressing the absorbed amount of proteins [0015] and particularly discloses adhesion of the protein component of plasma to membrane surfaces as an issue known in the art [0057].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah G Phillips whose telephone number is (571)270-0822. The examiner can normally be reached M-Th 8-6 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Del Sole can be reached at (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVANNAH G. PHILLIPS/Examiner, Art Unit 1763 /JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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