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 .
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 1-2, 6-8, 10-12 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk, US Patent No. 5,736,251 (hereinafter referred to as Pinchuk).
Regarding claims 1-2, 6-8, 10-12 and 14-15, Pinchuk discloses lubricious silicone surface modifying treatments and/or coatings, having a thickness of 0.01 microns/10 nm to 20 microns/20000 nm (as recited in claims 6-8), for modifying the frictional or slip surface characteristics of shaped elastomeric articles, such as thermoplastic medical devices including catheters and implants (as recited in claims 2, 10-12 and 14-15), are provided in surface modifications including a coating or surface modifying composition comprising:
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Pinchuk further discloses, the preferred silanes will include those wherein the silane moiety or R group is selected from aliphatic, cycloaliphatic, aromatic and alkyl aromatic groups having less than or equal to 10 carbon atoms. The R groups may be unsubstituted or may be substituted with halogen groups such as chloro, bromo or fluoro groups or may be mixtures of any of the foregoing (as recited in claim 1 and as one of the R1or R2 groups of the moiety is bonded to the substrate and reads on claims 11-13) (see Abstract and see Claims 1, 22 and 25 of Pinchuk).
Pinchuk differs from claim 1 in that Pinchuk discloses the genus for the compounds of claim 1 based on the formula in the Abstract, but not the specific species.
See MPEP 2131.02 - a generic chemical formula will anticipate or render obvious a claimed species covered by the formula when the species can be at once envisaged from the formula.
Regarding claim 16, Pinchuk further discloses that in order to apply a lubricious coating to surfaces that are generally more inert than these types of preferred substrate materials, adhesion can be greatly facilitated by chemically treating such inert surfaces in order to provide hydroxyl groups on or near the surface thereof. Exemplary chemical surface treatments in this regard include such known procedures as chemical etching, surfactant adsorption, coextrusion, actinic radiation, such as plasma discharge, surface oxidation or reduction, and surface grafting with materials such as polyvinyl alcohol, poly(2-hydroxyethyl methacrylate) and the like (Col. 6-7/L. 57-7).
Claim Rejections - 35 USC § 103
Claims 3-5, 9, 13 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pinchuk in view of Jelle, US Patent No. 6,706,408 (hereinafter referred to as Jelle).
Regarding claims 3-5, 9, 13 and 17-20, Pinchuk discloses all the limitations discussed above but does not explicitly disclose the polymeric moiety having an amine moiety as recited in claim 3.
Jelle discloses coating compositions with two or more coatings (see Abstract) having a first coating layer attached to an inorganic substrate, such as a medical device for insertion into the body of a mammal for vascular and urological purposes, such as, guidewires (as recited in claim 13) (see Abstract and Col. 2/L. 36-52) and includes the polymeric reaction product formed upon hydrolysis of a silane compound having at least two tri(C1-3) alkoxysilyl groups and forming a covalent bond between the first layer and the inorganic substrate (Col. 3/L. 12-25). The second and subsequent coating layers include at least one hydrophilic polymer, such as, polymethacrylamide copolymers and polyvinylpyrrolidone/polyacrylamide copolymers (as recited in claims 3-5) (see Abstract) and Col. 4/L. 1-5), at least one photoactivatable cross-linking agent which allows for covalent bonding between the second layer and the first layer (Col. 5-6/L. 54-6) and a photopolymer, such as, a copolymerization of 1-vinyl-2-pyrrolidone and N-(3-aminopropyl)methyacrylamide (as recited in claims 9 and 17-20) (Col. 7-8/L. 55-35). It would have been obvious to one of ordinary skill in the art at the time of the invention to use the amine-functionalized polymeric moieties of Jelle in the coating composition of Pinchuk in order to enhance the lubricous properties of the coating composition (Col. 4/L. 8-27 of Jelle).
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
7. Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,827,862. Although the conflicting claims are not identical, they are not patentably distinct from each other.
The co-pending '862 patent discloses the same limitations as the instant claims except “a base coat and a top coat”. This limitation would have been obvious in light of the disclosures discussed above and incorporated herein by reference.
These are the same reaction components recited in the instant claims. In re Vogel, 422 F. 2d 438, 164 USPQ 619, 622 (CCPA 1970).
Double Patenting II
8. Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,252,658. Although the conflicting claims are not identical, they are not patentably distinct from each other.
The co-pending '658 patent discloses the same limitations as the instant claims except “accessing a lumen of a subject”. This limitation would have been obvious in light of the disclosures discussed above and incorporated herein by reference.
These are the same reaction components recited in the instant claims. In re Vogel, 422 F. 2d 438, 164 USPQ 619, 622 (CCPA 1970).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VISHAL V VASISTH whose telephone number is (571)270-3716. The examiner can normally be reached M-F 9:00-4:30 and 7:00-10:00p.
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/VISHAL V VASISTH/Primary Examiner, Art Unit 1771
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