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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-11, in the reply filed on 8/6/2026 is acknowledged. The traversal is on the ground(s) that there is no search burden (remarks, page 1). This is not found persuasive because as explained in the Restriction Action dated 7/1/2026, restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art in view of their
different classification;
(b) the inventions have acquired a separate status in the art due to their
recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing differentsearch queries);
(d) the prior art applicable to one invention would not likely be applicable to
another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 102
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 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 –
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.
Claim(s) 1 and 7-11 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Frankson et al. (US 2018/0043056; “Frankson”).
Regarding claim 1, Frankson teaches an implantable medical device (para [0028] [0050]) comprising: a surface (para [0028], metal surface); and a reaction product of an organic coating compound comprising at least one of an amine group, a hydroxyl group, or a carbonyl group (para [0056]-[0060],coating 50 is applied on the surface, para [0059], hydroxyl-terminated polyethylene glycol coating, meeting the claimed limitations), the reaction product covalently bound directly to the surface via at least one of an amine linkage, an ether linkage, or a ketone linkage (para [0056]-[0057], i.e., covalently bound directly to the surface, ether bond, meeting the claimed limitations).
Regarding claim 7, Frankson does not teach or require the presence of silane on its implantable medical device (surface), and thus is considered as meeting the claimed limitations, i.e., the implantable medical device is free of silane.
Regarding claim 8, Frankson teaches the suitable medical device includes implantable lead, cardiac implant (para [0050]), meeting the claimed limitations.
Regarding claim 9, Frankson does not teach or require the presence of silane primer on its implantable medical device (surface), thus is considered as meeting the claimed limitations, i.e., the reaction product of the organic coating compound is covalently bound directly to the surface without a silane primer.
Regarding claim 10, Frankson does not teach or require the presence of a grafting primer on its implantable medical device (surface), thus is considered as meeting the claimed limitations, i.e., the reaction product of the organic coating compound is covalently bound directly to the surface without
Regarding claim 11, Frankson teaches the surface comprises a metal (para [0057]), meeting the claimed limitations.
Claim(s) 1-3 and 6 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Keogh et al. (US 5,925,552; “Keogh”).
Regarding claims 1 and 11, Keogh teaches an implantable medical device (col. 3, lines 35-65) comprising: a surface (col. 3, lines 35-50, biomaterial surface which could be , metal surface, meeting the claimed limitations of claim 11); and a reaction product of an organic coating compound comprising at least one of an amine group, a hydroxyl group, or a carbonyl group (col. 3, lines 50-65, organic coating is applied on the surface, having an amine functional group), the reaction product covalently bound directly to the surface via at least one of an amine linkage, an ether linkage, or a ketone linkage (col. 3, lines 35-50, col. 11, lines 47-50, i.e., providing a covalent amine linkage between the organic coating compound and the surface, meeting the claimed limitations).
Regarding claim 2, Keogh teaches its organic coating compound includes suitable polymer comprising repeating units comprising the at least one of an amine group, a hydroxyl group, or a carbonyl group (col. 20, lines 14-24, grafting copolymerization of the acrylamides/AAm, and APMA, i.e., amide carbonyl (C=O) functionality, i.e., repeating units comprising a carbonyl group, meeting the claimed limitations).
Regarding claim 3, the organic coating compound of Keogh is considered a thromboresistant polymer (col. 1, lines 20-30, col. 5, lines 45-65, col. 18, 1-20; the medical device surface is treated with the organic coating compound of Keogh in improving blood compatibility, inhibits blood coagulation).
Regarding claim 6, Keogh teaches the amine group of the organic coating compound is a primary amine (col. 3, lines 35-50, col. 11, lines 47-50, Keogh teaches an amine-functional biomolecule and further describes reaction of a primary amine with an aldehyde moiety, i.e., a primary amine, meeting the claimed limitations).
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) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Frankson as applied to claim 1 above, further in view of Cheng et al. (US 2020/0308440; “Cheng”).
The limitations of claim 1 are taught by Frankson as discussed above.
Regarding claim 4, Frankson teaches an implantable medical device having coating covalently bonded to the metal surface of the device (col. 3, lines 50-65), and Frankson teaches the grafting functional group to the coating to impart desired biological functionality (col. 3, lines 50-65). But Frankson does not specifically teach the inclusion of zwitterionic group in its organic coating compound.
Cheng teaches a durable antifouling coating suitable for medical device having a metal substrate surface (para [0003] [0015]). Cheng teaches its durable cross-linked zwitterionic coatings that are grafted to the surface of a substrate through covalent bonding (para [0015]). Cheng teaches the use of zwitterionic functional polymeric coatings on medical device surface to resist adhesion of biomolecules, cells, tissue and bacteria (para [0016]).
It would have been obvious to one of ordinary skill in the art to modify Frankson in view the teachings of Cheng, to provide the functionalized coating of Frankson with the zwitterionic group functionality as taught by Cheng, in order to impart antifouling properties of such zwitterionic group functionality and to reduce undesirable biological adhesion to the implant surface of medical device as taught by Cheng (para [0015] [0016]).
Regarding claim 5, Frankson teaches an implantable medical device having coating covalently bonded to the metal surface of the device (col. 3, lines 50-65), and Frankson teaches the grafting functional group to the coating to impart desired biological functionality (col. 3, lines 50-65). But Frankson does not specifically teach the organic coating compound is a polymer and further comprises repeating units comprising at least one zwitterionic pendant group.
Cheng teaches a durable antifouling coating suitable for medical device having a metal substrate surface (para [0003] [0015]). Cheng teaches its durable cross-linked zwitterionic coatings that are grafted to the surface of a substrate through covalent bonding (para [0015]). Cheng teaches the use of zwitterionic functional polymeric coatings on medical device surface to resist adhesion of biomolecules, cells, tissue and bacteria (para [0016]). Cheng teaches copolymers with repeating unit structures, i.e., having repeating units comprising zwitterionic pendant group (para [0020]), meeting the claimed material limitations.
It would have been obvious to one of ordinary skill in the art to modify Frankson in view the teachings of Cheng, to provide the functionalized coating of Frankson with the zwitterionic group functionality as taught by Cheng, in order to impart antifouling properties of such zwitterionic group functionality and to reduce undesirable biological adhesion to the implant surface of medical device as taught by Cheng (para [0015] [0016]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Callaghan (US 7,157,538) that teaches a covalently-bound, hydrophilic copolymer coating for medical implants (col. 1, lines 5-10).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN LAN whose telephone number is (571)270-3687. The examiner can normally be reached Monday - Friday 7AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at 5712728935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN LAN/Primary Examiner, Art Unit 1782
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