DETAILED ACTION
Claims 1, 3-4, 6-20, and 38 are pending. Of these, claims 11 and 18-20 are withdrawn as directed to a nonelected invention. Therefore, claims 1, 3-4, 6-10 and 12-17 are under consideration on the merits.
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 .
Status of the Rejections
The 103 rejection is withdrawn in view of the amendment, but a new rejection incorporating the teachings of a new reference is applied as detailed below.
The provisional double patenting rejection is replaced with a nonprovisional rejection in view of the issuance of the reference application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/22/26 was filed prior to the mailing date of a Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
37 CFR 1.121
The following is a quotation of 37 CFR 1.121(c):
(Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
The amendment submitted 6/22/26 is not in compliance with 37 CFR 1.121, since claim 11 is withdrawn as directed to a nonelected species but is listed as currently amended, but no amendment was in fact made to this claim. Therefore, this amendment has not been entered, and the amendment being treated in this Office Action is the amendment dated 1/07/2019. Applicant is reminded to ensure that the claim identifiers are correct in the response to this Office Action.
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, 3-4, 6-10, 12-17, and 38 are rejected under 35 U.S.C. 103 as unpatentable over Anzai et al. (US Pat. Pub. 2014/0172117; of record in IDS) in view of Jaffer et al. (Journal of Thrombosis and Haemostasis, 13 (Suppl. 1): S72-S81 (2015); of record) and Feijen et al. (US Pat. No. 4,634,762).
As to claims 1, 3-4, 6-10, 12-17, and 38, Anzai discloses an antithrombotic coating layer on a medical device of claim 17 (paragraphs 2, 50), and exemplifies a coating layer comprising a polymer comprising monomers of 2-acrylamide-2-methylpropanesulfonic acid (AMPS) (an anticoagulant polymer having a plurality of hemocompatible groups that is the elected species, i.e., sulfonic acid of claims 1 and 4, and which comprises the elected species of formula (A-1) of claims 1 and 6-10 wherein P1 is a divalent methylpropyl group which reads on Applicant’s election of P1 as comprising a C1-10 alkylene group)(paragraphs 22, 73, 77, 81). Anzai further teaches that acrylic acid monomers (a species of formula B-1 of claims 12-15 that differs from the elected species of B-1 only in that Rc is H instead of C1-C6 alkyl) can be incorporated into the polymer to form an AMPS-acrylic acid copolymer (claim 16), which advantageously allows for fixing the polymer to the medical device via a chemical bond (paragraph 8).
As to claims 1, 3-4, 6-10, 12-17, and 38, Anzai does not further expressly disclose a base layer comprising a protein on which the polymer layer is disposed as recited by claim 1 and which is albumin (claim 3), nor that the polymer layer is crosslinked to the protein (claim 1) via amide bonds formed between the protein and the polymer (claim 38). .
Jaffer discloses that medical devices that contact blood may fail as a result of thrombus formation (Summary on page S72). Jaffer discusses methods to prevent thrombosis on such devices by rendering their surfaces less thrombogenic (paragraph bridging pages S74 and S75) and teaches that albumin has been used as an inert thromboresistant coating on medical devices because it induces less platelet adhesion (page S75, 2nd paragraph of right column).
Feijen discloses conjugates comprising an anticoagulant covalently bonded to a protein via a crosslinking be amide bonds formed between the anticoagulant and the protein (see claim 1 of Feijen and column 1, 2nd paragraph), wherein the protein is preferably albumin (last paragraph of column 2). Feijen teaches that the conjugate improves the blood compatibility of a material surface that is coated with the conjugate and that the conjugate possesses desirable anti-thrombogenic activity (column 4, 1st full paragraph and Example II).
As to claims 1, 3-4, 6-10, 12-17, and 38, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the anti-thrombotic medical device coating of Anzai by incorporating a base layer comprising albumin over which the polymer layer is disposed and conjugated to the albumin via a crosslinking reaction that forms amide bonds between the polymer and the protein, because Jaffer teaches that albumin coatings are useful in imparting thromboresistance to medical devices, such that the skilled artisan reasonably would have expected that an albumin base layer would advantageously impart additional antithrombogenic properties to the medical device of Anzai, and Feijen discloses that anti-thrombotic coatings comprising an albumin layer and an anticoagulant may be formed by bonding the protein to the anticoagulant via a crosslinking reaction involving amide bonds formed between the anticoagulant and the protein (see claim 1 of Feijen and column 1, 2nd paragraph), such that the skilled artisan reasonably would have expected that the albumin coating of Jaffer could be incorporating into the Anzai coating via the same type of crosslinking.
It further would have been prima facie obvious to select the elected methacrylic species of formula (B-1) due to the very close structural similarity with the acrylic acid monomer taught by Anzai differing only by one additional C1 alkyl group, such that the skilled artisan reasonably would have expected them to have similar properties when incorporated into the Anzai polymer. Similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious). Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979) (Claimed and prior art compounds were both directed to heterocyclic carbamoyloximino compounds having pesticidal activity. The only structural difference between the claimed and prior art compounds was that the ring structures of the claimed compounds had two carbon atoms between two sulfur atoms whereas the prior art ring structures had either one or three carbon atoms between two sulfur atoms. The court held that although the prior art compounds were not true homologs or isomers of the claimed compounds, the similarity between the chemical structures and properties is sufficiently close that one of ordinary skill in the art would have been motivated to make the claimed compounds in searching for new pesticides.).
Response to Applicant’s Arguments
Applicant argues that the cite art does not teach or suggest that the polymer is conjugated to the protein via a crosslink as recited by the claims. Applicant asserts that Anzai mentions the use of a crosslinking agent only as a binder between the surface of the base material and the antithrombotic material.
In response the new ground of rejection relies on Feijen for providing a motivation to use a crosslink to connect the protein to the polymer.
Applicant also argues that Anzai teaches away from conjugating the polymer to a base layer through crosslinking, because Anzai mentions that its main object is to coat or fix antithrombotic material on a surface of a base material under mild conditions without requiring heating or the like and impairing the physical property of the base material. Applicant concludes that modifying Anzai to use crosslinking to conjugate the protein to the polymer would render the reference unsuitable for its intended purpose.
In response, the portions of Anzai referenced by Applicant are with respect to fixing the antithrombotic material to the surface of a medical device and not to a protein, since Anzai does not disclose the presence of a protein layer. Therefore, Anzai’s remarks concerning how the antithrombotic material is affixed to the surface of the medical device is not applicable to the issue of how the antithrombotic material is affixed to the protein layer. Additionally, the Office notes that Feijen teaches that the crosslinking of the protein to the anticoagulant also does not require heating as it is performed at room temperature (see Example 1).
Applicant also argues that there is not motivation to combine Anzai and Jeffer because Jaffer teaches that the purpose of the albumin layer is to improve blood compatibility and not to improve the performance of any subsequent coating such as the antithrombotic material of Anzai.
In response, Jaffer’s teaching that the albumin layer improves blood compatibility is sufficient to establish a motivation to incorporate such a layer into the Anzai composition; it is not necessary that the art provide an additional motivation regarding the ability of the albumin layer to improve the antithrombotic layer taught by Anazi.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3-4, 6-10, and 12-17 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of U.S. Pat. No. 12,599,707 and in view of Anzai et al. (US Pat. Pub. 2014/0172117) and/or and Feijen et al. (US Pat. No. 4,634,762 where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite a coating for a medical device and a medical device having a surface coated with the coating, the coating comprising a base layer comprising a protein such as albumin which is covalently conjugated to a surface layer comprising a plurality of sulfonic acid groups and a plurality of hemocompatible groups represented by formula B-1 corresponding to formula A-1 of the present claims, wherein the albumin is covalently bonded to the polymer chain.
Although the reference claims do not expressly recite the elected species of formula (A-1) nor the presence of the elected species of formula (B-1) of the present claims so as to form a copolymer, it would have been prima facie obvious to select the elected species of (A-1) and to incorporate a methacrylic monomer to form a copolymer in light of Anzai’s express teaching that the elected species and acrylic monomers are suitable monomers for use in an antithrombotic copolymer coating and due to the very close structural similarity between acrylic and methacrylic monomers such that the skilled artisan reasonably would have expected them to function similarly in the copolymer. Similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”).
Although the reference claims do not expressly recite that the covalent bond between the albumin and the surface layer comprising hemocompatible groups is in the form of crosslinked amide bonds, it would have prima facie obvious to form the covalent bond in this way because Feijen discloses that anti-thrombotic coatings comprising an albumin layer and an anticoagulant may be formed by bonding the protein to the anticoagulant via a crosslinking reaction involving amide bonds formed between the anticoagulant and the protein (see claim 1 of Feijen and column 1, 2nd paragraph), such that the skilled artisan reasonably would have expected that the covalent bond between the albumin coating and the hemocompatible polymer layer of the reference claims could be formed via the same type of crosslinking.
Response to Applicant’s Arguments
Applicant argues that Anzai cannot be relied upon for the same reasons discussed above against the 103 rejection.
In response, this argument is not persuasive because the new ground of rejection relies upon Feijen to provide a motivation to crosslink the protein and the polymer layer.
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 GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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