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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 –
(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, 5, 8, 12-13, 19, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luo et al. (US 20180163152 A1, hereafter “Luo”).
Regarding claim 1, Luo discloses an intermittent catheter comprising a hollow polymeric tubular body (see para. [0003], discloses the application of this external coating/formulation for guidewires and catheters-tubular devices) comprising a base polymer (first crosslinked polymeric matrix, para. [0014-0017, 0140]) and further comprising an amphiphilic additive (polymeric adhesion promoter, para. [0014-0017]) at and/or on an outer surface of the body (see para. [0003], discloses the application of this external coating/formulation for guidewires and catheters-tubular devices; also see general procedure 1 in para. [0199] and examples 1 and 2 in para. [0213-0217] wherein the catheter tubing is dip-coated with the base and/or additive) wherein the base polymer is independently cross-linked (para. [0016, 0096, 0140]) and/or the base polymer and additive are cross-linked with each other, and wherein the additive is located as a layer or coating on the base polymer (the adhesion promoter can be physically bound to the first crosslinking agent to form one network after curing, para. [0125]); and wherein the base polymer comprises a polymer selected from the group consisting of. polyethylene, polypropylene, thermoplastic elastomeric material, and combinations thereof (para. [0006, 0125]).
Regarding claim 5, Luo discloses the device of claim 1 and further discloses wherein the base polymer (first crosslinked polymeric matrix) is cross-linked at and/or on the outer surface (para. [0014-0017, 0140], see para. [0003], discloses the application of this external coating/formulation for guidewires and catheters-tubular devices; also see general procedure 1 in para. [0199] and examples 1 and 2 in para. [0213-0217] wherein the catheter tubing is dip-coated with the base and/or additive).
Regarding claim 8, Luo discloses the device of claim 1 and further discloses wherein the additive is an amphiphilic A-B block copolymer comprising an A-block comprising a hydrophobic hydrocarbon portion and a hydrophilic B-block (para. [0013-0017]).
Regarding claim 12, Luo discloses the device of claim 1 and further discloses wherein the additive is at and/or on at least 50% of the outer surface area of the polymeric tubular body (the catheter is dip-coated and therefore the outer surface would be more than 50% covered by the coating, para. [0014-0017, 0140], see para. [0003], discloses the application of this external coating/formulation for guidewires and catheters-tubular devices; also see general procedure 1 in para. [0199] and examples 1 and 2 in para. [0213-0217]).
Regarding claim 13, Luo discloses a method of manufacturing an intermittent catheter, the method comprising the steps of:
a. providing a base polymer (first crosslinked polymeric matrix, para. [0014-0017, 0140]) and an amphiphilic additive (polymeric adhesion promoter, para. [0014-0017, 0199]); and
b. forming a hollow polymeric tubular catheter body comprising the base polymer and additive (see para. [0003], discloses the application of this external coating/formulation for guidewires and catheters-tubular devices; also see general procedure 1 in para. [0199] and examples 1 and 2 in para. [0213-0217] wherein the catheter tubing is dip-coated with the base and/or additive), such that the additive is located as a layer or coating on the base polymer (the adhesion promoter can be physically bound to the first crosslinking agent to form one network after curing, para. [0125]),
wherein the method further comprises the step of independently cross-linking one or both of the base polymer (para. [0016, 0096, 0140]) and additive and/or cross-linking the base polymer and the additive with each other.
Regarding claim 19, Luo discloses the method of claim 13 and further discloses wherein the method comprises cross-linking one or both of the base polymer (first crosslinked polymeric matrix, para. [0014-0017, 0140]) and the additive independently and/or cross-linking the base polymer and the additive with each other during co-granulation of the base polymer with the additive; and wherein the base polymer comprises a polymer selected from the group consisting of. polyethylene, polypropylene, thermoplastic elastomeric material, and combinations thereof (para. [0006, 0125]).
Regarding claim 24, Luo discloses the method of claim 13 and further discloses wherein the additive is an amphiphilic A-B block copolymer comprising an A-block comprising a hydrophobic hydrocarbon portion and a hydrophilic B-block (para. [0013-0017]).
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.
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) 9 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luo (US 20180163152 A1) in view of Madsen et al. (WO 2006037321 A1, hereafter “Madsen”).
Regarding claims 9 and 25, Luo discloses the device and method of claims 8 and 24, respectively. However, Luo fails to disclose wherein the additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH3CH2(CH2CH2)a where "a" is 5-25, and a hydrophilic B-block.
Madsen teaches a similar method in the same field of endeavor wherein the additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH3CH2(CH2CH2)a where "a" is 5-25, and a hydrophilic B-block (page 8 lines 4-10, page 8 lines 19-23, also see page 9 lines 12-14 wherein the amphiphilic block copolymer is a poly alpha-olefin and includes polyethylene—the chain block itself).
Luo discloses the hydrophilic and hydrophobic copolymers and gives plenty of examples of potential hydrophobic copolymers that can be used (para. [0021, 0024, 0129, 0132]), but does not specifically list a polymer with the claimed polyethylene chain. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a poly alpha-olefin with a long chain of polyethylene as shown in Madsen for the hydrophobic block in Luo with predictable results—namely, a hydrophobic polymer/block to be used with the hydrophilic block forming the amphiphilic copolymer.
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 ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 11 March 2026