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 of Group I, claims 1-4, in the reply filed on 24 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 March 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/395,795 (hereinafter “’795”; cited as US 2024/0139384 A1) in view of Whitbourne (US 5,997,517).
With respect to claims 1-3, ‘795 discloses an elongated medical device having a coating film on a surface of a base material, where the coating film is composed of a polymeric material in which a copolymer containing a polymerization unit having a hydrophilic structure has been crosslinked and has a structure given by formula (1) shown below, where R1 represents a hydrogen atom, a linear alkyl group having 1 or more carbon atoms, or a branched alkyl group having 1 or more carbon atoms; R2 is an alkylene group having 1 or more carbon atoms, a divalent alicyclic hydrocarbon group containing an alicyclic structure having 3 or more carbon atoms, or a divalent aromatic group containing an aromatic ring structure having 6 or more carbon atoms, and the alkylene group, the alicyclic hydrocarbon group, and the aromatic group may have a divalent group between the carbon atoms represented by -NR3-, where R3 is a hydrogen atom or an alkyl group having 1 to 8 carbon atoms (claim 1).
-CH(OH)-CH(R1)-O-C(=O)-NH-R2-NH-C(=O)-O-CH(R)-CH(OH)-
Formula (1)
However, while ‘795 discloses the coating being on a surface of a base material, ‘795 does not disclose wherein the base material (i.e., base layer) is on a substrate, nor wherein the base layer includes an isocyanate compound having two or more isocyanate groups, nor wherein at least some isocyanate groups of the isocyanate compound react with at least some of the hydroxy groups in the structure represented by the above formula (1) in the polymer material and are covalently bonded thereto.
Whitbourne discloses a guide wires, catheters, drainage tubes, and feeding tubes (i.e., elongated medical devices) (Col. 3, lines 30-38) comprising a substrate (Col. 3, lines 39-40), a thin polymer layer (Col. 3, line 63-Col. 4, line 2), and other layers (Col. 4, lines 2-3). The thin polymer layer comprises a polymer with a hydroxyl or carboxyl group (Col. 4, lines 60-64) and isocyanates (Col. 5, lines 9-10). The other layers include an outer layer that is hydrophilic and react with the thin polymer layer that is a bond coat (claim 21).
‘795 and Whitbourne are analogous inventions in the field of elongated medical devices having outer hydrophilic layers.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base material of ‘795 to have a base layer made from the thin polymer layer comprising a polymer with a hydroxyl or carboxyl group and isocyanates, and to include a substrate as taught by Whitbourne and thereby arrive at the claimed invention. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding wherein at least some isocyanate groups of the isocyanate compound react with at least some of the hydroxy groups in the structure represented by the above formula (1) in the polymer material and are covalently bonded thereto, while there may be no explicit disclosure from ‘795 in view of Whitbourne regarding at least some isocyanate groups of the isocyanate compound reacting with at least some of the hydroxy groups in the structure represented by the above formula (1) in the polymer material and being covalently bonded thereto, given that ‘795 in view of Whitbourne disclose an otherwise identical elongated medical device made from otherwise identical layers made from otherwise identical materials as that presently claimed, it is clear that at least some isocyanate groups of the isocyanate compound would necessarily inherently react with at least some of the hydroxy groups in the structure represented by formula (1) in the polymer material and be covalently bonded thereto, absent evidence to the contrary.
With respect to claim 4, ‘795 discloses wherein the hydrophilic structure includes at least one of a betaine structure, an amide structure, a lactam structure, and a polyalkylene oxide structure (claim 3).
The above rejections are provisional nonstatutory double patenting rejections.
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.
Claim 3 is 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.
With respect to claim 3, the claim recites “wherein the copolymer includes a polymer unit having a hydrophilic structure” in lines 1-2. However, claim 1 recites “a copolymer comprising a polymer unit having a hydrophilic structure” in lines 5-6. It is unclear if claim 3 refers to another, different polymer unit having a different hydrophilic structure, or if claim 3 refers to the same polymer unit having the same hydrophilic structure of claim 1. Clarification is respectfully requested.
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 1-4 are rejected under 35 U.S.C. 103 as being obvious over Whitbourne (US 5,997,517) in view of Yamamoto et al. (US 2024/0209131 A1, “Yamamoto”). The applied reference Yamamoto has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
These rejections under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
With respect to claims 1-4, Whitbourne discloses a guide wires, catheters, drainage tubes, and feeding tubes (i.e., elongated medical devices) (Col. 3, lines 30-38) comprising a substrate (Col. 3, lines 39-40), a thin polymer layer (Col. 3, line 63-Col. 4, line 2), and other layers (Col. 4, lines 2-3). The thin polymer layer comprises a polymer with a hydroxyl or carboxyl group (Col. 4, lines 60-64) and isocyanates (Col. 5, lines 9-10). The other layers include an outer layer that is hydrophilic (claim 21).
However, while Whitbourne discloses the use of other layers, Whitbourne does not disclose wherein the other layers are a polymer material with a copolymer comprising a polymer unit having a hydrophilic structure is crosslinked by a structure represented by formulas (1) to (3) as claimed.
Yamamoto teaches a coating capable of affording both high hydrophilicity and high water resistance ([0031]) made from a copolymer having a structural unit (A) having a cyclic carbonate structure and a structural unit (B) having a hydrophilic structure ([0007]). The hydrophilic structure has at least one structure selected from the group consisting of a betaine structure, an amide structure, an alkylene oxide structure, and a lactam structure ([0011]). The structural unit (B) is crosslinked in a crosslinked structure represented by the formula (2) –X1—Z—R4—Z—X2—, where X1 and X2 represent, independently, —CH(OH)—CH(R6)—O—C(=O)—* and —CH(CH(R6)(OH))—O—C(=O) —*, where * is bonded to Z; R4 is a linear or branched alkylene group having 1-11 carbon atoms, an alicyclic hydrocarbon group having 3-12 carbon atoms containing an alicyclic structure having 3-6 carbon atoms, or an aromatic group having 6-20 carbon atoms containing an aromatic ring structure having 6-10 carbon atoms; R6 represents a hydrogen atom or a linear or branched alkyl group or alkenyl group having 1-4 carbon atoms, wherein at least one hydrogen atom of R6 may be replaced by a halogen atom, and at least one carbon atom (—C—) may be replaced by —O—, —S—, and —P—; and Z represents —O— or —N(—H) — ([0025-0030]). Yamamoto further teaches that the copolymer reacts with a polyamine crosslinking agent ([0022-0023]) to produce crosslinked structure identical to that presently claimed ([0111]). Thus, the crosslinked structure corresponds to a crosslinked structure represented by formulas (1) to (3) as presently claimed.
Whitbourne and Yamamoto are analogous inventions in the field of hydrophilic coatings containing groups that react with isocyanate groups.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrophilic other coating of Whitbourne to be the hydrophilic copolymer having a structural unit (A) having a cyclic carbonate structure and structural unit (B) having a hydrophilic structure as taught by Yamamoto in order to provide a coating with high hydrophilicity and water resistance (Yamamoto, [0031]).
Regarding wherein at least some isocyanate groups of the isocyanate compound react with at least some hydroxy groups in the structures represented by formulas (1) to (3) in the polymer material and are covalently bonded thereto, given that Whitbourne in view of Yamamoto discloses an otherwise identical medical device made from otherwise identical layers made from otherwise identical materials as that presently claimed and used in the instant application (see specification, page 7, [0023]) it is clear that at least some isocyanate groups of the isocyanate compound would necessarily inherently react with at least some hydroxy groups in the structures represented by formulas (1) to (3) in the polymer material and be covalently bonded thereto, absent evidence to the contrary.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 5,997,517) in view of Endo et al. (JP H06-322029 A, “Endo ‘029”). The disclosure of Endo ‘029 is based off a machine translation of the reference included with this action.
With respect to claims 1-4, Whitbourne discloses a guide wires, catheters, drainage tubes, and feeding tubes (i.e., elongated medical devices) (Col. 3, lines 30-38) comprising a substrate (Col. 3, lines 39-40), a thin polymer layer (Col. 3, line 63-Col. 4, line 2), and other layers (Col. 4, lines 2-3). The thin polymer layer comprises a polymer with a hydroxyl or carboxyl group (Col. 4, lines 60-64) and isocyanates (Col. 5, lines 9-10). The other layers include an outer layer that is hydrophilic (claim 21).
However, while Whitbourne discloses the use of other layers, Whitbourne does not disclose wherein the other layers are a polymer material with a copolymer comprising a polymer unit having a hydrophilic structure is crosslinked by a structure represented by formulas (1) to (3) as claimed.
Endo ‘029 teaches a polymer made from ethylenically unsaturated monomers having a cyclic carbonate group that is modified with an aliphatic polyamine ([0001]). The ethylenically unsaturated monomers include (meth)acrylates comprising a cyclic carbonate group ([0010], [0025]) as well as additional monomers such as (meth)acrylamide ([0027]). Given the polymer includes (meth)acrylamide, it would necessarily be a hydrophilic polymer, and thus the hydrophilic structure comprises an amide structure. The aliphatic polyamine includes hexamethylenediamine ([0044]), which is identical to that used in the present invention (see specification, page 18, [0058]). Given that Endo ‘029 teaches reacting a polymer and a polyamine which are both identical to that used in the present invention, it is clear the polymer would necessarily include the presently claimed structures represented by formulas (1) to (3). The polymer is non-shrinkable ([0007], [0061]).
Whitbourne and Endo ‘029 are analogous inventions in the field of hydrophilic coatings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrophilic coating of Whitbourne to be the polymer made from ethylenically unsaturated monomers having a cyclic carbonate group modified with an aliphatic polyamine taught by Endo ‘029 in order to provide a hydrophilic polymer that is non-shrinkable (Endo ‘029, [0007], [0061]).
Regarding wherein at least some isocyanate groups of the isocyanate compound react with at least some hydroxy groups in the structures represented by formulas (1) to (3) in the polymer material and are covalently bonded thereto, given that Whitbourne in view of Endo ‘029 discloses an otherwise identical medical device made from otherwise identical layers made from otherwise identical materials as that presently claimed and used in the instant application (see specification, page 7, [0023]) it is clear that at least some isocyanate groups of the isocyanate compound would necessarily inherently react with at least some hydroxy groups in the structures represented by formulas (1) to (3) in the polymer material and be covalently bonded thereto, absent evidence to the contrary.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 5,997,517) in view of Endo et al. (JP H06-136229 A, “Endo ‘229”). The disclosure of Endo ‘229 is based off a machine translation of the reference included with this action.
With respect to claims 1-4, Whitbourne discloses a guide wires, catheters, drainage tubes, and feeding tubes (i.e., elongated medical devices) (Col. 3, lines 30-38) comprising a substrate (Col. 3, lines 39-40), a thin polymer layer (Col. 3, line 63-Col. 4, line 2), and other layers (Col. 4, lines 2-3). The thin polymer layer comprises a polymer with a hydroxyl or carboxyl group (Col. 4, lines 60-64) and isocyanates (Col. 5, lines 9-10). The other layers include an outer layer that is hydrophilic (claim 21).
However, while Whitbourne discloses the use of other layers, Whitbourne does not disclose wherein the other layers are a polymer material with a copolymer comprising a polymer unit having a hydrophilic structure is crosslinked by a structure represented by formulas (1) to (3) as claimed.
Endo ‘229 teaches a non-shrinkable crosslinkable polymer obtained by compounding an aliphatic polyamine with a copolymer containing a cyclic carbonate structure ([0001], [0042]). The cyclic carbonate structure is copolymerized with (meth)acrylic monomers including (meth)acrylamide ([0018]). Given the copolymer contains (meth)acrylamide, it would necessarily be a hydrophilic polymer and thus the hydrophilic structure comprises an amide structure. The aliphatic polyamine includes hexamethylenediamine ([0029]), which is identical to that used in the present invention (see specification, page 18, [0058]). Given that Endo ‘229 teaches reacting a polymer and a polyamine which are both identical to that used in the present invention, it is clear the polymer would necessarily include the presently claimed structures represented by formulas (1) to (3).
Whitbourne and Endo ‘229 are analogous inventions in the field of hydrophilic coatings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hydrophilic coating of Winn to be the copolymer made from a cyclic carbonate group, (meth)acrylamide, and aliphatic polyamine taught by Endo ‘229 in order to provide a hydrophilic polymer that is non-shrinkable (Endo ‘229, [0001], [0042]).
Regarding wherein at least some isocyanate groups of the isocyanate compound react with at least some hydroxy groups in the structures represented by formulas (1) to (3) in the polymer material and are covalently bonded thereto, given that Whitbourne in view of Endo ‘229 discloses an otherwise identical medical device made from otherwise identical layers made from otherwise identical materials as that presently claimed and used in the instant application (see specification, page 7, [0023]) it is clear that at least some isocyanate groups of the isocyanate compound would necessarily inherently react with at least some hydroxy groups in the structures represented by formulas (1) to (3) in the polymer material and be covalently bonded thereto, absent evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven A Rice whose telephone number is (571)272-4450. The examiner can normally be reached Monday/Wednesday 07:30-12:30 and 20:30-22:30; Tuesday/Thursday/Friday 07:30-16:30 Eastern.
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/STEVEN A RICE/Examiner, Art Unit 1787
/CALLIE E SHOSHO/Supervisory Patent Examiner, Art Unit 1787
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