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 Amendment
The amendment filed 06 November 2025 has been entered. Claims 1-12 are currently pending in the application. Claims 9-11 are withdrawn. The rejections of record from the office action dated 07 August 2025 not repeated herein have been withdrawn.
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.
Claims 1-6, 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ogura et al. (US 2009/0198021 A1) in view of Nakai et al. (US 2016/0024343 A1).
Regarding claims 1-6, 8 and 12, Ogura discloses a flexible tube for an endoscope (flexible tube for an endoscope; endoscopic medical device comprising the flexible tube) comprising a flexible tube material (i.e. sleeve-shaped flexible-tube base) and a jacket (i.e. cover layer covering the outer periphery of the flexible-tube base)(abstract), wherein the jacket comprises a polyester comprising polybutylene naphthalate (i.e. wherein the cover layer includes a polyester having a naphthalene structure)([0011], claim 7).
Ogura does not disclose that the polyester is a chain extended product including a constituent component derived from an epoxy compound, an isocyanate compound, an amine compound, an oxazoline compound, a carbodiimide compound having a molecular weight of less than 3,000 or a carboxylic anhydride.
Nakai discloses a flexible tube for an endoscope having a flexible tube base and a resin layer that coats the flexible tube base, wherein the resin layer comprises a polyester, wherein the polyester may be chain extended with epoxy compounds, polyfunctional isocyanate compounds, polyfunctional amino compounds, oxazoline compounds, carbodiimide compounds and acid anhydrides, wherein the chain extension improves performance of the resin layer in particular the peracetic acid resistance, elasticity and bending durability (i.e. chain extended product includes a constituent component derived from a chain extender selected from an epoxy compound, an isocyanate compound, an isocyanate compound, a amine compound, an oxazoline compound)(abstract, [0011], [0015]-[0016], [0045], [0086]).
Ogura and Nakai are analogous art because they both teach about flexible tubes for endoscopes having a flexible base tube and a cover layer comprising polyester. It would have been obvious to one of ordinary skill in the art to chain extend the naphthalene based polyester of the cover layer of Ogura as taught by Nakai in order to provide a cover layer having improved performance, in particular the peracetic acid resistance, elasticity and bending durability and because doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
Regarding claim 2, modified Ogura discloses that the epoxy compound may have 2 or more epoxy groups (bifunctional)(Nakai [0090]).
Regarding claim 3, modified Ogura discloses that the isocyanate compounds are polyfunctional and may be diisocyanates (i.e. bifunctional)(Nakai [0096]).
Regarding claim 4, modified Ogura discloses that the amine compounds may be diamines (i.e. bifunctional)(Nakai [0102]).
Regarding claim 5, modified Ogura discloses that the oxazoline compound may be polyoxazoline compounds (i.e. polymeric oxazoline compound)(Nakai [0104]).
Regarding claim 6, modified Ogura discloses that the carbodiimide compound may have a molecular weight of 100 to 30,000 and may be aromatic (i.e. overlapping less than 3,000; having a ring structure)(Nakai [0098]-[0100]).
Regarding claim 12, it is noted that Ogura discloses an embodiment wherein the cover layer is a single layer jacket for an endoscope (Ogura claims 10-11). It is noted that no further layers are required. Therefore, it is the examiner’s position that it would have been obvious for the cover layer to be a single layer. It is noted that Ogura discloses examples using 50% or more of PBN (Table 1, Ex. 1, 4). Therefore, it is the examiner’s position that it would have been obvious to use this amount of PBN.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ogura et al. (US 2009/0198021 A1) and Nakai et al. (US 2016/0024343 A1), as applied to claim 1 above, in view of Berthelon et al. (WO 2006/122896 A1).
Regarding claim 7, modified Ogura discloses all of the claim limitations as set forth above. Modified Ogura does not disclose that the carboxylic anhydride is a tetracarboxylic dianhydride.
Berthelon discloses chain extending a polyester using a tetracarboxylic dianhydride in order to improve thermal and light stability (abstract, Pages 5-7).
Berthelon and Ogura are analogous art because they both teach about polyesters. It would have been obvious to on or ordinary skill in the art to use the tetracarboxylic dianhydride chain extender of Berthelon in the tube of Ogura in order to provide a cover layer having improved thermal and light stability and because doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
Response to Arguments
Applicant's arguments filed 06 November 2025 have been fully considered but they are not persuasive.
Applicant argues that Ogura does not teach a chain-extended product as set forth in claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that Nakai does not teach that a chain-extended product of the polyester elastomer having a naphthalene structure is contained in the resin layer.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that one or ordinary skill in the art would not have been motivated to apply a chain extender taught by Nakai to chain extend the polyester of Ogura.
Applicant’s argument is unpersuasive given that applicant provides no evidence that one of ordinary skill in the art would not have combined Ogura and Nakai.
Examiner’s position remains that it would have been obvious to one of ordinary skill in the art to chain extend the naphthalene based polyester of the cover layer of Ogura as taught by Nakai in order to provide a cover layer having improved performance, in particular the peracetic acid resistance, elasticity and bending durability and because doing so would amount to nothing more than using a known material in a known environment to accomplish an entirely expected result.
Applicant argues that the instant invention provides unexpected results of bending durability and sterilization durability and points to Examples 1-25 in Tables 1-1 to 1-5.
However, applicant’s argument is unpersuasive given that the data presented is not commensurate in scope with the instant claims given that instant claim 1 recites any amount of any polyester having naphthalene structure, while the examples teach 79.5-99.5 of polyester elastomer having polybutylene naphthalate as a structural unit. Instant claim 1 recites any amounts of any A-F, while the Examples use A-D and F at 0.5 and E at 0.1-1, and A is bisphenol A glycidyl ether, glycerol triglycidyl ether, or tetraglycidyl diaminodiphenylmethane, B is p-Toylol isocyanate, 1,3 Bis(isocyanatomethyl)benzene, or 1,3,5-Tris(6-isocyanatohex-1-yl)-1,3,5-triazine-2,4,6 (1H, 3H, 5H)-trione, C is 4,4’-Diaminodiphenylmethane, or 1,3,5-Triazine-2,4,6-triamine or Tetrakis(4-aminophenyl)methane, D is 2,2’-(1,3-Phenylenebis(2-oxazoline)), polymeric oxazoline, and E is low molecular weight monocarbodiimide or cyclic carbodiimide, and F is 4-Ethynylphthalic anhydride or 1,2,4,5-Cyclohexanetetracarboxylic dianhydride or 3,3’,4,4’-Diphenyl ether tetracarboxylic dianhydride.
Applicant argues regarding claim 6, that [0077] of the present specification defines “carbodiimide compound having a ring structure” as a compound having a ring including a carbodiimide group as a ring forming component.
Applicant’s argument is unpersuasive given that claim 6 recites “derived from a carbodiimide compound having a ring structure”. Given the use of the phrase “derived from”, a carbodiimide compound having a ring including a carbodiimide group as a ring forming component is not required.
Applicant argues regarding claim 12, that Nakai has 2 layers.
However, note that while Nakai does not disclose all the features of the present claimed invention, Nakai is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely the polyester may be chain extended with epoxy compounds, polyfunctional isocyanate compounds, polyfunctional amino compounds, oxazoline compounds, carbodiimide compounds and acid anhydrides, wherein the chain extension improves performance of the resin layer in particular the peracetic acid resistance, elasticity and bending durability (i.e. chain extended product includes a constituent component derived from a chain extender selected from an epoxy compound, an isocyanate compound, an isocyanate compound, a amine compound, an oxazoline compound)(abstract, [0011], [0015]-[0016], [0045], [0086]), and in combination with the primary reference, discloses the presently claimed invention.
Applicant argues regarding claim 12, that modified Ogura does not teach that the polyester having a naphthalene structure is 50% by mas or more.
As set forth above, it is noted that Ogura discloses examples using 50% or more of PBN (Table 1, Ex. 1, 4). Therefore, it is the examiner’s position that it would have been obvious to use this amount of PBN.
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 JAMES C YAGER whose telephone number is (571)270-3880. The examiner can normally be reached 9-6 EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES C YAGER/ Primary Examiner, Art Unit 1782