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 .
This office action is in response to applicant’s communication of 6/24/2026. Currently claims 1-20 are pending and rejected below.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 7-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bahar et al. (US 2020/0353417 A1).
Bahar teaches a coated tubing (figure 4 and figure 6-7), comprising an etched PTFE tubing (see para [0010] and scaffold PTFE) with an inner surface and an outer surface,(as in figure 4 for one example) wherein the outer surface comprises a layer of PEBA (see paras [0009]-[0010] and PEBA coated on the scaffold) thereon with an average thickness of less than 1 micron (see para [0009] and preferably less than 5 μm).
Concerning claim 3 and prepared using a PEBA-containing solution (see para [0011] and solution casting).
Concerning claim 4 and the PEBA-containing solution comprises a solvent selected from methanol, ethanol, 2-methyl-2-propanol, 1-butanol, 2-butanol, and mixtures thereof (see para [0029] and solvent is ethanol).
Concerning claim 7 and the PEBA-containing solution is at a temperature of 20*C to 100*C at the time of coating (see para [0029]-[0031] and note the temp during drying and coating).
Concerning claim 8 and the average thickness of the layer of PEBA is below 0.9 μm (see paras [0009]-[0010] and PEBA coated on the scaffold).
Concerning claim 9 and the average thickness of the layer of PEBA is below 0.8 μm (see paras [0009]-[0010] and PEBA coated on the scaffold).
Concerning claim 10 and a jacket layer comprising PEBA or a polyamide coated on the layer of PEBA (see figure 5 and note multiple layers of PEBA 20 forming a jacket layer on the underlying layers of PEBA).
Concerning claim 11 and the layer of PEBA consists essentially of PEBA (see para [0006], [0009] and the discussion of the PEBA film).
Concerning claim 12 and the layer of PEBA comprises one or more additives (see para [0018] and biocide addition).
Concerning claim 13 and the layer of PEBA is substantially free of residual solvent (see para [0015] and water use instead of solvent).
Concerning claim 14 and the coated tubing is a catheter liner (see para [0005] and use in catheters).
Concerning claim 15 and a catheter comprising the coated tubing (see para [0005] and use in catheters).
Concerning claim 16 and a coated tubing comprising a tubing comprising (figure 4 and figure 6-7) a fluoropolymer (see para [0010] and scaffold PTFE), with an inner surface and an outer surface (as in figure 4 for example), wherein the outer surface comprises a tie-layer thereon, wherein the tie-layer has an average thickness of less than 1 micron (see para [0009] and preferably less than 5 μm).
Concerning claim 17 and a method of preparing a coated tubing with an inner surface and an outer surface, comprising: providing an etched PTFE tubing (see para [0010] and scaffold PTFE), with an inner surface and an outer surface; dissolving PEBA in one or more solvents to provide a PEBA-containing solution (see para [0011] and solvent casting); and applying the PEBA-containing solution to the outer surface of the etched PTFE tubing to give a layer of PEBA thereon with an average thickness of less than 1 micron (again see para [0011] and solvent casting para [0009] and preferably less than 5 μm).
Concerning claim 18 and the dissolving comprises heating and/or agitating the PEBA in one or more solvents (see para [0015] and heating).
Concerning claim 19 and the PEBA-containing solution comprises a solvent selected from non-aromatic alcohols (see para [0029] and solvent is ethanol a nonaromatic alcohol compound).
Concerning claim 20 and the non-aromatic alcohol is selected from methanol, ethanol, 2- methyl-2-propanol, 1-butanol, 2-butanol, and mixtures thereof (again see para [0029] and solvent is ethanol - a nonaromatic alcohol compound).
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.
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bahar et al. (US 2020/0353417 A1).
Bahar discloses the claimed invention except for explicitly stating that the PEBA has a durometer of 25 to 72. It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the PEBA with a durometer of 25 to 72, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). It is disclosed the the PEBA may be the PEBAX product (para [0003]) and this is known to have a durometer of 25 to 72 (see Key Properties of Pebax® Elastomers | Arkema High Performance Polymers as evidence of this property).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bahar et al. (US 2020/0353417 A1) in view of Montes de Oca et al. (US 2019/0030214 A1).
Bahar discloses the claimed invention except for the the PEBA-containing solution comprises 1-butanol. Montes de Oca teaches that it is known to use the PEBA-containing solution comprises 1-butanol as set forth in para [0026] to providing a suitable medium that allows application or wetting of a coating formulation to a surface of a tubular catheter. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bahar with the PEBA-containing solution comprises 1-butanol as taught by Montes de Oca, since such a modification would provide the system with the PEBA-containing solution comprises 1-butanol for providing a suitable medium that allows application or wetting of a coating formulation to a surface of a tubular catheter.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bahar et al. (US 2020/0353417 A1).
Bahar discloses the claimed invention except for the PEBA-containing solution at a wt/vol ratio of less than 0.10 g/mL . It would have been obvious to one having ordinary skill in the art at the time the invention was made to have PEBA-containing solution at a wt/vol ratio of less than 0.10 g/mL, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). Bahar discloses adjusting the ratio but does not specify less than 0.10 g/mL (see para [0029]-[0031]. Examiner is of the position that Bahar discusses using little or no solvent (see para [0015] and water use instead of solvent) so examiner is of the position that a PHOSITA would use a ratio less than 0.10g/mL in order to form the PEBA layer in order to adhere and dry as appropriate to the adherence needed to form a compliant catheter with safe and biocompatibility.
Response to Arguments
Applicant's arguments filed 6/24/2026 have been fully considered but they are not persuasive. Applicant’s argue that the prior art fails to teach a “etched PTFE” tubing. Examiner disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “etched”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitation of the claim. Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon.
Examiner is of the position that the term “etched” is a functional type limitation that is drawn the method of making or forming the device and does not result in a structural difference to the device, rather how the layer of tubing is formed. Examiner is of the positon that this is a apparatus type claim and the “etched” claim language it to the process in which the tubing is formed. In such case the scope is based on the structure of the claims not the process of forming (i.e. etched).
Concerning the applicant’s arguments regarding the language of “average thickness of less than 1 micron…” examiner is of the position that the BAHAR as in para [0009] for example states that the thickness is “even more preferably less than 5 μm”. Examiner is of the position that this would include sizes less than 1 micron. If the total size thickness of the layer was less than 5 than the individual layers would by necessity be less than 5 and therefore individual layers would be less than 5 as well, and thus would disclose the range from 0 to 1 micron.
The elements disclosed in the prior art of record are fully capable of satisfying all structural, functional, spatial, and operational limitations in the amended claims, as currently written, and the rejection is made.
It is recommended that applicant amend the claims to greater distinguish over the prior art of record.
Conclusion
THIS ACTION IS MADE FINAL. 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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
Prosecution Insights