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 .
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Drummond et al. (US-20080093157-A1) in view of Caballero et al. (US-20180236144-A1), Parthasarathy et al. (US-20150165097-A1), Peters et al (US-20130045146-A1), and Horbach et al. (EP 2099370 B1; herein English machine translation used for all citations) (newly cited), as evidenced by Optical Clarity of Parylene at Increased Thickness (Optical Clarity of Parylene at Increased Thickness, 2023, Specialty Coating Systems, Pages 4-6).
Regarding claim 1, Drummond teaches a medical article comprising: a tube with an interior surface and an exterior surface (see stethoscope) (Drummond, Abstract, Par. 0001). Drummond teaches the exterior of the tube is coated with parylene (Drummond, Par. 0020 and 0029-0031). Parylene satisfies the limitation of being derived from a barrier polymer derived from at least one ethylenically unsaturated monomer as it is given as an example of one by the instant claim 5. Parylene coatings further are transparent as evidenced by Optical Clarity of Parylene at Increased Thickness (Optical Clarity of Parylene at Increased Thickness, Page 4).
Drummond is silent regarding at least a portion of the exterior of the surface of the tube being a printed surface.
Caballero teaches a medical tubing comprising a printing (marking) on an exterior surface to mark the medical tubing as needed (Caballero, Abstract, Par. 0002, 0006, 0012-0016, 0079, and 0113).
Drummond and Caballero are analogous art as they both teach medical tubing. 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 the teachings of Caballero and printed on the exterior surface of the medical tubing of Drummond. This would allow for markings on the medical tubing as needed (Caballero, Abstract, Par. 0002, 0006, and 0012-0016). Furthermore, as the barrier polymer is transparent as stated above, this would result in the printed surface being visible through the coating.
Modified Drummond is silent regarding the tube comprising a polymer composition containing one or more extractable components.
Parthasarathy teaches a medical article comprising a tube (see stethoscope) that is formed from a polymer composition containing one or more extractable components (plasticizers) (Parthasarathy, Abstract, Par. 0004-0005). Plasticizers satisfy the limitation of the extractable component as it is given as an example of one by the instant specification Page 2.
Modified Drummond and Parthasarathy are analogous art as they both teach medical articles comprising a tube (see stethoscope). 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 the material of Parthasarathy as the material of the tube of modified Drummond. This would allow for stethoscope with anti-microbial properties (Parthasarathy, Abstract and Par. 0003-0005).
Modified Drummond is silent regarding the coating being a vapor-deposited coating that reduces the extraction of extractable components from the tube.
Peters teaches a medical article comprising a tube with an interior surface and an exterior surface, comprising a vapor-deposited coating of a barrier polymer derived from an ethylenically unsaturated monomer (parylene) covering a portion of the exterior surface of the tube, such that the vapor-deposited polymer coating barrier reduces the extraction of extractable components from the tube (Peters, Abstract, Par. 0010-0011, 0015-0020, and 0043). Parylene satisfies the limitation of being derived from an ethylenically unsaturated monomer as it is given as an example of one by the instant claim 5. Furthermore, Parylene coatings are transparent as evidenced by Optical Clarity of Parylene at Increased Thickness (Optical Clarity of Parylene at Increased Thickness, Page 4).
Modified Drummond and Peters are analogous art as they both teach medical articles comprising tube coated with parylene. 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 the vapor-deposited coating of Peters as the coating of modified Drummond. This would allow for prevention of contamination from the material of the tube (Peters, Abstract).
Modified Drummond is silent regarding the vapor-deposited coating covering a portion of the interior surface of the tube.
Horbach teaches a medical article comprising a tube, wherein both the interior and exterior surface of the tube are coated with a parylene coating to reduce friction (see lubricating ability) (Horbach, Par. 0001, 0019-0021).
Modified Drummond and Horbach are analogous art as they both teach medical tubes comprising a parylene coating. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have coated both the interior and exterior surface of modified Drummond with the vapor-deposited coating formed from parylene. This would allow for a lubricating ability and/or good chemical resistance and antibacterial effect (Horbach, Par. 0021).
Regarding claim 2, modified Drummond teaches the polymer composition comprises plasticized polyvinyl chloride (PVC) (Parthasarathy, Par. 0010-0012, 0017, 0031-0032, and 0046-0047).
Regarding claim 3, the limitation of the printed surface being formed by hydrographic printing is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113). The printed surface structure of the prior art discloses a product which reasonably appears to be either identical or substantially identical to the claimed product-by-process printed surface structure subjected to the process steps of hydrographic printing, and therefore absent any objective evidence showing to the contrary, the addition of the process limitations of claim 3 does not provide a patentable distinction over the prior art.
Regarding claim 4, modified Drummond teaches the printed surface comprises a pattern comprising indicia (Caballero, Abstract, Par. 0013-0020).
Regarding claims 5-6, modified Drummond teaches the vapor-deposited coating comprises parylene N or C (Peters, Par. 0017-0018, 0021-0022, and 0041).
Regarding claims 7-8, modified Drummond teaches the vapor-deposited barrier polymer coating has a thickness of less than 20 µm (Peters, Par. 0042), which overlaps the claim 7 range of 0.2-10 micrometers and the claim 8 range of 1-5 micrometers and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Regarding claim 9, modified Drummond teaches the polymer composition has a thickness of 3.4 or 3.7 mm (Parthasarathy, Par. 0111), which lies within the claimed range of from 0.1-7 mm and therefore satisfies the claimed range, see MPEP 2131.03. While these thicknesses are disclosed in the examples, in the absence of a general disclosure of the thickness, it would have been obvious to one of ordinary skill in the art to look towards the examples for guidance on the thickness of the polymer composition, see MPEP 2143.
Regarding claim 10, modified Drummond teaches the tube comprises tubing for a stethoscope (Drummond, Abstract).
Regarding claim 11, modified Drummond teaches the reduction of extraction of extractable components from the tube comprises a reduction in solvent extraction by solvents (Peters, Par. 0040), and would thus comprise a reduction in solvent extraction by polar or nonpolar solvents as the solvents must be either polar or nonpolar.
Furthermore, Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01. Modified Drummond teaches a coating formed from parylene N or C with a thickness of less than 20 µm (Peters, Par. 0017-0018, 0021-0022, and 0041-0042), which is the same as the claimed invention per the instant claims 6-9. The instant specification Pages 17-18 further indicate that a parylene N or C coating results in a reduction in solvent extraction by polar or nonpolar solvents. Modified Drummond therefore teaches a coating that is identical or substantially identical to the claimed invention. Therefore, absent objective evidence to the contrary, modified Drummond would have inherently exhibited the claimed reduction in solvent extraction by polar or nonpolar solvents.
Allowable Subject Matter
Claims 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record does not teach or render obvious each and every limitation of the instant claim 12.
The closest prior art of record is considered to be modified Drummond as stated above.
The differences between the closest prior art of record and the instant claim 12 is described below.
Modified Drummond does not teach that the vapor-deposited coating comprises a copolymer of parylene and at least one (meth)acrylate. While previously cited Wright discussed including a (meth)acrylate in a coating composition that could react with other materials in the coating, Wright does not render obvious including a (meth)acrylate in a coating of parylene such that the parylene and (meth)acrylate would react to form a copolymer of the parylene and the (meth)acrylate.
The closest prior art of record thus does not teach or render obvious each and every limitation of the instant claim 12. Therefore, claim 12 and all claims dependent thereof indicate allowable subject matter.
Response to Arguments
Applicant’s remarks and amendments filed 05 March 2026 have been fully considered.
Applicant requests withdrawal of the objection and rejections under 35 USC § 112 set forth in the previous office action.
The objection and rejections under 35 USC § 112 set forth in the previous office action have been withdrawn due to the present claim amendments.
Applicant argues that Drummond does not teach the coating on an interior surface of the tube. This is found moot.
The grounds of rejection have been updated above in view of the present claim amendments. In the grounds of rejection above, Drummond is not relied upon to render obvious the coating being present on an interior surface of the tube. Instead, newly cited Horbach is utilized to render obvious the coating on an interior surface as stated above.
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 THOMAS J KESSLER JR whose telephone number is (571)272-3075. The examiner can normally be reached 7:30-5:30 M-Th.
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, 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.
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.
/THOMAS J KESSLER/Examiner, Art Unit 1782