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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-13, drawn to a medical article.
Group II, claims 14-20, drawn to a method of preparing a medical article.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of the medical article of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Drummond et al. (US-20080093157-A1) in view of Parthasarathy et al. (US-20150165097-A1) and Peters et al (US-20130045146-A1) as evidenced by Optical Clarity of Parylene at Increased Thickness (Optical Clarity of Parylene at Increased Thickness, 2023, Specialty Coating Systems, Pages 4-6).
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 6. 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 the tube comprising a polymer composition containing one or more extractable components and is silent regarding at least a portion of the exterior surface of the tube containing an anti-microbial.
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. Parthasarathy further teaches an antimicrobial on an exterior surface of the tube (Parthasarathy, Abstract, Par. 0004, 0007-0008, 0011, 0027-0028, 0065, and 0069 and Claim 30).
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 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).
Regarding the limitation at least a portion of the anti-microbial being capable of passing through the barrier polymer providing anti-microbial activity on a surface of the vapor-deposited barrier polymer coating, modified Drummond teaches a medical article that is identical or substantially identical to the claimed medical article. 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 the polymer composition comprises plasticized polyvinyl chloride (PVC) (Parthasarathy, Par. 0010-0012, 0017, 0031-0032, and 0046-0047), which is the same as the instant invention per the instant claim 2. Modified Drummond teaches the antimicrobial is benzalkonium chloride (Parthasarathy, Par. 0004), which is the same as the instant invention per the instant claim 3. Modified Drummond teaches the vapor-deposited barrier polymer comprises parylene N or C (Peters, Par. 0017-0018, 0021-0022, and 0041), which is the same as the instant invention per the instant claims 6-7. Modified Drummond teaches the vapor-deposited barrier polymer coating has a thickness of less than 20 µm (Peters, Par. 0042), which overlaps the range of the instant invention per the instant claims 8-9. Modified Drummond further teaches the antimicrobial can migrate through the polymer composition to the surface (Parthasarathy, Abstract, Par. 0004, 0007-0008, 0011, 0027-0028, 0065, and 0069 and Claim 30). Modified Drummond thus teaches a medical article that is identical or substantially identical to the claimed invention. Therefore, absent objective evidence to the contrary, at least a portion of the anti-microbial of modified Drummond would have been capable of passing through the barrier polymer providing anti-microbial activity on a surface of the vapor-deposited barrier polymer coating.
During a telephone conversation with Iona Kaiser on 04 December 2025 a provisional election was made without traverse to prosecute the invention of group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 recites a list without the words “and” or “or” preceding the last item of the list. This is believed to be a typographical error and claim 3 should instead recite “chlorhexidine gluconate, or fatty acid monoesters.”
Appropriate correction is required.
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.
Claims 1-13 are 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.
Claim 1 recites the phrase “through the barrier polymer layer providing anti-microbial activity on the surface of the barrier polymer surface” in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not previously recite a barrier polymer layer or a barrier polymer surface. It is thus unclear as to what is being referred as the barrier polymer layer and surface. For purposes of examination, claim 1 is interpreted as instead reciting “through the barrier polymer a vapor-deposited barrier polymer coating
Claim 12 recites the limitation "wherein the crosslinked polymer" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 12 depends, does not previously recite a crosslinked polymer. It is thus unclear to what is being referred as “the crosslinked polymer.” For purposes of examination, claim 12 is interpreted as instead reciting “wherein the vapor-deposited coating comprises a crosslinked polymer, wherein the crosslinked polymer comprises a copolymer…” as supported by the instant specification Page 11.
Claim 1-11 and 13 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, since these claims depend from the claims rejected above and do not remedy the aforementioned deficiencies.
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 1-4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Drummond et al. (US-20080093157-A1) in view of Parthasarathy et al. (US-20150165097-A1) and Peters et al (US-20130045146-A1) 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 6. 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 the tube comprising a polymer composition containing one or more extractable components and is silent regarding at least a portion of the exterior surface of the tube containing an anti-microbial.
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. Parthasarathy further teaches an antimicrobial on an exterior surface of the tube (Parthasarathy, Abstract, Par. 0004, 0007-0008, 0011, 0027-0028, 0065, and 0069 and Claim 30).
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 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).
Regarding the limitation at least a portion of the anti-microbial being capable of passing through the barrier polymer providing anti-microbial activity on a surface of the vapor-deposited barrier polymer coating, modified Drummond teaches a medical article that is identical or substantially identical to the claimed medical article. 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 the polymer composition comprises plasticized polyvinyl chloride (PVC) (Parthasarathy, Par. 0010-0012, 0017, 0031-0032, and 0046-0047), which is the same as the instant invention per the instant claim 2. Modified Drummond teaches the antimicrobial is benzalkonium chloride (Parthasarathy, Par. 0004), which is the same as the instant invention per the instant claim 3. Modified Drummond teaches the vapor-deposited barrier polymer comprises parylene N or C (Peters, Par. 0017-0018, 0021-0022, and 0041), which is the same as the instant invention per the instant claims 6-7. Modified Drummond teaches the vapor-deposited barrier polymer coating has a thickness of less than 20 µm (Peters, Par. 0042), which overlaps the range of the instant invention per the instant claims 8-9. Modified Drummond further teaches the antimicrobial can migrate through the polymer composition to the surface (Parthasarathy, Abstract, Par. 0004, 0007-0008, 0011, 0027-0028, 0065, and 0069 and Claim 30). Modified Drummond thus teaches a medical article that is identical or substantially identical to the claimed invention. Therefore, absent objective evidence to the contrary, at least a portion of the anti-microbial of modified Drummond would have been capable of passing through the barrier polymer providing anti-microbial activity on a surface of the vapor-deposited barrier polymer coating.
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, modified Drummond teaches the antimicrobial is benzalkonium chloride (Parthasarathy, Par. 0004).
Regarding claim 4, the limitation of the anti-microbial being contacted to the surface of the tube by soaking, dipping, wiping, coating, printing, or spraying 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 tube structure of the prior art discloses a product which reasonably appears to be either identical or substantially identical to the claimed product-by-process tube structure subjected to the process steps of soaking, dipping, wiping, coating, printing, or spraying, and therefore absent any objective evidence showing to the contrary, the addition of the process limitations of claim 4 does not provide a patentable distinction over the prior art.
Regarding claims 6-7, modified Drummond teaches the vapor-deposited barrier polymer comprises parylene N or C (Peters, Par. 0017-0018, 0021-0022, and 0041).
Regarding claims 8-9, modified Drummond teaches the vapor-deposited barrier polymer coating has a thickness of less than 20 µm (Peters, Par. 0042), which overlaps the claim 8 range of 0.2-10 micrometers and the claim 9 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 10, 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 11, modified Drummond teaches the tube comprises tubing for a stethoscope (Drummond, Abstract).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Drummond et al. in view of Parthasarathy et al. and Peters et al as evidenced by Optical Clarity of Parylene at Increased Thickness as applied to claim 1 above, further in view of Caballero et al. (US-20180236144-A1).
Regarding claim 5, modified Drummond teaches all of the elements of the claimed invention as stated above for claim 1. Modified Drummond is silent regarding a discontinuous or continuous layer on the exterior surface of the tube, wherein the discontinuous or continuous layer comprises a graphic layer.
Caballero teaches a medical tubing comprising a discontinuous graphic layer (marking) on an exterior surface to mark the medical tubing as needed (Caballero, Abstract, Par. 0002, 0006, 0012-0016, 0079, and 0113).
Modified 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 included the marking on the exterior surface of the medical tubing of modified Drummond. This would allow for markings on the medical tubing as needed (Caballero, Abstract, Par. 0002, 0006, and 0012-0016).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Drummond et al. in view of Parthasarathy et al. and Peters et al as evidenced by Optical Clarity of Parylene at Increased Thickness as applied to claim 1 above, further in view of Wright et al. (US-20100266794-A1).
Regarding claims 12-13, modified Drummond teaches all of the elements of the claimed invention as stated above for claim 1. Modified Drummond is silent regarding the vapor-deposited coating of a barrier polymer comprising a crosslinked polymer wherein the crosslinked polymer comprises a copolymer of parylene and at least one (meth)acrylate as required by claim 15 and is silent regarding the at least one (meth) acrylate comprising at least on C3-C18 alkyl (meth)acrylate) as required by claim 16.
Wright teaches a medical article formed from a substrate, wherein the substrate is coated by vapor deposition with a cross-linked polymer derived from an ethylenically unsaturated monomer that is a C3-C18 alkyl methacrylate (see, for example, butyl methacrylate) (Wright, Abstract, Par. 0007, 0009, 0034-0035, 0046, 0072, 0147, and 0153). Wright teaches the alkyl methacrylate may be reacted with other monomers in a coating composition (Wright, Par. 0206-0207).
Modified Drummond and Wright are analogous art as they both teach medical articles formed from a substrate wherein the substrate is coated by vapor deposition. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the ethylenically unsaturated monomers of Wright in the vapor deposited coating of modified Drummond. This would allow for improved physical and chemical properties (Wright, Par. 0002, 0005, and 0009). This would further result in the C3-C18 alkyl methacrylate monomers reacting with the parylene monomers and crosslinking, resulting in a crosslinked copolymer of parylene and a C3-C18 alkyl methacrylate, satisfying the claimed limitation.
Conclusion
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.
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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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/THOMAS J KESSLER/Examiner, Art Unit 1782