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
This office action is responsive to the amendment filed on July 20, 2026. As directed by the amendment: claims 8-10 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-24 are presently pending in this application. Applicant’s amendment are sufficient to overcome the claim objections of the previous action.
Response to Arguments
Applicant's arguments filed July 20, 2026 have been fully considered but they are not persuasive.
On page 5, Applicant argues the §112(b) rection of the previous action, and that the test results recited in the pending claims are known parameters, and that the application provides a method by which such values can be tested to reproduce the disclosed results with minimal experimentation and evaluate other catheter assemblies using only routine experimentation. In response, Examiner notes that MPEP 2164.06 references “experimentation” with regard to a reasonable amount of experimentation to make and use the claimed invention. Routine experimentation is irrelevant to indefiniteness. The rejections of the previous action are maintained, see below.
On page 6, Applicant argues the §112(b) rejection of the previous action related to “unexpanded” UHMWPE, arguing that a person of ordinary skill in the art would recognize the absence of any step in Applicant’s experimental section of the written description that would lead to the formation of expanded UHMWPE as support for claiming “unexpanded” UHMWPE. In response, Examiner notes that although the absence of a step is evidence that Applicant teaches unexpanded UHMWPE, the issue here with regard to the §112(b) rejection is claim indefiniteness, and then how to interpret the claim limitation reciting “unexpanded” UHMWPE. The rejections of the previous action are maintained, see below.
On page 8 of the Remarks, Applicant argues that one of ordinary skill in the art would not predictably be led to the claimed catheter based on the teachings of the cited prior art of the previous action. In response, Examiner notes that the relevant issues with regard to the prior art rejections are anticipation and obviousness, and that the claims are interpreted for purposes of examination as noted below due to the issues stemming from claim indefiniteness.
On pages 8-10, to the best of Examiner’s understanding, Applicant is arguing that Goldberg teaches Dyneema, a typically porous and fibrous/filamentary tube, and that Maximum Work of Advancement as claimed in is not inherent to Goldberg. In response, Examiner notes that the relevant question is whether Goldberg anticipates or renders obvious the claimed unexpanded UHMWPE liner, which is related to the issue of claim interpretation noted in the indefiniteness rejection below.
On pages 12-13 of the Remarks, Applicant argues Yaritz. To the best of Examiner’s understanding, Applicant is arguing that Yaritz is not analogous art because it is not related to medical devices. MPEP 2141.01(a) recites “A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention).”. Here, the reference is reasonably pertinent to the problem faced by the inventor, which is improving the processability of UHMWPE, P0005.
On page 13 of the Remarks, Applicant argues Yamaguchi. Per MPEP 2141.01(a), In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Here, Yamaguchi is reasonably pertinent to the problem faced by the inventor, which is the problem of which specific alpha-olefin may be used in a material comprised of UHMWPE and alpha-olefin, to reduce friction. Alpha-olefins are used with UHMWPE material for the purpose of reducing friction, wherein reduced friction is important for catheter liners because catheter liners are used for passing items through their lumen. Yamaguchi teaches specific types of alpha-olefins for use with UHMWPE, for the purpose of reducing friction, Yamaguchi P0003 and P0008.
In summary, the claims set forth different functional capabilities of the catheter without reciting all of the required structure for performing those capabilities. Based on Applicant Remarks, the presence of an unexpanded UHMWPE alone is not sufficient to satisfy any of the claimed capabilities, and the recited Maximum Work of Advancement of a catheter and the recited Maximum Work of Advancement of a Guidewire therethrough are not inherent to all UHMWPE liners. The current record fails to make it clear what structure is required for a catheter to satisfy the claimed functional limitations. For example, the applicant has not pointed out any physical components or features of the liner (e.g. pore sizes or density, surface topography, treatments applied to the liner, etc…) which ensure that it satisfies the required limitations.
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 1-24 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 lines 4-7 recite “…wherein the catheter exhibits one or both of: a) a Maximum Work of Advancement of 12,000 mN*cm or less; and b) a Maximum Work of Advancement of a 0.014’’ guidewire of 2500 mN*cm or less…”. MPEP 2111.01(II) recites that it is improper to import claim limitations from the specification. Here, it is impossible to determine the scope of the claims 1 and 14-20 without importing limitations from the written description because the claim limitations regarding a catheter that exhibits a maximum work of advancement and a maximum force of advancement are test results derived from lab testing a catheter set forth in the written description. Additionally, MPEP 2173.02(II) recites “… claims are required to be cast in clear—as opposed to ambiguous, vague, indefinite—terms…it is the claims that notify the public of what is within the protections of the patent, and what is not…”. Here, the claims are indefinite because they make reference to test results derived from lab testing a catheter according to a testing protocol that is set forth in the written description to determine maximum work of advancement and maximum force of advancement. Per the claims, anticipation is determined by lab testing a catheter which requires building a catheter. If built and tested, it is not clear that any results would be relevant given any differences between the tested catheters of the written description and a prior art catheter or potentially infringing catheter. Unless a tested catheter is exactly the same as those described in the written description, it is not clear if such results will be of any value in determining which catheters are anticipated by the claims. Claims 2-22 and 24 are rejected at least because they depend from claim 1. Claims 14-20 are similarly rejected. Independent claim 23 is similarly rejected. For purposes of examination, prior art that teaches the claimed catheter structure is understood to satisfy the claim limitations regarding maximum work of advancement and maximum force of advancement.
Claim 1 line 3 recites “…wherein the UHMWPE is unexpanded…”, and then recites test results in lines 5-7 related to the catheter having an unexpanded UHMWPE liner. However, table 4 of the written description, from which the test results of claim 1 draw support, does not identify a catheter built with unexpanded UHMWPE, only UHMWPE. Thus, it is not clear if unexpanded UHMWPE is different from UHMWPE, and what the difference might be since the written description only describes what unexpanded UHMWPE is not. For purposes of examination, UHMWPE is interpreted to be unexpanded UHMWPE. Claims 2-22 and 24 are rejected at least because they depend from claim 1. Independent claim 23 is similarly rejected.
Claim 1 line 4 recites “..the catheter exhibits…”. It is not clear if a catheter that has the claimed structure will also exhibit test results as claimed, and if not why not. It may be more accurate to recite “the catheter when built and tested per the protocol set forth in the written description exhibits…”, though such a recitation would also be indefinite for the reasons stated above by requiring reference to test results derived from lab testing a catheter according to a testing protocol that is set forth in the written description. Claims 2-22 and 24 are rejected at least because they depend from claim 1. Independent claim 23 is similarly rejected.
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, 5-8, 11 and 14-24 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (Goldberg) 2019/0307589 A1 in view of Sbriglia US 2014/0212612 A1.
Regarding claim 1, Goldberg discloses a catheter (sheath 100 as shown in Figs. 2-5) comprising an Ultra High Molecular Weight Poly(Ethylene) ("UHMWPE") liner (inner layer 102 comprising ultra-high-molecular-weight polyethylene (UHMWPE), P0073), an optional reinforcement layer (braided layer 104, P0075), and a jacket (elastic layer 106, P0075).
Goldberg is silent with regard to wherein the UHMWPE is unexpanded.
However, Sbriglia teaches terminology wherein expanded UHMWPE is expressly identified as expanded UHMWPE see Abstract and P0008, in contrast to unexpanded UHMWPE which is identified simply as UHMWPE, see P0003. Therefore, one of ordinary skill in the art would understand Goldberg to teach unexpanded UHMWPE because a modifier (expanded and unexpanded) is only added when the material has been expanded. This terminology and logic is consistent with Applicant’s written description support for claiming unexpanded UHMWPE since Applicant’s written description is also silent as to wherein the UHMWPE is unexpanded as noted above in regard to Applicant’s table 4.
Goldberg does not teach wherein the catheter exhibits one or both of:
a) A Maximum Work of Advancement of 12,000 mN*cm; and b) a Maximum Work of Advancement of a 0.014’’ guidewire of 2500 mN*cm or less.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 5, Goldberg in view of Sbriglia teaches the catheter of claim 1, comprising the reinforcement layer (Goldberg, braided layer 104, P0075).
Regarding claim 6, Goldberg in view of Sbriglia teaches the catheter of claim 5, wherein the reinforcement layer is selected from the group consisting of a coil, a braid (Goldberg, braided layer 104, P0075), or a combination thereof.
Regarding claim 7, Goldberg in view of Sbriglia teaches the catheter of claim 5, wherein the reinforcement layer comprises a metallic or polymeric material (Goldberg, braided layer 104 can comprise metallic or synthetic wires or fibers, P0075).
Regarding claim 8, Goldberg in view of Sbriglia teaches the catheter of claim 1, wherein the UHMWPE liner comprises UHMWPE comprising at least 85% polymerized ethylene-derived monomer units (Goldberg, UHMWPE, a polyethylene, P0073).
Regarding claim 11, Goldberg in view of Sbriglia teaches the catheter of claim 1, wherein the UHMWPE liner consists essentially of UHMWPE (per MPEP 2111.03(III), the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention, and here the liner is formed of UHMWPE, P0073).
Regarding claim 14, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a Maximum Force of Advancement of a 0.014” guidewire that is at least about 20% lower than a Maximum Force of Advancement of a 0.014” guidewire of a comparable HDPE-lined catheter.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 15, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a Work of Advancement of a 0.014” guidewire that is at least about 25% lower than a Work of Advancement of a 0.014” guidewire of a comparable HDPE-lined catheter.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 16, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a Work of Advancement of a 0.014” guidewire that is within about 20% of a Work of Advancement of a 0.014” guidewire of a comparable PTFE-lined catheter.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 17, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a maximum Force of Advancement of 1200 mN or less.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 18, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a maximum Work of Advancement of 12,000 mN·cm or less.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 19, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a maximum Force of Advancement of a 0.014” guidewire of 60 mN or less.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 20, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the catheter exhibits a maximum Work of Advancement of a 0.014” guidewire of 2500 mN·cm or less.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 21, Goldberg in view of Sbriglia teaches the catheter of claim 1, wherein the UHMWPE liner has a wall thickness of about 0.001 to 0.002 inches (Goldberg, 0.00039 to 0.2 inches)
Regarding claim 22, Goldberg in view of Sbriglia teaches the catheter of claim 1, wherein the UHMWPE liner has been formed by a dip-coating process (this is being interpreted as a product by process claim limitation, wherein MPEP 2113(I) recites “"[E]ven 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.”. Here, the product of dip-coating is an UHMWPE liner which is the same as or obvious from the UHMWPE liner of Goldberg because they are both catheter liners made from UHMWPE).
Regarding claim 23, Goldberg discloses a catheter (sheath 100 as shown in Figs. 2-5) comprising an Ultra High Molecular Weight Poly(Ethylene) ("UHMWPE") liner (inner layer 102 comprising ultra-high-molecular-weight polyethylene (UHMWPE), P0073), and an optional reinforcement layer (braided layer 104, P0075), and a jacket (elastic layer 106, P0075).
Goldberg is silent with regard to wherein the UHMWPE is unexpanded.
However, Sbriglia teaches terminology wherein expanded UHMWPE is expressly identified as expanded UHMWPE see Abstract and P0008, in contrast to unexpanded UHMWPE which is identified simply as UHMWPE, see P0003. Therefore, one of ordinary skill in the art would understand Goldberg to teach unexpanded UHMWPE because a modifier (expanded and unexpanded) is only added when the material has been expanded. This terminology and logic is consistent with Applicant’s written description support for claiming unexpanded UHMWPE since Applicant’s written description is also silent as to wherein the UHMWPE is unexpanded.
Goldberg does not teach wherein the catheter exhibits both of: a) a Maximum Work of Advancement of 12,000 mN-cm or less; and b) a Maximum Work of Advancement of a 0.014" guidewire of 2500 mN-cm or less.
However, Table 3 of Applicant’s written description requires an UHMWPE liner, reinforcement and jacket to obtain the claimed test results, and because Goldberg teaches the claimed catheter structure including an UHMWPE liner, reinforcement and jacket, Goldberg is understood to satisfy the claim limitations.
Regarding claim 24, Goldberg in view of Sbriglia teaches the catheter of claim 1, wherein the catheter has an outer diameter of 0.02 inches to 0.1 inches (Goldberg, 0.1 inches, wherein the 3.7 mm is equivalent to 0.1 inches, accurate in relation to the number of significant digits claimed).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Sbriglia in view of Chludzinski et al. (Chludzinski) US 6,837,890 B1.
Regarding claim 2, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach the catheter further comprising a tie layer overlying at least a portion of the UHMWPE liner.
However, Chludzinski teaches an UHWWPE catheter liner further comprising a tie layer (tie layer, c 7 ln 23) overlying at least a portion of the UHMWPE liner (c 7 ln 23-26).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the catheter of Goldberg with a tie layer for the purpose of attaching the inner liner with an incompatible material, as taught by Chludzinski c 7 ln 23-26.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Sbriglia in view of Chludzinski in view of Van Hoven US 2014/0163421 A1.
Regarding claim 3, Goldberg in view of Sbriglia in view of Chludzinski teaches the catheter of claim 2.
Goldberg in view of Sbriglia in view of Chludzinski does not teach wherein the tie layer comprises a functionalized polyethylene.
However, Van Hoven teaches a catheter wherein the tie layer (middle layer 214, P0034) comprises a functionalized polyethylene (functionalized or maleic anhydride grafted polyethylene, P0034).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tie layer of Chludzinski with functionalized or maleic anhydride grafted polyethylene as taught by Van Hoven as a simple substitution of one known tie layer for another to obtain predictable results, see MPEP 2143(B). Chludzinski contained a catheter having a tie layer that differed from the claimed device by the substitution of the tie layer material. Functionalized or maleic anhydride grafted polyethylene used as a tie layer is well known in the art as demonstrated by Van Hoven. One of ordinary skill in the art could have substituted the tie layer of Van Hoven for the tie layer of Chludzinski, and results would have been predictable, and that is to adhere an inner layer to an outer layer.
Regarding claim 4, Goldberg in view of Sbriglia in view of Chludzinski in view of Van Hoven teaches the catheter of claim 3, wherein the functionalized polyethylene comprises maleic anhydride grafted polyethylene (Van Hoven, functionalized or maleic anhydride grafted polyethylene, P0034).
Claims 9 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Sbriglia in view of Yaritz et al. (Yaritz) US 2003/0193110 A1.
Regarding claim 9, Goldberg in view of Sbriglia teaches the catheter of claim 8.
Goldberg does not teach wherein the UHMWPE further comprises one or more α-olefins.
However, Yaritz teaches UHMWPE articles and methods of manufacture wherein the UHMWPE further comprises one or more α-olefins (the polymer is either a homopolymer of ethylene or a copolymer of ethylene, with at most 10 mol % of one or more alpha-olefins, P0008).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the liner of Goldberg as claimed for the purpose of reducing drag/friction of items that pass through the lumen of the liner.
Regarding claim 12, Goldberg in view of Sbriglia teaches the catheter of claim 1.
Goldberg does not teach wherein the UHMWPE liner comprises one or more particulate fillers.
However, Yaritz teaches UHMWPE articles and method of manufacture wherein the filler is a particulate filler, P0010.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the liner of Goldberg with a particulate filler as taught by Yaritz for the purpose of enhancing the wear resistance and mechanical properties of the UHMWPE.
Regarding claim 13, Goldberg in view of Sbriglia teaches the catheter of claim 1, wherein the UHMWPE liner consists essentially of UHMWPE (per MPEP 2111.03(III), the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention, and here the liner is formed of UHMWPE, P0073).
Goldberg does not teach the liner consisting of one or more particulate fillers.
However, Yaritz teaches UHMWPE articles and method of manufacture wherein the filler is a particulate filler, P0010.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the liner of Goldberg with a particulate filler as taught by Yaritz for the purpose of enhancing the wear resistance and mechanical properties of the UHMWPE.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Sbriglia in view of Yaritz in view of Yamaguchi et al. (Yamaguchi) US 2018/0100061 A1.
Regarding claim 10, Goldberg in view of Sbriglia in view of Yaritz teaches the catheter of claim 9.
Goldberg in view of Sbriglia in view of Yaritz does not teach wherein the one or more α-olefins are selected from the group consisting of 1-butene, 1-pentene, 1-hexene, 1-octene, 1-decene, 1-dodecene, 4-methyl-1-pentene, 3-methyl-1-pentene, and combinations thereof.
However, Yamaguchi teaches thermoplastic elastomer compositions comprising UHMWPE wherein the one or more α-olefins are selected from the group consisting of 1-butene (1-butene, P0080), 1-pentene, 1-hexene, 1-octene, 1-decene, 1-dodecene, 4-methyl-1-pentene, 3-methyl-1-pentene, and combinations thereof.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the liner of Goldberg in view of Sbriglia in view of Yaritz with 1-butene because 1-butene is a specific alpha-olefin for use in a UHMWPE that is a copolymer of an ethylene and alpha-olefin, Yamaguchi P0080.
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.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
