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/Arguments
Receipt is acknowledged of applicant's amendment filed 12/19/2025.
Claims 1-23 are pending. Claims 1, 3, 17-21 are amended. Claim 23 is added.
Applicant's amendments and arguments with respect to the rejection of present claims 1-2, 4-17 and 23 under 35 U.S.C. 103 as being unpatentable over Sbriglia (U.S. Publication No. 2014/0212612) in view of Li et al. (U.S. 2019/0185596; “Li”) have been fully considered, but are moot in view of new grounds of rejection based on newly discovered reference, as discussed in details below in the body of the rejection below.
Any rejections and/or objections, made in the previous Office Action, and not repeated in the present Office Action, are hereby withdrawn.
Claim Objections
Claims 19 and 21 are objected to because of the following informalities:
Applicant is advised that should claim 19 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 does not further limit the subject matter of the claim upon which it depends, i.e., claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-2, 4-17 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sbriglia (U.S. Publication No. 2014/0212612) in view of Chudzlinkski et al. (U.S. 6,837,890; “Chudzlinkski”).
Regarding Claim 1 and claims 6-7, Sbriglia teaches a tube (paragraph [0033], suitable for forming into tube) comprising Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (para [0024] [0034]).
Sbriglia teaches a tube of Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (para [0024] [0034]) and is considered as meeting the claimed limitations.
The transitional phrase “consisting essentially of” of claim 1 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. For the purposes of searching for and applying prior art under 35 U.S.C 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are “consisting essentially of” will be construed as equivalent to “comprising”. MPEP 2111.03 (III). Thus, In the present case, the Examiner treated the “consisting essentially of” language as an equivalent to “comprising” and rejected the claims under 35 U.S.C 102. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of ‘consisting essentially of, applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of Applicant's invention.
Further, the instant claim 1 recites “…optionally, one or more particulate fillers and/or one or more additional polymer materials and/or one or more additives selected from antioxidants, antimicrobials, processing aids, slip aids, and colorants…”. In the present case, the examiner considers the instant claim 1 does not require the presence of any of those optional elements.
Sbriglia does not specifically teach the thickness and tensile strength of its tube as instantly claimed.
In the same field of UHMWPE resin and catheter and catheter liner of UHMWPE resin, Chudzlinkski teaches a catheter liner comprising UHMWPE (col. 4, lines 30-35) that provides ease passage to access the coronary arteries (col. 7, lines 34-50, catheter liner). Chudzlinkski teaches its catheter liner/tube comprising UHMWPE ( col. 4, lines 30-35) having a thickness of 0.0002 to 0.006 inch, which is about 0.005 mm to 0.15 mm if calculated (col. 7, lines 48-49, the liner thickness, 1 inch is about 25.4 mm), which range overlaps with the instantly claimed range of 0.2 mm or less of instant claim 1, and which range overlaps with the instantly claimed range of 0.1 mm or less of instant claim 6, and which range overlaps with the instantly claimed range of 0.005 mm to 0.1 mm of instant claim 7. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art to modify Sbriglia in view the teachings of Chudzlinkski, to provide a tube of UHMWPE resin having a suitable thickness as taught by Chudzlinkski (i.e., having thickness of 0.005 mm to 0.15 mm as taught by Chudzlinkski), to provide a tube that is suitable to line a catheter for providing ease passage to access the coronary arteries as taught by Chudzlinkski (col. 7, lines 34-50), which would have predictably arrived at a satisfactory Ultra High Molecular Weight Poly(ethylene) (UHMWPE) tube that is the same as instantly claimed, i.e., having the thickness overlapping with those ranges as instantly claimed, in claims 1 and 6-7.
Because the UHMWPE tube of the modified Sbriglia and the instantly claimed UHMWPE tube are identical or substantially identical in composition and have the same or similar tube thickness (as discussed above), one would expect that the UHMWPE tube of modified Sbriglia would possess the same or similar properties as that of the instantly claimed tube, such as having a tensile stress at break in the range as instantly claimed in claim 1. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. See MPEP 2112. 01. Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference. See MPEP 2112.
Regarding Claim 2, it should be noted that the recitation of “the UHMWPE tube is prepared via extrusion of a billet comprising lubricant and UHMWPE resin through an annular die…” of claim 2 is considered as product-by-process limitations. It is the examiner’s position that the recited process does not result in a patentably distinctive structural difference in the resultant tube. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. [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”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113. In the present case, it is noted Sbriglia teaches using extrusion process (para [0033]).
Regarding Claims 4-5, it should be noted that the recitation of “the UHMWPE tube is prepared via extrusion over a metallic or non-metallic wire or mandrel” of claims 4-5 is considered as product-by-process limitations. It is the examiner’s position that the recited process does not result in a patentably distinctive structural difference in the resultant tube. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. [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”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113. In the present case, it is noted Sbriglia teaches using extrusion process (para [0033]).
Regarding Claim 8, Sbriglia teaches a tube of Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (para [0024] [0034]).
Because the UHMWPE tube of the modified Sbriglia and the instantly claimed UHMWPE tube are identical or substantially identical in composition and have the same or similar tube thickness (as discussed above), one would expect that the UHMWPE tube of modified Sbriglia would possess the same or similar properties as that of the instantly claimed tube, such as having a change in storage modulus in the range as instantly claimed. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. See MPEP 2112. 01. Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference. See MPEP 2112.
Regarding Claims 9-12, Sbriglia teaches a tube of Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (para [0024] [0034]). Because the UHMWPE tube of the modified Sbriglia and the instantly claimed UHMWPE tube are identical or substantially identical in composition and have the same or similar tube thickness (as discussed above), one would expect that the UHMWPE tube of modified Sbriglia would possess the same or similar properties as that of the instantly claimed tube, such as of having coefficient of friction of the inner surface of the tube as instantly claimed in claims 9-12. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. See MPEP 2112. 01. Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference. See MPEP 2112.
Regarding Claim 13, Sbriglia teaches a tube of Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (para [0024] [0034]) and is considered as meeting the claimed limitations. The transitional phrase “consisting essentially of” of claim 13 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. For the purposes of searching for and applying prior art under 35 U.S.C 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are “consisting essentially of” will be construed as equivalent to “comprising”. MPEP 2111.03 (III). Thus, In the present case, the Examiner treated the “consisting essentially of” language as an equivalent to “comprising” and rejected the claims under 35 U.S.C 102. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of ‘consisting essentially of, applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of Applicant's invention.
Regarding Claims 14-15, the claimed filler amount includes 0%. Sbriglia teaches a tube of Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (para [0024] [0034]) and is considered as meeting the claimed limitations.
Regarding Claim 16, Sbriglia teach the inclusion of suitable lubricant/processing aids (para [0031]), considered as meeting the claimed limitations.
Regarding Claim 17, Sbriglia teach the inclusion of suitable lubricant/processing aids (para [0031]), meeting the claimed limitations.
Claim(s) 1 and 6-7, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Chudzlinkski et al. (U.S. 6,837,890; “Chudzlinkski”).
Regarding Claim 1, claims 6-7 and claim 23, Chudzlinkski teaches a catheter liner (meeting the claimed limitations of claim 23) comprising a tube of UHMWPE (col. 4, lines 30-35) that provides ease passage to access the coronary arteries (col. 7, lines 34-50, catheter liner).
Chudzlinkski teaches a catheter liner of Ultra High Molecular Weight Poly(ethylene) (UHMWPE) (col. 4, lines 30-35) and is considered as meeting the claimed limitations.
The transitional phrase “consisting essentially of” of claim 1 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. For the purposes of searching for and applying prior art under 35 U.S.C 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are “consisting essentially of” will be construed as equivalent to “comprising”. MPEP 2111.03 (III). Thus, In the present case, the Examiner treated the “consisting essentially of” language as an equivalent to “comprising” and rejected the claims under 35 U.S.C 102. If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of ‘consisting essentially of, applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of Applicant's invention.
Further, the instant claim 1 recites “…optionally, one or more particulate fillers and/or one or more additional polymer materials and/or one or more additives selected from antioxidants, antimicrobials, processing aids, slip aids, and colorants…”. In the present case, the examiner considers the instant claim 1 does not require the presence of any of those optional elements.
Chudzlinkski teaches its catheter liner comprising UHMWPE ( col. 4, lines 30-35) having a thickness of 0.0002 to 0.006 inch, which is about 0.005 mm to 0.15 mm if calculated (col. 7, lines 48-49, the liner thickness, 1 inch is about 25.4 mm), which range overlaps with the instantly claimed range of 0.2 mm or less of instant claim 1, and which range overlaps with the instantly claimed range of 0.1 mm or less of instant claim 6, and which range overlaps with the instantly claimed range of 0.005 mm to 0.1 mm of instant claim 7. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Chudzlinkski does not specifically teach the tensile strength of its tube as instantly claimed.
Because the UHMWPE tube of the Chudzlinkski and the instantly claimed UHMWPE tube are identical or substantially identical in composition and have the same or similar tube thickness (as discussed above), one would expect that the UHMWPE tube of Chudzlinkski would possess the same or similar properties as that of the instantly claimed tube, such as having a tensile stress at break in the range as instantly claimed in claim 1. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. See MPEP 2112. 01. Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning tending to show inherency, the burden shifts to the applicant to show an unobvious difference. See MPEP 2112.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sbriglia in view of Chudzlinkski as applied to claims 1-2 above, further in view of Yang et al. (U.S. Pub. 2004/0106723, “Yang”).
The limitations of claims 1-2 are taught by Sbriglia in view of Chudzlinkski as discussed above.
Regarding claim 3, Sbriglia teaches a UHMWPE tube as discussed above, and Sbriglia teaches the inclusion of suitable lubricant (para [0031]). Sbriglia does not specifically teach the inclusion of the specific lubricant as instantly claimed, such as Isopar G.
Yang teaches a polyolefin pipe (paragraph 0193) and Yang teaches the inclusion of various additive including lubricant to the resin for obtaining enhanced performance properties (para [0193] [0217]). Yang teaches it is known in the art to use commercially available Isopar G (Table 1, para [0067]) for the purpose enhanced performance properties (para [0193]).
It would have been obvious to one of ordinary skill in the art to modify the modified Sbriglia in view the teachings of Yang, to select and include suitable lubricant such as Isopar G in UHMWPE resin as taught by Yang (Table 1, para [0067]), to provide a UHMWPE resin tube with enhanced performance properties, which would have predictably arrived at a satisfactory Ultra High Molecular Weight Poly(ethylene) (UHMWPE) tube that is the same as instantly claimed. One of ordinary skill would have understood how to modify and choose suitable additives for intended use. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. See MPEP 2144.05.
Claim(s) 18-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sbriglia in view of Chudzlinkski as applied to claim 1 above, further in view of Tam et al. (US 2010/0178503; “Tam”).
The limitations of claim 1 are taught by Sbriglia in view of Chudzlinkski as discussed above.
Regarding Claims 18-19 and 21, modified Sbriglia does not specifically teach the inclusion of additional polymers in the manner as instantly claimed.
Tam teaches a UHMWPE blend the includes UHMWPE and further comprising HDPE/additional polymer in amounts of less than about 50% by weight that provides a suitable UHMWPE blend allows the materials to have desirable handling properties and melt processability (para [0014]-[0016] [0024]), which range overlaps with the instantly claimed range additional polymer in amounts of less than 50% of instant claim 18, and which range overlaps with the instantly claimed range additional polymer in amounts of less than 20% of instant claim 19 and claim 21. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art to modify Sbriglia in view the teachings of Tam, to include in addition to UHMWPE, less than about 50% by weight HDPE/additional polymer as taught by Tam, to provide a suitable UHMWPE blend allows the materials to have desirable handling properties and melt processability as taught by Tam (para [0014]-[0016] [0024]), which would have predictably arrived at a satisfactory Ultra High Molecular Weight Poly(ethylene) (UHMWPE) tube that is the same as instantly claimed, in claims 18-19 and 21.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sbriglia in view of Chudzlinkski as applied to claim 1 above, further in view of Zhang et al. (CN 108047998; “Zhang”).
The limitations of claim 1 are taught by Sbriglia in view of Chudzlinkski as discussed above.
Regarding Claim 20, modified Sbriglia does not specifically teach the inclusion of additional polymers as instantly claimed.
Zhang relates to UHMWPE products and preparation (paragraph [0001] [0010]). Zhang teaches the addition of ethylene vinyl acetate in the form of dispersion to UHMWPE products for improved bonding (paragraph [0010]-[0014], paragraph [0007]).
It would have been obvious to one of ordinary skill in the art to modify Sbriglia in view the teachings of Zhang, to include in addition to UHMWPE, the ethylene vinyl acetate as taught by Zhang, to provide UHMWPE tube with improved bonding as taught by Zhang (paragraph [0007] [0010]-[0014]), which would have predictably arrived at a satisfactory Ultra High Molecular Weight Poly(ethylene) (UHMWPE) tube that is the same as instantly claimed.
Claim(s) 22 is rejected under 35 U.S.C. 103 as being unpatentable over Sbriglia in view of Chudzlinkski and Tam as applied to claim 18 above, further in view of Zhang et al. (CN 108047998; “Zhang”).
The limitations of claim 1 and claim 18 are taught by Sbriglia in view of Chudzlinkski and Tam as discussed above.
Regarding Claim 22, modified Sbriglia does not specifically teach the inclusion of additional polymers as instantly claimed.
Zhang relates to UHMWPE products and preparation (paragraph [0001] [0010]). Zhang teaches the addition of ethylene vinyl acetate in the form of dispersion to UHMWPE products for improved bonding (paragraph [0010]-[0014], paragraph [0007]).
It would have been obvious to one of ordinary skill in the art to modify Sbriglia in view the teachings of Zhang, to include in addition to UHMWPE, the ethylene vinyl acetate as taught by Zhang, to provide UHMWPE tube with improved bonding as taught by Zhang (paragraph [0007] [0010]-[0014]), which would have predictably arrived at a satisfactory Ultra High Molecular Weight Poly(ethylene) (UHMWPE) tube that is the same as instantly claimed.
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 YAN LAN whose telephone number is (571)270-3687. The examiner can normally be reached Monday - Friday 7AM-4PM.
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/YAN LAN/Primary Examiner, Art Unit 1782