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 action is entered in response to Applicant's amendment and reply of 2/4/26. The claims 1-20 are pending. The claims 1 has been amended. Claims 18-20 are withdrawn.
Response to Arguments
Applicant’s arguments, filed 2/4/26 with respect to the rejections of claims 1-5, 7, 9-15 under 35 U.S.C. 103 as being unpatentable over Nguyen (US2010/0094392) have been fully considered but they are not persuasive. Applicant argues, the previous office action does not identify a disclosure in Nguyen of an outer layer comprising a single compound composition that simultaneously includes a polymer matrix, an inorganic filler, and a solid lubricant filler in the claimed relative amounts. Examiner disagrees, as stated in the rejection, Nguyen discloses 0 wt% to less than 100 wt% of a first polymer comprising a polyether block amide, since the material is listed for the outer layer 26 in paragraph [0072] and would have some amount of weight between 0 wt% to 100 wt% of a total weight of the compound (outer layer) by just comprising the material. Furthermore, Nguyen also discloses less than about 65% of an inorganic filler based on a total weight of the first compound composition, since Nguyen discloses titanium dioxide as another material in the composition and a weight of 5% to 45% of the total weight of the compound (outer layer) in paragraph [0079]. Applicant further states the elements are from separate portions of Nguyen rather than a single teaching of a specific integrated formulation. Examiner disagrees, as stated above Nguyen list the materials and has the percentage weight of one of the materials; therefore, the weight of the other material used in the composition of the first polymer could be determined. Applicant further argues, Nguyen lists PTFE in paragraph [0072] among a list of alternative materials and makes the statement it is one option among numerous alternatives. Examiner disagrees, the paragraph [0072] states the outer layer 26 can comprise the list of materials described and clearly states the layer can comprise “combinations thereof” of the materials. Therefore, the disclosure does not limit layer to a single material. Furthermore, Applicant states Nguyen does not characterize this disclosure as being directed to lubricity or attribute a lubricious function to the outer layer. Examiner disagrees, where PTFE is known in the art to have provide excellent lubricity and Nguyen states PTFE is one of the materials used in the outer layer; therefore, the outer layer would include a lubricious material. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant further argues, the claimed lubricious material percentages constitute result effective variables whose optimization would not have been routine and that the rationale is unsupported since Nguyen does not appear to identify insertion force, reversible expansion performance, or kink resistance as results that depend on lubricous material concentration in the outer layer. Examiner disagrees, contrary to Applicants argument, Nguyen explicitly teaches that the lubricious quality of the outer layer material is for insertion performance through the sheath in paragraph [0073]; which states a liner made of PTFE can be lubricious for reducing the coefficient of friction for insertion through the layer 24. Therefore, it is evident lubricious material selection results in lower coefficient of friction which is directly related to ease of passage through the lumen. Therefore, a person having ordinary skill in the art would understand that varying the amount of lubricious material in the sheath composition predictably affects the force required to insert a device through the lumen.
Applicant further argues, claim 1 requires that the sheath exhibit at least 10% reduction in insertion force relative to a substantially identical reference sheath that does not comprise the first polymer layer having the claimed composition and is not taught by Nguyen. Examiner disagrees, where the sheath as claimed is taught by Nguyen, therefore, the sheath would exhibit this claimed feature of 10% reduction in insertion force compared to a sheath without the first polymer and kink resistance based on the material properties of the sheath.
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 of this title, 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.
Claims 1-5, 7, 9-15 rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2010/0094392).
Regarding claim 1, Nguyen discloses a sheath (22) for delivering a medical device ([0071]), wherein the sheath has a proximal and a distal end ([0011]) and comprises an elongated tube forming an outer layer (outer layer of the sheath 22) of the sheath that is positioned at the proximal end of the sheath and extending along at least a portion of a length of the sheath ([0071]), having an inner surface and an outer surface, and wherein the elongated tube comprises a first polymer layer (26), wherein the first polymer layer comprises a first compound composition comprising from greater than 0 wt% to less than 100 wt% of a first polymer comprising a polyether block amide, a polyurethane, or a combination thereof based on a total weight of the first compound composition (polyether block amide or PEBAX, polyurethane listed as possible materials for the outer layer 26 [0072]);
less than about 65% of an inorganic filler based on a total weight of the first compound composition (titanium dioxide, [0079]); and
wherein the elongated tube is configured to reversibly expand from an initial diameter do in an unexpended position to an expanded diameter de in an expanded position upon passage of a medical device ([0085]); and
wherein the sheath exhibits at least a 10% reduction in an insertion force when compared with a substantially identical reference sheath that does not comprise the first polymer layer (the sheath would exhibit this reduction in insertion force when compared to a sheath of a different material since it is the same as that claimed); and
wherein the elongated tube is substantially kink resistant (the sheath would exhibit the claimed feature of kink resistance based on the material properties of the sheath).
Nguyen does not explicitly disclose the first polymer layer comprises up to about 20% of a solid lubricant filler based on a total weight of the first compound composition. Nguyen teaches a combination of polymer materials, including a combination with PTFE, a solid lubricant material ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to comprise up to 20% of a solid lubricant filler, such as PTFE, since the solid lubricant filler percentage of the total weight of the compound composition is a result effective variable that contributes to the desired material properties of the layer of the sheath ([0073]-[0075]), such as a partial lubricant material with flexibility, strength, and biocompatibility for medical tubing applications such as passage of the sheath through the body. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 2, Nguyen makes obvious the sheath of claim 1, wherein a durometer of the first polymer at a proximal end of the elongated tube is different from a durometer of the first polymer at a distal end of the elongated tube and has a Shore D from about 20D to about 35D ([0075]]).
Regarding claim 3, Nguyen makes obvious the sheath of claim 1, wherein the first polymer comprises polyether block amide elastomer, polyurethane, or a combination thereof ([0072]).
Regarding claim 4, Nguyen makes obvious the sheath of claim 1, wherein the inorganic filler comprises barium sulfate ([0079]), bismuth subcarbonate ([0079), and is present in an amount of at least about 10% to less than about 50% based on a total weight of the first compound composition ([0079]).
Regarding claim 5, Nguyen makes obvious the sheath of claim 1, wherein the solid lubricant filler comprises a PTFE filler ([0010]).
Regarding claim 7, Nguyen makes obvious the sheath of claim 1, wherein the elongated tube comprises two or more polymer layers, and wherein at least a second polymer layer (24) comprising a second compound composition comprising from greater than 0 wt% to 100 wt% of a second polymer comprising polyether block amide, a polyurethane, or a composition thereof ([0010], [0072]); yet, does not explicitly disclose wherein the second polymer has a Shore A Durometer from about 20A to about 65A. Nguyen teaches the second polymer layer (inner layer) has some degree of hardness and teaches the outer layer has a Durometer hardness from about 25A to 75A ([0075]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second polymer layer have a shore A Durometer from about 20A to about 65A as taught by Nguyen for particular applications and desired properties of the sheath ([0075]).
Regarding claim 9, Nguyen makes obvious the sheath of claim 7, wherein the second polymer comprises polyurethane ([0010]).
Regarding claim 10, Nguyen makes obvious the sheath of claim 7, wherein the elongated tube has a predetermined thickness and wherein at least about 50% of the predetermined thickness comprises the first and/or the second compound composition ([0074]).
Regarding claim 11, Nguyen makes obvious the sheath of claim 7, wherein one or more additional polymer layers (28) are disposed between the first polymer layer and the second polymer layer ([0071]).
Regarding claim 12, Nguyen makes obvious the sheath of claim 11, wherein the one or more additional polymer layers comprise at least one intermediate reinforcement layer (28) extending axially at least a portion of a length of the elongated tube ([0092]), and wherein the at least one intermediate reinforcement layer comprises the first polymer, the second polymer, a polyolefin-based polymer, or a combination thereof (the reinforcement layer can be fused with the outer and inner layer and therefore comprise some amount of the outer or inner layer polymer, [0093]).
Regarding claim 13, Nguyen makes obvious the sheath of claim 12; yet, does not disclose wherein the at least one intermediate reinforcement layer comprises a material having a Shore D durometer from about 45D to about 76D. Nguyen teaches the intermediate layer has some degree of hardness and teaches the outer layer has a Durometer hardness from about 25A to 75A ([0075]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the intermediate layer have a shore A Durometer from about 20A to about 65A as taught by Nguyen for particular applications and desired properties of the sheath ([0075]).
Regarding claim 14, Nguyen makes obvious the sheath of claim 1, wherein the elongated tube exhibits a friction force of less than about 10 N in the dry state against a substrate surface comprising one or more of polytetrafluoroethylene or high-density polyethylene (the substrate surface is not positively recited, and is therefore capable of comprising PTFE or high-density polyethylene, further the elongated tube is capable of exhibit a friction force of less than 10 N in the dry state dependent on the size and shape of the substrate).
Regarding claim 15, Nguyen discloses a sheath (22) for delivering a medical device (see Abstract), wherein the sheath has a proximal and a distal end ([0011]) and comprises:
an expandable tubular inner liner (inner layer 68) comprising at least one folded portion, wherein the expandable inner liner has an inner surface, and an outer surface, wherein the inner surface of the expandable inner liner defines a lumen and forms an inner surface of the at least one folded portion ([0125]), and wherein the outer surface extends circumferentially to form an outer surface of the at least one folded portion ([0125]);
a first outer tubular layer (outer layer 70) having an inner surface and an outer surface, wherein the inner surface of the first outer tubular layer extends at least partially around the outer surface of the inner liner such that at least a portion of the inner surface of the first outer tubular layer is positioned adjacent to the outer surface of the at least one folded portion of the inner liner ([0125], see Fig. 32E); and
an elongated tube forming a second outer layer (outer covering layer 99) having an inner surface and an outer surface and wherein the elongated tube is positioned at the proximal end of the sheath and extending along at least a portion of a length of the sheath ([0125]), such that the inner surface of the elongated tube overlies at least a portion of the outer surface of the first outer tubular layer (see Fig. 32E), wherein the elongated tube comprises a first polymer layer (outer polymer layer 99).
Nguyen does not explicitly disclose wherein the first polymer layer comprises a first compound composition comprising from greater than 0% to less than 100% of a polymer comprising a polyether block amide, a polyurethane, or a combination thereof based on a total weight of the first compound composition ([0091]). Nguyen teaches other embodiments of an outer covering made of similar materials used for the other polymeric layers ([0091]), such as PEBAX, polyurethane, or a combination ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to comprise greater than 0% to less than 100% of a polymer comprising PEBAX, polyurethane, or a combination thereof since Nguyen teaches the polymers as a suitable material for the first polymer layer for desired properties of a sheath. Where Examiner interprets the modified invention as having any composition between 0% and 100% of the polymer.
Nguyen does not explicitly disclose the first polymer layer comprises less than about 65% of an inorganic filler based on a total weight of the first compound composition. Nguyen teaches other embodiments of an outer layer that includes less than 65% of an inorganic filler based on a total weight of the first compound composition ([0079]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to comprise inorganic filler in order to embed the first polymer layer with radiopaque materials for visualization ([0079])
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified first polymer layer of Nguyen to comprise less than about 65% of inorganic filler based on a total weight of the first compound composition as applicant appears to have placed no criticality on the claimed range (see paragraph [0145] of the instant specification indicating a range of percentages for the amount of inorganic filler) and since it has been held that “[i]n 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).
Nguyen does not explicitly disclose the first polymer layer comprises up to about 20% of a solid lubricant filler based on a total weight of the first compound composition. Nguyen teaches another embodiment where an outer layer comprises a combination of polymer materials, including a combination with PTFE a solid lubricant material ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to comprise PTFE, since Nguyen teaches the polymers as a suitable material for the first polymer layer for desired properties of a sheath.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to comprise up to 20% of a solid lubricant filler, such as PTFE, since the solid lubricant filler percentage of the total weight of the compound composition is a result effective variable that contributes to the desired material properties of the layer of the sheath ([0073]-[0075]), such as a partial lubricant material with flexibility, strength, and biocompatibility for medical tubing applications such as passage of the sheath through the body. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2010/0094392) in view of Shia (US2022/0126060).
Regarding claim 6, Nguyen makes obvious the sheath of claim 1; yet, is silent regarding wherein the first compound composition further comprises at least one tackiness reducing compound present in an amount from about 1% to about 20% based on a total weight of the first compound composition. Shia teaches catheter sheath designs, where an inner liner has a lubricious additive such as Propell, which is a tackiness reducing compound ([0135]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the first compound composition to include a tackiness reducing compound, such as Propell, in order to lubricate the surface to improve the passage of the device through the body ([0135]).
The modified invention does not disclose the tackiness reducing compound present in an amount from 1% to about 20% based on the total weight of the first compound composition. Nguyen teaches a combination of polymer materials, including a combination with PTFE a lubricant material ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to further comprise 1% to 20% of tackiness reducing compound for total weight composition, such as Propell as taught by Shia, since the tackiness reducing compound percentage of the total weight of the compound composition is a result effective variable that contributes to the desired material properties of the layer of the sheath ([0073]-[0075]), such as a low-friction material with flexibility, strength, and biocompatibility for medical tubing applications such as passage of the sheath through the body. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 8, Nguyen makes obvious the sheath of claim 7; yet, is silent regarding wherein the second compound composition further comprises up to 20% of tackiness reducing additive based on a total weight of the second compound composition. Shia teaches catheter sheath designs, where an inner liner has a lubricious additive such as Propell, which is a tackiness reducing compound ([0135]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the first compound composition to include a tackiness reducing compound, such as Propell, in order to lubricate the surface to improve the passage of the device through the body ([0135]).
The modified invention does not disclose the tackiness reducing compound present in an amount from 1% to about 20% based on the total weight of the first compound composition. Nguyen teaches a combination of polymer materials, including a combination with PTFE a lubricant material ([0072]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first polymer layer to further comprise 1% to 20% of tackiness reducing compound for total weight composition, such as Propell as taught by Shia, since the tackiness reducing compound percentage of the total weight of the compound composition is a result effective variable that contributes to the desired material properties of the layer of the sheath ([0073]-[0075]), such as a low-friction material with flexibility, strength, and biocompatibility for medical tubing applications such as passage of the sheath through the body. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2010/0094392) in view of Ingle (US2012/0101480).
Regarding claim 16, Nguyen makes obvious the sheath of claim 1; yet, is silent regarding further comprising a variable diameter inner liner comprising a sheet having a first edge and a second edge and is defined by an inner surface and an outer surface, wherein the sheet is wound in a spiral configuration such that at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of a cylinder having a longitudinal axis;
wherein the variable diameter inner liner is configured to reversible expand from a predetermined rest diameter dr to an expanded diameter dl by sliding the first edge of the sheet along at least a portion of the inner surface and sliding the second edge of the sheet along the at least a portion of outer surface, during application of a radial outward force by passage of a medical device through the lumen of the inner liner; and wherein the elongated tube is positioned such that the inner surface of the elongated tube overlies at least a portion of the outer surface of the inner liner.
Ingle teaches a catheter shaft having a helically wound tubular member formed from a helically wrapped length of material (see Abstract). The length of material 202 may vary along the length of the shaft 100, the inner diameter 112 of the catheter shaft 100, the distance of overlap 115, 119, 123 of adjacent turns, and/or the angle of the helical windings ([0033]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner liner to be a sheet wound in a spiral configuration as taught by the catheter shaft of Ingle, in order for the inner liner to have a wall thickness that changes dynamically along the length and generate variability in flexibility along the length in the fashion desired ([0038]). Where the inner liner as modified to be a wrapped sheet would be configured to be wrapped in a spiral fashion with overlapping segments to therefore meet the functional claimed limitations of at least a portion of the inner surface of the sheet overlays at least a portion of the outer surface of the sheet and wherein the first edge of the sheet is slidable along at least a portion the inner surface of the sheet and the second edge is slidable along at least a portion of the outer surface of the sheet, wherein the inner surface of the sheet defines a lumen of a cylinder having a longitudinal axis. Further the inner liner is expandable ([0073] of Nguyen, [0038] of Ingle) and would be capable of meeting the limitations of wherein the variable diameter inner liner is configured to reversible expand from a predetermined rest diameter dr to an expanded diameter dl by sliding the first edge of the sheet along at least a portion of the inner surface and sliding the second edge of the sheet along the at least a portion of outer surface, during application of a radial outward force by passage of a medical device through the lumen of the inner liner; and wherein the elongated tube is positioned such that the inner surface of the elongated tube overlies at least a portion of the outer surface of the inner liner.
Regarding claim 17, Nguyen/Ingle makes obvious sheath of claim 16, Nguyen further discloses comprising a braid positioned between the inner liner and the elongated tube ([0092]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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, Thomas Barrett can be reached on (571)272-4746. 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.
/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights