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
The amendment filed on 1/28/2026 has been entered. It is noted that the status identifiers of claims 3 and 11 are incorrect as the claims are withdrawn. The applicant is required to correct the status identifiers in any subsequent listing of claims.
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.
Claims 1, 2, 4-10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over USPN 6,001,125 to Golds in view of USPAP 2018/0344981 to Laduca and USPAP 2012/0298000 to Belfiore and further in view of (when necessary) USPN 3,734,100 to Walker.
Claim 1, Golds discloses a method for making an expandable sheath, the method comprising: sliding an expandable tubular structure into an outer liner and sliding an inner liner into the expandable tubular structure (see entire document including column 3, line 42 through column 4, line 16 and column 6, line 44 through column 7, line 48).
Golds does not appear to mention inflating the inner liner to expand up to the internal diameter of the outer liner but Laduca discloses that it is known in the art to laminate a tube composite by inflating the inner liner to expand up to the internal diameter of the outer liner while a die restricts the diameter from growing while under pressure and heat and that said method is low-cost (see entire document including [0133]). Laduca does not appear to mention a specific inflating method but Belfiore discloses that it is known in the art to use an inflatable silicone tube (see entire document including [0036]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the tubular composite of Golds by any suitable method, such as claimed, to reduce costs and/or because it is within the general skill of a worker in the art to select a known method on the basis of its suitability and desired characteristics.
Claim 2, Golds discloses that each of the inner and outer liners is an expanded polytetrafluoroethylene (ePTFE) (column 3, line 42 through column 4, line 16).
Claim 4, Golds discloses that adhesive may be applied to an outer surface of the inner liner (column 7, lines 36-39). The examiner takes official notice (now admitted prior art) that it is known in the art to use polyurethane as an adhesive. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use any suitable adhesive material, such as polyurethane, because it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability and desired characteristics.
Claim 5, Golds discloses that the expandable tubular structure may be made from nitinol wires (column 6, lines 44-56). Golds does not appear to specifically mention the wires being braided but Laduca discloses that it is known in the art to construct expandable nitinol wires in any desirable configuration including a braid (see entire document including [0093], [0101] and [0103]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the expandable tubular structure with any desirable configuration, such as braided, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability and desired characteristics.
Claim 6, Golds and Laduca teach that the inner liner and outer liner into contact with the inner surface of the expandable tubular structure and an inner surface of the heated die, respectively (Figure 8 of Golds and [0133] of Laduca).
Claim 7, it would have been obvious to use an inflatable silicone tube that has a free outer diameter that is less than an inner diameter of the inner liner to allow the silicone tube to be inserted into the inner liner.
Claim 8, Laduca discloses that inflation brings the outer liner into contact with the heated die [0133].
Claim 9, Laduca discloses that the inflation occurs inside the inner liner [0133].
Claim 10, Laduca discloses that the heated die is located outside of the outer liner [0133].
Claim 12, Laduca does not disclose a specific heated die temperature but the examiner takes official notice (now admitted prior art) that a temperature of 110ºC is typical in the art. Plus, considering that the applied prior art teaches a substantially identical composite in terms of structure and materials, it would have been obvious to one skilled in the art to heat the die to any desired temperature, such as claimed, capable of laminating the layer together. It is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). Only if the results of optimizing a variable are unexpectedly good can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon, 919 F.2d 688, 692, USPQ2d 1897, 1901 (Fed. Cir. 1990) (in banc). [In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1365 (Fed. Cir. 1997).]
Claim 13, Belfiore does not appear to mention a specific silicone tube hardness but Walker discloses that inflatable silicone with a Shore A hardness of about 20-30 provides tear resistance, provides equal pressure distribution and provides complete sealing even over irregularities (see entire document including column 5, lines 24-61, column 7, lines 5-27, column 8, lines 38-54 and claim 1). Therefore, it would have been obvious to one having ordinary skill in the art to use an inflatable silicone tube with the claimed Shore A hardness to provides tear resistance, equal pressure distribution, and/or provide complete sealing even over irregularities.
Claim 14, Golds teaches that the inner liner of the laminated expandable sheath has an irregular surface that conforms to contours of the expandable tubular structure (Figure 8).
Claim 15, Golds teaches that the outer liner of the laminated expandable sheath has a smooth surface (Figure 8).
Claim 16, Golds discloses that the laminated expandable sheath includes the inner liner, the outer liner, and the expandable tubular structure between the inner and outer liner (column 6, lines 44-56).
Response to Arguments
Applicant's arguments filed 1/28/2026 have been fully considered but they are not persuasive.
The applicant asserts that Golds fails to teach or suggest the claimed inflating method and that there is no motivation to build the laminated tubular structure of Golds by the claimed inflating method. The examiner agrees that Golds does not appear to mention inflating the inner liner to expand up (under pressure) to the internal diameter of the outer liner but Golds discloses that the strength of the interface between the two tubes may be independently varied through selection of processing conditions as desired (column 5, lines 15-23). In addition, Golds teaches that adhesive may be necessary to provide the desired amount of adherence through the spaces of the stent (column 7, lines 36-48). Laduca discloses that it is known in the art to laminate a tube composite by inflating the inner liner to expand up to the internal diameter of the outer liner while a die restricts the diameter from growing while under pressure and heat and that said method is low-cost (see entire document including [0133]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the tubular composite of Golds by the claimed inflating method to reduce costs and/or because it is within the general skill of a worker in the art to select a known method on the basis of its suitability and desired characteristics.
The applicant asserts that Golds teaches away from using pressure to expand the laminate layers because Golds discloses use of a mandrel made of stainless steel. Applicant’s argument is not persuasive because Golds does not require the mandrel be made of stainless steel. On the contrary, Golds discloses that tube 14 is expanded over a mandrel “such as a stainless steel mandrel” (column 4, lines 40-43).
The applicant also asserts that Golds fails to teach a heated die and that Laduca fails to teach an inflatable mandrel. Applicant’s argument is not commensurate in scope with the current rejection. Laduca discloses a heated die [0133] and Belfiore discloses that it is known in the art to use an inflatable silicone tube [0036].
The applicant also asserts that and that there is no motivation to combine the teachings of Laduca and Belfiore. The examiner respectfully disagrees. Golds does not appear to mention inflating the inner liner to expand up to the internal diameter of the outer liner but Laduca discloses that it is known in the art to laminate a tube composite by inflating the inner liner to expand up to the internal diameter of the outer liner while a die restricts the diameter from growing while under pressure and heat and that said method is low-cost (see entire document including [0133]). Laduca does not appear to mention a specific inflating method but Belfiore discloses that it is known in the art to use an inflatable silicone tube (see entire document including [0036]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the tubular composite of Golds by any suitable method, such as the claimed inflating method, to reduce costs and/or because it is within the general skill of a worker in the art to select a known method on the basis of its suitability and desired characteristics.
The applicant also asserts that there is nothing in Golds that suggests that an expendable mandrel would be in any way advantageous. The examiner respectfully disagrees. Golds teaches that the stent results in spacing between the inner and outer tubes and that adhesive may be necessary to provide adherence of the inner and outer tubes through said spaces of the stent (column 7, lines 36-48). Therefore, inflating would provide pressure to improve filling of the spaces of the stent.
The applicant also asserts that Belfiore alone fails to teach the claimed method. Applicant’s argument is not commensurate with the claimed rejection. The combination of references, including Belfiore, teaches the claimed method. Golds discloses a method for making an expandable sheath, the method comprising: sliding an expandable tubular structure into an outer liner and sliding an inner liner into the expandable tubular structure (see entire document including column 3, line 42 through column 4, line 16 and column 6, line 44 through column 7, line 48). Golds does not appear to mention inflating the inner liner to expand up to the internal diameter of the outer liner but Laduca discloses that it is known in the art to laminate a tube composite by inflating the inner liner to expand up to the internal diameter of the outer liner while a die restricts the diameter from growing while under pressure and heat and that said method is low-cost (see entire document including [0133]). Laduca does not appear to mention a specific inflating method but Belfiore discloses that it is known in the art to use an inflatable silicone tube (see entire document including [0036]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the tubular composite of Golds by any suitable method, such as claimed, to reduce costs and/or because it is within the general skill of a worker in the art to select a known method on the basis of its suitability and desired characteristics.
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).
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 ANDREW T PIZIALI whose telephone number is (571)272-1541. The examiner can normally be reached Monday-Thursday 7am-5pm.
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, Marla McConnell can be reached at 571-270-7692. 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.
/ANDREW T PIZIALI/Primary Examiner, Art Unit 1789
Prosecution Insights