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 in response to the amendment filed November 11, 2025. Claims 27, 38, 42, and 46 are amended. Claim 28 is cancelled. Claims 27 and 29-48 are pending and addressed below.
Response to Arguments
Applicant's arguments with respect to the 102(a)(2) rejection of claim 42 filed November 25, 2025 have been fully considered but they are not persuasive. Applicant argues that element 250 of Quadri (U.S. Pub. No. 2010/0298931) is not a handle because it is not clear how it can be grasped. Examiner submits that a practitioner could grasp the device by wrapping at least one finger and a thumb around element 250. Therefore, the arguments are unpersuasive.
Applicant’s remaining arguments with respect to claim(s) 27, 38, 42, and 46 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 27, 29-33, 42 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti (US 6068635 A) in view of Hall (US 5195985 A).
Regarding claim 27, Gianotti teaches a delivery system (150; Fig. 6), comprising a funnel (165 and 180 in combination; Fig. 6) having a proximal end (e.g., 183’; Fig. 6) and a distal end (e.g., 170’; Fig. 6), said funnel (165, 180) comprising a handle (187, 187’; Fig. 6), a first portion (187; Fig. 6) of said handle (187, 187’) extending beyond the diameter of the proximal end (183’) of the funnel (165, 180) and a second portion (187’; Fig. 6) of said handle (187, 187’) extending beyond the diameter of the proximal end (183’) of said funnel (165, 180) to engage an operator's finger or thumb (“grip elements,” Col. 6, lines 63-65), a funnel cap (157; Fig. 6) positioned at and in contact with the proximal end (183’) of said funnel (165, 180), and a scaffold (101; Fig. 6) positioned in said funnel (165, 180), said system further comprising an outer delivery sheath (115; Fig. 6), wherein said funnel cap (157) has an opening (see Fig. 10) configured to accept an elongate member (125; Fig. 6) inserted through said funnel cap (157, it is noted, an elongate member has not been positively recited, funnel cap 157 has an opening running through the cap and is therefore “configured to receive” an elongate member though it), said elongate member (125) when inserted extending beyond said distal end of said funnel (165, 180, see Fig. 6).
However, Gianotti does not explicitly disclose said first and second portions comprising a loop or curve with an aperture.
Hall teaches a known medical handle configuration similar to that of Gianotti with first and second flange grip elements (341; Fig. 24). Hall further teaches, alternatively, a medical handle configuration with first and second grip portions comprising a loop or curve with an aperture (314; Fig. 22).
Hall is considered to be analogous to the claimed invention because it is in the same field of medical device handles. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle configuration of Gianotti to incorporate the teachings of Hall by replacing the first and second flange grip elements with first and second grip portions comprising a loop or curve with an aperture. Doing so would be a simple substitution of one known handle grip element for another to obtain predictable results of providing a handle with a reasonable expectation of success.
Regarding claim 29, Gianotti further teaches said scaffold (101) is a radially self-expandable scaffold (Col. 5, lines 43-46, it is noted, the “endoprosthesis” 101 is taught as having similar characteristics as endoprosthesis 1, Col. 6, lines 38-40).
Regarding claim 30, Gianotti further teaches said funnel cap (157) allows for the scaffold (101) to be properly positioned in the system when it is desired to load said scaffold (e.g., pushing funnel cap 157 pushes scaffold 101 to properly position, Col. 8, lines 11-18).
Regarding claim 31, Gianotti further teaches said scaffold (101) is tubular (see Fig. 6) having an as-manufactured diameter and as-manufactured length (it is noted, the endoprosthesis innately has an as-manufactured diameter and as-manufactured length).
Regarding claim 32, Gianotti does not explicitly teach said as-manufactured diameter is between 5 mm and 40 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Gianotti to have an as-manufactured diameter is between 5 mm and 40 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Gianotti operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Gianotti. Further, applicant places no criticality on the dimensions claimed, indicating simply that “the as-manufactured (or unconstrained) diameter of the scaffold may range from 5 mm or less to 40 mm or more, for example, ranging from 5 mm to 10 mm to 15 mm to 20 mm to 25 mm to 30 mm to 35 mm to 40 mm (i.e., ranging between any two of the preceding numerical values), commonly ranging from 5 to 12 mm or from 15 to 30 mm” (see pp. [00209] of applicant’s specification).
Regarding claim 33, Gianotti does not explicitly teach said as-manufactured length is between 5 mm and 30 mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Gianotti to have an as-manufactured length is between 5 mm and 30 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the invention of Gianotti operates in the same manner as the claimed invention, and an invention having the claimed relative dimensions would not perform differently than the invention of Gianotti. Further, applicant places no criticality on the dimensions claimed, indicating simply that “the as-manufactured (or unconstrained) length may range from 5 mm or less to 30 mm or more, for example, ranging from 5 mm to 10 mm to 15 mm to 20 mm to 25 mm or 30 mm (i.e, ranging between any two of the preceding numerical values), commonly ranging from 8 to 12 mm or from 15 mm to 30” (see pp. [00209] of applicant’s specification).
Regarding claim 42, Gianotti teaches a delivery system (150; Fig. 6), comprising a handle (187, 187’; Fig. 6) and a funnel (165 and 180 in combination; Fig. 6) having a proximal end (e.g., 183’; Fig. 6) and a distal end (e.g., 170’; Fig. 6), a funnel cap (157; Fig. 6) positioned at and in contact with the proximal end (183’) of said funnel (165, 180), said funnel cap (157) comprising an opening (see Fig. 10), a scaffold (101; Fig. 6) positioned in said funnel (165, 180), an outer delivery sheath (115; Fig. 6), and an elongate member (125 and 135 in combination; Fig. 6) inserted into said opening in said funnel cap (157, see Fig. 6), said elongate member (125, 135) extending beyond said distal end of said funnel (165, 180, see Fig. 6), a first portion (187; Fig. 6) of said handle (187, 187’) extending above the funnel (165, 180) and a second portion (187’; Fig. 6) of said handle (187, 187’) extending below said funnel (165, 180) to engage an operator's finger or thumb (“grip elements,” Col. 6, lines 63-65).
However, Gianotti does not explicitly disclose said first and second portions comprising a loop or curve with an aperture.
Hall teaches a known medical handle configuration similar to that of Gianotti with first and second flange grip elements (341; Fig. 24). Hall further teaches, alternatively, a medical handle configuration with first and second grip portions comprising a loop or curve with an aperture (314; Fig. 22).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle configuration of Gianotti to incorporate the teachings of Hall by replacing the first and second flange grip elements with first and second grip portions comprising a loop or curve with an aperture. Doing so would be a simple substitution of one known handle grip element for another to obtain predictable results of providing a handle with a reasonable expectation of success.
Regarding claim 46, Gianotti teaches a delivery system (150; Fig. 6), comprising a funnel (165 and 180 in combination; Fig. 6) having a proximal end (e.g., 183’; Fig. 6) and a distal end (e.g., 170’; Fig. 6), said funnel (165, 180) comprising a handle (187, 187’; Fig. 6), said handle (187, 187’) comprising two portions (187 & 187’) extending laterally from the funnel (165, 180) in opposite directions to engage an operator’s finger or thumb (“grip elements,” Col. 6, lines 63-65), a funnel cap (157; Fig. 6) positioned at and in contact with the proximal end (183’) of said funnel (165, 180), and a scaffold (101; Fig. 6) positioned in said funnel (165, 180), said system further comprising an outer delivery sheath (115; Fig. 6), wherein said funnel cap (157) has an opening (see Fig. 10) configured to accept an elongate member (125; Fig. 6) inserted through said funnel cap (157, it is noted, an elongate member has not been positively recited, funnel cap 157 has an opening running through the cap and is therefore “configured to receive” an elongate member though it), said elongate member (125) when inserted extending beyond said distal end of said funnel (165, 180, see Fig. 6).
However, Gianotti does not explicitly disclose said first and second portions comprising a loop or curve with an aperture.
Hall teaches a known medical handle configuration similar to that of Gianotti with first and second flange grip elements (341; Fig. 24). Hall further teaches, alternatively, a medical handle configuration with first and second grip portions comprising a loop or curve with an aperture (314; Fig. 22).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the handle configuration of Gianotti to incorporate the teachings of Hall by replacing the first and second flange grip elements with first and second grip portions comprising a loop or curve with an aperture. Doing so would be a simple substitution of one known handle grip element for another to obtain predictable results of providing a handle with a reasonable expectation of success.
Claim(s) 34-37, 43-45, and 47-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti in view of Hall, and further in view of Pinchuk (U.S. Pub. No. 2007/0118210).
Regarding claims 34-37, Gianotti does not explicitly disclose the scaffold formed of polymeric materials, comprises one or more strands, is braided, or comprises a therapeutic agent.
Pinchuk teaches a heart valve (Fig. 11) formed of polymeric materials (pp. [0047]), comprises one or more strands (pp. [0047]), is braided (pp. [0047]), and comprises a therapeutic agent (pp. [0065]).
Pinchuk is considered to be analogous to the claimed invention because it is in the same field of deployable scaffold systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold formed of polymeric materials comprising one or more braided strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success. Further, applying a therapeutic agent to the scaffold would provide the added benefit of delivering a drug to the implant site without needing to insert another device.
Regarding claim 43-45, Gianotti does not explicitly disclose the scaffold formed of polymeric materials, comprises one or more strands, or is braided.
Pinchuk teaches a heart valve (Fig. 11) formed of polymeric materials (pp. [0047]), comprises one or more strands (pp. [0047]), and is braided (pp. [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold formed of polymeric materials comprising one or more braided strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success.
Regarding claim 47-48, Gianotti does not explicitly disclose the scaffold formed of polymeric materials or comprises one or more strands.
Pinchuk teaches a heart valve (Fig. 11) formed of polymeric materials (pp. [0047]), comprising one or more strands (pp. [0047]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Gianotti to incorporate the teachings of Pinchuk by providing a scaffold formed of polymeric materials comprising one or more strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacker et. al. (U.S. Pub. No. 2016/0346106) (priority to 05/28/2015), hereinafter, “Hecker,” in view of Inoue (U.S. Pub. No. 2003/0014103).
Regarding claim 38, Hecker teaches a delivery system (Fig. 15), comprising a funnel (308; Fig. 14A) having a proximal end (left side; Fig. 14A) and a distal end (324; Fig. 14A), a funnel cap (202; Fig. 17) positioned at the proximal end (see Fig. 17) of said funnel (308), an elongate pulling member (20; Fig. 16), and a scaffold (102; Fig. 4), said scaffold (102) comprising apertures (118; Fig. 4), said system further comprising an outer delivery sheath (302; Fig. 7) having a lumen (304; Fig. 7) and a distal end (the non-funnel end, see Fig. 14a), wherein said scaffold (102) is positioned in said sheath lumen (302, see Fig. 17), at least a portion of said pulling member (20) extending outside said distal end of said sheath (302, see Fig. 14A).
However, Hecker does not explicitly disclose one or more filaments looped through the apertures of the scaffold such that first and second ends of the filament are secured to the elongate pulling member.
Inoue teaches a scaffold (“A,” Fig. 14) with apertures (13; Fig. 14), wherein one or more filaments with first and second ends are looped through the apertures (13) of the scaffold (pp. [0122], see Figs. 12-14), such that first and second ends of the filament (4) are secured to an elongate pulling member (2; Fig. 14).
Inoue is considered to be analogous to the claimed invention because it is in the same field of scaffold loading systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connecting configuration between the scaffold and elongate pulling member of Hecker to incorporate the teachings of Inoue by connecting the scaffold and elongate pulling member by looping one or more filaments through the apertures of the scaffold such that first and second ends of the filament are secured to the elongate pulling member. Doing so would be combining prior art elements according to known methods to yield predictable results of connecting the scaffold to the elongate pulling member.
Claim(s) 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hecker in view of Inoue, and further in view of Pinchuk.
Regarding claim 39-41, Hecker does not explicitly disclose the scaffold comprises one or more strands, is braided, or comprises a therapeutic agent.
Pinchuk teaches a heart valve (Fig. 11) comprises one or more strands (pp. [0047]), is braided (pp. [0047]), and comprises a therapeutic agent (pp. [0065]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scaffold of Hecker to incorporate the teachings of Pinchuk by providing a scaffold comprising one or more braided strands. Doing so would be a simple substitution of one known scaffold composition and structure for another to obtain predictable results of providing a heart valve with a reasonable expectation of success. Further, applying a therapeutic agent to the scaffold would provide the added benefit of delivering a drug to the implant site without needing to insert another device.
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 DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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, Elizabeth Houston can be reached at 571-272-7134. 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.
/DANIEL ICET/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771