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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 23 recites “wherein the first recess wall is configured to abut against the first wire part at multiple first contact points, and wherein the second recess wall is configured to abut against the second wire part at multiple second contact points”. The original disclosure makes no mention of this claimed feature.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 now recites “wherein the first wire part and the second wire part form a shape, and wherein the one of the recesses has a recess shape that corresponds with the shape formed by the first wire part and the second wire part”. Claim 1 thus attempts to define the structure of the recess by comparing it to a non-positively recited element (the implant, or the wire parts thereof). The shape of the recess cannot be properly ascertained if the shape of the wire parts are not also known, and so it is unclear how the limitation would narrow the claimed structure of the recess.
Claim 5 recites “wherein the one of the tabs of the implant has a proximal end and a distal end that is between the proximal end and the first wire part, and wherein the first recess has a profile that follows a shape of the proximal end of the one of the tabs”. Similarly to the discussion for claim 1 above, claim 15 attempts to define the structure of the recess by comparing it to a non-positively recited and vaguely defined proximal end and a distal end of the tab. The specific shape of the proximal end and a distal end of the tab is not known, and so the shape of the recess cannot be ascertained.
Claim 22 recites “the recess shape is a larger version of the shape formed by the first wire part and the second wire part”. However, as discussed above, the wire parts are not positively recited and their shape and size are unknown, meaning the corresponding geometry of the recess cannot be ascertained.
The remaining claims are rejected by virtue of their dependency on claim 1 or 15.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 12-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (U.S. Patent 2012/0078350).
Claim 1: Wang et al. discloses a system (see especially embodiment of Figs. 6A-6C) for delivering an implant (a stent/heart valve 1) to a deployment site within a patient's vasculature, the implant having wires (struts 2) forming a pattern (e.g. Figs. 5A, 8), the system comprising: an elongated core member (50d); and an implant engagement member (30d) coupled to a distal end portion of the elongated core member, the implant engagement member comprising a surface (of 40d) and recesses (36d/38/39d/41d) at the surface, the recesses configured to accommodate parts of the wires of the implant (paragraph 79 and Fig. 6A); wherein the parts of the wires comprise a first wire part and a second wire part (two legs of the V-shaped junction), the first wire part and the second wire part defining a space therebetween (evident e.g. in Fig. 6A); wherein one of the recesses is configured to accommodate the first wire part and the second wire part (paragraph 79 and Fig. 6A); and wherein the first wire part and the second wire part form a shape (inherently), and wherein the one of the recesses has a recess shape that corresponds with the shape formed by the first wire part and the second wire part (noting that “corresponds” is interpreted broadly, given that it does not necessarily mean identical as shown in e.g. Fig. 7 of the instant application, where forked wires are accommodated in a solid, open (non-forked) recess).
It is further noted that a claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963). See MPEP 2115. In this case, the implant is not positively recited, and so it does not necessarily limit the claimed recess. The recess of Wang meets the claimed limitations as discussed above, but also if a hypothetical implant structure that “corresponds” in shape to the recess were received in the recess.
Claim 2: The one of the recesses (38) extends across the space defined between the first wire part and the second wire part when the one of the recesses accommodates the first wire part and the second wire part (as cited above).
Claim 3: The implant comprises tabs (4), and wherein the surface of the implant engagement member comprises additional recesses (36d) configured to accommodate respective tabs of the structure (paragraph 77, Fig. 6A).
Claim 4: The implant engagement member is configured to transfer a majority of a force applied at a proximal end of the elongated core member to a proximal end of the implant (the member 30d can push the proximal or right end of the stent, e.g. as shown in Fig. 6A, thus applying the force thereto).
Claim 5: The implant engagement member is configured to push only the proximal end (e.g. right end in Fig. 6A) of the implant to advance the implant distally while an entirety of the implant is inside a catheter (as shown in Fig. 1A). It is further noted that neither the implant nor the catheter are positively recited as of claim 5.
Claim 6: At least a part of the one of the recesses has a tapered configuration (evident in Figs. 6B-6C).
Claim 7: Opposing sides of the tapered configuration face respectively the first and second wire parts (evident from Figs. 6A-6C).
Claim 8: The at least the part of the one of the recesses (38) extends continuously across an area between opposing tapering sides of the tapered configuration (evident from Figs. 6A-6C).
Claim 12: The system further comprises an introducer sheath (22) containing the implant engagement member (paragraphs 45-46, 50; Fig. 1A).
Claim 13: The system further comprises a catheter (14) containing the implant and the implant engagement member (Fig. 1A; paragraph 45).
Claim 14: The system further comprises the implant (1), wherein a portion of the first wire part and a portion of the second wire part (legs of the V-shaped junction) are seated in the one of the recesses (38) at the surface of the implant engagement member (as cited above).
Claim 22: The recess shape is a larger version of the shape formed by the first wire part and the second wire part (Implied in paragraph 47. However, as noted above, the shape of the wire parts as claimed are not defined or positively recited and thus do not substantially limit the claim).
Claim 23: The one of the recesses comprises a first recess wall and a second recess wall (evident in Fig. 6A, any two of the inner surfaces can be walls, e.g. upper and lower sections thereof), wherein the first recess wall is configured to abut against the first wire part at multiple first contact points, and wherein the second recess wall is configured to abut against the second wire part at multiple second contact points (as noted above, the implant is not positively recited and so does not necessarily limit eh recess. Even so, the wires of the implant as shown could contact the recess at multiple points, where any surface contact would technically constitute infinite points of contact without further definition of what a “point” is).
Claim 15: Wang et al. discloses a system (see especially embodiment of Figs. 6A-6C) for delivering an implant (a stent/heart valve 1) to a deployment site within a patient's vasculature, the implant having wires (struts 2) and tabs (4) at an end (e.g. right end) of the implant, the system comprising: an elongated core member (50d); and an implant engagement member (30d) coupled to a distal end portion of the elongated core member, the implant engagement member comprising a surface (of 40d) and first recess (36d) at the surface, wherein the first recess has an elongated configuration (evident in Figs 6A-6C) configured to accommodate one of the tabs of the implant (paragraph 77 and Fig. 6A); wherein the surface of the implant engagement member comprises a second recess (38) at the surface, wherein the second recess is configured to accommodate a first wire part of the wires of the implant (either of two legs of the V-shaped junction - paragraph 79 and Fig. 6A); and wherein the one of the tabs of the implant has a proximal end (e.g. circular portion in Fig. 6A) and a distal end (corresponding to neck 39d) that is between the proximal end and the first wire part, and wherein the first recess has a profile that follows a shape of the proximal end of the one of the tabs (at least a semicircular portion of recess 36d that follows the circular portion).
Claims 16-17: It is noted that the implant is not a positively recited portion of the claimed system, and so its construction (e.g. braided wires or struts formed by laser-cutting a tube) is not limiting thereto (MPEP 2115).
Claim 18: The second recess (38) is configured to also accommodate a second wire part of the wires of the implant (the other of the two legs of the V-shaped junction - paragraph 79 and Fig. 6A).
Claim 19: The second recess (38) extends across a space between the first wire part and the second wire part when the second recess accommodates the first wire part and the second wire part (as evident from the figures).
Claim 20: The system further comprises a delivery catheter (14); wherein the elongated core member, the implant engagement member, and the implant are at least partially disposed within a lumen (defined by 22) of the delivery catheter (paragraphs 45-46, 50; Fig. 1A); wherein the implant engagement member and the delivery catheter are configured to cooperate with each other to grip the implant as the elongated core member is moved within the lumen (the lumen/sheath moves relative to the core) of the delivery catheter (e.g. paragraph 52).
Claim 21: The profile of the first recess is noncircular (the recess 36d, while having a semi-circular portion, is not purely circular as shown).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Plowiecki (FR2939637, cited in IDS, with reference to translation).
Wang et al. discloses a system substantially as claimed except for wherein the implant engagement member has a hardness that is at least 25A (Wang is silent regarding the material). However, Plowiecki teaches a similar implant engagement member (30) for a similar purpose having a hardness that is at least 25A. (page 4, lines 130-137, noting that 20 Shore D is approximately equal to 70-80 Shore A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the implant engagement member has a hardness that is at least 25A in order to ensure sufficient durability, for example.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of McWeeney (U.S. PGPub 2020/0214861).
Wang et al. discloses a system substantially as claimed, including the implant (1), except for wherein the wires of the implant comprise braided wires or are formed by laser-cutting a tube. However, McWeeney teaches that a stent may be made by either or even a combination of both methods. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the implant by either method since each may provide certain unique characteristics (paragraph 50).
Response to Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive. Applicant argues the following (italicized):
[Regarding claim 1] Rather, figure 6A of Wang (reproduced below) discloses a recess 38 having a rectangular recess shape. On the other hand, the wire parts 2 of Wang form a shape that is completely different from the rectangular recess shape of the recess 38. Thus, the shape of the wire parts 2 of Wang does not correspond with the recess shape of the recess.
The term “correspond” is somewhat broad and does not describe the extent of the correspondence. In fact, turning to the instant application, the shape of the recess portion (e.g. 714 in Fig. 7) accepting the wire parts is an open recess shape and not a bifurcated V-shape as with the wire parts 704. Thus, the shape of the recess is not entirely identical.
Wang also generally discusses that each recess “preferably has a similar shape and a slightly larger size than a conventional stent retention member” (e.g. paragraphs 47, 59), or “may have any other shape that can receive a corresponding stent strut” (paragraph 80). Wang is thus generally interested in providing some level or correspondence in the shapes of the recess and the stent structure.
It is also noted that the implant is not positively recited as claimed such that only the structure of the system, and specifically the recess, is what matters, and that the recess would read on the claim if a “corresponding” implant were received therein.
[Regarding claim 15] Figure 6A of Wang discloses a first recess 36d accommodating a tab 4 of an implant. However, the first recess 36d of Wang has a rectangular profile that completely deviates from the shape of the proximal end of the tab 4.
The recess portion 36d at least partially follows the proximal end (circular portion) of the tab (where the neck 39d may correspond to the distal portion) in that it also has an at least partially circular shape corresponding to the distal portion of the circular tab.
Furthermore, as noted above, the implant is not positively recited as claimed such that only the structure of the system, and specifically the recess, is what matters, and that the recess would “follow a shape of the proximal end of the one of the tabs” if such a tab were received therein.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P TRAVERS whose telephone number is (571)272-3218. The examiner can normally be reached 10:00AM-6:30PM.
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, Sunil K. Singh can be reached at 571-272-3460. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Matthew P Travers/Primary Examiner, Art Unit 3726
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