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 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 1-12 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.
Regarding claim 1, which recites the limitation “said support member”, on lines 11-12 and line 15; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what exact structure is meant by the limitation “said support member” and/or how exactly is relates to the structure of the device. For the purpose of examination, as can be gleaned from the originally filed disclosure, the above mentioned limitation shall be interpreted as “said support frame”. Furthermore, lines 13-14 set forth the parameter of “said support frame is configured to provide passage for blood flow through said inside luminal region preferably without restriction” (emphasis added); however the term “preferably” is considered to be indefinite because it is unclear whether the limitation following the term “preferably” is part of the claimed invention or not. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 3, which recites the limitation “said support member”, on line 3; there is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what exact structure is meant by the limitation “said support member” and/or how exactly is relates to the structure of the device. Furthermore, according to line 6 of claim 1, from which claim 3 depends, the step of “expanding” is directed toward the support frame, i.e. “expanding said support frame”; thus, it is further found to be unclear how the barbs/fixation members can have “said inactive configuration with said support frame in said expanded configuration” prior to said expanding. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Note
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 102
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, 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drasler et al. (US PG Pub. 2015/0173898), hereinafter Drasler.
Regarding claim 1, Drasler discloses a method for placing a device delivered via transcatheter methods within native heart valve tissue ([0018]) comprising the steps of providing an expandable support frame (66) having fixation members (340) attached thereto; expanding said support frame (66) from a smaller diameter, illustrated in Figures 46A and 46B, to a larger diameter and into contact with the native heart valve tissues while maintaining said fixation members (340) in an inactive configuration that does not restrict movement between said support frame and the native heart valve tissues, illustrated in Figures 46C and 46D ([0231]); activating said fixation members (340) to an active configuration placing at least a portion of said fixation members into contact with the native heart valve tissues to prevent movement of said support frame (66) relative to the native heart valve tissues, illustrated in Figures 46E and 46F ([0232] & [0233]), wherein an inside luminal region of said support frame (66) is configured to provide passage (via tube 344) for blood flow through said inside luminal region preferably without restriction of blood flow through said device during said expansion of said support member and during said activation of said fixation members to said active configuration, illustrated in Figures 46B,46 D and 46F ([0231], Line 13-14 – to clarify, tube 344 would allow blood flow through the inside luminal region of support frame 66 during expansion and activation steps).
Regarding claim 11, Drasler discloses the method of claim 1, wherein said support frame has a locking region (88) having a geometrical shape configured to lock with an expandable valve frame/stent-valve having replacement leaflets attached thereto, said expandable valve frame being placed within said inside luminal region of said support frame ([0161]).
Regarding claim 12, Drasler discloses the method of claim 1, wherein said method further comprising the steps of placing an expandable valve frame (166/52) via a valve frame delivery sheath within said inside luminal region of said support frame (164/66), said expandable valve frame (166/52) having replacement leaflets (100) attached thereto, said replacement leaflets (100) configured to direct the blood flow in a downstream direction; expanding said valve frame (166/52) within said inside luminal region of said support frame (164/66) such that said valve frame does not move axially with respect to said support frame ([0128]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,612,484. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a method of catheter delivery of a device to native heart valve tissue comprising placing/providing an expandable support frame in an unexpanded configuration within the native heart valve, wherein the support frame having a balloon/torus balloon attached thereto, and the support frame further having fixation members/barbs attached along a perimeter of the support frame perimeter; expanding the support frame to contact the native heart valve tissue, while the balloon/torus balloon is in an uninflated configuration and the fixation members having an inactive configuration, that does not contact the native heart valve tissue, during said expansion of the support frame; inflating the balloon/torus balloon to activate the fixation members into contact with the native heart valve tissues, wherein the fixation members are configured to prevent migration of said support frame relative to the native heart valve tissue.
Allowable Subject Matter
Claims 13-20 would be allowable if the Double Patenting rejection, set forth above, is overcome by filing an e-Terminal Disclaimer.
The following is a statement of reasons for the indication of allowable subject matter of independent claims 13 and 17: no prior art, by itself, or in combination with other art, could be found that discloses or fairly teaches a method of catheter delivery of a device to a native heart valve comprising placing a support frame in an unexpanded configuration within the native heart valve tissues, the support frame having a balloon/expansion member attached thereto and fixation members attached along a perimeter of the support frame; expanding the support frame into contact with native heart valve tissue while the balloon/expansion member is in an uninflated configuration, wherein the fixation members have an inactive configuration that does not contact the native heart valve tissues during the expansion of the support frame; inflating/expanding the balloon/expansion member to activate the fixation members into contact with the native heart valve tissue, wherein the fixation members are configured to prevent migration of the support frame relative to the native heart valve tissue.
Claims 2 and 4 would be allowable if rewritten to include all of the limitations of the base claim and any intervening claims, to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office Action, and over come the Double Patenting rejection, set forth above, by filing an e-Terminal Disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774