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 1-13 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.
Claims 1 and 8 recite the limitations, "a site” and “a native heart valve" in line 3 lack antecedence. The two “a” should be replaced by ---the---.
Claim Objections
Claim 1 is objected to because of the following informalities: the applicant’s representative should add the following words in order to properly identify that the retracting and advancing steps are steps, the words are:
In claim 1, line 10, add the following: ---the step of--- between the words “after” and “retracting”.
In claim 1, line 11, it should be the word “an” instead of “and”.
In claim 1, line 13, add: ---the step of--- between the words: “after” and “advancing”.
Appropriate correction is required.
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 1-4, 6, and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 of U.S. Patent No. 11,612,482 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both cases disclose the same delivery system deploying a heart valve. Both cases disclose a catheter having an outer shaft, intermediate shaft, an inner shaft and a heart valve having an outer member coupled to an inner member and leaflets connected to the inner member.
In addition to the structural limitations, the two cases disclose the step of retracting the outer shaft, advancing the catheter such that a brim of the outer member engages an upstream side of an annulus and after advancing the catheter, a retracting of the intermediate shaft releases the inner member of the heart valve prosthesis.
Regarding claim 3, see claim 14 of the patent.
Regarding claim 2, a mitral valve is an atrioventricular valve.
Regarding claim 4, see claim 15 of the patent.
Regarding claim 6, see claim 16 of the patent.
Regarding claim 7, see claim 17 of the patent.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of Keogh et al U.S. Patent No. 11,612,482 in view of Morriss et al US Patent 9,125,740 B2.
Keogh et al discloses the invention substantially as claimed. However, the claims are silent regarding a tricuspid valve.
Morriss et al teaches multiple embodiments comprising different catheters and different heart valves. In Fig. 2I and col. 43, lines 34-38 disclose different embodiments disclosing a tricuspid heart valve implant and bicuspid aortic valves for the purpose of treating different atrioventricular valves. Additionally, throughout the Keogh et al reference also discloses that the invention can also be use in tricuspid valves.
It would have been obvious to one ordinary skill in the art to modify the claimed bicuspid heart valve of the Keogh et al reference with the tricuspid valve of the Morriss et al reference in order to be able to replace any heart valve.
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, 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morriss et al US Patent 9,125,740 B2.
Morriss et al discloses a method of delivering and deploying a heart valve prosthesis (100, see Fig. 2I) at a site of a native heart valve (aortic valve), the method comprising: positioning a delivery catheter (200, see Fig. 10) at a site of a native heart valve with the heart valve prosthesis in a radially compressed configuration within the delivery catheter (see col. 54, lines 53-61). The heart valve prosthesis (100) includes an outer member (120) coupled to an inner member (110) and a prosthetic valve (150, see Figs. 2A2 and 2I) coupled to the inner member (110). The delivery catheter (200) includes an outer shaft (20), an intermediate shaft (226), and an inner shaft (204).
Retracting the outer shaft (20) to release the outer member of the heart valve prosthesis from the outer shaft such that the outer member radially expands (See col. 54, lines 50-55). After the step of retracting the outer shaft, the delivery catheter advances such that a brim of the outer member engages and upstream side of an annulus of the native heart valve (see note); and after advancing the delivery catheter, retracting the intermediate shaft to release the inner member of the heart valve prosthesis from the intermediate shaft such that the inner member radially expands (see col. 54, lines 55-64).
NOTE: even though the step of advancing the delivery catheter is not explicitly mentioned in col. 54, lines 28-64, it will be inherent to advance (move forward) the catheter (200) toward the Ascending Aorta (see Fig. 2I) in order to leave enough space to the arms (120) expand and later slightly retract the catheter in order to makes element 122 (see Fig. 2I) be in contact with the upstream annulus of the native heart valve for the purpose of compressing or retaining the leaflets between the arms.
The Examiner, is interpreting the advancing step of the delivery catheter broadly. For example, the step of “advancing the delivery catheter such that a brim…” does not require that the advancing step cause the brim engages the upstream side of the annulus. The Examiner is looking for a reference that has the step of advancing the delivery catheter (to expand the arms 120) with a different step of engaging the brim with the annulus, no matter if the step of engaging the brim with the annulus is by later retracting slightly the catheter.
In order to expand the arms (120) in the Morriss et al reference, the catheter needs to advance toward the Ascending Aorta, however, in order to the brim of the arms (120) engage with the upstream side of the annulus, the catheter has to slightly retract in order to element (122, see Fig. 2I) be in contact with the upstream annulus. Therefore, in order to overcome this rejection, the Applicant’s representative must clearly define that the distal advancing step of the delivery system is the step that engages an upstream side of the annulus by the brim.
Language that can be used:
“after the step of retracting the outer shaft, a brim of the expanded outer member engages an upstream side of an annulus of the native heart valve by distally advancing the delivery catheter”.
Regarding claim 5, see Fig. 2I showing a tricuspid valve.
Regarding claim 6, in the Morriss et al invention the inflow portion is always at the proximal portion of the catheter and the outflow portion is always the connection between the outer member and the inner member and always at the distal portion of the catheter.
Allowable Subject Matter
Claims 8-13 would be allowable if rewritten or amended 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 11/14/25