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 .
Drawings
The drawings are objected to because they have areas of dark shading that obscures the structures of the invention. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-5, 9, 11-16, 18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 12 and 20-27 of U.S. Patent No. 11,766,328. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘328 anticipates all the method steps of this application.
In regards to claim 1: The ‘328 patent claim recites the step of deflecting the first inner catheter within the left atrium in dependent claim 2, whereas this limitation is in the independent claim 1 of this application. It is considered obvious to put dependent limitations in an independent claim and vice versa. Additionally, claim 1 of ‘328 recites additional language of “deflecting away from the chordae tendinae”, wherein it is considered obvious to broaden the claim language by removing certain requirements.
Claim 1 is also anticipated by claim 12 of the ‘328 patent. Claim 12 of ‘328 recites additional steps of “expanding an expandable deflector…” and “… deflecting the first or second inner catheter within the left ventricle…” wherein it is considered obvious to broaden the claim language by removing certain requirements. This additional language anticipates claim 2 of this application. Claim 3 is also anticipated by claim 12, which recites the aortic valve.
Regarding claim 4: although claim 2 is not specific to a mitral valve and broadly recites “valve in a patient’s heart”, it would have been obvious to one of ordinary skill in the art to perform the procedure to repair a mitral valve as a substitution to the aortic valve, as there is a limited number of valves in the patient’s heart and one of ordinary skill in the art would have expected the procedure to work equally well for treating a mitral valve.
Regarding claim 5: Claim 12 of ‘328 recites additional steps of “expanding an expandable deflector…” It is considered obvious to broaden the claim language by removing certain requirements.
Claim 9 is anticipated by claim 20 of ‘328.
Claim 11 is anticipated by claim 21 of ‘328.
Claim 12 is anticipated by claim 22 of ‘328.
Claim 13 is anticipated by claim 23 of ‘328.
Claim 14 is anticipated by claim 24 of ‘328.
Claim 15 is anticipated by claim 25 of ‘328.
Claim 16 is anticipated by claim 26 of ‘328.
Claim 18 is anticipated by claim 27 of ‘328.
Claim 20 is anticipated by claim 12 of ‘328, wherein Claim 12 of ‘328 recites additional steps of “expanding an expandable deflector…” and “while deflecting away from the chordae tendinae…” It is considered obvious to broaden the claim language by removing certain requirements.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 12,390,328 in view of USPAP 2020/0254166 (Stack et al.). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 20 of ‘328 anticipates all the method steps of claims 1, 5, and 20 of this application.
In regards to claims 1, 5 and 20: Claim 20 of ‘328 fails to specify the outer surface of the first inner catheter is “annularly engaged” with and flush with an outer surface of the outer catheter “without a gap”. The phrase “annularly engaged” is considered to be an obvious description of an inner catheter placed within an outer catheter. The phrase “without a gap” is considered to be obvious, as this is a well known understanding of the term “flush.”
Claim 20 of the ‘328 patent fails to recite the step of “…deflecting the first inner catheter within the left atrium so that a distal end region of the first inner catheter assumes a first bend…” Stack discloses another method of treating an aortic valve, wherein a catheter is advanced through a transseptal puncture to access the left atrium (Figure 6A; [0122]). Stack teaches that the first inner catheter should be deflected within the left atrium (see Fig. 6B) so that a distal end region of the catheter assumes a first bend in order to steer the catheter from the left atrium towards the mitral valve and thus the left ventricle (LV) (Fig. 7; [0123]). The catheter is steered towards the aortic valve, or ventricular outflow tract, and a guidewire guided through the aortic valve and aortic arch (See Fig. 7; [0125]). In light of Stack’s disclosure, one of ordinary skill in the art would have found it obvious to recite the step of “…deflecting the first inner catheter within the left atrium so that a distal end region of the first inner catheter assumes a first bend…” in the claims of the ’328 patent, since this technique was known to be used to access an aortic valve from a transseptal puncture.
Claim 2 is considered to be anticipated by the step “steering the first inner catheter or the second inner catheter towards an aortic valve…” in claim 20 of ‘328.
Regarding claims 3 and 4, it would have been obvious to recite a specific valve of the heart where only a generic recitation was present, since there is only a limited number of heart valves.
Claim 6 is considered to be obviated by the limitation “advancing the outer catheter and the first inner catheter or the second inner catheter over the guidewire to the aortic valve…”, as this would result in the catheters having at least a portion in the ascending aorta.
Claim 7 is obviated by the step in claim 20 that the guidewire is left in place and the step of implanting a replacement valve.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,766,328 in view of US Patent No. 9,901,443 (Morris et al.).
The ‘328 patent claims fail to recite a step of advancing a second guidewire into the left ventricle after the first inner catheter has assumed the first bend. Morris discloses another method of delivering a prosthetic heart valve via a transseptal approach (see Fig. 47A-B), wherein the outer catheter (GC) assumes a first bend in the left atrium (LA) (Figure 47D). Morris teaches that a guidewire is then advanced into the left ventricle in order to aid in positioning a replacement valve (column 52, lines 10-50). Therefore, it would have been obvious to recite a step of advancing a guidewire into the left ventricle after the catheter assumes a first bend in the left atrium, as Morris teaches that this step is known in the art for guiding an inner catheter through a mitral valve.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,766,328 in view of US PAP 2021/0369257 (Huddleston).
Although the claims of the ‘328 patent fail to recite a second of expanding the transseptal puncture with an expandable member on the outer surface of the outer catheter, Huddleston teaches that this step is known in the art when performing a procedure in the heart with a catheter introduced through a transseptal opening [0062]. Therefore, it would have been obvious to recite a step of expanding the transseptal puncture with an expandable member on an outer surface of a first inner catheter in the claims of the ‘328 patent, as this step was known in the art for gradually increasing the size of the puncture for passage of a catheter [0062].
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,766,328 in view of USPAP 2021/0077084 (Stack et al.).
Regarding claim 17: the ‘328 patent claims fail to recite the advancement of a distally tapered initial inner catheter through the transseptal puncture before advancing the first inner catheter. Stack ‘084 discloses it is a well-known method to transseptal catheterization using a the needle is distally tapered initial inner catheter (see dilator 14 and 12 assembly positioned within outer catheter 10 in Figure 1; [0042]), wherein the initial inner catheter and outer catheter are annularly engaged so that the outer catheter passes through the transseptal puncture to the left atrium (see description of RLC 10 passing into left atrium at[0042]). Therefore, it would have been obvious to recite this well known method step of puncturing the septum before passing a catheter therethrough in the claims of the ‘328 patent.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,766,328 in view of US Patent App. Pub. No. 2012/0238872 (Schwager et al.).
The ‘328 patent claims fail to recite the delivery of contrast material from a side facing port of a guidewire. Schwager discloses guidewire for vascular procedures and teaches that contrast media [0069] can be delivered through side ports (spaces between coils 154 in Figure 1; [0091]) of a guidewire (100), in order to aid in imaging of the treatment area. Therefore, it would have been obvious to recite a step of delivering contrast media from a side port of a guidewire in the claims of the ‘328 patent.
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 2 is 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.
It appears that claim 2 may have a typographical error of the word “after” in line 1, as it is understood by the disclosure that the step of deflecting the catheter to face the ventricular outflow tract would occur before the guidewire is advanced out of the catheter and across a valve of the patient’s heart.
Conclusion
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774