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 .
Election/Restrictions
Applicant’s election of Group II in the reply filed on 1/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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(s) 26, 28-30 is/are 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.
Within claim 26, line 3: Applicant claims, “a subannular position distal to the annulus”; there is insufficient written description within the original disclosure for what makes up “a subannular position DISTAL to the annulus”. Although Applicant writes “a distal location on a valve refers to a portion of the valve furthest from the practitioner which exits the delivery catheter first, and which can be placed at or near distal subannular native tissue such as the ventricular outflow tract” within the specification [0057], this definition does not make logical sense – the valve is a portion of the native anatomy, as such no portion of it will exit the delivery catheter; further, a location in the body in relation to the practitioner could be different based on where the practitioner is positioned during the surgery (which could be affected by the surgical access point). For the purposes of examination, Examiner as assuming the subannular position distal to the annulus is referring to the left or right ventricular outflow tracts.
Within claim 28, line 2: Applicant claims, “proximal subannular tissue”; there is insufficient written description within the original disclosure for what makes up “PROXIMAL subannular tissue”. Although Applicant writes “A proximal location on a valve refers to a portion of the valve closest to the practitioner which exits the delivery catheter last, and which can be placed at or near proximal subannular native tissue such as tissue closest to the inferior vena cava” within the specification [0057], this definition does not make logical sense – the valve is a portion of the native anatomy, as such no portion of it will exit the delivery catheter; further, a location in the body in relation to the practitioner could be different based on where the practitioner is positioned during the surgery (which could be affected by the surgical access point). Claim(s) 29-30, which depend from claim 28, inherit all the problems associated with claim 28.
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.
Claim(s) 22-37 is/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 22 recites the limitation "the atrium" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 23-37, which depend from claim 22, inherit all the problems associated with claim 22.
Within claim 23, lines 1-2: Applicant claims, “the flow control component is configured to permit blood flow in a first direction”; it is unclear, and therefore indefinite, if Applicant is trying to claim merely the ABILITY of the flow control component for allow blood flow in a first direction (due to the “configured to” language) OR if Applicant is trying to positively recite the permitting of the blood flow in a first direction (as this claim is a method claim, which requires the actual steps/ functioning of the valve). For the purposes of examination, Examiner is assuming (as the claim is directed to a method of deploying) the aforementioned claim requirement should rewritten as --the flow control component permits blood flow in a first direction--.
Within claim 23, line 5: Applicant claims, “the prosthetic valve is a side-deliverable prosthetic valve”; it is unclear, and therefore indefinite, if Applicant is trying to claim merely the ABILITY of prosthetic valve to be side delivered (due to the “deliverABLE” language) OR if Applicant is trying to positively recite the side delivery of the prosthetic valve (as this claim is a method claim, which requires the actual steps/ functioning of the valve). For the purposes of examination, Examiner is assuming (as the claim is directed to a method of deploying) the aforementioned claim requirement should rewritten as --the prosthetic valve is a side-delivered prosthetic valve--.
Within claim 24, lines 1-2: Applicant claims, “the septal anchoring element is configured to stabilize the prosthetic heart valve”; it is unclear, and therefore indefinite, if Applicant is trying to claim merely the ABILITY of the septal anchoring element to stabilize the prosthetic heart valve (due to the “configured to” language) OR if Applicant is trying to positively recite the stabilization of the prosthetic heart valve (as this claim is a method claim, which requires the actual steps/ functioning of the valve). For the purposes of examination, Examiner is assuming (as the claim is directed to a method of deploying) the aforementioned claim requirement should rewritten as --the septal anchoring element stabilizes the prosthetic heart valve --.
Within claim 32, lines 3-4: Applicant claims, “the flow control component configured to permit blood flow through the prosthetic heart valve in a first direction”; it is unclear, and therefore indefinite, if Applicant is trying to claim merely the ABILITY of the flow control component for allow blood flow in a first direction (due to the “configured to” language) OR if Applicant is trying to positively recite the permitting of the blood flow in a first direction (as this claim is a method claim, which requires the actual steps/ functioning of the valve). For the purposes of examination, Examiner is assuming (as the claim is directed to a method of deploying) the aforementioned claim requirement should rewritten as --the flow control component permits blood flow through the prosthetic heart valve in a first direction --.
Claim 34 recites the limitation "the ventricle" in line 4. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 22, 24-29, 31-33 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Quill et al. (US 2017/0216026 A1).
With respect to claim 22:
Quill et al. discloses a method of deploying a prosthetic heart valve (prosthesis 100), as can be seen in figs. 4A-7 and 9-10D, in an annulus of a native valve of a heart of a patient (paragraphs 0071-0072]), the method comprising:
disposing in the atrium of the heart (left atrium) a distal end of a delivery catheter (guide catheter) having disposed in a lumen thereof the prosthetic heart valve (prosthesis 100) in a compressed configuration (radially compressed delivery configuration) (paragraph [0075]), the prosthetic heart valve (prosthesis 100) having a valve frame (frame 110) and a flow control component (prosthetic valve component 130) mounted within the valve frame (frame 110) (paragraph [0035]), the valve frame (frame 110) including a distal anchoring element (either subsection of radially extending segment 105 not near to posteromedial commissure PC OR support arm 142 OR one of supplemental support arms 146a-b, 148a-c), a proximal anchoring element (either another subsection of radially extending segment 105 not near to posteromedial commissure PC OR support arm 142 OR another one of supplemental support arms 146a-b, 148a-c), and a septal anchoring element (either subsection of radially extending segment 105 near to posteromedial commissure PC OR supplemental support arms 146c, 146d near to posteromedial commissure PC, as the posteromedial commissure PC defines a portion of the native septal wall) (paragraphs [0039, 0044]);
releasing the prosthetic heart valve (prosthesis 100) from the lumen of the delivery catheter (guide catheter) such that the prosthetic heart valve (prosthesis 100) transitions from the compressed configuration (radially compressed delivery configuration) to an expanded configuration (radially expanded configuration) (paragraph [0079]);
seating at least a portion (valve support 120) of the prosthetic heart valve (prosthesis 100) in the annulus (annulus AN) of the native valve (mitral valve) (paragraphs [0035, 0078-0079]); and
placing the septal anchoring element (either subsection of radially extending segment 105 near to posteromedial commissure PC OR supplemental support arms 146c, 146d near to posteromedial commissure PC) in contact with at least one of a native septal wall (posteromedial commissure PC) or a septal leaflet area to stabilize (anchor) the prosthetic heart valve (prosthesis 100) in the annulus (annulus AN) when the prosthetic heart valve (prosthesis 100) is seated in the annulus (annulus AN) (paragraphs [0039, 0044]).
With respect to claim 24:
Wherein the septal anchoring element (either subsection of radially extending segment 105 near to posteromedial commissure PC OR supplemental support arms 146c, 146d near to posteromedial commissure PC) stabilizes (assists in anchoring) the prosthetic heart valve (prosthesis 100) against at least one of intra-annular rolling forces or intra-annular twisting forces within the annulus (annulus AN) (the subsection of radially extending segment 105 near to posteromedial commissure PC OR supplemental support arms 146c, 146d near to posteromedial commissure PC both act to stabilize/ anchor the prosthesis 100 as a whole which would include any rolling forces or twisting forces within the annulus/ valve) (paragraphs [0039, 0044]).
With respect to claim 25:
Wherein the distal anchoring element (either subsection of radially extending segment 105 not near to posteromedial commissure PC OR support arm 142 OR one of supplemental support arms 146a-b, 148a-c) is at least one of a wire loop, a wire frame, a laser cut frame, an integrated frame section (part of a unitary structure), or a stent (paragraph [0049]),
the proximal anchoring element (either another subsection of radially extending segment 105 not near to posteromedial commissure PC OR support arm 142 OR another one of supplemental support arms 146a-b, 148a-c) is at least one of a wire loop, a wire frame, an integrated frame section (part of a unitary structure), or a stent (paragraph [0049]), and
the septal anchoring element (either subsection of radially extending segment 105 near to posteromedial commissure PC OR supplemental support arms 146c, 146d near to posteromedial commissure PC) is at least one of a wire loop, a wire frame, an integrated frame section (part of a unitary structure), or a stent (paragraph [0049]).
With respect to claim 26:
Wherein the native valve is a native mitral valve (mitral valve MV), the method further comprising:
placing the distal anchoring element (support arm 142) in a subannular position distal to the annulus (beneath the mitral valve and extending into the LVOT) (paragraph [0046]).
With respect to claim 27:
Wherein the native valve is a native tricuspid valve (tricuspid valve) (paragraphs [0034]), the method further comprising:
placing the distal anchoring element (support arm 142) in a right ventricular outflow track (RVOT) (paragraphs [0046, 0073]) (Note: when positioning the prosthetic heart valve (prosthesis 100) in the native tricuspid valve, the support arm (142) would be positioned in the same manner as that when implanted within mitral valve, such that the support arm (142) would be positioned within the RVOT).
With respect to claim 28:
Further comprising:
placing the proximal anchoring element (one of supplemental support arms 146a-b, 148a-c) in contact with proximal subannular tissue (tissue beneath the annulus of the valve) when the prosthetic heart valve (prosthesis 100) is seated in (positioned inside) the annulus (annulus AN) (paragraph [0044]).
With respect to claim 29:
Wherein placing the proximal anchoring element (one of supplemental support arms 146a-b, 148a-c) in contact with proximal subannular tissue (tissue beneath the annulus of the valve) includes transitioning the proximal anchoring element (one of supplemental support arms 146a-b, 148a-c) from a first configuration (in which the supplemental support arms 146a-b, 148a-c are expanded but have not assumed their final configuration as the valve support 120 is not in it’s final state, as can be seen in fig. 10C) to a second configuration (in which the supplemental support arms 146a-b, 148a-c are expanded and have assumed their final configuration as the valve support 120 also in it’s final state, as can be seen in fig. 10D) after the seating (positioning in) the prosthetic heart valve (prosthesis 100) in the annulus.
With respect to claim 31:
Further comprising:
advancing the prosthetic heart valve (prosthesis 100) in the compressed configuration (radially compressed delivery configuration) through the lumen of the delivery catheter (guide catheter) prior to releasing the prosthetic heart valve (prosthesis 100) (paragraph [0075]), the distal anchoring element (support arm 142 OR one of supplemental support arms 146a-b, 148a-c) being distal to the flow control component (prosthetic valve component 130) and the proximal anchoring element (a subsection of radially extending segment 105 not near to posteromedial commissure PC) being proximal to the flow control component (prosthetic valve component 130) during the advancing, as can be seen in fig. 9.
With respect to claim 32:
Wherein the valve frame (frame 110) includes a transannular region (valve support 120) comprising a plurality of wire cells (spaces defined by struts 128) having a geometry and orientation that allows the prosthetic heart valve (prosthesis 100) to be compressed along a central axis (longitudinal axis LA) (paragraphs [0035, 0051]), the flow control component (prosthetic valve component 130) configured to permit blood flow through the prosthetic heart valve (prosthesis 100) in a direction along the central axis (longitudinal axis LA) (paragraph [0042]).
With respect to claim 33:
Wherein the prosthetic heart valve (prosthesis 100) has a distal subannular portion (subsection of second end 127) that includes the distal anchoring element (support arm 142 OR one of supplemental support arms 146a-b, 148a-c) and a proximal subannular portion (a different subsection of second end 127) that includes the proximal anchoring element (the other of support arm 142 OR another one of supplemental support arms 146a-b, 148a-c), as can be seen in fig. 7.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 22-28, 32 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 20-25 of U.S. Patent No. 11234813. Although the claims at issue are not identical, they are not patentably distinct from each other because all the elements of the application claim(s) 22-28, 32 are to be found in patent claim(s) 20-25 (as the application claim(s) 22-28, 32fully encompass patent claim(s) 20-25). The difference between the application claim(s) 22-28, 32 and the patent claim(s) 20-25 lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim(s) 20-25 of the patent is in effect a “species” of the “generic” invention of the application claim(s) 22-28, 32. It has been held that the generic invention is “anticipated by the “species”. See In re Goodman, 29 USPQ 2d 2010 (Fed. Cir. 1993). Since application claim(s) 22-28, 32 is/are anticipated by claim(s) 20-25 of the patent, it is not patentably distinct from claim(s) 20-25 of the patent.
Claim from current application
Claim from 11,234,813
22
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Allowable Subject Matter
Claim(s) 30, 34-37 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and/ or 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 23:
Examiner can find no references alone nor in combination (other than that listed above in the double patenting rejection) which render obvious a method of deploying a prosthetic valve (as required by claim 22) wherein the prosthetic valve is side-delivered (such that when the prosthetic valve is compressed within the deliver catheter the longitudinal axis of the prosthetic heart valve is substantially orthogonal to the longitudinal axis of the delivery catheter (as required by claim 23). The aforementioned claimed feature is in direct conflict with the method of delivering the prosthesis (100), as disclosed by Quill et al. (as discussed above), which has the aforementioned auxesis aligned during delivery.
With respect to claim 30:
Examiner can find no references alone nor in combination which render obvious a method of deploying a prosthetic valve (as required by claims 22, 28, 29) wherein the proximal anchoring element is manipulated between the first and second configurations by a tensile member (as required by claim 30). The aforementioned claimed feature is in direct conflict with the method of delivering the prosthesis (100), as disclosed by Quill et al. (as discussed above), which is self-expanding (and the inclusion of additional manipulation members on the one of supplemental support arms (146a-b, 148a-c) would run the risk of tangling/ damage to the native tissues during and would therefore not be considered an obvious modification).
With respect to claim 34:
Examiner can find no references alone nor in combination which render obvious a method of deploying a prosthetic valve (as required by claims 22 and 33) wherein the proximal and distal anchoring elements are not inserted through the annulus at the same time (creating an angled delivery thru the annulus) (as required by claim 34). The aforementioned claimed feature is in direct conflict with the method of delivering the prosthesis (100), as disclosed by Quill et al. (as discussed above), which has the proximal and distal anchoring elements passing thru the annulus during the delivery at the same time (nor does there appear to be a justification for modification thereof).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774