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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/10/2026 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 18 and 20 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 18 recites the limitation "the fluid blocking material" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 20 recites the limitation "the expandable frame" in line 11. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
Claim(s) 1-5, 10-15 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowe et al. (US 2017/0056176).
Rowe discloses (see Fig. 13) a system and method for treating mitral valve insufficiency comprising the following claim limitations:
(claim 1) A device for blocking regurgitant blood flow into first and second pulmonary vein openings in a left atrium of a heart (see Abstract and Fig. 13), comprising: an expandable docking station (104, Fig. 13) ([0056]; [0058]-[0059]; docking station 104 expressly disclosed as a self-expanding Nitinol frame that is delivered within a delivery catheter) installed in the left atrium of the heart (as shown in Fig. 13); at least one valve (106, Fig. 13) retained in a docking portion of the docking station (104) (as shown in Fig. 13), the at least one valve (106) having an open configuration and a closed configuration ([0058]-[0059]; valve 106 expressly one-way flow of blood in an open configuration and minimizes and prevents mitral regurgitation in its closed configuration), wherein the docking station (104) is configured to (i.e., capable of) hold the at least one valve (106) in the left atrium between the first and second pulmonary vein openings and a mitral valve of the heart (as shown in Fig. 13); a fluid blocking material (108, Fig. 13) secured to the docking station (104) and configured to (i.e., capable of) surround the first and second pulmonary vein openings and provide a fluid seal around the at least one valve (106) (as shown in Fig. 13; [0059]); wherein the device is configured such that the open configuration of the at least one valve (106) permits blood to flow from a pulmonary vein into the left atrium and to the mitral valve when the pulmonary vein closure device is deployed in the left atrium (as shown in Fig. 13; [0058]-[0059]; valve 106 expressly helps regulate the flow of blood between the left atrium and the left ventricle in an open configuration); and wherein the device is configured such that the closed configuration of the at least one valve (106) blocks regurgitant blood flow through the mitral valve into the first and second pulmonary vein openings when the device is deployed in the left atrium (as shown in Fig. 13; [0058]-[0059]; valve 106 expressly prevents mitral regurgitation in its closed configuration);
(claim 2) wherein the docking station (104) is expandable into conforming engagement with the left atrium (as shown in Fig. 13; [0056]; [0058]-[0059]; docking station 104 expressly disclosed as a self-expanding Nitinol frame that is delivered to the left atrium within a delivery catheter and comprises flange 108 that engages and seals against the left atrium wall);
(claim 3) wherein the docking station (104) comprises one or more of a ring and a stent (as shown in Fig. 13; [0056]; docking station 104 is a stent having a ring configuration);
(claim 4) wherein the docking station (104) is configured to be (i.e., capable of) secured in the left atrium by friction fit (as shown in Fig. 13; [0059]; flange 108 of the docking station 104 flexes and is the sole contact point to hold the device in position while further providing a fluid seal against the left atrium wall);
(claim 5) wherein the docking station (104) is configured to be (i.e., capable of) secured to an inner wall of the left atrium spaced apart from the first and second pulmonary vein openings (as expressly shown in Fig. 13; [0058]-[0059]; docking station 104 are expressly disclosed between all pulmonary vein openings and the native mitral valve to regulate one-way flow of blood through the prosthetic valve and mitral valves in an open configuration and minimize and prevent mitral regurgitation in its closed configuration);
(claim 10) wherein the fluid blocking material (108) is configured to (i.e., capable of) surround third and fourth pulmonary vein openings in the left atrium of the heart (as shown in Fig. 13), such that the closed configuration of the at least one valve (106) blocks regurgitant blood flow through the mitral valve into the first, second, third and fourth pulmonary vein openings when the device is deployed in the left atrium (as expressly shown in Fig. 13; [0058]-[0059]; docking station 104 are expressly disclosed between all pulmonary vein openings and the native mitral valve to regulate one-way flow of blood through the prosthetic valve and mitral valves in an open configuration and minimize and prevent mitral regurgitation in its closed configuration);
(claim 11) A method of implanting a device for blocking regurgitant flow into first and second pulmonary vein openings of a heart (see Abstract and Fig. 13), the method comprising: advancing a docking station (104, Fig. 13) in an unexpanded condition into a left atrium of the heart (see Figs. 13; [0056]; [0058]-[0059]; docking station 104 expressly delivered to left atrium within a delivery catheter); expanding the docking station (104) in the left atrium to position the docking station (104) in the left atrium between the first and second pulmonary vein openings and the mitral valve (as shown in Fig. 13; [0056]; [0058]-[0059]; docking station 104 expressly disclosed as a self-expanding Nitinol frame that is delivered to the left atrium within a delivery catheter); advancing at least one valve (106, Fig. 13) in an unexpanded condition into the docking station (104) ([0056]; [0058]-[0059]; valve 106 expressly can delivered in a catheter separate from and after delivery of the docking station 104); expanding the at least one valve (106) into a docking portion of the docking station (104) (as shown in Fig. 13; [0058]-[0059]; expandable valve 106 expressly can delivered within a catheter for deployment/expansion into the docking station 104); wherein the at least one valve (106) is configured to (i.e., capable of) move to an open configuration permitting blood to flow from the first and second pulmonary vein openings into the mitral valve during diastole (as shown in Fig. 13; [0058]-[0059]; valve 106 expressly helps regulate the flow of blood between the left atrium and the left ventricle in an open configuration); and wherein the at least one valve (106) is configured to (i.e., capable of) move to a closed configuration blocking regurgitant blood flow through the mitral valve into the first and second pulmonary vein openings during systole (as shown in Fig. 13; [0058]-[0059]; valve 106 expressly prevents mitral regurgitation in its closed configuration);
(claim 12) further comprising providing fluid blocking material (108, Fig. 13) secured to the docking station (104) to provide a fluid seal around the at least one valve (106) (as shown in Fig. 13; [0059]);
(claim 13) wherein expanding the docking station (104) in the left atrium comprises expanding the docking station (104) into conforming engagement with the left atrium (as shown in Fig. 13; [0056]; [0058]-[0059]; docking station 104 expressly disclosed as a self-expanding Nitinol frame that is delivered to the left atrium within a delivery catheter and comprises flange 108 that engages and seals against the left atrium wall);
(claim 14) wherein expanding the docking station (104) in the left atrium comprises securing the docking station (104) in the left atrium by friction fit (as shown in Fig. 13; [0059]; flange 108 of the docking station 104 flexes and is the sole contact point to hold the device in position while further providing a fluid seal against the left atrium wall);
(claim 15) wherein expanding the docking station (104) in the left atrium comprises securing the docking station (104) to an inner wall of the left atrium spaced apart from the first and second pulmonary vein openings (as expressly shown in Fig. 13; [0058]-[0059]; docking station 104 are expressly disclosed between all pulmonary vein openings and the native mitral valve to regulate one-way flow of blood through the prosthetic valve and mitral valves in an open configuration and minimize and prevent mitral regurgitation in its closed configuration); and
(claim 19) wherein expanding the docking station (104) in the left atrium positions the docking station (104) in the left atrium between third and fourth pulmonary vein openings and the mitral valve (as shown in Fig. 13; [0059]), such that the closed configuration of the at least one valve (106) blocks regurgitant blood flow through the mitral valve into the first, second, third and fourth pulmonary vein openings (as expressly shown in Fig. 13; [0058]-[0059]; docking station 104 are expressly disclosed between all pulmonary vein openings and the native mitral valve to regulate one-way flow of blood through the prosthetic valve and mitral valves in an open configuration and minimize and prevent mitral regurgitation in its closed configuration); and
(claim 20) A system comprising: a device for blocking regurgitant blood flow into first and second pulmonary vein openings in a left atrium of a heart (see Abstract and Fig. 13), comprising: an expandable docking station (104, Fig. 13) ([0056]; [0058]-[0059]; docking station 104 expressly disclosed as a self-expanding Nitinol frame that is delivered within a delivery catheter) including a docking portion configured to (i.e., capable of) retain at least one valve (106, Fig. 13), wherein the docking station (104) is configured to (i.e., capable of) hold the at least one valve (106) in the left atrium between the first and second pulmonary vein openings and a mitral valve of the heart (as shown in Fig. 13); and a fluid blocking material (108, Fig. 13) secured to the docking station (104) and configured to (i.e., capable of) surround the first and second pulmonary vein openings and provide a fluid seal around the at least one valve (106) (as shown in Fig. 13; [0059]); and a delivery tube (i.e., delivery catheter) configured to (i.e., capable of) retain the expandable frame (104) in an unexpanded condition; and wherein the delivery tube (i.e., delivery catheter) is configured to (i.e., capable of) deploy the expandable docking station (104) in the left atrium of the heart (see Fig. 13; [0056]; [0058]-[0059]; docking station 104 expressly disclosed as a self-expanding Nitinol frame that is delivered to the left atrium within a delivery catheter).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe as applied to claims 1 and 11 above, and further in view of Schweich, Jr. et al. (US 2017/0095327).
Rowe, as applied above, discloses a system and method for treating mitral valve insufficiency comprising all the limitations of the claim except for the at least one valve comprising a plurality of valves.
However, Schweich teaches (see Figs. 25-26) a similar prosthetic valve system and method for treating mitral regurgitation comprising a plurality of valves (410, Figs. 25-26; dual valve assembly expressly taught). Accordingly, Schweich teaches that it is known that single valve assemblies and dual valve assemblies are elements that are functional equivalents for providing one-way blood flow from the left atrium to the left ventricle while preventing mitral regurgitation (see Fig. 25-26; [0022]-[0023]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the dual valve assembly taught by Schweich for the single valve assembly of Rowe because both elements were known equivalents for providing one-way blood flow from the left atrium to the left ventricle while preventing mitral regurgitation within the prosthetic valve art. The substitution would have resulted in the predictable results of providing one-way blood flow from the left atrium to the left ventricle while preventing mitral regurgitation to the device of Rowe.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rowe as applied to claim 1 above, and further in view of Chambers (US 2018/0042719).
Rowe, as applied above, discloses a system and method for treating mitral valve insufficiency comprising all the limitations of the claim except for a dome shaped support secured to the docking station and occupying an upper portion of the left atrium to hold the at least one valve in position in the left atrium.
However, Chambers teaches (see Fig. 12) a similar device and method for preventing mitral regurgitation comprising a dome shaped support (200/300, Fig. 12) secured to the docking station (100, Fig. 12) and occupying an upper portion of the left atrium to hold the at least one valve in position in the left atrium (see Fig. 12; [0071]; [0078]-[0081]) in order to beneficially assist in transmission of axial force to the atrial dome and distributed therearound the dome to assist in anchoring within the left atrium ([0071]; [0078]-[0081]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Rowe to have a dome shaped support secured to the docking station and occupying an upper portion of the left atrium to hold the at least one valve in position in the left atrium in order to beneficially assist in transmission of axial force to the atrial dome and distribute forces around the dome to assist in anchoring within the left atrium, as taught by Chambers.
Claim(s) 8-9 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe as applied to claims 1 and 11 above, and further in view of Chau et al. (US 2011/0112632).
Rowe, as applied above, discloses a system and method for treating mitral valve insufficiency comprising all the limitations of the claim except for first and second anchoring portions connected to the docking station and installed/configured to be installed in the first and second pulmonary vein openings, and the fluid blocking material forms a connecting piece between the first and second anchoring portions and the docking station.
However, Chau teaches (see Fig. 8) a similar device and method for implanting a prosthetic mitral valve with pulmonary vein anchoring comprising first and second anchoring portions (146, Fig. 8) connected to the docking station (144, Fig. 8) and installed/configured to be installed in the first and second pulmonary vein openings (61, Fig. 8), and the fluid blocking material (150, Fig. 8) forms a connecting piece (142, Fig. 8) between the first and second anchoring portions (146) and the docking station (144) (as shown in Fig. 8; [0063]) in order to beneficially enhance and improve device anchoring by utilizing the natural anatomy of the patient's heart in order to resist against upward migration of the valve assembly (see Abstract; [0015]; [0063]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Rowe to have first and second anchoring portions connected to the docking station and installed/configured to be installed in the first and second pulmonary vein openings, and the fluid blocking material forms a connecting piece between the first and second anchoring portions and the docking station in order to beneficially enhance and improve device anchoring by utilizing the natural anatomy of the patient's heart in order to resist against upward migration of the valve assembly, as taught by Chau.
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 1-7, 10-12 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11 and 15-20 of U.S. Patent No. 12,245,756. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 12,245,756
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1-9,15-20
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1-9,15-20
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15-20
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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