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 .
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 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 2, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation - 35 USC § 112
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“torque biasing device” in claim 7; and
“tissue gripping structure” in claim 8.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them 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.
Claim 5 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.
Claim 5 recites the limitation “said four-hinge mechanism” in line 2. There is insufficient antecedent basis for this limitation in the claim because the claim lacks a prior reference to such a mechanism, thus rendering the claim indefinite.
Claim Rejections - 35 USC § 103
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.
Claims 1-8, 10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Spector et al. (U.S. Patent Application Publication No. 20220313303; hereinafter “Spector”) in view of Podmore et al. (U.S. Patent Application Publication No. 20220183714; hereinafter “Podmore”).
Regarding claim 1, Spector discloses a heart valve tissue cutting device (100; Figs. 14-18) comprising:
a housing (157) formed with an elongate opening (159; Figs. 14E-14H);
a cutting guide arm (124) pivoted to said housing by a hinge assembly (Figs. 14, 14F-15), said cutting guide arm being formed with a guide slot (e.g., the lumen formed by the tubular shape of blade protector (124); Fig. 18; para. [0086]); and
a cutting element (136) comprising a cutting blade (136) and a stabbing element (137; Figs. 14A-14B), said cutting element being arranged to move on a track structure in said housing (Fig. 14C; para. [0082]); wherein a sharp pointed end of said stabbing element points towards said cutting guide arm (Figs. 16-18), and wherein said cutting blade is arranged, when in a deployed position, to pass through said guide slot (Fig. 18; para. [0091]).
The device of Spector is not explicitly disclosed with a sharp pointed end of the stabbing element being tilted with respect to the cutting blade.
Podmore, a reference in the transcatheter tissue modification device field of endeavor, teaches configuring the sharp pointed end of a stabbing element (1403) to be tilted with respect to a cutting blade (1401; figs. 13B-13D) to prevent snagging tissue during a procedure and facilitate slicing tissue (para. [0110]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the sharp pointed end of said stabbing element to be tilted with respect to said cutting blade, in view of Podmore, to facilitate cutting tissue and preventing the blade from snagging tissue during a procedure.
Regarding claim 2, the modified device discloses wherein said cutting blade and said stabbing element are tilted with respect to said cutting guide arm at different angles from each other (e.g., Spector discloses the cutting blade (136) being at an angle to the cutting guide arm (124; Figs. 16-18) and Podmore discloses the stabbing element (1403) being tilted with respect to the guide arm (Figs. 13B-13D) at different angles).
Regarding claim 3, Spector discloses wherein said hinge assembly comprises a four-hinge mechanism (Fig. 14F; para. [0084]).
Regarding claim 4, Spector discloses wherein a blade protector rib (107) is pivoted to said cutting guide arm (e.g., via pivot connections with guiding structure (116); Figs. 14C-114H; paras. [0082]-[0086]).
Regarding claim 5, Spector discloses wherein when said cutting guide arm is pivoted outwards, a portion of said four-hinge mechanism passes through said guide slot (Figs. 15-18; paras. [0088]-[0091]).
Regarding claim 6, Spector discloses wherein said cutting guide arm is constructed of first and second concentric semi-tubular elements (e.g., the inner tubular surface and outer tubular surface of blade protector (124); Fig. 16; para. [0086]).
Regarding claim 7, Spector discloses wherein a torque biasing device (biasing device (150) meets or is an equivalent of the corresponding structure described in the specification as performing the claimed function) is positioned at a link member of said four-hinge mechanism to deploy said cutting guide arm from a collapsed position to a deployed position (Fig. 14C; para. [0084]).
Regarding claim 8, Spector discloses wherein said cutting guide arm comprises tissue gripping structure (edges of blade protector (124) contact and grip leaflet tissue (Figs. 15-18) meet or are an equivalent of the corresponding structure described in the specification as performing the claimed function) for gripping tissue during cutting of the tissue (Figs. 7A-9E; paras. [0053]-[0061]).
Regarding claim 10, Spector discloses wherein said cutting guide arm comprises a semi-tubular, U-shaped structure (Figs. 14-18; para. [0086]).
Regarding claim 12, Spector discloses a method for cutting heart valve tissue comprising using the device of claim 1 to grasp a leaflet between said cutting guide arm and said housing (Figs. 7A-9E), and while the leaflet is grasped, moving the cutting element to cut the leaflet (para. [0091]).
Regarding claim 13, the modified invention discloses wherein said stabbing element punctures the leaflet and forms a starting point for said cutting blade to pass through and cut the leaflet (Podmore; para. [0110]).
Regarding claim 14, the modified invention discloses wherein said stabbing element prevents the leaflet from sliding off the cutting blade (Podmore; para. [0110]).
Regarding claim 15, Spector discloses wherein the leaflet is sandwiched between said cutting element and said cutting guide arm, with said cutting guide arm acting as an anvil (para. [0007], [0090]-[0091]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Spector and Podmore, as applied to claim 8 above, and further in view of Caffes et al. (U.S. Patent Application Publication No. 2020/0093478; hereinafter “Caffes”).
Examiner notes that claim 9 recites sufficient structure for the claimed tissue gripping structure (i.e., saw tooth edge) for performing the function of tissue gripping. Thus, the limitation “tissue gripping structure” in claim 9 is not interpreted under 35 USC 112(f).
Regarding claim 9, the modified device discloses the invention substantially as claimed, except for the tissue gripping structure including a saw tooth edge.
Caffes, a reference in the transcatheter tissue modification device field of endeavor, teaches providing a tissue gripping structure (106) with a saw tooth edge (112; Fig. 2A) to enhance the griper’s ability to retain a valve leaflet (para. [0030]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide tissue gripping structure with a saw tooth edge, in view of Caffes, to facilitate gripping and retaining a valve during a procedure.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Spector and Podmore, as applied to claim 1 above, and further in view of Childs et al. (U.S. Patent Application Publication No. 20210346081; hereinafter “Childs”).
Regarding claim 11, the modified device discloses the invention substantially as claimed, except for the cutting element including an electric cutting element.
Childs, a reference in the transcatheter tissue modification device field of endeavor, teaches configuring a cutting element to be an electric cutting element to facilitate cutting leaflet tissue (para. [0044]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the cutting element to include an electric cutting element, in view of Childs, in order to facilitate cutting leaflet tissue to treat a patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Metchik et al. (U.S. Patent No. 10238493) disclosing a valve repair device having a barbed portion (Figs. 51A-51E);
Paul et al. (U.S. Patent No. 8398663) disclosing a valvulotome device having multiple blades (Figs. 16-17).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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