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 .
Restriction/Election
Applicant’s election without traverse of claims 1-8 in the reply filed on 06/04/2026 is acknowledged. Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“a coaptation element” in claim 5.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Basude et al. US 20200383782 A1, herein referred to as Basude, in view of Wei et al. WO 2016099650 A1, herein referred to as Wei.
Regarding claim 1, Basude discloses a sensing valve repair device (Fig 70; see annotated figure below) comprising: a pair of inner paddles (13,191,195/15,197,193); a pair of outer paddles (102/101) connected to the pair of inner paddles (Fig 34 shows connection via 176/177); a pair of clasps (12,192/14,194), each clasp having a fixed arm (see annotated Figure 70 below) attached to one of the pair of inner paddles (see annotated Fig 70 below), a movable arm (125/126), and a hinge portion (283) connecting the movable arm to the fixed arm (Fig 70); and a sensor ([0476]).
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However, Basude does not explicitly disclose a pair of sensors wherein each sensor of the pair of sensors is attached to one or more of one the fixed arms.
Additionally, in the same field of invention, Wei discloses a similar sensing valve repair device (Fig 9a-b) comprising; inner (402) and outer paddles (18’), a pair of clasps (416), each clasp having a fixed arm (74’) attached to one of the pair of inner paddles. Wei teaches a pair of sensors wherein each sensor of the pair of sensors is attached to one or more of one the fixed arms of the pair of clasps and one of the pair of inner paddles ([0091]; Wei teaches attaching on each side).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Basude incorporate a pair of sensors wherein each sensor of the pair of sensors is attached to one or more of one the fixed arms, as taught and suggested by Wei in order to aid in device placement (Wei [0091]).
Regarding claim 2, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the sensor is configured to sense one or more of pressure, capacitance, and inductance (Basude ([00483).
Regarding claim 3, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally wherein at least a portion of each sensor is disposed in a space between the movable arm and the fixed arm of one of the pair of clasps (Wei [0091]).
Regarding claim 4, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein at least a portion of each sensor is closer to the hinge portion than a free end of the movable arm of one of the pair of clasps (Wei Fig 9a; [0091).
Regarding claim 5, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches a coaptation element (this element is interpreted under 112(f) as a “spacer, coaption element, gap filler” or “spacer, plug, filler, foam, sheet, membrane”, see [0089] and [0096] of the instant application, and equivalents thereof; Basude Fig 30,70) attached to the pair of inner paddles.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basude, in view of Wei, and in further view of Charthad WO 2020210490 A1 et al., herein referred to as Charthad.
Regarding claim 6, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not explicitly disclose further comprising a transmitter configured to a transmit sensed data from at least one of the pair sensors to a receiver.
However, in the same field of invention, Charthad discloses a similar heart repair sensor ([0017] and [0022]). Further, Charthad teaches a transmitter (Fig 3, 334) configured to a transmit sensed data from at least one of the pair sensors to a receiver (Fig 3, 338; [0078).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Basude as modified by Wei and incorporate a transmitter configured to a transmit sensed data from at least one of the pair sensors to a receiver, as taught by Charthad, in order to allow analyzing of physiological data (Charthad [0127]).
Regarding claim 7, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 5, but does not explicitly disclose a ventricular pressure sensor disposed at a distal end of the device and an atrial pressure sensor disposed at a proximal end of the device.
However, in the same field of invention, Charthad discloses a similar heart repair sensor ([0017] and [0022]). Further, Charthad teaches a ventricular pressure sensor and an atrial pressure sensor (Charthad teaches measure both ventricular and atrial pressure changes [0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Basude as modified by Wei and include a ventricular pressure sensor disposed at a distal end of the device and an atrial pressure sensor disposed at a proximal end of the device, as suggested by Charthad, as doing so would have yielded predictable results, namely provided providing sensing to both areas of the heart.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Basude in view of Wei, and further in view of Metchik al. US 20190209297 A1, herein referred to as Metchik.
Regarding claim 8, Basude as modified by Wei discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the sensing valve repair device is configured for implantation within a mitral valve.
Metchik discloses a similar sensing valve repair device. Metchik teaches wherein the sensing valve repair device is configured for implantation within a mitral valve (Metchik Fig 14b [0028]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Basude as modified by Wei to be configured for implantation within a mitral valve, as taught and suggested by Metchik, in order monitor leaflet condition in the mitral valve (Metchik [0091]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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