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 .
Response to Amendment
Acknowledgment is made to the amendment received 1/13/2026 and 2/18/2026.
Response to Arguments
Applicant’s arguments with respect to claims 1, 11, 22, and 31 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Miles in view of Witzel, and claims 11, 22, and 31 were rejected under 35 U.S.C. 103 as being unpatentable over Engelman in view of Witzel. Now, based on amendments to the claim language, claims 1, 11, 22, and 31 are rejected under
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 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 limitations 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 limitations are: "a mechanism to actively increase the spacing" in claims 5 and 15; “a mechanism that actively decreases the spacing” in claim 10; “energy delivery mechanism” in claims 11 and 16; “a mechanism thereby decreasing the distance” in claim 19; “a mechanism to actively increase the spacing” in claim 25; “the mechanism thereby actively decreasing the spacing” in claim 28; “approximation mechanism configured to apply… a force” in claim 31; “energy delivery mechanism configured to deliver an energy modality” in claim 32; and “approximation mechanism” in claim 44.
"A mechanism to actively increase the spacing" is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“A mechanism that actively decreases the spacing” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“Energy delivery mechanism” is seen as an electrode in the specification ([0048]), or an equivalent thereof.
“A/the mechanism thereby decreasing the spacing” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“A mechanism actively increasing the spacing” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“Approximation mechanism configured to apply a force” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
“Approximation mechanism” is seen as a linkage connecting the engagement, a worm gear or a pull-wire in the specification ([0034]-[0035] and [0053]), or an equivalent thereof.
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 limitations 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 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.
Claims 1-42 and 44 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.
Regarding claims 1, 11, 22, 31, and 44, the claims recite “applying, based on a desired amount of shrinkage, an approximating force to at least one of the electrodes in an approximating direction counter to the direction of the naturally occurring tension to thereby reduce the naturally occurring tension without compressing oppositely facing surfaces of the cardiac valve annulus”, “applying, based on a desired amount of shrinkage, an approximating force to at least one of the engagement members in an approximating direction counter to a direction of a naturally occurring tension of the cardiac tissue to reduce the naturally occurring tension of the cardiac tissue between the engagement members without compressing oppositely facing surfaces of the cardiac tissue”, “applying, based on a desired length of shrinkage, an approximating force to at least one of the engagement members to reduce a naturally occurring tension of the cord segment in a direction of the length of the cord segment without compressing the thickness of the cord segment between the engagement members”, “wherein the approximating force is configured to counter a direction of a naturally occurring tension of cardiac tissue between the engagement members to reduce the naturally occurring tension of cardiac without compressing oppositely facing surfaces of the cardiac tissue”, and “wherein the approximating force counters a naturally occurring tension of the cardiac tissue between the engagement members to reduce the naturally occurring tension of the cardiac tissue without compressing oppositely facing surfaces of the cardiac tissue”, respectively. However, there does not appear to be support in applicant’s disclosure for the negative limitation “without compressing oppositely facing surfaces of the cardiac tissue”. Paragraph [0047] of applicant’s specification states “The desired shrinkage may be in a circumferential direction (e.g., around the cardiac valve annulus), or it may be in another direction.” This direction could be oppositely facing surfaces of the cardiac tissue. Also, Figure 4D in applicant’s disclosure depicts the electrodes moving around the circumference of an annulus, compressing tissue around the circumference. If the electrodes continue to move around the circumference of the annulus, eventually, the whole circumference of the annulus will be compressed. Therefore, the opposite facing surface of each site of compression and ablation will be compressed. Thus, there does not appear to be support for the negative limitation “without compressing oppositely facing surfaces of the cardiac tissue” in applicant’s disclosure and therefore, claims 1, 11, 22, 31, and 44 are rejected under 35 U.S.C. 112(a).
Regarding dependent claims 2-10, 12-21, 23-30, and 32-42, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(a).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm ESTEST.
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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