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 3/26/2026 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 § 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) 12-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Powell et al. (US 2006/0229708) in view of Dubi et al. (US 2010/0022821).
Powell discloses (see Fig. 29) methods and systems for cardiac valve repair comprising the following claim limitations:
(claim 12) A method for treating a heart valve (see Abstract), the method comprising: introducing a delivery system holding a papillary muscle manipulation device (2910, Fig. 29) into a ventricle of a heart (see Abstract and claims 11 and 14; see exemplary Figs. 21-25 for left ventricle delivery; [0009]; [0128]-[0132]), the papillary muscle manipulation device (2910) including a spring (at 2910) (see annotated Fig. 29 below; [0135]), a first arm (see annotated Fig. 29 below; [0135]), and a second arm (see annotated Fig. 29 below; [0135]), the first arm and the second arm projecting from the spring (2910) at a relative angle (Fig. 29 depicts a 180 degree angle with the spring 2910 under tension), the spring (2910) positioned at an apex of the papillary muscle manipulation device (as expressly shown in Fig. 29); deploying the papillary muscle manipulation device (2910) from the delivery system into the ventricle (as shown in exemplary Figs. 21-25 and 29; [0135]); and applying spring tension in the spring (2910) to the first arm and the second arm to cause the first arm and the second arm to reshape ventricular anatomy of the heart (as shown in Fig. 29; [0135]; spring biasing force between papillary muscles is expressly disclosed);
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(claim 13) wherein the first arm and the second arm each have a sleeve covering, the sleeve covering comprising at least one of cloth or polymer ([0135]; fabric spring sleeve covering expressly disclosed);
(claim 16) A method for treating a heart valve (see Abstract), the method comprising: introducing a delivery system holding a papillary muscle manipulation device (2910, Fig. 29) into a ventricle of a heart (see Abstract and claims 11 and 14; see exemplary Figs. 21-25 for left ventricle delivery; [0009]; [0128]-[0132]), the papillary muscle manipulation device (2910) including: a spring (at 2910) (see annotated Fig. 29 below; [0135]); a first arm that emanates from a first end of the spring (2910) (see annotated Fig. 29 below; [0135]); and a second arm that emanates from a second end of the spring coil (2910) (see annotated Fig. 29 below; [0135]); deploying the papillary muscle manipulation device (2910) from the delivery system between a first papillary muscle (i.e., “left” PM in Fig. 29) and a second papillary muscle (i.e., “right” PM in Fig. 29) within the ventricle (as shown in Fig. 29); securing the first arm to first papillary muscle anatomy associated with the first papillary muscle (as shown in Fig. 29; [0135]); securing the second arm to second papillary muscle anatomy associated with the second papillary muscle (as shown in Fig. 29; [0135]); and using spring force of the spring (2910) to draw the first arm and the second arm together to thereby draw the first and second papillary muscles together (as shown in Fig. 29; [0135]; spring biasing force between papillary muscles is expressly disclosed);
(claim 17) wherein securing the first arm to the first papillary muscle anatomy involves puncturing the first papillary muscle anatomy with a free end of the first arm (as expressly shown in Fig. 29; [0135]; barbed ends shown puncturing first and second papillary muscles);
(claim 18) further comprising creating a torsion force on the first arm and the second arm using the spring (2910) when the first arm and the second arm are secured to the first and second papillary muscle anatomy (PM), respectively (as expressly shown in Fig. 29; [0135]; biasing force/tension applied to the first and second arms expressly disclosed);
(claim 19) wherein the spring (2910), the first arm, and the second arm are formed of a single unitary wire (as expressly shown in Fig. 29); and
(claim 20) wherein deploying the papillary muscle manipulation device (2910) involves placing the spring (2910) at an internal apex region of the ventricle (as shown in Fig. 29).
Powell, as applied above, discloses methods and systems for cardiac valve repair comprising all the limitations of the claim wherein the use of different springs is further expressly disclosed ([0135]). However, Powell fails to expressly disclose the spring being a spring coil and having a biased U-shape or V-shape.
Dubi teaches (see Fig. 3A) a similar method and system for cardiac valve repair comprising a spring coil (30) having a biased V-shape (at 13a, see Fig. 3A) (see claim 2; [0017]; [0025]; [0080]). Accordingly, Dubi teaches that it is known that a spring coil having a biased V-shape and a semicircular spring having a U-shape are elements that are functional equivalents for providing a biasing force to reshape/repair ventricular anatomy and function in a heart of a patient. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the spring coil having a biased V-shape taught by Dubi for the semicircular spring having a U-shape of Powell because both elements were known equivalents for providing a biasing force to reshape/repair ventricular anatomy and function in a heart of a patient. The substitution would have resulted in the predictable results of providing a biasing force to reshape/repair ventricular anatomy and function in a heart of a patient to the device of Powell.
Allowable Subject Matter
Claims 1-11 are allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a method for treating a heart valve as claimed that includes, in combination with the claim(s) as a whole, a spring coil having first and second arms including the steps of wrapping the first arm around first papillary muscle anatomy and wrapping the second arm around second papillary muscle anatomy. The closest prior art appears to be Powell et al. (US 2006/0229708) disclosing methods and systems for cardiac valve repair using different springs, but failing to disclose or teach a spring coil having first and second arms including the steps of wrapping the first arm around first papillary muscle anatomy and wrapping the second arm around second papillary muscle anatomy.
Claims 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see Rafiee et al. (US 2007/0078297) teaching spring coils with opposed arms for providing torsion/tension within the left ventrer5icle to treat valve regurgitation (see Figs. 1-2 and 7-8).
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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