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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
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.
Status of the Claims
Claim(s) 1-20 is/are pending. Claim(s) 15-20 is/are withdrawn.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 9/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/10/2025.
Product By Process
The Examiner recognizes claims 6-7 and 11-13 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claims see Table I below require the see Table I below to comprise the following structural elements in addition to those in the claims from which they depend: see Table I below.
Table I: Product-by-Process Language
Claim
Product-by-Process Language
Structure Imparted to the Final Product in addition to remaining structures claimed
6
at least one of the sliders is electropolished
a slider surface having the friction-reducing coating thereon
7
the slider screw … is anodized
an oxide layer on the slider screw
11
the anchor housing is smoothed
an anchor housing with the friction-reducing coating thereon
12
the anchor housing is tumbled
an anchor housing with the friction-reducing coating thereon
13
the coated surface … has not been subjected to a pre-treatment process recommended for acceptance of the … coating
an anchor housing with the friction-reducing coating thereon
In the prior art rejection in this Office action, Examiner considers claims 6-7 and 11-13 to be met when a reference teaches these structural limitations.
Claim Interpretation - 35 USC § 112, 6th paragraph
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
Claim limitation “see Table II below” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “see Table II below” coupled with functional language “see Table II below” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. see Table II below.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) see Table II below has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: see Table II below.
Table II: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
From the Specification
1
components
movable
[0006] at least one slider and associated slider screw extending through the slider
[0007] at least one anchor moveable with respect to the frame member
3
structure
mounting
[0006] part of the slider screw
[0043] #324, couples the frame to hold the screw axially along A
[0043] substantially barbell-shaped & within the window
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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: see Table III below in claim see Table III below.
Table III: Language Not Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
From the Specification
2
components
movable
at least one of a slider and associated slider screw
10
components
movable
at least one anchor
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 § 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 1-14 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 1, line 4 recites the limitation "the shape". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a shape”.
Claim 2, line 2 recites “the plurality of movable components include at least one slider and associated slider screw extending through the slider”. It is unclear if the plurality of components includes at least one slider and then the slider screw is in addition to the plurality of movable components or if the plurality of movable components include both the at least one slider and the slider screw. For purposes of examination the Examiner considers this language to be met when the plurality includes the at least one slider.
Claim 2, line 5 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1 or a separate coating. For purposes of examination the Examiner considers this language to be “the friction-reducing coating”.
Claim 3, line 10 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1, claim 2, or a separate coating. For purposes of examination the Examiner considers this language met when there is a friction-reducing coating on the slider neck.
Claim 4, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1, claim 2, claim 3, or a separate coating. For purposes of examination the Examiner considers this language to be met when the slider has a friction-reducing coating.
Claim 5, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1, claim 2, claim 3, claim 4, or a separate coating. For purposes of examination the Examiner considers this language to be met when there is a friction-reducing coating on the internal threads of the slider.
Claim 6, lines 1-2 recites “at least one of the sliders”, while claim 1 introduces this limitation as “at least one slider”. Claim 1 includes one slider, while claim 6 excludes this option. Therefore, it is unclear how many sliders are intended to be claimed. For purposes of examination the Examiner considers this language to be “at least one of the at least one sliders”.
Claim 6, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1, claim 2, or a separate coating. For purposes of examination the Examiner considers this language to be met when the slider(s) has/have a friction-reducing coating.
Claim 7, lines 1-2 recite “a slider screw”. It is unclear if this is the same or a different slider screw than introduced earlier in claim 2, from which claim 7 depends. For purposes of examination the Examiner considers this language to be “the slider screw”.
Claim 7, line 2 and Claim 8, line 2 and Claim 9, line 2 each recites “the at least one slider”. It is unclear if this refers to that introduced in claim 1 or in claim 6.
Claim 8, lines 1-2 recites “the slider screw”. It is unclear if this instance is referencing the slider screw introduced earlier in either or both of claims 2 and 7. The Examiner notes if the related issue in claim 7 is address as noted supra, then this rejection would become moot.
Claim 8, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1, claim 2, or a separate coating. For purposes of examination the Examiner considers this language to be met when there is a friction-reducing coating on a slider.
Claim 9, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1, claim 2, or a separate coating. For purposes of examination the Examiner considers this language to be met when there is a friction-reducing coating on a slider.
Claim 10, lines 5-6 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1 or a separate coating. For purposes of examination the Examiner considers this language to be met when there is a friction-reducing coating on an anchor housing.
Claim 10, lines 2-3 require “the plurality of movable components include at least one anchor movable with respect to the frame member”, while claim 1 also requires the movable components “adjust the shape of the frame”. It is unclear how the anchors are able to adjust the shape of the frame as they go through openings to anchor the device into tissue. For purposes of examination the Examiner considers this language to be met when the overall plurality of movable components performs the shape adjustment and/or when the anchors hold the final shape of the device in place within the implant site, which is consistent with Applicant’s specification (e.g. Applicant’s Figure 1).
Claim 11, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1 or a separate coating. For purposes of examination the Examiner considers this language to be met when there is a friction-reducing coating on an anchor housing.
Claim 12, line 2 recites “a friction-reducing coating”. It is unclear if this is the same coating as introduced in claim 1 or a separate coating. For purposes of examination the Examiner considers this language to be met when there is a friction-reducing coating on an anchor housing.
Claim 13, lines 1-2 recites the limitation "the coated component". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “the at least one portion of the surface of the one of the plurality of movable components having the friction-reducing coating”.
Claim 14, line 3 recites “recommended”. It is unclear what the bounds of an unknown recommendation are.
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.
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.
Functional language and intended use language is presented in italicized font.
Claim(s) 1-6 and 9-14 is/are rejected under 35 U.S.C.103 as being unpatentable over Lashinski, et al (Lashinski) (US 2016/0015513 A1) in view of Finley (US 2008/0057298 A1).
Regarding Claim 1, Lashinski teaches an implantable annuloplasty device (e.g. abstract, Figures 6D, 6I) comprising:
a frame member (e.g. Figures 6D, 6I; portion shown in 6F, top); and
a plurality of movable components (e.g. Figures 6D, #s 630/634/635) and 6I, #s 670/671/673; [0010], rotatable anchors) movable with respect to the frame member to adjust the shape of the frame member (e.g. [0089]; [0099]; [0010], rotatable anchors rotate relative to the frame during engagement with the tissue).
Lashinski discloses the invention substantially as claimed but fails to teach a friction-reducing coating is applied to at least a portion of a surface of one of the plurality of movable components.
Finley teaches low-friction coatings (e.g. abstract) including PTFE (e.g. abstract) used with medical articles (e.g. [0016]) and with moving components of those articles (e.g. [0027]).
Lashinski is concerned with the same field of endeavor as the claimed invention, namely tissue anchors and Finley is concerned with the same field of endeavor as the claimed invention, namely low-friction coatings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lashinski such that the movable components are coated with the friction-reducing coating as taught by Finley in order to reduce the friction between components and thus allow for easier movement between the parts (e.g. Finley, [0016], [0027]).
Regarding Claim 2, the plurality of movable components include at least one slider and associated slider screw extending through the slider (e.g. Lashinski, Figure 6D, screw #630 moves through slider # 634; Figure 6I, screw #670 moves through slider # 671) and at least a portion of a surface of at least one of the slider or the slider screw is coated with a friction-reducing coating (discussed supra for claim 1).
Regarding Claim 3, the slider screw (e.g. Lashinski, Figure 6D, #630; Figure 6I, #670) includes a mounting structure (e.g. Lashinski, Figure 6D, #635; Figures 6I, #673) mounted in a window in the frame member (e.g. Lashinski, Figures 6D, 6I, window formed by two adjacent struts), a threaded portion (e.g. Lashinski, Figures 6D, 6I, threaded outer surfaces of the screws; annotated Figure 6D below) engageable with internal threads within the slider (e.g. Lashinski, [0089], [0099]), and a neck between the mounting structure and the threaded portion (e.g. Lashinski, annotated Figure 6D below) and extending through an axial opening in the window in the frame member (e.g. Lashinski, annotated Figure 6D below);
the slider is held against axial movement with respect to the frame member (e.g. Lashinski, Figure 6I, right hand side, at least by lock #672) and is rotatable with respect to the frame member and the slider to cause axial advancement or retraction of the slider with respect to the frame member (e.g. Lashinski, [0099]-[0100]); and
at least a portion of one of the slider threaded portion, the slider mounting structure, or the slider neck is coated with a friction-reducing coating (all are coated with the coating, discussed supra for claim 1).
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Annotated Figure 6I, Lashinski
Regarding Claim 4, at least a portion of the slider is coated with a friction-reducing coating (discussed supra for claim 1).
Regarding Claim 5, the internal threads of the slider are coated with a friction-reducing coating (discussed supra for claim 1; Finley further teaches the parts are coated by dip-coating, which covers all surfaces of the part, e.g. Finley, [0023]).
Regarding Claim 6, at least one of the sliders is electropolished before application of a friction-reducing coating thereto (discussed supra for claim 1 and in the product-by-process section)
Regarding Claim 9, the slider screw associated with the at least one slider is coated with a friction-reducing coating (discussed supra for claim 1).
Regarding Claim 10, the plurality of movable components include at least one anchor (e.g. Lashinski, [0010], when the anchors are the type that rotate to engage the tissue) movable with respect to the frame member to secure the frame member to an implant site (e.g. Lashinski, [0010], rotatable anchors rotate relative to the frame during engagement with the tissue), and an associated anchor housing mounted to the frame member (e.g. Lashinski, [0010], the portion of the frame the rotatable anchors are placed through) and through which the at least one anchor extends (discussed with the preceding element); and at least a portion of a surface of the anchor housing is coated with a friction-reducing coating (discussed supra for claim 1).
Regarding Claim 11, the anchor housing is smoothened before application of the friction-reducing coating thereto (discussed supra for claim 1 and in the product-by-process section).
Regarding Claim 12, the anchor housing is tumbled before application of the friction-reducing coating thereto (discussed supra for claim 1 and in the product-by-process section).
Regarding Claim 13, the coated component is formed of a metal (e.g. Lashinski, [0064], [0082], [0091]) and the friction-reducing coating is a polytetrafluoroethylene coating (discussed supra for claim 1, from Finley).
Regarding Claim 14, the coated surface is an untreated surface which has not been subjected to a pre-treatment process recommended for acceptance of the friction-reducing coating on the surface prior to application of the friction-reducing coating thereto (discussed supra for claim 1 and in the product-by-process section).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski, et al (Lashinski) (US 2016/0015513 A1) in view of Finley (US 2008/0057298 A1) and further in view of Davidson, et al (US 5,674,280).
Regarding Claim 7, the combination of Lashinski and Finley discloses the invention substantially as claimed but fails to teach a slider screw associated with the at least one slider is anodized.
Davidson teaches anodizing (creating an oxide layer on) an annuloplasty device in order to create a hardened surface to for a wear resistant device (e.g. column 1, lines 20-28).
Davidson is concerned with the same field of endeavor as the claimed invention, namely anodized implants. Lashinski is concerned with the same field of endeavor as the claimed invention, namely tissue anchors and Finley is concerned with the same field of endeavor as the claimed invention, namely low-friction coatings.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lashinski and Finley such that the annuloplasty implant is anodized (has an oxide layer) as taught by Davidson in order to provide wear resistance for the annuloplasty device (e.g. Davidson, column 1, lines 20-28).
Regarding Claim 8, the slider screw associated with the at least one slider is coated with a friction-reducing coating (discussed supra for claim 1).
Relevant Prior Art
US 2014/0303720 A1 to Sugimoto, et al teaches a heart valve annulus implant that is a coiled structure (e.g. abstract, Figures 1-2), where the helical structure is coated with PTFE to reduce the frictional coefficient of the fastener (e.g. [0025]).
US 2007/0232898 A1 to Huynh, et al teaches lubricious coatings between components of a medical device (e.g. [0035]).
US 2017/0135816 A1 to Lashinski, et al teaches a heart valve annulus implant (e.g. Figures 1-2) having movable components and rotatable anchors (e.g. Figures 1-2).
US 2002/0013605 A1 to Bolduc, et al teaches helical tissue anchors (e.g. abstract) having a friction reducing coating (e.g. claim 13).
US 2012/0136436 A1 to Cabiri, et al teaches a coiled annuloplasty implant having tissue anchors (e.g. abstract, Figures 1, 10-11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 11/10/2025