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 Objections
Claims 1, 10, and 15 are objected to because of the following informalities:
Claim 1, line 5 recites “a actuator shaft”, which should be “an actuator shaft”.
Claim 10, line 2 recites “opposite first side and second side”, which should be “opposite first and second sides” or “a first side opposite a second side”.
Claim 15, line 2 recites “the double-line structures are”, which should be “the double-line structure is” to match the single instance introduced in the claim. If the claim is amended to require more than one double-line structure, then the original language noted would become grammatically correct.
Appropriate correction is required.
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 1-20 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, lines 6-7 recites “the clamping arm”. It is unclear which clamping arm is being referred back to as “at least one pair of clamping arms” is introduced earlier in the claim. For purposes of examination the Examiner considers this language to be “each of the clamping arms”
Claim 1, line 8 recites the limitation "the outer peripheral surface". There is insufficient antecedent basis for this limitation in the claim, since objects have multiple surfaces (e.g. one on each face of the object). For purposes of examination the Examiner notes this language is being interpreted as “an outer peripheral surface”.
Claim 1, line 13 and Claim 2, line 3 recites the limitation "the edge". There is insufficient antecedent basis for this limitation in the claim, since objects have multiple edges. For purposes of examination the Examiner notes this language is being interpreted as “an edge”.
Claim 2, line 3 recites the limitation "the groove and/or protrusion". 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 groove and/or a protrusion”.
Claim 4, lines 1-2 recites the limitation "the groove or the protrusion". There is insufficient antecedent basis for this limitation in the claim. The Examiner notes this rejection becomes moot if claim 2 is addressed as noted supra and claim 4 remains dependent from claim 2.
Claim 5, lines 2-3 and Claim 6, lines 1 and 4 each recites the limitation "the inner cavity". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an inner cavity” for first instance in a given claim chain.
Claim 6, lines 3-4 recites “there is a gap between the second end of the locking member and the inner cavity of the fixing base”. It is unclear how there is a gap between an element within a cavity and the cavity. For purposes of examination the Examiner considers this language to be “there is a gap between the second end of the locking member and an inner wall of the fixing base”, which is consistent with Applicant’s Figures 7 and 9.
Claim 7, line 1 recites the limitation “the proximal end”. There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the proximal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a proximal end”.
Claim 7, line 4 recites the limitation "the distal end surface". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the distal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a distal end surface”.
Claim 8, line 1 recites the limitation "the side wall". 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 side wall”.
Claim 9, line 2 recites the limitation "the inner wall". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an inner wall”.
Claim 10, line 3 recites the limitation "the proximal end surface". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the proximal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a proximal end surface”.
Claim 11, lines 3-4 recites the limitation "the proximal end". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the proximal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a proximal end”.
Claim 11, line 4 recites the limitation "the inner wall". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an inner wall”.
Claim 12, lines 2-3 recites the limitation "the inner wall". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an inner wall” in the first instance of this element in a given claim chain.
Claim 13, line 2 recites the limitation "the middle". 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 middle”.
Claim 14, lines 3-4 recites the limitation "the proximal end". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the proximal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a proximal end”.
Claim 15, lines 2-3 recite “a double-line structure” and “the double-line structures are arranged side by side and are both looped”. It is unclear how many double-line structures are claimed. As introduced, there is one. But, as referred back to it appears there are more than one. For purposes of examination the Examiner considers this language to be met when the prior art teaches at least one double-line structure.
Claim 16, line 4 recites the limitation "the valve". 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 valve”.
Claim 17, line 3 recites “the outside”. It is unclear what element is being referenced. For purposes of examination the Examiner considers this language to be “an outside surface”.
Claim 18, line 2 recites the limitation "the distal end". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the distal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a distal end”.
Claim 18, line 3 recites the limitation "the proximal end". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the proximal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a proximal end”.
Claim 19, line 2 recites “the exterior and/or interior”. It is unclear what element is being referenced. For purposes of examination the Examiner considers this language to be “the exterior surface and/or the interior surface”.
Claim 19, lines 2-3 recites the limitation "the gripping arm and/or the clamping arm". It is unclear which gripping arm and/or which clamping arm is being referred back to as these elements are introduced as “at least one pair of gripping arms” (claim 16) and “at least one pair of clamping arms” (claim 1). For purposes of examination the Examiner considers this language to be met when at least one of the respective elements meets the required limitation.
Claim 20, line 3 recites the limitation "the distal end". There is insufficient antecedent basis for this limitation in the claim, because as claimed any end can be the distal end, thus there are multiple options for this element. For purposes of examination the Examiner notes this language is being interpreted as “a distal end”.
Claim 20, line 4 recites the limitation "the unlocking member". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an unlocking member”. The Examiner notes “an unlocking member” is introduced in claim 11, but claim 20 is not in a claim chain including claim 11.
Claim(s) 3 are rejected as dependent from a rejected claim.
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 I 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 I below” coupled with functional language “see Table I below” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. see Table I 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 I 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 I below.
Table I: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
in the Specification
1, 5, 16, 17, 18
Base
Fixing
[0046] has an outer surface, other elements disposed in the fixing base (thus, an opening is present)
[0059] has a rectangular frame, a connecting block, fixing blocks, a protrusion, a through hole
[0061] has an inner wall
1, 16, 19
Arm
Clamping
[0050] has a connecting frame, a clamping frame, a surface is recessed inward forming a groove
1
Portion
Positioning
[0048] engages the edge of the locking hole
[0057] is a protrusion on the actuator shaft, has a plurality of grooves facing the locking hole
1, 7
Member
Pushing
[0061] has first and second sides, is a sheet-like structure, made of an elastic material, bent middle portion, has a latching piece, has a through hole, has a recessed portion
12
Piece
Latching
[0063] penetrates the second side of the pushing member
16, 19
Arms
Gripping
[0044] #64
17, 18, 19
Member
Adjusting
[0092] of an elastic material, has first and second ends
20
Member
Unlocking
[0065] is a symmetrical open structure
[0066] has a double-line structure looped on the second end of the locking member, made of nickel-titanium line through heat-setting
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 II below in claim see Table II below.
Table II: Language Not Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure
in the Claim
1-20
Device
Valve Clamping
All structures for the respective claim, other than those invoking 112(f)
1, 20
Mechanism
Locking
Includes the locking member (see next row)
1
Member
Locking
Hole
2
Portion
Positioning
A plurality of grooves and/or protrusions
5, 6, 7, 10
Member
Locking
First end
Second end, opposite the first end
5, 6
Base
Fixing
Inner cavity
Has a projection
9, 10, 11, 12
Base
Fixing
Inner wall
10, 11
Member
Pushing
First end
Second end, opposite the first end
12, 13
Member
Pushing
First side
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 § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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) 1-3, 5-12, 14-16, and 20 is/are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Goldfarb, et al (Goldfarb) (US 2006/0020275 A1).
Regarding Claim 1, Goldfarb teaches a valve clamping device (e.g. Figures 1, 5-8, [0084], [0094]) with a locking mechanism (e.g. [0068]), comprising:
a fixing base (e.g. Figures 5, 8A, [0066], #3 and unlabeled element extending up to #19; annotated Figure 5 below, shaded portions below the dashed line);
at least one pair of clamping arms (e.g. Figure 1, #s 18), the at least one pair of clamping arms being connected to the fixing base (e.g. Figure 1, at the apex of the V-shape ) and can be opened and closed relative to the fixing base (e.g. Figure 1, [0067], [0084]);
an actuator assembly (e.g. Figures 1, 5, 8A, [0068], #s 68, 74, and actuator rod), the actuator assembly comprising a actuator shaft movably inserted in the fixing base (e.g. [0068], #74, actuator rod), the actuator shaft moving in an axial direction (e.g. [0075], when unlocked) to actuate the clamping arm to open and close relative to the fixing base (e.g. [0067], [0075], #58 in Figure 9A is equivalent to #68 in Figure 1), with a positioning portion (e.g. [0096], Figure 14A, threading on #74; Figure 14A shows a way of connecting #74 to base #3 applicable to Figures 1, 5, 7) being provided on the outer peripheral surface of the actuator shaft (e.g. Figure 14A); and
a locking mechanism (e.g. Figures 5, 8A, #106, [0078], [0085], [0094]), the locking mechanism comprising a locking member (e.g. Figures 5, 8A, #450) and a pushing member (e.g. Figures 5, 8A, #114, [0075]), the locking member being provided with a locking hole in the axial direction (e.g. Figure 6, #460), the actuator shaft being inserted into the locking hole (e.g. Figures 5, 8A), and the pushing member abutting against the locking member (e.g. Figures 5, 8A) and being obliquely arranged in the fixing base (e.g. Figures 5, 8A, [0078]-[0079], #450 rotates around an axis into-out of the page) so that the edge of the locking hole is engaged with the positioning portion (e.g. Figures 5, 8A).
If not inherent that Figures 1, and 5 or 8A-B represent a single embodiment based on Goldfarb’s disclosures at [0094], [0105], [0106], then 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 embodiment of Figure 1 such that the locking device is that of Figure 5 or Figure 8 as it is a simple substitution of one known element (locking mechanism) for another to obtain predictable results of a mechanism to lock and unlock movement to adjust the position of the leaflet grasping structures.
Each Goldfarb embodiment is concerned with the same field of endeavor as the claimed invention, namely leaflet clipping devices.
PNG
media_image1.png
738
586
media_image1.png
Greyscale
Annotated Figure 5, Goldfarb
Regarding Claim 2, the positioning portion comprises a plurality of grooves and/or protrusions disposed facing the locking hole (e.g. Figure 14A, each ridge along the axial length formed by the threading; see also Figure 4C) and the edge of the locking hole is engaged with the groove and/or protrusion (e.g. Figures 5, 8A; while #74 is being rotated into place the threads are at the edge of the locking hole when they pass through it to reach the configuration in Figure 14A).
Regarding Claim 3, the plurality of grooves and/or protrusions are arranged in parallel (e.g. Figure 14A, they are parallel to each other).
Regarding Claim 5, the locking member comprises a first end and an opposite second end (e.g. Figures 5, 8A, left and right ends as shown), the first end abuts the inner cavity of the fixing base (e.g. Figures 5, 8A, #450 is within the bounds of the fixing member and thus both ends are abutting the inner cavity of the fixing base), and the second end can rotate around the first end to a position where the axis of the locking hole is coaxial with the axial direction of the fixing base (e.g. Figures 5, 8A, [0078]-[0079], #450 rotates around an axis into-out of the page, thus each end rotates around the opposing end).
Regarding Claim 6, the inner cavity of the fixing base is provided with a protrusion (e.g. Figure 5, below the left side of #450; Figures 8A, below the right side of #450), the first end of the locking member abuts against the protrusion (e.g. Figures 5, 8A, where the first end is the end resting on the protrusion), and there is a gap between the second end of the locking member and the inner cavity of the fixing base (e.g. Figures 5, 8A, filled by #108; the Examiner notes a cavity is the opening, here within the fixing base, thus the Examiner considers this language met when the gap is as disclosed by Applicant, which is between the end and the wall; this interpretation is consisted with Applicant’s Figures 7 and 9, which shows a gap between the locking member and the wall of the fixing base).
Regarding Claim 7, the proximal end of the protrusion is provided with an inclined surface (e.g. Figures 5, 8A), the first end of the locking member overlaps the inclined surface (e.g. Figures 5, 8A, the first end is above the inclined surface as shown), and the pushing member abuts against the proximal surface of the locking member (e.g. Figures 5, 8A, where the proximal surface is considered the upper surface) so that the distal end surface of the first end is attached to the inclined surface (e.g. Figures 5, 8A, via the thickness of #450).
Regarding Claim 8, the side wall of the first end is an arc surface (e.g. Figure 5, curved ends).
Regarding Claim 9, the arc surface contacts the inclined surface and the inner wall of the fixing member simultaneously (e.g. Figure 8, when #450 is rotated to contact the inclined surface, the arc surface also contacts the inner wall of the fixing member).
Regarding Claim 10, the pushing member includes opposite first side and second side (e.g. Figures 5, 8A, where the first side is the top as shown and the second side is the bottom as shown), the first side abuts against the inner wall of the fixing base (e.g. Figures 8A-B; Figure 5, when flattened #114 would contact the inner wall of the fixing base because #108 is two wires with a gap between them as seen in Figure 4B), and the second side abuts against the proximal end surface of the locking member (e.g. Figure 5A, 8A).
Regarding Claim 11, the pushing member is made of an elastic material (e.g. [0075], springs are inherently elastic), and the pushing member further comprises a middle part connected between the first side and the second side (e.g. Figures 5, 8A, central bend of #114), the middle part bends towards the proximal end, and gradually abuts against the inner wall of the fixing base (e.g. Figures 5, 8A).
Regarding Claim 12, a latching piece is provided on the first side of the pushing member (e.g. annotated Figure 8B below, circled portion with dashed arrow (the solid arrow in the right hand side image is the end of the pushing member); the Examiner notes this interpretation is consisted with Applicant’s element #845 in Figures 25-26), and a latching slot is provided on the inner wall of the fixing base (e.g. annotated Figure 8B below, solid arrow, left hand side image), and the latching piece is engaged in the latching slot (e.g. Figure 8B; the Examiner notes as #114 flattens, the engagement is increased).
PNG
media_image2.png
496
756
media_image2.png
Greyscale
Annotated Figure 8B, Goldfarb
Regarding Claim 14, the locking mechanism further comprises an unlocking member (e.g. Figures 5, 8A, #108, [0078] describes the motion of #108), the unlocking member is connected to the second end of the locking member (e.g. [0078]), and the unlocking member is pulled toward the proximal end so that the second end of the locking member rotates around the first end (e.g. [0078]).
Regarding Claim 15, the unlocking member comprises a double-line structure (e.g. Figure 4B), and the double-line structures are arranged side by side (e.g. Figure 4B) and are both looped on the second end of the locking member (e.g. Figures 5, 8A, [0078], when contacting the locking member).
Regarding Claim 16, the valve clamping device further comprises at least one pair of gripping arms (e.g. Figure 1, #s 16), the gripping arms are arranged between the fixing base and the at least one pair of clamping arms (e.g. Figure 1; the Examiner notes this is consistent with Applicant’s disclosure in e.g. Figure 4), each of the gripping arms cooperates with the clamping arm at the corresponding side to grip the valve (e.g. Figure 1, [0066]).
Regarding Claim 20, Goldfarb teaches a valve repair system (e.g. Figure 1 and [0066] interventional tool and #92), comprising the valve clamping device according to claim 1 (discussed supra for claim 1), and a delivery device detachably connected to the valve clamping device (e.g. [0066], interventional tool), wherein the delivery device comprises an operating line (e.g. Figure 1, #92), and the distal end of the operating line and the unlocking member of the locking mechanism are detachably connected (e.g. Figure 1, unlocking member #108 (operation discussed supra for claim 14); [0071], #92 is a suture and thus can be cut to detach from #108).
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.
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb, et al (Goldfarb) (US 2006/0020275 A1) as discussed supra and further in view of Lashinski, et al (Lashinski) (US 2018/0228610 A1).
Regarding Claim 4, a width of the groove or the protrusion is in a range of 0.04 to 0.30 mm.
Lashinski teaches a threaded screw for use in a heart at an annulus having a pitch of 10-150 threads per inch (e.g. [0224]). As the pitch is the distance between turns, the spacing between turns is in the range of 1/150 inches to 1/10 inches, which is 0.17 mm to 2.54 mm.
Lashinski and Goldfarb are concerned with the same field of endeavor as the claimed invention, namely implants anchored at a heart valve location.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goldfarb such that the width of the groove or the protrusion is in a range of 0.04 to 0.30 mm since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb, et al (Goldfarb) (US 2006/0020275 A1), alone.
Regarding Claim 13, Goldfarb discloses the invention substantially as claimed but fails to teach a through hole is defined in the middle of the pushing member along the axial direction, and the actuator shaft is inserted through the through hole in the axial direction.
Goldfarb is silent as to the shape of the pushing member #114 and only shows the cross-section as seen in e.g. Figures 5 and 8A.
Goldfarb teaches the pushing member generates sufficient force to force #452 of #450 downward (e.g. [0079]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Goldfarb such that the pushing element is a sheet having the same rectangular size (length and width) as the rectangular #450 (see Goldfarb Figure 6) and thus the same central opening, since this shape would evenly distribute the force across the surface of #450 which would allow for easier movement than if the pushing member covered only a portion of #450.
Further, this modification is obvious as it has been held that solving a recognized problem or need in the art by choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious to try (MPEP 2143(I)). Here, Goldfarb indicates the pushing member must be able to put force on element #450, thus it is needed to determine how Goldfarb can accomplish this function with a pushing member. Goldfarb’s e.g. Figure 5 shows that the pushing member extends side to side over #450 and approximately shares the length of #450, thus the options for the shape of Goldfarb are a thin strip to a full width device. These options could be determined by dividing the maximum width into quarter or even ten options to determine the force distribution and ease of operation. Either of these options would present a reasonable number of experimental options. Therefore, it would have been obvious to try the above combination of prior art features resulting in the claimed limitations.
In the modified Goldfarb, the actuator shaft is through the hole in the pushing member as the modified pushing member is aligned with #450.
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb, et al (Goldfarb) (US 2006/0020275 A1) as discussed supra and further in view of McNiven, et al (McNiven) (US 2016/0374811 A1).
Regarding Claim 17, Goldfarb discloses the invention substantially as claimed but fails to teach the valve clamping device further comprises an adjusting member, and the adjusting member is arranged the outside of the fixing base.
McNiven teaches a valve clamping device (e.g. Figures 1-2) having an adjusting member (e.g. Figures 1-2, #111, [0026]), and the adjusting member is arranged the outside of the fixing base (e.g. Figure 1).
McNiven and Goldfarb are concerned with the same field of endeavor as the claimed invention, namely valve clamping devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Goldfarb to have the adjusting member as taught by McNiven as it is combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)). Here, the results are predictable because each claimed element performs in the same manner in the combination as it does separately. Specifically, the valve clamping device’s functions are unchanged, while the addition of #111 of McNiven performs an additional function of controlling the gripping arms from an opposing end of the device. The combination of the two control methods provides for finer control over the placement allowing for more precise placement.
Claims 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb, et al (Goldfarb) (US 2006/0020275 A1) in view of McNiven, et al (McNiven) (US 2016/0374811 A1) as discussed supra and further in view of JP 2009536074 A (‘074).
Regarding Claim 18, the distal end of the adjusting member is fixedly connected to the fixing base (e.g. McNiven, Figure 1), and the proximal end of the adjusting member is suspended (e.g. McNiven, Figure 1, suspended by the delivery tool).
The combination of Goldfarb and McNiven discloses the invention substantially as claimed but fails to teach the adjusting member is made of elastic material.
‘074 teaches a wire used in heart implants (e.g. abstract) made of nitinol (e.g. translation section, overall page 38, line 21 of text).
‘074 and the combination of Goldfarb and McNiven are concerned with the same field of endeavor as the claimed invention, namely implants for the heart.
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 wire of the combination of Goldfarb and McNiven to be nitinol as taught by ‘074 in order to provide a wire than can return to its initial shape after being manipulated (e.g. as the McNiven wire is manipulated, discussed supra for claim 17) and as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143(I)) of using a common and known (e.g. per ‘074) implantable material of nitinol.
Regarding Claim 19, a biocompatible mesh membrane covers the exterior and/or interior of the adjusting member, the gripping arm and/or the clamping arm (e.g. Goldfarb, [0070]; incorporated 10/441531 corresponds to US 2004/0049207 A1 which teaches in its [0029] the covering all of the fixation device is covered with a biocompatible material and in [0155] of ‘207 the covering is a biocompatible mesh).
Relevant Prior Art
US 7,635,329 to Goldfarb, et al teaches a heart valve clip (e.g. Figure 3), but lacks an elastic pushing element actuation mechanism.
US 2018/0008403 A1 to Freschauf, et al teaches a heart valve clip system (e.g. abstract, Figures 5-6).
US 2019/0209293 A1 to Metchik, et al teaches a heart valve clip system (e.g. abstract, Figure 6), but lacks the required locking/unlocking mechanism and actuation mechanism.
US 2018/0325671 A1 to Abunassar, et al teaches a heart valve clip system (e.g. abstract, Figure 1), but lacks the required locking/unlocking mechanism and actuation mechanism.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 11/12/2025