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 .
Specification
The use of the term Gor-Tex (pg. 1, line 21), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
1. "Figs" should be Fig, as the line is drawing attention to one figure (pg. 5, line 16).
Appropriate correction is required.
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 limitation(s) 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.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Examiner notes the applicant’s specification: “it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms "means for" or "step for"15 are recited in a aim”.
If applicant does not intend 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 avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. US 20180185153 A1, herein referred to as Bishop, in view of Spence et al. US 7166127 B2, herein referred to as Spence.
Regarding Claim 1, Bishop discloses: An anchor assembly (Fig. 39C, 302/308) configured to be implanted into a heart wall of a heart of a patient (abstract) to anchor a suture (Fig 38G, suture 344 [0304]) that is configured to extend from a valve leaflet of the heart as an artificial chorda ([0320], Fig 38H), the anchor assembly (Fig 39C 302/308) comprising: an anchor hub (Fig 39C, anchor hub 308) having a proximal drive socket (Fig 39C and [0304], recess that engages 306’ of driver 309) configured to interface with a delivery tool (Fig 39C, driver 309) and defining an outer clamp surface (outer surface of 308); a helical coil (Fig 39C, helical anchor 302) extending distally from the anchor hub and having a sharpened tip (Annotated Fig 38G below) configured to embed the helical coil into the heart wall upon rotation of the helical coil caused by the delivery tool interfacing with the drive socket ([0307]).
Annotated Figure 39C, Bishop et al.
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Annotated Figure 38G, Bishop et al.
Bishop fails to disclose: a spring crimp having an open position and a closed position, the spring crimp being biased towards the closed position; and a locking element configured to interface with the spring crimp to selectively hold the spring crimp in the open position, wherein removal of the locking element from the spring crimp with the spring crimp positioned over the anchor hub causes the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension as an artificial chordae extending from the valve leaflet to the anchor.
However, Spence also discloses a similar anchor assembly system comprising an anchor (Fig 15D. fastener/anchor 140) having an anchor hub (Fig 15C, fastener3 delivery system). Spence teaches: a spring crimp (Fig 15D, crimp 150) having an open position and a closed position (Col. 17, lines 21-13), the spring crimp being biased towards the closed position (Col 9, lines 10-19); and a locking element (Col. 17, 42-43, magnets 142, 144 and fasteners 140) configured to interface with the spring crimp to selectively hold the spring crimp in the open position (Col. 9, lines 7-36), wherein removal of the locking element (Col. 9, lines 7-36) from the spring crimp with the spring crimp positioned over the anchor hub causes the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension as an artificial chordae extending from the valve leaflet to the anchor (Col 7, lines 5-21; Col 9, lines 1-36; Col 17, lines 48-63).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bishop’s anchor assembly for implant implanting artificial chorda with Spence to include a spring crimp having an open position and a closed position, the spring crimp being biased towards the closed position; and a locking element configured to interface with the spring crimp to selectively hold the spring crimp in the open position, wherein removal of the locking element from the spring crimp with the spring crimp positioned over the anchor hub causes the spring crimp to clamp onto the outer clamp surface of the anchor hub with sufficient force to hold a suture between the spring crimp and the outer clamp surface under tension as an artificial chordae extending from the valve leaflet to the anchor, as taught and suggested by Bishop to reduce mitral regurgitation while implanting an artificial chorda tendinea (¶ 0006).
Regarding Claim 8, Bishop discloses an anchor assembly (Fig. 39C, 302/308) configured to be implanted into a heart wall of a heart of a patient (abstract) to anchor a suture (Fig 38G, suture 344 [0304]) that is configured to extend from a valve leaflet of the heart as an artificial chorda (abstract, Fig 38H), the anchor assembly comprising: an anchor (Fig 39C, tissue anchor 302) configured to be inserted into a heart wall of a patient (Fig 38H, tissue anchor 302);
But Bishop fails to disclose a spring crimp having an open position and a closed position, the spring crimp being biased towards the closed position; and a locking element configured to selectively hold the spring crimp in the open position, wherein removal of the locking element from the spring crimp with the spring crimp positioned over the anchor causes the spring crimp to clamp onto the anchor with sufficient 18force to hold a suture between the spring crimp and the anchor under tension as an artificial chordae extending from the valve leaflet to the anchor.
But Spence also discloses a similar anchor assembly system comprising an anchor (Fig 15D. fastener or anchor 140) having an anchor hub (Fig 15C, fastener delivery system). Spence teaches: a spring crimp (Fig 15D, crimp 150) having an open position and a closed position (Col. 17, lines 21-13), the spring crimp being biased towards the closed position (Col 9, lines 10-19); and a locking element (Col. 17, 42-43, magnets 142, 144 and fasteners 140) configured to selectively hold the spring crimp in the open position (Col 9, lines 10-19, prior demonstrates locking and unlocking as needed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bishop’s anchor assembly for implant implanting artificial chorda with Spence to include a spring crimp having an open position and a closed position, the spring crimp being biased towards the closed position; and a locking element configured to selectively hold the spring crimp in the open position, wherein removal of the locking element from the spring crimp with the spring crimp positioned over the anchor causes the spring crimp to clamp onto the anchor with sufficient 18force to hold a suture between the spring crimp and the anchor under tension as an artificial chordae extending from the valve leaflet to the anchor, as taught and suggested by Bishop to reduce mitral regurgitation (¶ 0006).
Claim(s) 2, 3, 9, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop and in view of Spence as applied to claims 1 and 8 above, and further in view of Wilson et al. US 20190000624 A1, herein referred to as Wilson.
Regarding claim 2, Bishop in view of Spence discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose
wherein the spring crimp comprises one or more locking rings, and wherein the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position.
But Wilson discloses a similar anchor assembly (Fig 4, delivery device 130). Wilson teaches a similar anchor assembly: wherein the spring crimp (Spence Fig 15D, tensile member 148 and crimp 150) comprises one or more locking rings (Wilson Fig 11A, knot rings 280), and wherein the locking element (Wilson Fig 11A, slot SL) interfaces with the one or more locking rings to hold the spring crimp in the open position (Fig. 11A, [0094], prior art recites multiple “rings” by using the plural “rings”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Bishop and Spence to incorporate wherein the spring crimp comprises one or more locking rings, and wherein the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position, as taught and suggested by Wilson, in order to improve stabilization of anchoring (Wilson [0094]).
Regarding claim 3, the combination of Bishop, Spence, and Wilson as discussed above in claim 2 teaches Wherein the spring crimp (Spence Fig 15D, tensile member 148 and crimp 150) comprises a pair of locking 17rings (Wilson Fig 11A, knot rings 280) that are axially aligned in the open position (¶ 0143, line 13) (Fig. 11A, [0094] Figure recites use of plural rings and depicts at least two rings axially aligned in open and closed position).
Regarding claim 9, the combination of Bishop, Spence, and Wilson as discussed above in claim 2 teaches: wherein the spring crimp comprises one or more locking rings (Wilson Fig 11A, knot rings 280), and wherein the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position wherein the spring crimp comprises one or more locking rings (Lock is secured with the alignment of rings, Fig 15D knot rings 280), and wherein the locking element interfaces with the one or more locking rings to hold the spring crimp in the open position (Fig. 11A, [0094] Figure recites use of plural rings and depicts at least two axial aligned in open and closed position).
Regarding claim 10, the combination of Bishop, Spence, and Wilson as discussed above in claim 9 teaches wherein the spring crimp comprises a pair of locking rings that are axially aligned in the open position. (Fig. 1B).
Claim(s) 4-7, 11, 12, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Spence in claims 1 above, and further in view of Huddleston US 20220296365 A1, herein referred to as Huddleston.
Regarding claim 4, Bishop in view of Spence discloses the invention substantially as claimed and as discussed above with respect to claim 1, but does not disclose wherein the locking element is configured as an elongate rod.
However, Huddleston discloses a similar anchoring system (Fig 6A, epicardial anchoring device). Huddleston teaches a similar anchoring system: wherein the locking element (Annotated Fig 6A below) is configured as an elongate rod (Fig 6A, rod 481).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify combination of Bishop and Spence to include wherein the locking element is configured as an elongate rod, as taught and suggested by Huddleston, in order improve surgical transition (¶0007 lines 5-6).
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Regarding Claim 5, the combination of Bishop, Spence, and Huddleston as discussed above in claim 4 teaches wherein the elongate rod (Fig 6A, rod 481) is inserted through one or more openings in the suture crimp to hold the suture crimp in the open position (¶ 0085, line 8-9) (Fig. 7C).
Regarding Claim 6, the combination of Bishop, Spence, and Huddleston as discussed above in claim 4 teaches wherein the elongate rod is configured to be moved proximally relative to the anchor to be removed from the spring crimp (Figure 6C).
Regarding Claim 7, the combination of Bishop, Spence, and Huddleston as discussed above in claim 4 teaches wherein the elongate rod is configured to extend from the anchor inserted into the heart wall thorough the patient's vasculature and outside of the body (Figure 3E).
Regarding claim 11, the combination of Bishop, Spence, and Huddleston as discussed above in claim 4 teaches: wherein the locking element is configured as an elongate rod (584) (¶ 0085, line 8-9) (Fig. 7C).
Regarding claim 12, the combination of Bishop, Spence, and Huddleston as discussed above in claim 11 teaches wherein the elongate rod is inserted through one or more openings in the suture crimp to hold the suture crimp in the open position. (¶ 0085, line 8-9) (Fig. 7C).
Regarding Claim 13, the combination of Bishop, Spence, and Huddleston as discussed above in claim 11 teaches wherein the elongate rod is configured to be moved [0078] proximally relative to the anchor to be removed from the spring crimp ([0078], locking rod capable of changing locking orientation, alternative rod configurations are anticipated in the prior art).
Regarding Claim 14, the combination of Bishop, Spence, and Huddleston as discussed above in claim 13 teaches wherein the elongate rod is configured to extend from the anchor (tether T) inserted into the heart wall thorough the patient's vasculature and outside of the body ([1580], [0103] and [0098], prior art is silent regarding remote use, therefore the device must be operate by surgeon in some manner outside the body through the vasculature as describe as it is with the vasculature to secure an implant in the heart.).
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bishop in view of Spence and Wilson, and further in view of Huddleston US 20220054258 A1.
Regarding claim 15, Bishop discloses an anchor assembly (Fig. 39C, 302/308) configured to be implanted into a heart wall of a heart of a patient (Fig 38G, suture 344 [0304]) to anchor a suture that is configured to extend from a valve leaflet of the heart as an artificial chorda (abstract, [0302], Fig 7).
But fails to disclose the anchor assembly comprising: a spring crimp having an open position and a closed position, the spring crimp being biased towards the closed position and including one or more locking rings; and a locking element configured to be inserted through the one or more locking rings of the spring crimp to selectively hold the spring crimp in the open position, wherein removal of the locking rod from the one or more locking rings of the spring crimp with the spring crimp positioned over a suture anchor causes the spring crimp to clamp onto the outer clamp surface of the suture anchor with sufficient force to hold a suture between the spring crimp and the suture anchor under tension as an artificial chordae extending from the valve leaflet to the suture anchor.
But Spence discloses a similar anchor assembly system comprising an anchor (Fig 15D. fastener or anchor 140) having an anchor hub (Fig 15C, fastening system).
Spence teaches: a spring crimp (Fig 15D, crimp 150) having an open position and a closed position (Col. 17, lines 21-13), the spring crimp being biased towards the closed position (Col 9, lines 10-19).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Bishop’s anchor assembly for implant implanting artificial chorda with Spence to include a spring crimp having an open position and a closed position, the spring crimp being biased towards the closed position, as taught and suggested by Bishop to reduce mitral regurgitation (¶ 0006).
But the combination of Bishop and Spence fails to disclose including one or more locking rings; and a locking element configured to be inserted through the one or more locking rings of the spring crimp to selectively hold the spring crimp in the open position, wherein removal of the locking rod from the one or more locking rings of the spring crimp with the spring crimp positioned over a suture anchor causes the spring crimp to clamp onto the outer clamp surface of the suture anchor with sufficient force to hold a suture between the spring crimp and the suture anchor under tension as an artificial chordae extending from the valve leaflet to the suture anchor.
However, Wilson discloses a similar anchor assembly (Fig 4, delivery device 130). Wilson teaches a similar anchor assembly: comprising a locking element (Wilson Fig 11A, slot SL), including one or more locking rings (Wilson Fig 11A, knot rings 280, also discloses the plural of rings).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Bishop and Spence to incorporate wherein the spring crimp comprises one or more locking rings, as taught and suggested by Wilson, in order to improve stabilization of anchoring (Wilson [0094]).
But the combination of Bishop, Spence and Wilson fails to disclose a locking element configured to be inserted through the one or more locking rings of the spring crimp to selectively hold the spring crimp in the open position
However, Huddleston discloses a similar anchoring assembly (Fig 6A, epicardial anchoring device). Further, Huddleston teaches a similar anchoring assembly: a locking element (Annotated Fig 6A above) configured to be inserted (Fig 6A, rod 481), through the one or more locking rings (Wilson Fig 11A, knot rings 280) of the spring crimp to selectively hold the spring crimp (Fig 15D, tensile member 148 and crimp 150) in the open position (combination would be capable of claimed of locking element into locking rings in an open position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify combination of Bishop and Spence to include wherein a locking element configured to be inserted through the one or more locking rings of the spring crimp to selectively hold the spring crimp in the open position, as taught and suggested by Huddleston, in order improve surgical transition (¶0007 lines 5-6).
The phrase “wherein removal of the locking rod from the one or more locking rings of the spring crimp with the spring crimp positioned over a suture anchor causes the spring crimp to clamp onto the outer clamp surface of the suture anchor with sufficient force to hold a suture between the spring crimp and the suture anchor under tension as an artificial chorda extending from the valve leaflet to the suture anchor” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing or being manipulated to the recited function in order to meet the claim requirements. In this case, the locking element is considered to be capable of clamping to the anchor hub with sufficient force to anchor a suture act to act as an artificial chorda tendineae.
Regarding Claim 16, the combination of Bishop, Spence, Wilson and Huddleston as discussed above in claim 15 teaches wherein the spring crimp comprises a pair of locking rings that are axially aligned in the open position (Fig. 1B).
Regarding Claim 17, the combination of Bishop, Spence, Wilson and Huddleston as discussed above in claim 15 teaches wherein the locking element is configured as an elongate rod (481).
Regarding Claim 18, the combination of Bishop, Spence, Wilson and Huddleston as discussed above in claim 17 teaches wherein the elongate rod (584) is inserted through one or more openings in the suture crimp to hold the suture crimp in the open position (¶ 0085, line 8-9) (Fig. 7C).
Regarding Claim 19, the combination of Bishop, Spence, Wilson and Huddleston as discussed above in claim 17 teaches: wherein the elongate rod is configured to be moved proximally relative to the anchor to be removed from the spring crimp (Figure 6C).
Regarding Claim 20, the combination of Bishop, Spence, Wilson and Huddleston as discussed above in claim 17 teaches wherein the elongate rod is configured to extend from the anchor inserted into the heart wall thorough the patient's vasculature and outside of the body (Figure 3E).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADRIAN FLORES/Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799