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 .
Election/Restrictions
Applicant’s election of Group I claims 1-13 in the reply filed on 07/29/2026 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Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected system and method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/29/2026.
Claim Objections
Claims 9-11 and 13 are objected to because of the following informalities:
Claim 9 line 3 and lines 9-10 “the form of a suture” is suggested to read “the form of the suture” due to it being previously introduced and consistency of claim language.
Claim 9 line 6 and line 8 and lines 9-10 “the form of an anchor” is suggested to read “the form of the anchor” due to it being previously introduced and consistency of claim language.
Claim 10 line 2 “the form of a suture” is suggested to read “the form of the suture” due to it being previously introduced and consistency of claim language.
Claim 10 lines 3-4 “the form of an anchor” is suggested to read “the form of the anchor” due to it being previously introduced and consistency of claim language.
Claim 11 line 1 “the elongated element” is suggested to read “the elongated component” for better claim language consistency.
Claim 13 line 1 “the elongated element” is suggested to read “the elongated component” for better claim language consistency.
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.
Claim 12 is 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 12 recites the limitation "the suture" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant meant to recite the elongated component, or if the Applicant meant to introduce another element that is a suture also extending through the first channel. For the purposes of examination, the Office will interpret the suture to mean “the elongated component.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-6 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller et al. (US PGPub 2007/0112425) in view of Epstein et al. (US PGPub 2019/0282226), hereinafter known as “Schaller” and “Epstein,” respectively.
With regards to claim 1, Schaller (Figures 1-6B) discloses a delivery catheter 54 (paragraph 80) comprising:
a first channel (space within 56; will further be identified as 56) extending from a proximal end of the delivery catheter 54 to a distal end of the delivery catheter 54, the first channel 56 configured for axial translation of an elongated component 64 therethrough (paragraph 88; figures 5A-5F); and
a second channel (space within 58; will further be identified as 58), extending from the proximal end of the delivery catheter 54 to the distal end of the delivery catheter 54, the second channel 58 configured for axial translation of two or more tissue-engaging components 62, each including a coupler (see eyelet in figures 5F-6B where the elongated component 64 is attached to) configured to engage the elongated component 64 (figure 2), therethrough to a treatment site (paragraphs 80 and 89; figures 5A-5F), the second channel 58 further configured for axial translation of the coupler of each of the two or more tissue-engaging components 62 therein and therethrough while engaged with the elongated component 64;
wherein:
the delivery catheter 54 is configured to allow each of the two or more tissue-engaging components 62 to be coupled to the elongated component 64 across a passage between the first channel 56 and the second channel 58 (distal end 58 where elongated component 64 extends into is the passage across first channel 56 and second channel 58), for axial translation of the two or more tissue-engaging components 62 through the second channel 58 in coordination with axial translation of the elongated component 64 through the first channel 56 for concurrent deployment of at least one of the two or more tissue-engaging components 62 and the elongated component 64 from the delivery catheter 54 (figures 2 and 5A-5F; paragraphs 80 and 91-96).
Schaller is silent wherein a slit is defined longitudinally along and between the first channel and the second channel and extending from a proximal end of the second channel; and each of the two or more tissue-engaging components is coupled to the elongated component across the slit.
However, in a similar field of endeavor of deploying anchors, Epstein teaches (Figures 3A, 4A-4B and 9A-9B) wherein a slit 117 is defined longitudinally along and between the first channel and second channel and extending from a proximal end of the second channel (paragraph 72 – “Needle 108 optionally has a longitudinal slit 117 which extends from edge 110 to either a proximal edge (not shown) of the needle”); and each of the two or more tissue-engaging components 112 to be coupled to the elongated component 118 across the slit 117 (figures 3A and 4A-4B in combination with figures 9A-9B; paragraphs 72 and 84).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery catheter of Schaller to include the slit as taught by Epstein for the purpose of preventing the suture from contacting the sharpened edge of the tip during piercing, thereby to avoid cutting the suture.
The combination of Schaller in view of Epstein results in the slit 117 of Epstein longitudinally extending between the first channel 56 of Schaller and the second channel 58 of Schaller from a proximal end of the second channel 58 of Schaller, akin to figure 9B of Epstein where the slit 117 is shown extending across the needle 108, where individual portions of the elongated component 64 of Schaller are attached through the longitudinal slit 117 of Epstein to the coupler (eyelet of Schaller) of the at least two tissue-engaging components 62 of Schaller.
With regards to claim 2, Schaller/Epstein disclose wherein the first channel (Schaller: 56) and the second channel (Schaller: 58) are configured to couple at least two of the two or more tissue-engaging components (Schaller: 62), spaced apart from each other, to the elongated component (Schaller: 64) across the slit (Epstein: 117) while limiting interaction between the two or more tissue-engaging components (Schaller: 62) and the elongated component (Schaller: 64; paragraph 80 and 91-96; suture 64 is coupled through the anchors 62 through the second channel 58 in only one direction and extends back through the first channel 56, therefore limiting the interaction between the two or more tissue-engaging components 62 and the elongated component 64).
With regards to claim 3, Schaller further discloses wherein the first channel 56 is configured to limit rotational movement of the elongated component 64 during translation of the elongated component 64 through the first channel 56 (functional limitation - paragraph 80 – push rod 60 pushes the two or more tissue-engaging components 62, thus pushing the elongated component 64, therefore resulting in an axial movement and not rotational), and wherein the second channel 58 is disposed within a portion of the first channel 56 (figure 2 – second channel 58 is disposed within the first channel 56).
With regards to claim 4, Schaller further discloses wherein the first channel 56 comprises a bore (space within 56) sized to limit rotation of the elongated component 64 (functional limitation - paragraph 80 – push rod 60 pushes the two or more tissue-engaging components 62, thus pushing the elongated component 64, therefore resulting in an axial movement and not rotational), and wherein the second channel 58 is disposed between features of the elongated component 64 (figure 2 – second channel 58 comprises the elongated component 64 extending through the two or more tissue-engaging components 62, therefore the second channel 58 is disposed between features of the elongated component 64).
With regards to claim 5, Schaller further discloses wherein the bore (space within 56) corresponds in size and shape to the elongated component 64 (figure 2 – elongated component 64 fits inside the bore of 56 and therefore the bore corresponds in size and shape to elongated component 64).
With regards to claim 6, Schaller further discloses further comprising an axially translatable opening between the first channel 56 and the second channel 58 (see annotated figure 2 below - opening at the distal end of 56 and 58 where the two or more tissue-engaging components 62 and elongated component 64 extends out from).
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With regards to claim 8, Schaller further discloses wherein the coupler (see eyelet in figures 5F-6B where the elongated component 64 is attached to) is configured for passage of the elongated component 64 therethrough, and the second channel 58 is configured to carry a body portion of the at least one of the tissue-engaging components 62 from which the coupler extends (figure 2).
With regards to claim 9, Schaller/Epstein disclose wherein:
the elongated component (Schaller: 64) is in the form of a suture and the first channel (Schaller: 56) is configured for axial translation of the elongated component (Schaller: 64), in the form of a suture, therethrough (Schaller: 64; paragraph 80);
the at least two tissue-engaging components (Schaller: 62) are in the form of an anchor and the second channel (Schaller: 58) is configured for axial translation of the at least two tissue-engaging components (Schaller: 62), in the form of an anchor, therethrough (Schaller: 62); and
the slit (Epstein: 117), the first channel (Schaller: 56), and the second channel (Schaller: 58) are configured to allow the at least two tissue-engaging components (Schaller: 62) in the form of an anchor (Schaller: 62) to be spaced apart from each other within the second channel (Schaller: 58) and coupled, through the slit (Epstein: 117), to the elongated component (Schaller: 64) in the form of a suture (Schaller: 64) in the first channel (Schaller: 56; figure 2; paragraphs 80 and 93-96).
With regards to claim 10, Schaller/Epstein disclose wherein the elongated component (Schaller: 64) in the form of a suture (Schaller: 64) extends through the slit (Epstein: 117) and into the second channel (Schaller: 58) to be engaged with the coupler (Schaller: see eyelet in figures 5F-6B where the elongated component 64 is attached to) of each of the two or more tissue-engaging components (Schaller: 62) in the form of an anchor (Schaller: 62).
With regards to claim 11, Schaller/Epstein disclose wherein the elongated element (Schaller: 64) extends through the slit (Epstein: 117) and into the second channel (Schaller: 58) to be engaged with the coupler (Schaller: eyelet) of each of the two or more tissue-engaging components (Schaller: 62).
With regards to claim 12, Schaller further discloses wherein the first channel 56 is configured for the elongated component 64 (see 112(b) rejection above) to extend therethrough from a proximal handle 76 of the delivery catheter 54 through the coupler (eyelet) of each of the two or more tissue-engaging components 62 and back to the proximal handle 76 (figures 1-2; paragraph 80).
With regards to claim 13, Schaller/Epstein disclose wherein the elongated element (Schaller: 64) is in the form of a suture (Schaller: 64) and the at least two of the tissue-engaging components (Schaller: 62) each comprise an anchor (Schaller: 62; figure 2), and the first channel (Schaller: 56), the second channel (Schaller: 58), and the slit (Epstein: 117) are configured for the suture (Schaller: 64) to be fixedly attached to a first anchor (Schaller: 62) of the at least two anchors (Schaller: 62) and to extend through the anchors (Schaller: 62) to the proximal end of the delivery catheter (Schaller: 54; figures 1-2; paragraph 80 and 93-96; suture is attached to eyelet of anchor 62).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schaller in view of Epstein, as applied to claim 6 above, and further in view of Surti (US PGPub 2009/0082786).
With regards to claim 7, Schaller/Epstein disclose the delivery catheter as claimed in claim 6. Schaller/Epstein further disclose wherein the delivery catheter (Schaller: 54) further comprises:
a guide catheter (Schaller: 56) disposed within the delivery catheter (Schaller: 54), the first channel (Schaller: space within 56) disposed between the guide catheter (Schaller: 56) and the delivery catheter (Schaller: 54; first channel (space within 56) is disposed between all of the guide catheter 56 (including the inside of guide catheter 56) and the delivery catheter 54); and
an anchor catheter (Schaller: 58; 58 is denoted as a needle and is interpreted as an anchor catheter due to the needle being shaped tubular and comprising of the two or more tissue-engaging components 62 within; figure 2) disposed within the guide catheter (Schaller: 56), the slit (Epstein: 117) extending through the anchor catheter from a distal end of the anchor catheter to a proximal end of the anchor catheter (Epstein: paragraph 72; see figures 4A-4B and 9A-9B where the slit 117 extends through the inner catheter that is akin to Schaller’s anchor catheter 58), the anchor catheter (Schaller: 58) providing the second channel (Schaller: space within 58).
Schaller/Epstein are silent wherein the guide catheter comprises a window extending therethrough.
However, in a similar field of endeavor of deploying anchors, Surti teaches (Figure 8) the sheath 224 comprises a window 248 extending therethrough (paragraphs 26-28).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the delivery catheter of Schaller/Epstein to include the window on the guide catheter as taught by Surti for the purpose of securely maintaining the suture (paragraph 27 of Surti).
The combination of Schaller/Epstein/Surti results in the window (Surti: 248) slidably disposed over the slit (Epstein: 117) of the anchor catheter (Schaller: 58), wherein the window (Surti: 248) of the guide catheter (Schaller: 56) and slit (Epstein: 117) of the anchor catheter (Schaller: 58) cooperate to provide the axially translatable opening (Schaller: see annotated figure 2 above - opening at the distal end of 56 and 58 where the two or more tissue-engaging components 62 and the elongated component 64 extends out from) between the first channel (Schaller: space within 56) and the second channel (Schaller: space within 58).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 08/04/2026
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