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 .
Response to Amendment
This office action is responsive to the amendment filed on 01/06/2026. As directed by the amendment: claims 1, 9, 10, 15, 20, and 33 have been amended. Thus, claims 1-36 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pg. 9, filed 01/06/2026, with respect to the rejection of claims 9-19 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 9-19 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-21, 24, 33, and 34 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 9-36 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 9 recites the limitation "the lugs" in lines 13 and 14. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the lugs” will be interpreted as “the coupling features”. Appropriate correction is required.
Claim 20 recites “when a sufficient external force is applied, the loop member will be released from the frame”. The scope of “sufficient force” is unclear. How large or small does the force need to be to meet the claim limitation of “sufficient”. Appropriate correction is required.
Claims 23 and 24 recite the limitation "the bend" in lines 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the bend” will be interpreted as “the plane”. Appropriate correction is required.
Claim 33 recites “a frame” in line 5 and “a frame” in line 8. It is unclear if the frame of line 5 is the same as line 8. For examination purposes “a frame” in line 8 will be interpreted as “the frame”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3, 5, 7-10, 12, 14, 16, 17, 20-25, 28-30, 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shankarsetty et al. (US 20160262763 A1).
Regarding claim 1 Shankarsetty discloses (fig. 6-11A) an apparatus for treating tissue by applying a force to the tissue, the apparatus comprising:
a frame 24
a deployable segment 36 having a proximal region and a distal region, and a main body extending therebetween (see fig. 11A and [0048]), wherein the deployable segment comprises a loop member 36a formed at the distal region of the deployable segment (see fig. 10-11 and [0049]); and
at least three lugs 52 (see fig. 10A-11A and [0049]);
wherein the frame 24 is operatively coupled to the loop member by the lugs 52 (see fig. 10 and [0049]); and
wherein each lug 52 defines a slit (see fig. 11A), and wherein the loop member 36a extends through the slit of each lug 52 (see fig. 10A-11A and [0049])
wherein the loop member 36a is held within the slits when external forces are not applied to the loop member (configuration of fig. 10, see [0049] and [0055]); and
when an external force is applied that is sufficient to overcome counteractive force applied by the lugs, the loop member will be released from the lugs 52 with the lugs 52 remaining coupled to the frame 24, thereby achieving a detachment of the loop member from the frame 24 (see fig. 10-11, [0049], and [0056]), such that the deployable segment 36a is placed within a patient's body (see fig. 11 with 36a surrounding tissue T), maintaining engagement with tissue to provide a continuous compressive force upon the tissue (36a provides a continuous compressive force while in the position of fig. 11, see [0056]).
Regarding claim 9 Shankarsetty discloses (fig. 6-11A) an apparatus for treating tissue by applying a force to the tissue, the apparatus comprising:
a frame 24
a deployable segment 36 having a proximal region and a distal region, and a main body extending therebetween (see fig. 11A and [0048]), wherein the deployable segment comprises a loop member 36a formed at the distal region of the deployable segment (see fig. 10-11 and [0049]); and
wherein the frame 24 is operatively coupled to the loop member 36a (via 52, see fig. 10A and [0049])
wherein the frame comprises coupling features 52 (see fig. 10A-11A and [0049]) configured for operatively coupling the loop member 36a and the frame 24 (see fig. 10A, [0049], and [0055]);
wherein the loop member 36a is held within the coupling features when external forces are not applied to the loop member (configuration of fig. 10, see [0049] and [0055]); and
when an external force is applied that is sufficient to overcome counteractive force applied by the coupling features, the loop member will be released from the coupling features 52 with the coupling features 52 remaining coupled to the frame 24, thereby achieving a detachment of the loop member from the frame 24 (see fig. 10-11, [0049], and [0056]), such that the deployable segment 36a is placed within a patient's body (see fig. 11 with 36a surrounding tissue T), maintaining engagement with tissue to provide a continuous compressive force upon the tissue (36a provides a continuous compressive force while in the position of fig. 11, see [0056]).
Regarding claim 20 Shankarsetty discloses (fig. 6-11A) an apparatus for treating tissue by applying a force to the tissue, the apparatus comprising:
a frame 24
a deployable segment 36 having a proximal region and a distal region, and a main body extending therebetween (see fig. 11A and [0048]), wherein the deployable segment comprises a loop member 36a formed at the distal region of the deployable segment (see fig. 10-11 and [0049]); and
wherein the frame 24 is operatively coupled to the loop member 36a (via 52, see fig. 10A and [0049])
wherein the loop member 36a remains coupled to the frame 24 when external forces are not applied (configuration of fig. 10, see [0049] and [0055]); and when a sufficeint external force is applied, the loop member will be released from the frame 24, thereby achieving a detachment of the loop member from the frame 24 (see fig. 10-11, [0049], and [0056]), such that the deployable segment 36a is placed within a patient's body (see fig. 11 with 36a surrounding tissue T), maintaining engagement with tissue to provide a continuous compressive force upon the tissue (36a provides a continuous compressive force while in the position of fig. 11, see [0056]);
wherein the frame comprises a proximal region and a distal region (see fig. 10), wherein the frame assumes a plane that is angled relative to a first longitudinal axis of the proximal region of the deployable segment (see annotated fig. 7 below).
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Regarding claims 3 and 12 Shankarsetty further discloses (fig. 6-11A) the at least three lugs 52 comprise a first lug, a second lug, and a third lug, wherein the first lug is spaced apart from the second lug and the second lug is spaced apart from the third lug (see fig. 10).
Regarding claims 5 and 14 Shankarsetty further discloses (fig. 6-11A) the at least three lugs 52 comprise a first lug, a second lug, a third lug, and a fourth lug, wherein each lug is spaced apart from each of the other lugs (see fig. 10).
Regarding claims 7 and 16 Shankarsetty further discloses (fig. 6-11A) each of the at least three lugs further comprises a first end and a second end, wherein one or more of the at least three lugs comprises a taper at the first end (see annotated fig. 7 below).
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Regarding claims 8, 17, and 28 Shankarsetty further discloses (fig. 6-11A) a cannula 12 comprising a lumen extending therethrough (see fig. 6 and [0046]), wherein the cannula is dimensioned to circumferentially surround at least a portion of the deployable 36a segment and at least a portion of the frame 24 (see fig. 3 and [0047]-[0048]).
Regarding claim 10 Shankarsetty further discloses (fig. 6-11A) the coupling features comprise at least three lugs 52, wherein each lug defines a slit (see fig. 11A), and wherein the loop member extends through each lug slit (see fig. 10A and [0049]).
Regarding claim 21 Shankarsetty further discloses (fig. 6-11A) at least two lugs 52 configured to couple the frame 24 to the loop member 36a (see fig. 10 and [0049]).
Regarding claim 22 Shankarsetty further discloses (fig. 6-11A) the distal region of the frame 24 is collapsible (see [0047]) and wherein the frame comprises a loop shape (opening is a loop shape, see fig. 10).
Regarding claim 23 Shankarsetty further discloses (fig. 6-11A) the plane (see 112b interpretation) is at an angle within a range of about 0 degrees to about 90 degrees (see annotated fig. 7 above; there are many planes at all different angles that extend through the frame; the plane identified above is at approximately 90 degrees).
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Regarding claim 24 Shankarsetty further discloses (fig. 6-11A) the plane (see 112b interpretation above) is disposed proximal to the at least two lugs (see annotated fig. 7 above).
Regarding claim 25 Shankarsetty further discloses (fig. 6-11A) at least a portion of the frame 24 comprises a fold at the distal region of the frame (see fig. 13, the frame folds when collapsed).
Regarding claim 29 Shankarsetty further discloses (fig. 6-11A) the frame 24 comprises a second longitudinal axis, wherein the second longitudinal axis and the first longitudinal axis intersect (see annotated fig. 7 below).
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Regarding claim 30 Shankarsetty further discloses (fig. 6-11A) the loop shape of the frame is disposed within the distal portion of the cannula (see fig. 6 and [0047]).
Regarding claim 33 Shankarsetty discloses (fig. 1, 6-11A) a method of treating tissue by applying a force to the tissue, the method comprising:
inserting an apparatus 10 for treating tissue by applying a force to the tissue in a patient, wherein the apparatus comprises
a frame 24
a deployable segment 36 having a proximal region and a distal region, and a main body extending therebetween (see fig. 11A and [0048]), wherein the deployable segment comprises a loop member 36a formed at the distal region of the deployable segment (see fig. 10-11 and [0049]); and
wherein the frame 24 is operatively coupled to the loop member 36a (via 52, see fig. 10A and [0049]);
expanding the frame (24 is expanded when advanced out of the shaft, see [0049]);
retracting the loop member 36a (see [0056]), wherein retracting the loop member 36a comprises decoupling the loop member 36a from the frame 24 (see fig. 11 and [0056]); and
deploying the deployable segment 36a (see [0056]), such that the deployable segment 36a is placed within a patient's body (see fig. 11 with 36a surrounding tissue T), maintaining engagement with tissue to provide a continuous compressive force upon the tissue (36a provides a continuous compressive force while in the position of fig. 11, see [0056]).
Regarding claim 34 Shankarsetty further discloses (fig. 6-11A) the frame 24 is operatively coupled to the loop member 36a by at least two lugs 52 (see [0049]) movably coupled to the frame (the lugs move with the frame, thus they are moveably coupled).
Regarding claim 35 Shankarsetty further discloses (fig. 6-11A) expanding the frame 24 further comprises extending the frame 24 from a cannula 12 in a distal direction (see [0049]), wherein the frame further comprises a bend (curve of the opening of 24) relative to a first longitudinal axis of the proximal region of the deployable segment (see fig. 7).
Claims 20 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura et al. (US 20160310155 A1).
Regarding claim 20 Kimura discloses (fig. 17A-17B) an apparatus for treating tissue by applying a force to the tissue, the apparatus comprising:
a frame 4
a deployable segment 6 having a proximal region and a distal region, and a main body extending therebetween (see fig. 17A), wherein the deployable segment comprises a loop member (loop of 6) formed at the distal region of the deployable segment (see fig. 17A and [0085]); and
wherein the frame 4 is operatively coupled to the loop member 6 (see fig. 17A-B and [0086])
wherein the loop member 6 remains coupled to the frame 4 when external forces are not applied (see [0086]); and when a sufficient external force is applied, the loop member will be released from the frame 4, thereby achieving a detachment of the loop member 6 from the frame 4 (see [0086]), such that the deployable segment 6 is placed within a patient's body (see [0086]), maintaining engagement with tissue to provide a continuous compressive force upon the tissue (6 provides a continuous compressive force while around appendage A, see [0086]);
wherein the frame 4 comprises a proximal region and a distal region (see annotated fig. 17A below), wherein the frame assumes a plane that is angled relative to a first longitudinal axis of the proximal region of the deployable segment (see annotated fig. 17A below).
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Regarding claim 27 Kimura further discloses (fig. 17A-17B) the frame 4 is stiffer than the loop member (the loop is flexible and the frame is stiff, see fig. 17A and [0086]).
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.
Claims 6, 15, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Shankarsetty.
Regarding claims 6 and 15, Shankarsetty discloses the claimed invention substantially as claimed, as set forth above for claims 5 and 14. Shankarsetty fails to expressly disclose the at least three lugs are spaced apart along the frame so that the first lug is about 60 degrees to about 100 degrees from the second lug, the second lug is about 60 degrees to 100 degrees from the third lug, and the third lug is about 60 degrees to about 100 degrees from the fourth lug.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to space the lugs of Shankarsetty as modified 60 to 100 degrees apart because Applicant places no criticality on the claimed range simply indicating that in some embodiments the lugs are spaced with a larger range than the claimed range (see [0040]). One of ordinary skill in the art, furthermore, would have expected Shankarsetty’s loop, and applicant’s invention, to perform equally well with either the spacing taught by Shankarsetty or the claimed spacing because both spacing angles would perform the same function of connecting the loop and the frame.
Therefore, it would have been prima facie obvious to modify Shankarsetty to obtain the invention as specified in claims 6 and 15 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Shankarsetty.
Regarding claim 36, Shankarsetty discloses the claimed invention substantially as claimed, as set forth above for claim 35. Shankarsetty fails to expressly disclose the bend is at an angle within a range of about 0 degrees to about 90 degrees.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the bend of Shankarsetty at an angle within a range of about 0 degrees to about 90 degrees as modified because Applicant places no criticality on the claimed range simply indicating that the angle “may be” within in the claimed range (see [0008]). One of ordinary skill in the art, furthermore, would have expected Shankarsetty’s frame, and applicant’s invention, to perform equally well with either the angle taught by Shankarsetty or the angle claimed because both measures would allow the frame to compress.
Therefore, it would have been prima facie obvious to modify Shankarsetty as modified to obtain the invention as specified in claim 36 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Shankarsetty.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shankarsetty in view of Kimura.
Regarding claims 4 and 13, Shankarsetty discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 10. Shankarsetty is silent regarding the loop member has a diameter, and the slit defines an opening having a width, wherein the width of the slit opening is less than the diameter of the loop member.
However Kimura, in the same filed of endeavor, teaches (fig. 17A-17B) a frame (2+3; see [0056]), a deployable segment 6 (see fig. 17A), wherein the deployable segment comprises a loop member (loop of 6) formed at a distal region of the deployable segment (see fig. 17A and [0085]); and wherein the frame (2+4) is operatively coupled to the loop member 6 via lugs 4 (see fig. 17A-B and [0085]); wherein the loop member 6 remains coupled to the frame when external forces are not applied (see [0086]); and when a sufficient external force is applied, the loop member will be released from the frame, thereby achieving a detachment of the loop member 6 from the frame (see [0086]), the loop member has a diameter, and the lugs comprise a slit defining an opening 11 having a width (see fig. 17B), wherein the width of the slit opening 11 is less than the diameter of the loop member 6 (see fig. 17B and [0086]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Shankarsetty to have the loop member has a diameter, and the slit defines an opening having a width, wherein the width of the slit opening is less than the diameter of the loop member as taught by Kimura, for the purpose of retaining the loop in the lugs until is pulled to release therefrom to maintain it in the correct location during use (see Kimura [0086]).
Claims 18, 19, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Shankarsetty in view of Heuser et al. (US 20010031970 A1).
Regarding claims 18 and 31, Shankarsetty discloses the claimed invention substantially as claimed, as set forth above for claims 17 and 28. Shankarsetty further discloses (fig. 1-3A and 4-5) the cannula comprises: i. a distal portion, ii. a proximal portion (see fig. 1).
Shankarsetty is silent regarding the distal portion is more flexible than the proximal portion.
However Heuser, in the same filed of endeavor, teaches (fig. 3-4) a cannula 12 comprising a distal portion 24 and a proximal portion (remainder of 12; see fig. 3), wherein the distal portion 24 is more flexible than the proximal portion (see [0021]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Shankarsetty to have the distal portion is more flexible than the proximal portion in the form of a distal coil as taught by Heuser, for the purpose of being able to visualize the distal end under fluoroscopy and increasing flexibility at the distal end of the device to improve trackability to the treatment location (see Heuser [0021]).
Regarding claim 19 and 32, Shankarsetty as modified discloses the claimed invention substantially as claimed, as set forth above for claim 18 and 31. Shankarsetty as modified fails to expressly disclose the distal portion comprises about 10% to about 40% of the cannula and the proximal portion comprises about 60% to about 90% of the cannula.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the distal portion comprises about 10% to about 40% of the cannula and the proximal portion comprises about 60% to about 90% of the cannula of Shankarsetty as modified because Applicant places no criticality on the claimed range simply indicating that in some embodiments the portions are in the claimed range (see [0031]). One of ordinary skill in the art, furthermore, would have expected Shankarsetty as modified’s cannula, and applicant’s invention, to perform equally well with either the percentages taught by Shankarsetty as modified or the percentages spacing because both percentages angles would provide flexibility to the distal end of the cannula.
Therefore, it would have been prima facie obvious to modify Shankarsetty as modified to obtain the invention as specified in claim 19 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Shankarsetty as modified.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Shankarsetty in view of Ravikumar et al. (US 20160324515 A1).
Regarding claim 26, Shankarsetty discloses the claimed invention substantially as claimed, as set forth above for claim 20. Shankarsetty is silent regarding a tip coupled to the distal region of the frame.
However Ravikumar, in the same filed of endeavor, teaches (fig. 1-5) a tip 30 coupled to the distal region of the frame 100 (see fig. 1-5 and [0044]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Shankarsetty to have a tip coupled to the distal region of the frame as taught by Ravikumar, for the purpose being able to self insert the device without a port or trocar to reduce the complexity and time of a procedure (see Ravikumar [0044]).
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious (in addition to the limitations of claim 1 and 10): the at least three lugs each further define a lug aperture, and wherein the frame is configured to extend through each lug aperture.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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