DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendments filed on 12/08/2025 have been entered. Claims 1-20 remain pending in the application.
Allowable Subject Matter
Claims 8-20 are allowed.
The following is an examiner’s statement of reasons for allowance: Regarding claim 8, the prior art of record fails to teach or render obvious a ligation clip wherein the inner hinge surface includes a concave portion having a first end directly joining the heel and a second end joining the second tissue clamping inner surface, in combination with the remaining limitations. See applicants’ arguments field on 12/08/2025 which are found to be persuasive. Regarding claim 15, the prior art of record fails to teach or render obvious a ligation clip having a heel including at least one tooth configured to engage tissue, and the first and second jaw members are configured to pinch a proximal portion of tissue prior to the ligation clip reaching a fully closed position, in combination with the remaining limitations. See applicants’ arguments field on 12/08/2025 which are found to be persuasive.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments with regard to claim 1 filed 12/08/2025 have been fully considered but they are not persuasive. Applicant argues that the device of Menn fails to teach the first convex inner segment being located between the hinge portion and the first concave inner segment and the second convex inner segment being located between the hinge portion and the second concave inner segment. Examiner respectfully disagrees in view of the alternative interpretation set forth below which applies the broadest reasonable interpretation of a “segment”. Examiner suggests that specifying the S-shaped inner surface to be formed continuously along a longitudinal axis of the clip (instead of transversely to the axis as is found in the device of Menn) would overcome the prior art rejection.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 and 7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Menn (US 2011/0224701) in view of Whiting (US 2009/0171380).
Regarding claims 1-3, Menn discloses a ligation clip (1, FIG 1-14, [0061]) for ligating a tissue, the ligation clip comprising: first (2) and second (3) jaw members (FIG 1) having proximal portions (Region of each arm on the end towards hinge 4) and distal portions (Regions of each arm on the end towards the free ends), the first and second jaw members extending generally longitudinally (FIG 3) and movably coupled to each other by a hinge portion (4) at the proximal portions (FIG 3, [0065]), the first and second jaw members moveable from an open configuration (FIG 3) to a closed configuration (FIG 8-9); wherein the first jaw member includes a first inner surface (Inner surface of region 2b, FIG 1 and 3) and the second jaw member includes a second inner surface (Inner surface of region 3b, FIG 3); wherein the first inner surface includes a first S-shaped inner surface (See cross section of FIG 4 and 10, wherein the cross sectional shape runs along the length of the jaw member) having a first convex inner segment (Either of convex ridges 12, 13. The ‘segment’ is interpreted as a portion located towards the hinge end of the clip) and a first concave inner segment (formed by either of concave grooves 10 and 11. The ‘segment’ is interpreted as a portion located towards the free end of the clip) between the distal end and the hinge portion (FIG 1 shows the grooved surface is between the hinge and the distal ends), the first convex inner segment being located between the hinge portion and the first concave inner segment (As set forth in the interpretation and because ‘segment’ can refer to only a particular portion of an element, the convex segment is interpreted as a portion located more towards the hinge side and the concave segment is interpreted as a portion located more towards the distal end, thereby meeting the limitation of the claim), the first convex inner segment being closer to the hinge portion than the distal end (As shown in FIG 1, there is at least some section of the inner surface at 2b which comprises the convex segment and is closer to the hinge), the second inner surface includes a second S-shaped inner surface (See cross section of FIG 10) having a second concave inner segment (formed by either of concave grooves 15 and 16. The ‘segment’ is interpreted as a portion located towards the free end of the clip) and a second convex inner segment (Either of convex ridges 17, 18. The ‘segment’ is interpreted as a portion located towards the hinge end of the clip) between the distal end and the hinge portion (FIG 5 shows the grooved surface is between the hinge and the distal ends), the second convex inner segment being located between the hinge portion and the second concave inner segment (As set forth in the interpretation and because ‘segment’ can refer to only a particular portion of an element, the convex segment is interpreted as a portion located more towards the hinge side and the concave segment is interpreted as a portion located more towards the distal end, thereby meeting the limitation of the claim), and the second convex inner segment being closer to the hinge portion than the distal end (As shown in FIG 3, there is at least some section of the inner surface at 3b which comprises the s-shape, concave, and convex segments and is closer to the hinge), and wherein the first convex inner segment of the first jaw member is configured to pinch a portion of the tissue when the first and second jaw members are in the closed configuration or moving to the closed configuration (As shown in FIG 10, the first convex inner segment pinches tissue of vessel V), and wherein the second concave inner segment of the second inner surface of the second jaw member faces the first inner surface of the first jaw member when the first and second jaw members are in the closed configuration (As shown in FIG 10 wherein 15 faces the inner surface of jaw 2) such that the tissue is clamped by the second concave inner segment of the second jaw member and the first inner surface of the first jaw member (See clamping of tissue in FIG 10, [0076-0077]).
Menn is silent regarding a first latching feature on the distal portion of the first jaw member; a second latching feature on the distal portion of the second jaw member, the second latching feature being configured to mate with the first latching feature to secure the ligation clip in the closed configuration, and a pair of first laterally-extending cylindrical bosses positioned on opposing sides of the distal portion of the first jaw member and a pair of second laterally-extending cylindrical bosses positioned on opposing sides of the distal portion of the second jaw member.
However, Whiting teaches a ligation clip (100, FIGS 1-3, paragraphs [0025-0036]) comprising a first jaw member (104, FIG 2) having a first latching feature (160, [0036]) on the distal portion of the first jaw member (FIG 2), a second jaw member (102) having a second latching feature (126, [0029]) on the distal portion of the second jaw (FIG 2), the second latching feature being configured to mate with the first latching feature to secure the ligation clip in the closed configuration (FIG 6, [0036]) a pair of first laterally-extending cylindrical bosses (152, 154, paragraphs [0035-0036]) positioned on opposing sides of the distal portion of the first jaw member (104, FIG 3) and a pair of second laterally-extending cylindrical bosses (146, 148, paragraphs [0035-0036]) positioned on opposing sides of the distal portion of a second jaw member (102, FIG 3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first and second jaw members to have a first and second latching feature at their respective distal ends configured to mate with one another to secure the ligation clip in the closed configuration, as taught by Whiting, for the purpose of having an additional means for retaining the jaws in the closed configuration to clamp the tissue and prevent undesired opening of the jaws ([0036]). Furthermore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the distal portions of the first and second jaw members of Perlin to each comprise a pair of laterally extending cylindrical bosses, as taught by Whiting, for the purpose providing engagement points at which a clip applicator instrument can attach for manipulating the device (Paragraph [0036]).
Regarding claim 4, Menn/ Whiting discloses the invention substantially as claimed, as set forth above for claim 1.
Menn is silent regarding the hinge portion including a wall defining an opening.
However, Whiting teaches a ligation clip (100, FIGS 1-3, paragraphs [0025-0036]) comprising first and second jaw members (102, 104) connected by a hinge portion (106) wherein the hinge portion includes a wall defining an opening (120, FIGs 1-3, paragraph [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time at the time of the invention to modify the hinge of Menn to comprise an opening, as taught by Whiting, for the purpose of providing the hinge portion with added flexibility and resiliency (Paragraph [0028]).
Regarding claim 5, Menn/ Whiting discloses the invention substantially as claimed, as set forth above for claim 1. Menn further discloses the ligation clip is made of a non-metallic biocompatible material ([0088] disclose the clip being made of plastic. One of ordinary skill in the art would understand this material to be biocompatible).
Regarding claim 7, Menn/ Whiting discloses the invention substantially as claimed, as set forth above for claim 1.
Menn is silent regarding the first jaw member includes a piercing element at the distal portion of the first jaw, wherein the piercing element includes a longitudinally extending edge, and the second jaw includes an edge receiver on the distal portion.
However, Whiting teaches a ligation clip (100, FIGS 1-3, paragraphs [0025-0036]) comprising first and second jaw members (104, 102) wherein the first jaw member includes a piercing element (128, FIG 1, paragraph [0029 and 0035-0036]) at the distal portion of the first jaw (FIGs 1-3), wherein the piercing element includes a longitudinally extending edge (An edge of tip section 128), and the second jaw includes an edge receiver on the distal portion 9Paragraph [0036] discloses how 128 is aligned and engaged with a receiving feature of the opposing jaw in order to secured the clip in a latched condition).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the distal portions of the first jaw of Menn to comprise a piercing element having a longitudinally extending edge and the distal portion of the second jaw to comprise an edge receiver, as taught by Whiting, for the purpose of providing opposing engagement features to maintain a clamped configuration of the jaws (Paragraph [0036]).
Claims 1 and 5-6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Perlin (US 4,726,372) in view of Menn (US 2011/0224701).
Regarding claims 1, 5, and 6, Perlin discloses a ligation clip (10, FIG 8) for ligating a tissue, the ligation clip comprising: first (12) and second (14) jaw members (FIGs 8-10) having proximal portions (Region of each arm on the end towards hinge 16) and distal portions (Regions of each arm on the end towards the locking pawl and mechanism), the first and second jaw members extending generally longitudinally (FIGs 8-10) and movably coupled to each other by a hinge portion (16) at the proximal portions, the first and second jaw members moveable from an open configuration (FIG 8) to a closed configuration (FIG 9); a first latching feature (54) on the distal portion of the first jaw member (FIG 8); a second latching feature (64) on the distal portion of the second jaw member (FIG 8), the second latching feature being configured to mate with the first latching feature to secure the ligation clip in the closed configuration (Col 6 lines 1-19); wherein the first jaw member includes a first inner surface (22) and the second jaw member includes a second inner surface (24); wherein the ligation clip is made of a non-metallic biocompatible material (Abstract, col 7 lines 7-10 disclose the clip being made of plastic. One of ordinary skill in the art would understand this material to be biocompatible), and the hinge portion is asymmetrically positioned relative to the first and second jaw members (FIG 8 shows the asymmetrical positioning of the hinge relative to each of the jaw members).
Perlin is silent regarding the first inner surface including a first S-shaped inner surface having a first convex inner segment and a first concave inner segment between the first latching feature and the hinge portion, the first convex inner segment being located between the hinge portion and the first concave inner segment, the first convex inner segment being closer to the hinge portion than the first latching feature, the second inner surface includes a second S-shaped inner surface having a second concave inner segment and a second convex inner segment between the second latching feature and the hinge portion, the second convex inner segment being located between the hinge portion and the second concave inner segment, and the second convex inner segment being closer to the hinge portion than the second latching feature, and wherein the first convex inner segment of the first jaw member is configured to pinch a portion of the tissue when the first and second jaw members are in the closed configuration or moving to the closed configuration and wherein the second concave inner segment of the second inner surface of the second jaw member faces the first inner surface of the first jaw member when the first and second jaw members are in the closed configuration such that the tissue is clamped by the second concave inner segment of the second jaw member and the first inner surface of the first jaw member.
However, Menn teaches a ligation clip (1, FIG 1-14, [0061]) comprising: first (2) and second (3) jaw members (FIG 1) having proximal portions (Region of each arm on the end towards hinge 4) and distal portions (Regions of each arm on the end towards the free ends), movably coupled to each other by a hinge portion (4) at the proximal portions (FIG 3, [0065]), wherein the first jaw member includes a first inner surface (Inner surface of region 2b, FIG 1 and 3) and the second jaw member includes a second inner surface (Inner surface of region 3b, FIG 3); wherein the first inner surface includes a first S-shaped inner surface (See cross section of FIG 10) having a first convex inner segment (Either of convex ridges 12, 13. The ‘segment’ is interpreted as a portion located towards the hinge end of the clip) and a first concave inner segment (formed by either of concave grooves 10 and 11. The ‘segment’ is interpreted as a portion located towards the free end of the clip) between the distal end and the hinge portion (FIG 1 shows the grooved surface is between the hinge and the distal ends), the first convex inner segment being located between the hinge portion and the first concave inner segment (As set forth in the interpretation and because ‘segment’ can refer to only a particular portion of an element, the convex segment is interpreted as a portion located more towards the hinge side and the concave segment is interpreted as a portion located more towards the distal end, thereby meeting the limitation of the claim), the first convex inner segment being closer to the hinge portion than the distal end (As shown in FIG 1, there is at least some section of the inner surface at 2b which comprises the s-shape, concave, and convex segments and is closer to the hinge), the second inner surface includes a second S-shaped inner surface (See cross section of FIG 10) having a second concave inner segment (formed by either of concave grooves 15 and 16. The ‘segment’ is interpreted as a portion located towards the free end of the clip) and a second convex inner segment (Either of convex ridges 17, 18. The ‘segment’ is interpreted as a portion located towards the hinge end of the clip) between the distal end and the hinge portion (FIG 5 shows the grooved surface is between the hinge and the distal ends), the second convex inner segment being located between the hinge portion and the second concave inner segment (As set forth in the interpretation and because ‘segment’ can refer to only a particular portion of an element, the convex segment is interpreted as a portion located more towards the hinge side and the concave segment is interpreted as a portion located more towards the distal end, thereby meeting the limitation of the claim), and the second convex inner segment being closer to the hinge portion than the distal end (As shown in FIG 3, there is at least some section of the inner surface at 3b which comprises the s-shape, concave, and convex segments and is closer to the hinge), and wherein the first convex inner segment of the first jaw member is configured to pinch a portion of the tissue when the first and second jaw members are in the closed configuration or moving to the closed configuration (As shown in FIG 10, the first convex inner segment pinches tissue of vessel V), and wherein the second concave inner segment of the second inner surface of the second jaw member faces the first inner surface of the first jaw member when the first and second jaw members are in the closed configuration (As shown in FIG 10 wherein 15 faces the inner surface of jaw 2) such that the tissue is clamped by the second concave inner segment of the second jaw member and the first inner surface of the first jaw member (See clamping of tissue in FIG 10, [0076-0077]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the first and second inner surfaces to each comprise at least one convex ridge and concave groove, as taught by Menn, for the purpose of increasing the ability of the jaw members to ligate or occlude a tubular blood vessel without piercing or cutting the vessel ([0077]), thus providing an advantage over the smooth flat inner surfaces of Perlin alone.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771