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
Claims filed on December 24th, 2025 have been entered. Claims 1-5 and 7-20 are pending in the application. The amendment to the claims overcome the previous claim objections, the previous 35 U.S.C. 112(b) rejections, and the claim amendments overcome the previous 35 U.S.C. 101 rejection.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-20 under 35 U.S.C. 103 over Balasubramanian (WO 2017/025986) has been withdrawn in light of applicant’s amendments and arguments; specifically Balasubramanian does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member and wherein the distance between a tip of the jaw of the third member and a root of the adventitia is less than a quarter of the natural outer perimeter of the blood vessel to be occluded.
Claim(s) 1- 5 and 7- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balasubramanian (WO 2017/025986) in view of Eggert et al. (US 2021/0169651).
Regarding claim 1, Balasubramanian teaches a three jaw clamp apparatus (200)(Figs. 8a- 10b) for occluding a blood vessel and opening a lumen of the blood vessel (abstract and Paragraph 00139), the three jaw clamp apparatus comprising:
A first member (202), a second member (204), a third member (206); wherein each member comprises a handle (202b, 204b, 206b) and a jaw (202a, 204a, 206a)(Paragraph 00139); and
Wherein the first member and the second member are laterally moveable toward and away from one another (Paragraph 00139);
Wherein the third member is laterally moveable toward and away from the first member (Paragraph 00139);
Wherein the first member and the second member are configured to occlude the blood vessel in between corresponding jaws when a pinch force is applied on the handle of the first member and the handle of the second member (Paragraph 00141);
Wherein the third member and the first member are configured to occlude an adventitia of the blood vessel in between corresponding jaws when a pinch force is applied on the handle of the third member and the handle of the first member (Paragraph 00142); and
Wherein the third member and the first member are configured to maintain a tension in the adventitia by creating a holding tension on the adventitia to open the blood vessel (Paragraph 00139).
Regarding the steps of applying the pinch force, on the handle of the first member and the handle of the second member, causing corresponding jaws to open; positioning the open jaws about the blood vessel; and releasing the pinch force, on the handle of the first member and the handle of the second member; and causing the open jaws to close on the blood vessel, Balasubramanian teaches the structure (see above) and these steps (Paragraph 000141).
Regarding the steps of applying the pinch force, on the handle of the third member and the handle of the first member, causing corresponding jaws to open; positioning the adventitia between the open jaws; and releasing the pinch force, on the handle of the third member and the handle of the first member, causing the open jaws to close on the adventitia, Balasubramanian teaches the structure (see above) and these steps (Paragraph 000142).
Balasubramanian does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member, or wherein the distance between the a tip of the jaw of the third member and a root of the adventitia is less than a quarter of the natural outer perimeter of the blood vessel to be occluded.
Furthermore, since Balasubramanian teaches a three jaw clamp apparatus for occluding a blood vessel and opening the lumen of a blood vessel (abstract and Paragraph 00139), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the a tip of the jaw of the third member and a root of the adventitia is less than a quarter of the perimeter of the maximum size of the blood vessel, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Balasubramanian does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member.
Eggert (Eggert et al.) teaches a similar clamp apparatus (100)(Figs. 1A- 1D) for clamping tissue (abstract), the apparatus comprising: a first member (part of body 105, see annotated Fig. 1A and 1C below), a second member (122), and a third member (120), wherein the second member is laterally movable toward and away from the first member and the third member is laterally movable toward and away from the first member (see annotated Fig. 1A and 1C below)(Paragraphs 0036- 0037) and wherein the jaw of the third member has a width of approximately half of the width of the jaw of the first member (Paragraph 0039).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the jaw of the third member as taught by Balasubramanian to have the same width as the jaw of the third member as taught by Eggert, for the purpose of grasping tissue within the body. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the shape of the jaw of the third member as taught by Balasubramanian for the shape of the jaw of the third member as taught by Eggert because both shapes are disclosed as equivalent structures for providing a grasping force upon tissue within the body (Balasubramanian, Paragraph 00142; Eggert, Paragraphs 0036- 0039) and substitution of one for the other would have resulted in the predictable result of providing a different amount of grasping force for one part of the tissue. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member.
Eggert sets forth that width is a result effective variable, wherein the width can be modified according to apportioning of it with each member and can be approximately half of the width of the first member 105 (Paragraph 0039 of Eggert). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the width of the jaw of the third member to be 60% of the that of the jaw of the first member, for the purpose of grasping tissue within the body, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (MPEP 2144.05)(In re Aller, 105 USPQ 233)
Regarding claim 2, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the apparatus comprises at least one biasing unit (208a, 208b) placed between each adjacent pair of the handles of each member to impart a pinch force along a length of corresponding jaws (see annotated Fig. 8b below)(Paragraphs 00140 and 00154).
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Regarding claim 3, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the holding tension in the adventitia in an outward direction opposes the collapse of the blood vessel by lifting an intima of the blood vessel to open the blood vessel and keeps the blood vessel in an opened state (Paragraphs 00143- 00145).
Regarding claim 4, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the jaw of the first member and the jaw of the second member are selectively movable from a first position relative to the jaw of the first member and the jaw of the second member to a second position when the pinch force is applied on the handle of the first member and the handle of the second member (Paragraph 00146).
Regarding claim 5, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the jaw of the first member and the jaw of the third member are selectively movable from a first position relative to the jaw of the first member and the jaw of the third member to a second position when the pinch force is applied on the handle of the first member and the handle of the third member (Paragraph 00147).
Regarding claim 7, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the first handle, second handle, and third handle comprise at least one non- slip surface, at least one of a flat configuration, a curved configuration, and combinations thereof (Paragraph 00148).
Regarding claim 8, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the first jaw, second jaw, and third jaw comprise at least one non- slip surface, at least one of a flat configuration, a curved configuration, and combinations thereof (Paragraphs 00149 and 00151).
Regarding claim 9, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the first jaw, second jaw, and third jaw comprise at least one insert mounted on at least one contact surface (Paragraph 00151).
Regarding claim 10, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the first jaw, second jaw, and third jaw and the first handle, second handle and third handle are made of a single member or one or more joint members (Paragraphs 00152 and 00153).
Regarding claim 11, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Regarding wherein the structure of the handle of the third member is configured to travel a minimum distance before coming in contact to the handle of the first member upon complete opening of the jaw of the third member relative to the jaw of the first member, since this language is functional, the structure only needs to have the ability to complete the function, which the structure taught by Balasubramanian would have as the structure of the third member is similar to the claimed structure (see Fig. 8b)(Paragraphs 00139- 00142).
Regarding claim 12, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein an additional member (biasing unit 208a)(For purposes of examination, as claim 12 depends from claim 1, the biasing unit of Balasubramanian is considered for this claim to be an additional member.) placed between the handle of the first member and the handle of the third member (see Fig. 8a)(Paragraph 00154).
Regarding the additional member being configured to reduce travel of the handle of the third member before coming in contact with the handle of the first member upon complete opening of the jaw of the third member relative to the jaw of the first member, as the additional member is between the two handles, it takes up space and would therefore reduce the travel of the handle of the third member compared to if the additional member was not present between the two handles.
Regarding claim 13, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the handles of the first, second, and third member comprise structural gaps (see annotated Fig. 8a below).
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Regarding the structural gaps permitting the biasing units to pass through during their travel, since this language is functional, the structure only needs to have the ability to complete the function, as the biasing members are within the structural gaps between the handles (see Fig. 8a), when the biasing units move during their travel, they move within the gaps and therefore are able to pass through them.
Regarding claim 14, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teach wherein the handles of the first, second, and third member comprise structural gaps (see annotated Fig. 8a below).
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Regarding the structural gaps permitting cleaning agents and other accessory instruments to reach a space between the handles and biasing units, since this language is functional, the structure only needs to have the ability to complete the function, as the gaps provide a space between the handles and the biasing units (see Fig. 8a), cleaning agents and other accessory instruments are able to reach.
Regarding claim 15, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the handles of the first, second, and third member comprise structural gaps to permit biasing units to pass through a structure of the handles of the members (see annotated Fig. 8a below)(As the biasing units are disposed within the structure of the first, second, and third members (see Fig. 8a), they are able to pass through the structure of the handles.).
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Regarding claim 16, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the handles of the first, second, and third member comprise structural gaps (see annotated Fig. 8a below).
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Regarding wherein members of the biasing units are joined via welding at one welding point or surface, this claim limitation is a product by process limitation and therefore is only considered as it affects the final product, in the instant case the claimed method imparts to the product attaching the biasing units. Since Balasubramanian teaches that at least one set of the biasing units are attached (see Fig. 8a), Balasubramanian teaches this claim.
Regarding the structural gaps permitting a welding electrode to reach the welding point or surface, since this language is functional, the structure only needs to have the ability to complete the function, as the gaps provide a space between the handles and the biasing units (see Fig. 8a), a welding electrode would be able to reach the welding point or surface.
Regarding claim 17, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein the one or more biasing members comprise a curved structure (see annotated Fig. 8a below).
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Regarding the curved structure reducing concentration of stress to promote longevity of the apparatus, since this language is functional, the structure only needs to have the ability to complete the function, which a curved structure on the one or more biasing members would have.
Regarding claim 18, Balasubramanian teaches a three jaw clamp system (1000)(Figs. 10a- 10b) for occluding a blood vessel and opening a lumen of the blood vessel (abstract and Paragraphs 00157- 00158), the three jaw clamp apparatus comprising:
A pair of three jaw clamp apparatuses (200a and 200b), wherein each of the three jaw clamp apparatuses are configured to occlude the blood vessel (Paragraphs 000157- 000158 ); and
A support member (210) connecting the pair of three jaw clamp apparatuses, in proximity to each other (Paragraph 00158), wherein each of the three jaw clamp apparatuses comprises:
A first member (202), a second member (204), a third member (206); wherein each member comprises a handle (202b, 204b, 206b) and a jaw (202a, 204a, 206a)(Paragraph 00139); and
Wherein the first member and the second member are laterally moveable toward and away from one another (Paragraph 00139);
Wherein the third member is laterally moveable toward and away from the first member (Paragraph 00139);
Wherein the first member and the second member are configured to occlude the blood vessel in between corresponding jaws when a pinch force is applied on the handle of the first member and the handle of the second member (Paragraph 00141);
Wherein the third member and the first member are configured to occlude an adventitia of the blood vessel in between corresponding jaws when a pinch force is applied on the handle of the third member and the handle of the first member (Paragraph 00142); and
Wherein the third member and the first member are configured to maintain a tension in the adventitia by creating a holding tension on the adventitia to open the blood vessel (Paragraph 00139).
Regarding the steps of applying the pinch force, on the handle of the first member and the handle of the second member, causing corresponding jaws to open; positioning the open jaws about the blood vessel; and releasing the pinch force, on the handle of the first member and the handle of the second member; and causing the open jaws to close on the blood vessel, Balasubramanian teaches the structure (see above) and these steps (Paragraph 000141).
Regarding the steps of applying the pinch force, on the handle of the third member and the handle of the first member, causing corresponding jaws to open; positioning the adventitia between the open jaws; and releasing the pinch force, on the handle of the third member and the handle of the first member, causing the open jaws to close on the adventitia, Balasubramanian teaches the structure (see above) and these steps (Paragraph 000142).
Balasubramanian does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member, or wherein the distance between the a tip of the jaw of the third member and a root of the adventitia is less than a quarter of the natural outer perimeter of the blood vessel to be occluded.
Furthermore, since Balasubramanian teaches a three jaw clamp apparatus for occluding a blood vessel and opening the lumen of a blood vessel (abstract and Paragraph 00139), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the distance between the a tip of the jaw of the third member and a root of the adventitia is less than a quarter of the perimeter of the maximum size of the blood vessel, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Balasubramanian does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member.
Eggert (Eggert et al.) teaches a similar clamp apparatus (100)(Figs. 1A- 1D) for clamping tissue (abstract), the apparatus comprising: a first member (part of body 105, see annotated Fig. 1A and 1C below), a second member (122), and a third member (120), wherein the second member is laterally movable toward and away from the first member and the third member is laterally movable toward and away from the first member (see annotated Fig. 1A and 1C below)(Paragraphs 0036- 0037) and wherein the jaw of the third member has a width of approximately half of the width of the jaw of the first member (Paragraph 0039).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the jaw of the third member as taught by Balasubramanian to have the same width as the jaw of the third member as taught by Eggert, for the purpose of grasping tissue within the body. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the shape of the jaw of the third member as taught by Balasubramanian for the shape of the jaw of the third member as taught by Eggert because both shapes are disclosed as equivalent structures for providing a grasping force upon tissue within the body (Balasubramanian, Paragraph 00142; Eggert, Paragraphs 0036- 0039) and substitution of one for the other would have resulted in the predictable result of providing a different amount of grasping force for one part of the tissue. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
The combination does not teach wherein the jaw of the third member has a width less than 60% of that of the jaw of the first member.
Eggert sets forth that width is a result effective variable, wherein the width can be modified according to apportioning of it with each member and can be approximately half of the width of the first member 105 (Paragraph 0039 of Eggert). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the width of the jaw of the third member to be 60% of the that of the jaw of the first member, for the purpose of grasping tissue within the body, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (MPEP 2144.05)(In re Aller, 105 USPQ 233).
Regarding claim 19, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian does not teach in the current embodiment wherein the support member is one of a connector, an approximator, a retractor, and a frame.
Balasubramanian teaches in a second embodiment, a jaw clamp system (700)(Figs. 7a- 7b) for occluding a blood vessel and opening a lumen of the blood vessel (abstract and Paragraphs 00120), the three jaw clamp apparatus comprising: a pair of jaw clamp apparatuses (100a and 100b), wherein each of the three jaw clamp apparatuses are configured to occlude the blood vessel (Paragraph 00120); a support member (118) connecting the pair of jaw clamp apparatuses, in proximity to each other (Paragraph 00120) and wherein the support member is one of a connector, an approximator or a frame (Paragraph 00137), wherein each of the three jaw clamp apparatuses comprises: A first member (102), a second member (104), a third member (106); wherein each member comprises a handle (102b, 104b, 106b) and a jaw (102a, 104a, 106a)(Paragraph 00120).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the support member as taught by the first embodiment of Balasubramanian to be a connector, an approximator, or a frame as taught by the second embodiment of Balasubramanian, since Balasubramanian teaches both support members and that the support member of both embodiments connects the two pair of jaw clamp apparatuses (Paragraphs 00120 and 00157- 00158).
Regarding claim 20, Balasubramanian and Eggert make obvious the three jaw clamp apparatus as discussed above.
Balasubramanian further teaches wherein a biasing member is placed in contact between the approximator and each second member of the pair of three jaw clamp apparatuses (see annotated Fig. 10a below).
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Regarding the language of is configured to impart adequate frictional force large enough to prevent undesired sliding and provide smooth motion upon applying deliberate force to cause relative motion, since this language is functional, the structure only needs to have the ability to complete the function, as Balasubramanian teaches a similar structure with the biasing member being placed in contact between the approximator and each second member, the structure would be able to impart adequate frictional force.
Response to Arguments
Applicant’s arguments, see Pages 14- 23, filed December 24th, 2025, with respect to the rejection(s) of claim(s) 1-20 under Balasubramanian (WO 2017/025986) regarding that Balasubramanian does not teach or make obvious a third jaw having a width less than 60% of the width of the first jaw have been fully considered and are persuasive and the amendments to claims 1 and 18 overcome the previous prior art rejection. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Eggert et al. (US 2021/0169651). It is noted that Balasubramanian (WO 2017/025986) is still relied upon in this rejection.
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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771