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 without traverse of Group I in the reply filed on August 17, 2026 is acknowledged. Applicant cancelled non-elected claims 6, 9, 11-12, 19-20, and 24-40 in the reply filed August 17,2026
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-5, 7-8, 10, 13-18, 21-23, 41-51 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
These claims contain recitations which encompass a human organism contravening 35 U.S.C. 101 and AIA section 33(a). For example, claims 1 and 41 recites that “one or more lymphatic channels into an open end of a vein or artery from supporting tissue…” Thus, the claim appears to require the presence of a one or more lymphatic channels into an open end of a vein or artery as part of the claimed closure device. It is suggested to amend this claim and any other claim reciting these structures with terminology such as “configured to” to thus only functionally recite these limitations to overcome this rejection. For example, the cited portion of claim 1 could read as “a coupling device that is configured to couple .
Claim Rejections - 35 USC § 102
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 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 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 1-5, 7-8, 10, 13-14, 41-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayakawa et. al. (WO2020/225603A1).
Regarding claim 1, Hayakawa discloses: a device for lymphovenous bypass surgery (Abstract, para. [0002]) comprising: a coupling device (Fig. 12) that couples one or more lymphatic channels into an open end of vein or artery from supporting tissue (para. [0059]-[0061] discloses arteries and veins require connection or anastomosis when transferring tissue from one part of the body to another and can be utilized in other surgical specialties), the coupling device having a first tissue grasping element 2 (Fig. 12) that extends in a first direction from a first side (tissue grasping element 2 is shown as attaching to a tubular tissue element 10) and configured to attach to the vein or artery and a second tissue grasping element 2 that extends in a second direction from a second side (Fig. 12) and configured to attach to a portion of the supporting tissue (para. [0059]); and wherein coupling device has an opening configured to receive the vein or artery (see Fig. 12 reproduced below).
The coupling device is fully capable of coupling one or more lymphatic channels into an open end of a vein or artery from supporting tissue, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
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Regarding claim 2, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the first tissue grasping element extends from a coupling device surface (i.e., at 1a as shown above with regard to Fig. 12) on a first side of a plane extending through the coupling device (Fig. 12) and the second tissue grasping element extends from a further coupling device surface (1b as shown above with regard to Fig. 12) on an opposite side of the plane (Fig. 12 above).
Regarding claim 3, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the coupling element has a cone- shaped surface extending around an aperture of the coupling element (Fig. 12 above) along a central axis orthogonal to a plane extending between opposite sides of the coupling device (Fig. 12).
Regarding claim 4, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the first tissue grasping element and the second tissue grasping element each include one or more pins that are rigid or semi-rigid elements (i.e., para. [0043] disclose stainless steel spikes 2) extending from respective opposing coupling device surfaces surrounding the opening (Fig. 8, 9, 12).
Regarding claim 5, Hayakawa discloses the device of claim 1. Hayakawa further discloses: further comprising a first cap 3’ element that encloses the first tissue grasping element (Fig. 12) and a second cap element 3’ that encloses the second tissue grasping element (Fig. 12).
Regarding claim 7, Hayakawa discloses the device of claim 5. Hayakawa further discloses: wherein the first cap element is connected to the second cap element (i.e., at least indirectly coupled since 2 couples 1a and 1b together such that the corresponding caps 3’ would also be indirectly connected).
Regarding claim 8, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the coupling device comprises a ring 6a,6b having a first radius D2 defining positions of a plurality of first tissue grasping elements spaced around a first circumference (Figs. 8, 9, 12) and wherein the ring has a second radius D1 defining positions of a plurality of second tissue grasping elements spaced around a second circumference (Figs. 8, 9, 12).
Regarding claim 10, Hayakawa discloses the device of claim 8. Hayakawa further discloses: wherein the second radius is smaller than the first radius (Fig. 12).
Regarding claim 13, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the first and second tissue grasping elements are equally spaced around respective opposing sides of the coupling device (Figs. 8, 9, 12).
Regarding claim 14, Hayakawa discloses the device of claim 1. Hayakawa further discloses: wherein the opening has a diameter in a range of 0.5 - 1.5 mm (para. [0049]).
Regarding claim 41, Hayakawa discloses: a device for lymphovenous bypass surgery (Abstract, para. [0002]) comprising: a coupling device (Fig. 12) that couples one or more lymphatic channels into an open end of vein or artery from supporting tissue (para. [0059]-[0061] discloses arteries and veins require connection or anastomosis when transferring tissue from one part of the body to another and can be utilized in other surgical specialties), the coupling device having a first tissue grasping element 2 (Fig. 12) that extends in a first direction from a first side (tissue grasping element 2 is shown as attaching to a tubular tissue element 10) and configured to attach to the vein or artery and a second tissue grasping element 2 that extends in a second direction from a second side (Fig. 12) and configured to attach to a portion of the supporting tissue (para. [0059]); and wherein coupling device has an opening configured to receive the vein or artery (see Fig. 12 reproduced above), the first tissue grasping element and the second tissue grasping element extending in opposite directions from opposing surfaces of the coupling device that surround the opening (i.e., see Fig. 12 reproduced above).
The coupling device is fully capable of coupling one or more lymphatic channels into an open end of a vein or artery from supporting tissue, if one desired to do so - note that the limitations of claim 1 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 42, Hayakawa discloses the device of claim 41. Hayakawa also discloses wherein the coupling element has a cone-shaped surface extending around an aperture of the coupling element along a central axis orthogonal to a plane extending between opposite sides of the coupling device (see Fig. 12 reproduced above).
Regarding claim 43, Hayakawa discloses the device of claim 41. Hayakawa also discloses wherein the first tissue grasping element and the second tissue grasping element each include one or more pins that are rigid or semi-rigid elements (i.e., para. [0043] disclose stainless steel spikes 2) extending from respective opposing coupling device surfaces surrounding the opening (Fig. 8, 9, 12).
Regarding claim 44, Hayakawa discloses the device of claim 41. Hayakawa also discloses further comprising a first cap element 3’ that encloses the first tissue grasping element (Fig. 12) and a second cap element 3’ that encloses the second tissue grasping element (Fig. 12).
Regarding claim 45, Hayakawa discloses the device of claim 41. Hayakawa also discloses wherein the coupling device comprises a ring 6a,6b having a first radius D2 defining positions of a plurality of first tissue grasping elements spaced around a first circumference (Figs. 8, 9, 12) and wherein the ring has a second radius D1 defining positions of a plurality of second tissue grasping elements spaced around a second circumference (Figs. 8, 9, 12).
Regarding claim 46, Hayakawa discloses the device of claim 45. Hayakawa further discloses: wherein the second radius is smaller than the first radius (Fig. 12).
Regarding claim 47, Hayakawa discloses the device of claim 41. Hayakawa further discloses: wherein the first and second tissue grasping elements are equally spaced around the respective opening sides of the coupling device (Figs. 8, 9, 12) and wherein the opening has a diameter in a range of 0.5 - 1.5 mm (para. [0049]).
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 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.
Claims 15-17, 21-22, 48, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa in view of Milliman et al. (US 20020019642 A1).
Regarding claim 15, Hayakawa discloses the device of claim 1. Hayakawa doesn’t directly disclose further comprising a grasping tool including a tubular body that is configured to extend through an opening in the coupling element.
In the same field of endeavor, namely anastomosis instrument and method, Milliman discloses a similar device to Hayakawa and also discloses: comprising a grasping tool including a tubular body that is configured to extend through an opening in the coupling element (para. [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hayakawa with a grasping tool including a tubular body that is configured to extend through an opening in the coupling element for purposes of connecting the vein or artery to the coupling element (para. [0103]).
Regarding claim 16, Hayakawa and Milliman disclose the device of claim 15. The resulting device would also teach wherein the tubular body has a diameter in a range of 0.5-1.5 mm (i.e., at least because the grasper has to pass through the coupling element which Hayakawa disclosed falls within the claimed range (para. [0049]).
Regarding claim 17, Hayakawa and Milliman disclose the device of claim 15. Milliman also discloses wherein the grasping tool has one or more distal elements configured to grasp (i.e., surgical hook or graspers as disclosed in para. [0103]).
The grasping tool is fully capable of grasping the one or more lymphatic channels, if one desired to do so - note that the limitations of claim 17 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
Regarding claim 21, Hayakawa and Milliman disclose the device of claim 15. The resulting device of Hayakawa as modified by Milliman also teaches wherein the tubular body extends through the coupling element to grasp the one or more lymphatic channels with distal elements and pull ends of the one or more lymphatic channels through the opening of the coupling element and into the vein or artery (i.e., as disclosed by para. [0103]).
The grasping tool is fully capable of grasping the one or more lymphatic channels with distal elements and pull ends of the one or more lymphatic channels through the opening of the coupling element and into the vein or artery, if one desired to do so - note that the limitations of claim 21 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
Regarding claim 22, Hayakawa and Milliman disclose the device of claim 15. Hayakawa also discloses wherein the coupling device has an outer circumference configured to have a size such that the supporting tissue is positioned around at least a portion of the circumference to engage the second tissue grasping element (Fig. 12). Milliman also discloses wherein the coupling device has an outer circumference configured to have a size such that the supporting tissue is positioned around at least a portion of the circumference to engage the second tissue grasping element (para. [0103]).
Regarding claim 48, Hayakawa discloses the device of claim 41. Hayakawa doesn’t directly disclose further comprising a grasping tool including a tubular body that is configured to extend through an opening in the coupling element.
In the same field of endeavor, namely anastomosis instrument and method, Milliman discloses a similar device to Hayakawa and also discloses: comprising a grasping tool including a tubular body that is configured to extend through an opening in the coupling element (para. [0103]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hayakawa with a grasping tool including a tubular body that is configured to extend through an opening in the coupling element for purposes of connecting the vein or artery to the coupling element (para. [0103]).
Regarding claim 50, Hayakawa and Milliman disclose the device of claim 48. The resulting device of Hayakawa as modified by Milliman also teaches wherein the tubular body extends through the coupling element to grasp the one or more lymphatic channels with distal elements and pull ends of the one or more lymphatic channels through the opening of the coupling element and into the vein or artery (i.e., as disclosed by para. [0103]).
The grasping tool is fully capable of grasping the one or more lymphatic channels with distal elements and pull ends of the one or more lymphatic channels through the opening of the coupling element and into the vein or artery, if one desired to do so - note that the limitations of claim 21 are merely functional limitations and do not affect the structure of the claimed invention as discussed above.
Claims 18, 23, 49, 51 are rejected under 35 U.S.C. 103 as being unpatentable over Hayakawa in view of Milliman et al. (US 20020019642 A1) and further in view of McKenna et al. (US 20080082114 A1).
Regarding claim 18, Hayakawa and Milliman disclose the device of claim 17. Hayakawa and Milliman don’t directly disclose wherein the grasping tool further comprises an actuator that moves the one or more distal elements on the tubular body to grasp tissue.
In the same field of endeavor, namely adhesive mechanical fastener for lumen creation utilizing tissue necrosing means, McKenna discloses a similar device to Hayakawa including a coupling element (Fig. 2) and further including a grasping tool 80 wherein the grasping tool further comprises an actuator (i.e., on the handle as shown in Fig. 5) that moves the one or more distal elements on tubular body 82 to grasp tissue (i.e., see Figs 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hayakawa and Milliman to have an actuator on the grasping tool for purposes of grasping the device/tissue in situ (Fig. 8; para. [0031]).
Regarding claim 23, Hayakawa and Milliman disclose the device of claim 15. McKenna also discloses wherein the grasping tool includes one or more manually actuated elements coupled to distal grasping elements (i.e., handle as shown in Fig. 5), the manually actuated elements having flexible surface elements such that a user adjusts an applied pressure to tissue being grasped using tactile sensing of applied pressure (i.e., at least by manipulating the handle to apply more or less pressure such that the clamping force directly corresponds to user control (para. [0031]).
Regarding claim 49, Hayakawa and Milliman disclose the device of claim 48. Milliman also discloses wherein the grasping tool has one or more distal elements configured to grasp the one or more lymphatic channels (para. [0103]). Hayakawa and Milliman don’t directly disclose an actuator that moves the one or more distal elements on the tubular body to grasp tissue.
In the same field of endeavor, namely adhesive mechanical fastener for lumen creation utilizing tissue necrosing means, McKenna discloses a similar device to Hayakawa including a coupling element (Fig. 2) and further including a grasping tool 80 wherein the grasping tool further comprises an actuator (i.e., on the handle as shown in Fig. 5) that moves the one or more distal elements on tubular body 82 to grasp tissue (i.e., see Figs 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Hayakawa and Milliman to have an actuator on the grasping tool for purposes of grasping the device/tissue in situ (Fig. 8; para. [0031]).
Regarding claim 51, Hayakawa and Milliman disclose the device of claim 48. McKenna also discloses wherein the grasping tool includes one or more manually actuated elements coupled to distal grasping elements (i.e., handle as shown in Fig. 5), the manually actuated elements having flexible surface elements such that a user adjusts an applied pressure to tissue being grasped using tactile sensing of applied pressure (i.e., at least by manipulating the handle to apply more or less pressure such that the clamping force directly corresponds to user control (para. [0031]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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