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 in response to the applicant’s communication filed 06/02/2026.
Status of the claims:
Claims 1 – 6, 8 – 17, and 19 – 20 are pending in the application.
Claims 1, 2, 4 – 6, 8 – 9, 12, 14, 15, 17, and 19 are amended.
Drawings
The replacement drawings for Fig. 2A were received on 06/02/2026. These drawings are acceptable and overcome the previous drawing objections in the Non-Final office action mailed on 03/04/2026.
Claim Objections
The objections to claims 9, 14, 15, 17, and 18 in the previous action dated 03/02/2026 have been withdrawn in light of the Applicant’s amendments filed 06/02/2026. Specifically, the objection to claims 9 and 18, regarding the phrase “the top of incision assembly”, and the objection to claims 15 and 17, regarding the phrase “a force”, have all been withdrawn as the appropriate corrections have been made. However, the objection to claim 14 has been maintained as the amendment did not correct the issue at hand; the objection has been repeated below.
Claim 14 is objected to because of the following informalities:
Claim 14 recites “to energy to”, however this is not grammatically correct, therefore the Examiner suggests the line be amended to read “energy to”;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of claims 1 – 20 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 03/02/2026 have been withdrawn in light of the Applicant’s amendments filed 06/02/2026. Specifically, the rejection of claims 1, 7, 8, 9, 15, 17, and 18 regarding the lack of clarity in the phrase "reversibly extends", the rejection of claim 14 regarding the lack of clarity in the phrase "incision device", and the rejection of claims 2 – 14 and 18 – 20 for being dependent on an indefinite claim have all been withdrawn as the appropriate corrections have been made. However, new rejections under U.S.C 35 112(b) regarding indefiniteness have been set forth below in light of the amendments.
Claims 15 and 16 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.
Regarding claim 15, the phrases "stabilizing members at least one stabilizing member are adjacent" renders the claim indefinite because it is unclear if Applicant is intending to require multiple stabilizing members or require only “at least one” stabilizing member. For the purpose of examination and based off Applicant’s disclosure, the Examiner will read the limitation as “stabilizing members, wherein at least one of the stabilizing members is adjacent”.
Claim 16 is rejected for being dependent on an indefinite claim.
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 (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 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 – 6, 8, 9, 11, 14 – 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman (US 2,816,552) (previously recited).
Regarding claim 1, Hoffman teaches a device (teat bistoury) (col. 1 lines 15 – 55, col. 2 lines 16 – 30, col. 2 line 55 – col. 3 line 5, col. 4 lines 7 – 60, and Figs. 9 – 13) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. Additionally, as stated in col. 4 lines 7 – 15 the construction and parts of the device in the embodiment of Figs. 9 – 13 are the same as those in the embodiment of Figs. 1 – 8, therefore, although the Examiner is relying upon the embodiment of Figs. 9 – 13, citations may be made to the structure and construction of parts in the embodiment of Figs. 1 – 8 for the purpose of showing the structure and construction of parts for the embodiment of Figs. 9 – 13) comprising:
an elongated body (barrel 14) with a proximal end and a distal end, and extending along a longitudinal length (Fig. 10), wherein the elongated body comprises an opening (opening between shoulders 16 on the left-hand side of the barrel 14 when looking at Fig. 10) extending longitudinally (Figs. 9 – 13);
an incision assembly (first ferrule / collar 56, left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10, second ferrule / collar 58) coupled to the distal end of the elongated body (col. 2 line 55 – col. 3 line 7 and Fig. 10), the incision assembly (first collar 56, one of the blades 60, second collar 58) comprising an incision member (left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10) aligned with the longitudinal length of the elongated body and comprising respective first and second ends (ends coupled to the collars) rotationally engaged to the incision assembly (col. 2 line 55 – col. 3 line 5 and Fig. 10) (Examiner’s note: col. 4 lines 32 – 36, the blades are swung open / bowed to the [outward] position shown in Fig. 9, and in col. 2 lines 55 – 70 states the ends of the blades are keyed to fit into the upper and lower ferrules. In order to let the central / intermediate portion of the blade swing outward the ends must be hingedly (i.e., rotatably) engaged with the rest of the incision assembly),
wherein the incision member (left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10) comprises an intermediate flexible portion (arched central portion shown in Fig. 10) extending at least between the first and second ends (Figs. 9 – 11) (Examiner’s note: col. 4 lines 32 – 36, the blades bow outward, therefore the blades are considered to be flexible) and is extendable through the opening and laterally from the elongated body into an extended position (position shown in Figs. 9 and 11) and retractable from the extended position into an unextended position within the incision assembly (col. 4 lines 31 – 45 and Figs. 9 – 11) (Examiner’s note: as stated in col. 4 lines 40 – 45 the diameter of the blade in the contracted state is less than outside diameter of the barrel 14 therefore the incision member gets retracted to an unextended position within the incision assembly).
Regarding claim 2, Hoffman discloses further comprising an actuator (rod 40) operably coupled to the incision assembly (first collar 56, left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10, second collar 58), the actuator traversing along the longitudinal length of the elongated body (barrel 14) from a first configuration (configuration when the rod 40 is removed from the barrel – discussed in col 2. Lines 55 – 65) disengaged with the incision member to a second configuration (configuration when within the barrel 14 via threaded attachment 44 – discussed in col. 2 lines 55 – 65) engaged with the incision member (left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10) such that in the second configuration the incision member is laterally extended from the elongated body (barrel 14) (Examiner’s note: as stated in col. 2 line 55 – col. 3 line 5 the blades have a normally contracted stated, which means that the blades are in the contracted state when the rod 40 (i.e., the actuator) is removed / disengaged from the incision assembly and thus the incision member, furthermore, when the rod 40 is coupled to the distal end of the barrel via the threaded attachment 44 and rotated, (as described in col. 4 lines 31 – 60), the blades flex / extend outward laterally from the barrel 14 (i.e., the elongated body). Thus, Hoffman discloses the limitations substantially as claimed).
Regarding claim 3, Hoffman discloses wherein the actuator (rod 40) is a rigid rod (col. 2 lines 55 – 60).
Regarding claim 4, Hoffman discloses wherein the incision member (left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10) is planar (col. 2 line 60 – col. 3 line 5 and Figs. 10,11).
Regarding claim 5, Hoffman discloses further comprising an actuator (rod 40) operably coupled to the incision assembly (first collar 56, left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10, second collar 58) and structured to operably retract and extend the incision assembly from the elongated body (barrel 14) by respectively removing (Fig. 10) and applying (Fig. 11) a force (compression / torsional force) to the incision assembly (col. 4 lines 15 – 20, col. 4 lines 35 – 44, and Figs. 9 – 11).
Regarding claim 6, Hoffman discloses wherein the intermediate flexible portion of the incision member (central bowed portion on left hand-side blade 60 of the four blades 60 of cutter 52 looking at Fig. 10) is a sharpened edge (col. 1 lines 45 – 54) and/or is energizable with electrical current or radio frequency (Examiner’s note: the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the blade can be energized with current or a radio frequency. Therefore, Hoffman discloses the limitation as claimed).
Regarding claim 8, Hoffman discloses further comprising one or more stabilizing members (the other blade 60 not designated by the Examiner as the “incision member”) configured to reversibly extend laterally from the elongated body (col. 4 lines 31 – 60 and Figs. 9,11).
Regarding claim 9, Hoffman discloses further comprising: two or more stabilizing members (the central blades and the right most blade of the blades 60 not considered as the incision member shown in Fig. 10) positioned radially about the incision assembly and circumferentially spaced from the opening (opening between shoulders 16 on the left-hand side of the barrel 14 when looking at Fig. 10) (Examiner’s note: as shown in Fig. 10 the other blades are circumferentially spaced from the designated opening).
Regarding claim 11, Hoffman discloses further comprising a dilator (nose 48) adjacent the distal end of the incision assembly (Figs. 9 – 11) (Examiner’s note: Applicant equates a “dilator” as a conical tapered nose cone structure, and as stated in col. 2 lines 55 – 65 and shown in Figs 9 – 11, the distal tip is a bullet-shaped / conical tapered nose cone; therefore, the nose 48 is considered as a dilator).
Regarding claim 14, Hoffman discloses further comprising a controller (lever 90) engaged to the incision assembly (first collar 56, blades 60, second collar 58) (col. 2 lines 55 – 70, col. 4 lines 20 – 70, and Figs. 9 – 13), wherein the controller is structured to provide at least one of: rotation of the elongated body, extension and retraction of the incision device (col. 4 lines 20 – 70), and/or to energize the incision device.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2,816,552) (previously recited), as applied to claim 1 above, and further in view of Laufer et al (US 2016/0206345 A1) (previously recited).
Regarding claim 10, as discussed above, Hoffman discloses the tissue transection device of claim 1.
However, Hoffman is silent regarding (i) a retractable sheath covering the incision assembly.
As to the above, Laufer teaches a device (treatment device 100) for cutting tissue comprising an elongated body (shaft 110) and an incision assembly (cutting assembly 140) coupled to a distal end of the elongated body (shaft 110) comprising an incision member (cutting edge 142) coupled to the incision assembly and structured to reversibly extend out of an opening (opening 124) of the elongated body (shaft 110) (abstract, paragraphs [0040 – 0046], and Figs. 1,2A-C), the device further comprising a retractable sheath (sheath 164) covering the incision assembly for the purpose of having an added safety measure (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Hoffman to incorporate a retractable sheath, based on the teachings of Laufer, for the purpose of adding an extra safety measure to protect against unintended tissue cutting (paragraph [0045] – Laufer).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2,816,552) (previously recited), as applied to claim 1 above, and further in view of Long et al (US 2012/0220998 A1) (previously recited).
Regarding claim 13, as discussed above, Hoffman discloses the tissue transection device of claim 1.
However, Hoffman is silent regarding (i) wherein the pericardial transection device is sterilized.
As to the above, Long teaches a medical device for cutting tissue, wherein the medical device is sterilized before surgery for the purpose of killing harmful bacteria (abstract and paragraph [0101]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify to modify the device of Lary to be sterilized, as taught by Long, for the purpose of killing harmful bacteria on the device which could prove harmful to the patient (paragraph [0101] – Long).
Claims 1, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1) (previously recited) and in view of Carli et al (US 2008/0300636 A1) (previously recited).
Regarding claim 1, Lary discloses a device (myocardium transection 10) (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88), the device comprising:
an elongated body (catheter 28) with a proximal end and a distal end, and extending along a longitudinal length (paragraphs [0047 – 0029] and Fig. 5A), wherein the elongated body (catheter 28) comprises an opening (opening though which blade 60 extends – shown in the movement progression of blade 60 in Fig. 5A to Fig. 5B); and
an incision assembly (nuts 62,64 and blade 60) coupled to the distal end of the elongated body (catheter 28) (paragraph [0046] and Fig. 5A), the incision assembly (nuts 62,64 and blade 60) comprising an incision member (blade 60) aligned with the longitudinal length of the elongated body (Fig. 5A) and comprising an intermediate portion (central portion of blade 60) extending between respective first and second ends engaged to the incision assembly (nuts 62,64 and blade 60) (Fig. 5A); and
wherein the intermediate portion (central portion of blade 60) is extendable through the opening and laterally from the elongated body into an extended position and retractable from the extended position into an unextended position within the incision assembly (progression of the system from the configuration in Fig. 5A to the configuration of Fig. 5B).
However, Lary is silent regarding (i) wherein the incision member has rotatably engaged ends and a flexible intermediate portion.
As to the above, Carli teaches a surgical cutting device (reduction instrument 1) comprising an elongated body (tube 20), an incision assembly (arms 13, 14, blade 5, foramen 34) comprising an incision member (blade 5; which equates to the blade 60 of Lary) with an intermediate flexible portion (blade 5) extending between first and second ends (arms 13, 14) (abstract, paragraphs [0032 – 0039], and Figs. 1,2,8), wherein the first and second ends (arms 13/14) are rotationally engaged with the incision assembly (Examiner’s note: arm 14 is directly rotationally engaged via foramen 34 and arm 13 is indirectly rotationally engaged via arm 14 to foramen 34), and the intermediate flexible portion (blade 5) is extendable laterally through an opening (intrapedicular part 23) of the elongated body (tube 25) from an extend position to an unextend position (paragraphs [0036 – 0039] and Figs. 5 – 8).
It should be understood that Lary and Carli are known references in the art that teach tissue cutting devices with blades extendable laterally through an elongated opening in an outer member from a retracted position to an extended position via a linear, and longitudinally extending, actuation member (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C – Lary ; abstract, paragraphs [0032 – 0039], and Figs. 1,2,8 – Carli); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one incision member, actuation means, and method of actuating the incision member for another incision member, actuation means, and method of actuating the incision member (i.e., substituting the blade, coupling means, actuation rod, and means of actuating the blade out of the elongate body of Lary for that of Carli), and the results of the substitution would have been predictable and resulted in the modified device of Lary being able to function as intended to properly cut / transect tissue. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that the modification makes obvious wherein the first and second ends are indirectly and directly engaged, respectively, with the incision assembly.
Regarding claims 11 and 12, as discussed above, the combination of Lary and Carli teaches the system of claim 1. Additionally, Lary discloses a dilator (distal end 30) (Examiner’s note: Applicant equates a “dilator” as a conical tapered nose cone structure; and the distal end 30 is a conical tapered nose cone structure. Therefore, the distal end 30 is considered a dilator), the dilator (distal end 30) structured for receiving a guidewire (guide wire 32) (paragraph [0040] and Figs. 5A, 5B).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1) (previously recited) and in view of Barnes et al (US 2019/0262024 A1) (previously recited) and Carli et al (US 2008/0300636 A1) (previously recited).
Regarding claim 17, Lary discloses a device (myocardium transection 10) (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C) capable of transecting pericardial tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88), the device comprising:
an elongated body (catheter 28) with a proximal end and a distal end, and extending along a longitudinal length (paragraphs [0047 – 0029] and Fig. 5A), wherein the elongated body (catheter 28) comprises an opening (opening though which blade 60 extends – shown in the movement progression of blade 60 in Fig. 5A to Fig. 5B); and
an incision assembly (nuts 62,64 and blade 60) coupled to the distal end of the elongated body (catheter 28) (paragraph [0046] and Fig. 5A), the incision assembly (nuts 62,64 and blade 60) comprising an incision member (blade 60) aligned with the longitudinal length of the elongated body (Fig. 5A) and comprising respective first and second ends engaged to the incision assembly (nuts 62,64 and blade 60) (Fig. 5A), wherein the incision member has a sharpened edge (paragraph [0046]);
a stabilizing member (brace 58) adjacent to aligned on a bottom of the incision member (nuts 62,64 and blade 60) structured to reversibly extend laterally from the elongated body (paragraph [0048] and Fig. 5C) (Examiner’s note: as discussed in the 112(b) rejection above, the Examiner is reading “reversibly extend” to mean to move from an extended position to an un-extended position); and
an actuator (screw rod 63) operably coupled to the incision assembly (nuts 62,64 and blade 60).
However, Lary is silent regarding (i) wherein the incision member has rotatably engaged ends and a flexible intermediate portion, (ii) the actuator is movable to traverse along the longitudinal length of the elongated body from a first configuration disengaged with the incision member to a second configuration engaged with the incision member, wherein in the second configuration, the actuator contacts and applies force to the incision assembly such that the intermediate flexible portion of the incision member flexes and is urged to extend laterally through the opening, and (iii) comprising two or more stabilizing members positioned radially about the incision assembly wherein each of the stabilizing members are independently operable to be extended and retracted from the elongated body.
As to (i) and (ii), Carli teaches a surgical cutting device (reduction instrument 1) comprising an elongated body (tube 20), an incision assembly (arms 13, 14, blade 5, foramen 34) comprising an incision member (blade 5; which equates to the blade 60 of Lary) with an intermediate flexible portion (blade 5) extending between first and second ends (arms 13, 14) (abstract, paragraphs [0032 – 0039], and Figs. 1,2,8), wherein the first and second ends (arms 13/14) are rotationally engaged with the incision assembly (Examiner’s note: arm 14 is directly rotationally engaged via foramen 34 and arm 13 is indirectly rotationally engaged via arm 14 to foramen 34), and an actuator (tube 25) coupled to the incision assembly (Fig. 8), the actuator (tube 25) moveable to traverse the length of the body (tube 20) (Fig. 8) from a first configuration disengaged (see Fig. 5) with the incision member (blade 5) and to a second configuration (see Figs. 7 and 8) wherein the actuator (tube 25) contacts and applies force to the incision assembly such that the intermediate flexible portion (blade 5) flexes and is urged to extend laterally through an opening (intrapedicular part 23) of the elongated body (tube 25) (paragraphs [0036 – 0039] and Figs. 5 – 8).
It should be understood that Lary and Carli are known references in the art that teach tissue cutting devices with blades extendable laterally through an elongated opening in an outer member from a retracted position to an extended position via a linear, and longitudinally extending, actuation member (abstract, paragraphs [0046 – 0049], and Figs. 5A,B,C – Lary ; abstract, paragraphs [0032 – 0039], and Figs. 1,2,8 – Carli); and the examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one incision member, actuation means, and method of actuating the incision member for another incision member, actuation means, and method of actuating the incision member (i.e., substituting the blade, coupling means, actuation rod, and means of actuating the blade out of the elongate body of Lary for that of Carli), and the results of the substitution would have been predictable and resulted in the modified device of Lary being able to function as intended to properly cut / transect tissue. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. It should be understood that the modification makes obvious wherein the first and second ends are indirectly and directly engaged, respectively, with the incision assembly.
As to (iii), Barnes teaches a device capable of transecting pericardial tissue comprising an elongated body (shaft 120) with an opening, a proximal end (proximal end 112), and a distal end (distal end 114), and extending along a longitudinal length (paragraphs [0102 – 0105] and Figs. 1, 8 – 13), an incision assembly (base plate 128 and blade 126) coupled to the distal end of the elongated body (paragraph [0103] and Figs. 8 – 13), the incision assembly comprising an incision member (blade 126) aligned with the longitudinal length of the elongated body (Fig. 8) and comprising respective first and second ends (left and right lateral ends of blade 126) coupled to the incision assembly (Fig. 8,9), and two or more stabilizing members (balloons 136, 134a, and 134b) positioned radially about the incision assembly, aligned on a bottom of the incision member (blade 126), and independently operable to retract and extend from the extending body (paragraphs [0102], [0112], [0114], [0115], and Figs. 12,13).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Lary to incorporate additional stabilizers, based on the teachings of Barnes, for the purpose of adding additional stabilization to the device during the procedure.
Regarding claim 19, as discussed above, it would have been obvious to modify the device of Lary with additional stabilizers and with the blade / actuation means of Barnes and Carli, respectively. Additionally, the combination makes obvious wherein at least a portion of the incision member (blade 5) is a sharpened edge (Examiner’s note: although Carli does not recite wherein the blade 5 has a sharpened edge; it would be obvious to one of ordinary skill in the art for the blade 5 of Carli with the device of Lary to have a sharpened cutting edge, based on the teachings of Lary, for the purpose of being able to cut / transect the tissue as desired, as taught by Lary – paragraph [0035]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Lary (US 2009/0125044 A1) (previously recited) in view of Barnes et al (US 2019/0262024 A1) (previously recited) and Carli et al (US 2008/0300636 A1) (previously recited), as applied to claim 17 above, and further in view of Laufer et al (US 2016/0206345 A1) (previously recited).
Regarding claim 20, as discussed above, the combination Lary, Barnes, and Carli teaches the tissue transection device of claim 17.
However, the combination Lary, Barnes, and Carli is silent regarding (i) a retractable sheath covering the incision assembly.
As to the above, Laufer teaches a device (treatment device 100) for cutting tissue comprising an elongated body (shaft 110) and an incision assembly (cutting assembly 140) coupled to a distal end of the elongated body (shaft 110) comprising an incision member (cutting edge 142) coupled to the incision assembly and structured to reversibly extend out of an opening (opening 124) of the elongated body (shaft 110) (abstract, paragraphs [0040 – 0046], and Figs. 1,2A-C), the device further comprising a retractable sheath (sheath 164) covering the incision assembly for the purpose of having an added safety measure (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Lary in view of McDonald, and Carli, to incorporate a retractable sheath, based on the teachings of Laufer, for the purpose of adding an extra safety measure to protect against unintended tissue cutting (paragraph [0045] – Laufer).
Allowable Subject Matter
Claim 15 would be allowable if rewritten or amended 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.
Claim 16 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.
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 make obvious a pericardial tissue transecting device comprising, inter alia, an elongated body with a longitudinal opening therein, an incision assembly coupled to the distal end of the elongated body and including an incision member aligned with the longitudinal axis of the body with two ends coupled to the assembly which are separated by a fixed distance and a flexible intermediate portion extending therebetween, the device further comprising an actuator moveable to disengage and engage the incision member to move the incision member from a retracted state to an extended, flexed, state. The closest prior art, Lary in view of Carli with or without Barnes (as cited and discussed above), fails to teach, in combination, a device that comprises, inter alia, a flexible incision member that has two ends that remain at a fixed distance apart from each other in addition to an actuator that is moveable to engage and disengage the incision member in order to flex the incision member from a retracted state to an extended state.
Response to Arguments
Applicant’s arguments, filed 06/02/2026, with respect to the rejection of independent claim 15 under Larry in view of McDonald and Carli have been fully considered and are persuasive. See reasons for indicating allowable subject matter above for the reason as to why claim 15 has been withdrawn.
Applicant's arguments filed 06/02/2026, directed at the rejection of claim 1 under Hoffman and claim 17 under Lary in view of Carli and McDonald have been fully considered but they are not persuasive. More specifically:
With respect to the arguments directed at Hoffman not disclosing the newly added limitations, the Examiner has provided a response in the rejection above. With respect to the additional arguments directed towards Hoffman, on page 2 (12), the Examiner notes that the claims only require that the ends the blade / incision member be rotationally engaged, which requires only that the ends of the blade / incision member be capable of rotating / pivoting / hinging / swinging relative to the other parts of the incision assembly, and as described in the rejection above, the ends of the blade / incision member are swung / pivoted radially (to some degree) in order to expand the central portion of the blade; the means and direction of said rotation is not further defined by the claim. Therefore, the argument is not persuasive.
With respect to the arguments directed at Lary in view of Carli and McDonald, found on page 4 (14), the Examiner notes that the claims do not require each end of the incision member to be rotationally fixed to the incision assembly. As stated in the rejection above, the modified device comprises one end of the of the incision member that is directly, and rotatably, coupled to the incision assembly and the other end is indirectly, and rotatably, coupled, via the first end, to the incision assembly; therefore, under BRI the prior art meets the requirements of the claims as currently written. The Examiner suggests further defining wherein each of the first and second ends of the incision member are rotatably and fixedly engaged with the incision assembly. Lastly, the Examiner notes, regarding the further arguments on page 4 (14) directed to McDonald, that the Examiner is not relying upon the incision member of McDonald. Therefore, the Examiner has found these arguments to be not persuasive.
Applicant’s arguments, filed 06/02/2026, with respect to the rejection of independent claim 1 under Barnes, and separately, under Larry have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. More specifically, the rejections were withdrawn as neither Larry nor Barnes, separately, teach rotatably engaged ends of the incision member.
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.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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