DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/11/2025 has been entered.
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 .
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 8, 10-12, 16, 22, 26-27, 30, 33, 45-47, 50-52, and 54-56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmidt, (US 5972013).
Regarding claim 1, Schmidt (Figures 2-4) discloses a pericardiotomy device (10) configured to create an opening through a pericardium (51), the pericardiotomy device (10) comprising: an elongated shaft (14); and an end effector (11) disposed distally on the elongated shaft, the end effector (11) comprising a tip portion comprising an opening (27) configured to engage a target portion of a pericardium (51), wherein the tip portion is configured, upon application of vacuum (A) to the tip portion, to separate the target portion of the pericardium (51) from an underlying surface of a heart; and at least one penetrating element (12) disposed within the tip portion and rotatable radially inward along an arcuate path about an axis transverse to a dominant longitudinal axis of the elongated shaft (as shown in Figures 2-4, element 12 moves radially inward into bleb 50 once the bleb is suctioned into opening 27, and element 12 is configured to be rotatable as well using the proximal grip) so that, with vacuum (A) applied to the tip portion, the at least one penetrating element (12) is configured to selectively rotate and create an opening through the target portion of the pericardium (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63: element 12 may be moved axially and rotated by element 56, therefore element 56 may rotate element 12 as it is moved axially from the proximal, retracted position to the distal, extended position).
Regarding claim 3, Schmidt (Figures 2-4) further discloses wherein the opening (27) comprises a distal opening (distal portion of opening 27); and wherein the at least one penetrating element (12) is recessed proximally within the tip portion relative to the distal opening (distal portion of opening 27), (Col. 5, lines 33-45; Col. 6, lines 10-52).
Regarding claim 8, Schmidt (Figures 2-4) further discloses wherein the at least one penetrating element (12) comprises a needle (Col. 5, lines 33-45; Col. 6, lines 10-52).
Regarding claim 10, Schmidt (Figures 2-4) further discloses a handle (16) disposed proximally on the elongated shaft (14); wherein the handle (16) comprises a needle-releasing actuator (56) operable to release the needle (12) from a retracted, proximal position into a distal, extended position (Col. 7, lines 46-63).
Regarding claim 11, Schmidt (Figures 2-4) further discloses wherein the handle (16) comprises a needle-retracting actuator (56) operable to move the needle (12) from the extended position to the retracted position (Col. 7, lines 46-63).
Regarding claim 12, Schmidt (Figures 2-4) further discloses wherein the handle (16) comprises a needle-depth actuator (56) operable to adjust a longitudinal position of the needle's (12) extended position (Col. 7, lines 46-63).
Regarding claim 16, Schmidt (Figures 2-4) further discloses a handle (16) disposed proximally on the elongated shaft (14); wherein the handle (16) comprises a needle-rotating actuator (56) operable to rotate the needle (12) from a retracted, proximal position into a distal, extended position (Col. 7, lines 46-63).
Regarding claim 22, Schmidt (Figures 2-4) discloses a method of creating an opening through a pericardium (51), the method comprising: applying vacuum (A) to an opening (27) of a tip portion of an end effector (11) of a pericardiotomy device (10), where the end effector (11) includes a penetrating element (12) disposed proximate the opening (27), while the end effector (11) is proximate a pericardium (51) to draw the pericardium (51) toward the opening (27); increasing a distance between a target portion of the pericardium (51) and an underlying surface of a heart to effectuate a penetration spacing by applying vacuum (A) to the tip portion; and creating an opening through the target portion of the pericardium (51) that includes rotating the penetrating element (12), from radially inward along an arcuate path about an axis transverse to a dominant longitudinal axis of the elongated shaft (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63: (as shown in Figures 2-4, element 12 moves radially inward into bleb 50 once the bleb is suctioned into opening 27, and element 12 is configured to be rotatable as well using the proximal grip).
Regarding claim 26, Schmidt (Figures 2-4) further discloses wherein creating the opening through the target portion of the pericardium (51) includes moving the penetrating element (12) distally relative to the tip portion to penetrate the target portion of the pericardium (51), (Col. 5, lines 33-45; Col. 6, lines 10-52).
Regarding claim 27, Schmidt (Figures 2-4) further discloses wherein moving the penetrating element (12) distally relative to the tip portion to penetrate the target portion of the pericardium (51) comprises releasing the penetrating element (12) from a proximal, retracted position to move to a distal, extended position (Col. 5, lines 33-45; Col. 6, lines 10-52).
Regarding claim 30, Schmidt (Figures 2-4) further discloses further comprising, before moving the penetrating element (12) distally relative to the tip portion, operating a needle-depth actuator (56) to adjust a longitudinal position of the penetrating element (12) in the extended position (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 33, Schmidt (Figures 2-4) further discloses wherein the penetrating element (12) comprises a curved needle (as shown in Figures 3-4); and wherein rotating the penetrating element (12) includes rotating the curved needle (12) about a diametrically oriented axle (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 45, Schmidt (Figures 2-4) further discloses wherein the at least one penetrating element (12) includes a spoon shaped blade (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63: the element is a spoon/scoop shaped blade at the distal end).
Regarding claim 46, Schmidt (Figures 2-4) discloses a pericardiotomy device (10) configured to create an opening through a pericardium (51), the pericardiotomy device (10) comprising: an elongated shaft (14); and an end effector (11) disposed distally on the elongated shaft, the end effector (11) comprising a tip portion comprising a tip opening (27) configured to engage a target portion of a pericardium (51), wherein the tip portion is configured, upon application of vacuum (A) to the tip portion, to separate the target portion of the pericardium (51) from an underlying surface of a heart; and at least one penetrating element (12) disposed within the tip portion and rotatable along an arcuate path (as shown in Figures 2-4, element 12 moves radially inward into bleb 50 once the bleb is suctioned into opening 27, and element 12 is configured to be rotatable as well using the proximal grip) so that, with vacuum (A) applied to the tip portion, the at least one penetrating element (12) is configured to selectively rotate and create an opening through the target portion of the pericardium (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63: element 12 may be moved axially and rotated by element 56), wherein the at least one penetrating element (12) is rotatable about an axle (19) extending normal to a dominant longitudinal axis of the shaft (14), (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 47, Schmidt (Figures 2-4) further discloses wherein: the pericardiotomy device includes a handle (16) extending proximally from the elongated shaft (14) ; the end effector (11) comprises a penetrating element-operating mechanism; the penetrating element-operating mechanism comprises the at least one penetrating element (12) rotatably disposed on an axle extending normal to a dominant longitudinal axis of the elongated shaft (14); the pericardiotomy device (10) comprises a linkage (56) operatively coupling the penetrating element-operating mechanism and a handle control (52), (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 50, Schmidt (Figures 2-4) further discloses at least one vacuum connector (21) fluidically coupled to the tip portion and configured to fluidically connect to a vacuum source (suction source), (Col. 5, lines 21-31).
Regarding claim 51, Schmidt (Figures 2-4) further discloses before moving the penetrating element (12) distally relative to the tip portion, moving the penetrating element (12) proximally from the extended position to the retracted position and holding the penetrating element (12) in the retracted position (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 52, Schmidt (Figures 2-4) further discloses wherein moving the penetrating element (12) distally relative to the tip portion comprises operating a penetrating element release actuator (56) associated with a handle (16) of the pericardiotomy device (10), (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 54, Schmidt (Figures 2-4) further discloses enlarging the opening through the target portion of the pericardium by moving the end effector (11) laterally on the pericardium (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 55, Schmidt (Figures 2-4) discloses a method of engaging tissue, the method comprising: repositioning an end effector (11) proximate to a tissue surface (51); repositioning the end effector (11) in a direction opposite the tissue surface (51) to cause the tissue to tent inside the end effector (11); rotating a penetrator (12) about an axle from a retracted position to a more distal extended position to form an opening through the tent of the tissue (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Regarding claim 56, Schmidt (Figures 2-4) further discloses applying vacuum to the end effector (11) while the end effector (11) is proximate the tissue surface (51), wherein repositioning the end effector (11) proximate to the tissue surface includes forming a seal between the end effector (11) and the tissue surface (Col. 5, lines 21-31 & 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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(s) 35, 48-49, and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Callas, as applied to claims 1 and 32, and further in view of Dharan et al., (US 20200222078; hereinafter Dharan).
Regarding claim 35, Schmidt (Figures 2-4) further discloses wherein rotating the penetrating element (12) comprises rotating the penetrating element (12) from a proximal, retracted position to a partially extended position rotationally between the retracted position and an extended position to engage the penetrating element (12) with the target portion of the pericardium (51); and rotating the penetrating element (12) from the partially extended position to the extended position to cut the target portion of the pericardium (51) to create the opening therethrough (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63: element 12 may be moved axially and rotated by element 56, therefore element 56 may rotate element 12 as it is moved axially from the proximal, retracted position to the distal, extended position).
Schmidt fails to disclose verifying engagement of the penetrating element with the target portion of the pericardium. However, Dharan (Figures 5B-5C) teaches a method of creating an opening (512) through a target tissue, wherein engagement of a penetrating element (520) with the target tissue is verified prior to creating the opening (512) through the target tissue ([0250]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt to include the step of verifying engagement of the penetrating element with the target tissue prior to creating the opening through the target tissue, as taught by Dharan, because the modification would ensure that the operation is performed accurately with the target tissue placed properly in relation to the penetrating element (Dharan; [0250]).
Regarding claim 48, Schmidt discloses the pericardiotomy device of claim 1, but fails to disclose wherein the tip portion is formed in a bell shape so that a proximal portion of the tip portion has an outer diameter approximately the same as an outer diameter of the elongated shaft and a distal end of the tip portion has an outer diameter that is greater than the outer diameter of the elongated shaft. However, Dharan (Figures 15A-15B) teaches a pericardiotomy device (1500), wherein the tip portion (distal portion) of a shaft (1510) is formed in a bell shape so that a proximal portion of the tip portion has an outer diameter approximately the same as an outer diameter of the shaft (1510) and a distal end of the tip portion has an outer diameter that is greater than the outer diameter of the shaft (1510), ([0362]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt to include the tip portion formed in a bell shape so that a proximal portion of the tip portion has an outer diameter approximately the same as an outer diameter of the elongated shaft and a distal end of the tip portion has an outer diameter that is greater than the outer diameter of the elongated shaft, as taught by Dharan, since applicant has not disclosed that having the bell shape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the bell shape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding claim 49, Schmidt teaches the pericardiotomy device of claim 48, but fails to teach wherein the outer diameter of the distal end of the tip portion is about twice the outer diameter of the elongated shaft. However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schmidt to include the outer diameter of the distal end of the tip portion being about twice the outer diameter of the elongated shaft 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(I).
Regarding claim 53, Schmidt (Figures 2-4) further discloses before rotating the penetrating element (12) from the partially extended position to the extended position, moving the pericardiotomy device (10) proximally to further increase the distance between the target portion of the pericardium and the exterior surface of a heart (Col. 5, lines 33-45; Col. 6, lines 10-52, Col. 7, lines 46-63).
Response to Arguments
Applicant's arguments filed 11/11/2025 have been fully considered but they are not persuasive. With regard to Applicant’s argument that the cited Schmidt reference fails to disclose the newly amended limitation “at least one penetrating element disposed within the tip portion and rotatable radially inward along an arcuate path about an axis transverse to a dominant longitudinal axis of the elongated shaft so that, with vacuum applied to the tip portion, the at least one penetrating element is configured to selectively rotate and create an opening through the target portion of the pericardium” in independent claim 1, as well as similar amendments in independent claims 22 and 46, Examiner respectfully disagrees. Although it was initially agreed (in the interview held on 11/10/2025) that these amendments would overcome the previous rejections, after further search and consideration, it has been determined that the amendments are disclosed by the Schmidt reference. Specifically, as shown in Figures 2-4, element 12 moves radially inward into bleb 50 once the bleb is suctioned into opening 27, and element 12 is configured to be rotatable as well using the proximal grip. Accordingly, the element 12 is rotatable radially inward along an arcuate path about an axis transverse to a dominant longitudinal axis of the elongated shaft in the curved path in direction B. Therefore, Examiner maintains that the cited Schmidt reference discloses the invention as claimed at least in amended independent claims 1, 22, and 46. However, Examiner suggests incorporating language to recite that the radial rotation of the at least one penetrating element is performed along an at least partially circumferential path within the elongated shaft to make it clear that the at least one penetrating element is not simply rotating in place as it moves radially inward.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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