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 .
Claim Objections
Claim 9 objected to because of the following informalities: Claim 9 recites “defines define” which should be amended to delete the repeated word. 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.
Claims 4-6, 12-14 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.
Claim 4 recites “connector of any of claim 1”; it is unclear and indefinite what “any of claim 1” means. Claim should be amended to “connector of claim 1”.Claims 5-6 are rejected for depending on rejected claim 4 and failing to remedy the deficiency.
Claim 12 recites “can be detected”; it is unclear whether this limitations is required or is optional.
Claim 13 recites “can be detected”; it is unclear whether this limitations is required or is optional.
Claim 14 recites “can be detected”; it is unclear whether this limitations is required or is optional.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-3, 7-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20220088395 to Yang et al. (hereinafter “Yang” – on IDS) in view of CN109314345 to Hammerling (on IDS).
Regarding Claims 1, 11 and 20 (Currently Amended): Yang discloses an adjustable rotational connector configured to establish electrical communication between an implantable medical lead and a cable of an external testing device, wherein the adjustable rotational connector comprises (para 0015-0094, figs 1-5): a pin that is electrically conductive (para 0036, electrical contact 68); an socket that is electrically conductive (para 0035 electrical connector 66b) to receive a lead connector (para 0035, lead 22) of the implantable medical lead, wherein a proximal end of the adjustable socket is mechanically and electrically coupled to the pin to provide electrical communication between the pin and the lead connector, and a bearing (para 0035, bearing 64) configured to facilitate rotation of the pin relative to the cable.
Yang fails to disclose the socket to be adjustable and to elastically deform [] configured to receive lead connectors of different sizes and having an actuatable element that surrounds at least a portion of the adjustable socket, wherein the actuatable element is configured to: while in a first position relative to the adjustable socket, be disengaged from the adjustable socket to allow the adjustable socket to elastically deform to receive the lead connector of the implantable medical lead; and while in a second position relative to the adjustable socket, be engaged to the adjustable socket to secure the lead connector of the implantable medical lead in the adjustable socket.
Hammerling, from a similar field of endeavor teaches, having a socket (5) that is adjustable, deformable, and an actuatable element (Description, para 0010-0043, fig. 1-4, elastic arm 9) that surrounds at least a portion of the adjustable socket (locking arm 5), wherein the actuatable element is configured to: while in a first position relative to the adjustable socket, be disengaged from the adjustable socket to allow the adjustable socket to elastically deform to receive the lead connector of the implantable medical lead; and while in a second position relative to the adjustable socket, be engaged to the adjustable socket to secure the lead connector of the implantable medical lead in the adjustable socket (description). 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 disclosure of Yang with the teachings Hammerling to provide the predictable result of providing reliable electrical and mechanical connection.
Regarding Claim 2 (Original): Yang as modified by Hammerling renders obvious the adjustable rotational connector of claim 1, further comprising an electrical contact structure configured to establish electrical communication between the pin and the cable, wherein the pin is rotatable along a longitudinal axis relative to the contact surface, and wherein the pin comprises: a pin base defining a recess; a pin tip; and a pin biasing member configured to force the pin tip against the contact surface (para 0036, electrical contact 68, figs 1-5).
Regarding Claim 3 (Currently Amended): Yang as modified by Hammerling renders obvious the adjustable rotational connector of claim 1, wherein the adjustable socket is configured to receive a lead connector of an IS-1 connector, a DF-4 connector, and an IS-4 lead connector size configuration (see combination of claim 1, KSR, MPEP 2143, “(A) Combining prior art elements according to known methods to yield predictable results;”).
Regarding Claim 7 (Currently Amended): Yang as modified by Hammerling renders obvious the adjustable rotational connector of claim 1, wherein an inner diameter of a distal portion of the adjustable socket is uniform (para 0035 electrical connector 66b).
Regarding Claim 8 (Currently Amended): Yang as modified by Hammerling renders obvious the adjustable rotational connector of claim 1,wherein the adjustable socket further comprises one or more features that extend from an inner surface of the adjustable socket, and wherein the one or more features are configured to contact the lead connector when the lead connector is secured by the adjustable socket (see rejection of claim 1, figs 1-5).
Regarding Claim 9 (Currently Amended): Yang as modified by Hammerling renders obvious the adjustable rotational connector claim 1, wherein the adjustable socket defines define one or more indentations that allows the adjustable socket to elastically deform to receive the lead connector (para 0035 electrical connector 66b; known to provide indentations to improve connection security)
Regarding Claim 10 (Original): Yang as modified by Hammerling renders obvious the adjustable rotational connector of claim 9, wherein the one or more indentations comprise one or more slits extending axially along the adjustable socket from a distal end of the adjustable socket such that a distal portion of the adjustable socket is radially elastically deformable (para 0035 electrical connector 66b; known to provide indentations to improve connection security).
Regarding Claim 12 (Original): Yang as modified by Hammerling renders obvious the system of claim 11, wherein the adjustable rotational connector is configured to conduct a cardiac electrogram signal in which left bundle branch tissue features can be detected during rotation of the implantable medical lead (para 0004, 0006, 0024, etc.).
Regarding Claim 13 (Currently Amended): Yang as modified by Hammerling renders obvious the system of claim 11, wherein the adjustable rotational connector is configured to conduct a cardiac electrogram signal in which left bundle branch tissue features can be detected during rotation of the implantable medical lead (para 0004, 0006, 0024, etc.).
Regarding Claim 14 (Currently Amended): Yang as modified by Hammerling renders obvious the system of claim 11, wherein the adjustable rotational connector is configured to conduct a cardiac electrogram signal in which His-Purkinje conduction system features can be detected during rotation of the implantable medical lead (para 0004, 0006, 0024, etc.).
Regarding Claim 15 (Currently Amended): Yang as modified by Hammerling renders obvious the system of claim 11, further comprising an electrical contact structure configured to establish electrical communication between the pin and the cable (see rejection of claim 11), wherein the pin is rotatable along a longitudinal axis relative to the contact surface (para 0029, etc.), and wherein the pin comprises: a pin base defining a recess; a pin tip; and a pin biasing member configured to force the pin tip against the contact surface (para 0009, 0042, etc.).
Regarding Claim 16 (Currently Amended): Yang as modified by Hammerling renders obvious the system of claim 11, wherein the adjustable socket is configured to receive a lead connector of an IS-1 connector, a DF-4 connector, and an IS-4 lead connector size configuration (see combination of claim 1, KSR, MPEP 2143, “(A) Combining prior art elements according to known methods to yield predictable results;”).
Regarding Claim 18 (Currently Amended): Yang as modified by Hammerling renders obvious the system of claim 11, wherein at least a section of the portion has an inner diameter that is less than an inner diameter of the channel immediately distal of the section such that the wall is disengaged from the adjustable socket while the actuatable element is in the first position relative to the adjustable socket (see rejection of claim 11)
Regarding Claim 19 (Currently Amended): Yang as modified by Hammerling renders obvious the system of claim 11, wherein the adjustable socket defines define one or more indentations that allows the socket to elastically deform to receive the lead connector (para 0035 electrical connector 66b; known to provide indentations to improve connection security).
Allowable Subject Matter
Claim 17 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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