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 of Species A in the reply filed on 04/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MEPP 818.03(a)).
Claims 13-15 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/21/2026.
Claim Objections
Claims 5 and 9 are objected to because of the following informalities:
In claim 5, line 3, the phrase “the first rail and the second rail” should read “the corresponding first rail and the corresponding second rail” or similar language, since the claim language recites each of the first and second portions of the actuator placed over each of the first rails and the second rails.
In claim 9, lines 3-4, the phrase “each of a corresponding first portion of the main body and the second portion of the main body” should read “of the corresponding first portion of the main body and the corresponding second portion of the main body” or similar language, to remain consistent in referring to corresponding portions of the main body.
In claim 9, lines 4-5, the phrase “wherein each keyed portion has a cross-sectional shape” should read “wherein each of the keyed portions has a cross-sectional shape” or similar language, to properly refer to each of the keyed portions previously introduced.
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.
Claim 20 is 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 20, the claim recites “a first main body portion” in line 5. It is unclear whether the phrase is referring to the first main body portion previously introduced, or introducing a new, separate first main body portion. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the first main body portion previously introduced.
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.
Claim(s) 1, 3-5, 7-9 and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weber (US 6743185 B2).
Regarding claim 1, Weber discloses (see abstract; col. 3 line 65-col. 6 line 20; figs. 1-12) a medical device (fig. 1), comprising:
a handle (20, col. 4 lines 37-57; fig. 1) including a main body (24) and an actuator (22);
wherein the main body includes a first portion (includes portion of 28a forming slot, fig. 5) and a second portion (includes portion of 28b forming slot), and the main body has an open configuration (figs. 2-3) and a closed configuration (figs. 4-5); and
wherein the actuator includes a first portion (23a, figs. 5-8) and a second portion (23b), the actuator has an open configuration (figs. 6-7) and a closed configuration (assembled configuration, fig. 1), and the actuator translates relative to the main body in the closed configurations of the main body and the actuator (actuator 22 translates proximally and distally on body member 24, col. 4 lines 12-57; fig. 1).
Regarding claim 3, Weber discloses the medical device of claim 1. Weber further discloses wherein each of the first portion and the second portion of the main body includes a first rail and a second rail (arm portions 28a and 28b, annotated fig. 5), wherein each of the first rail and the second rail extends longitudinally in a proximal to distal direction (fig. 5) and define a slot (38, col. 5 lines 1-5) therebetween.
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Annotated Figure 5 of Weber
Regarding claim 5, Weber discloses the medical device of claim 3. Weber further discloses wherein each of the first portion of the actuator and the second portion of the actuator includes indentations for placing over the first rail and the second rail (annotated fig. 5 and figs. 6-7, considered to be indentations formed on each portion of actuator 22).
Regarding claim 7, Weber discloses the medical device of claim 1. Weber further discloses wherein the handle includes a distal tip (portion of arms including clips 32a and 32b, fig. 2), wherein the distal tip includes a first portion (includes 32a and 34a) and a second portion (includes 32b and 34b), and the distal tip has an open configuration (figs. 2-3) and a closed configuration (figs. 4-5).
Regarding claim 11, Weber discloses the medical device of claim 7. Weber further discloses wherein a shaft (12, col. 4 lines 12-30; fig. 1) extends from a distal end of the handle (fig. 1) and radially surrounds a wire (control members 16 which are placed within tube 50, col. 5 lines 25-42; fig. 8), wherein the shaft includes a shaft crimp (proximal end of conduit 12 gripped by U-shaped channels 30a and 30b having an inside diameter slightly less than the outside diameter of the conduit, considered to form a crimp structure due to shape of U-shaped channels and pinching the proximal end of the conduit, col. 4 lines 37-57; fig. 3), and wherein the wire includes a wire crimp (bends 52a and 52b, considered to meet the definition of a crimp, fig. 8), wherein the wire crimp is positionable in the actuator (fig. 8), and the shaft crimp is positionable in the distal tip (gripped within channels 30a and 30b, col. 4 lines 37-57).
Regarding claim 12, Weber discloses the medical device of claim 11. Weber further discloses wherein a first end of the actuator includes a first wire opening and a first crimp slot, and a second end of the actuator includes a second wire opening and a second crimp slot (annotated fig. 8, note under broadest reasonable interpretation a “first end” and a “second end” encompass any two ends of the actuator).
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Annotated Figure 8 of Weber
Regarding claim 1, Weber discloses (see abstract; col. 3 line 65-col. 6 line 20; figs. 1-12), under an alternative interpretation with respect to the main body, a medical device (fig. 1), comprising:
a handle (20, col. 4 lines 37-57; fig. 1) including a main body (24) and an actuator (22);
wherein the main body includes a first portion (28a, fig. 5) and a second portion (28b), and the main body has an open configuration (figs. 2-3) and a closed configuration (figs. 4-5); and
wherein the actuator includes a first portion (23a, figs. 5-8) and a second portion (23b), the actuator has an open configuration (figs. 6-7) and a closed configuration (assembled configuration, fig. 1), and the actuator translates relative to the main body in the closed configurations of the main body and the actuator (actuator 22 translates proximally and distally on body member 24, col. 4 lines 12-57; fig. 1).
Regarding claim 4, Weber discloses the medical device of claim 1. Weber further discloses wherein each of the first portion of the main body and the second portion of the main body includes a wire channel (39, col. 5 lines 1-5) extending longitudinally.
Regarding claim 1, Weber discloses (see abstract; col. 3 line 65-col. 6 line 20; figs. 1-12), under an additional alternative interpretation with respect to the main body, a medical device (fig. 1), comprising:
a handle (20, col. 4 lines 37-57; fig. 1) including a main body (28a) and an actuator (22);
wherein the main body includes a first portion (portion of 28a forming first set of clips 32a and ridges 34a) and a second portion (portion of 28a forming second set of clips 32a and ridges 34a, see annotated fig. 2 depicting formed boxes around each set), and the main body has an open configuration (figs. 2-3) and a closed configuration (figs. 4-5); and
wherein the actuator includes a first portion (23a, figs. 5-8) and a second portion (23b), the actuator has an open configuration (figs. 6-7) and a closed configuration (assembled configuration, fig. 1), and the actuator translates relative to the main body in the closed configurations of the main body and the actuator (actuator 22 translates proximally and distally on 28a, col. 4 lines 12-57; fig. 1).
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Annotated Figure 2 of Weber
Regarding claim 7, Weber discloses the medical device of claim 1. Weber further discloses wherein the handle includes a distal tip (28b), wherein the distal tip includes a first portion (at least one set of clips 32b and ridges 34b) and a second portion (at least a second set of clips 32b and ridges 34b, see annotated fig. 2 depicting sets in each box), and the distal tip has an open configuration (figs. 2-3) and a closed configuration (figs. 4-5).
Regarding claim 8, Weber discloses the medical device of claim 7. Weber further discloses wherein each of the first portion of the distal tip and the second portion of the distal tip defines a proximal slot proximal of and communicating with a distal slot having a cross-section that is wider than a cross-section of the proximal slot (annotated fig. 2, depicting distal slots formed by 34b, distal to cutouts which are considered to be proximal slots).
Regarding claim 9, Weber discloses the medical device of claim 8. Weber further discloses wherein the proximal slot and the distal slot of each of the first portion of the distal tip and the second portion of the distal tip respectively receives a neck portion (clip 32a considered to have neck portion matching the slots) and a keyed portion (clip 32a considered to have keyed portion matching the slots) of each of a corresponding first portion of the main body and the second portion of the main body, wherein each keyed portion has a cross-sectional shape to match a shape of a corresponding distal slot (corresponding shapes of clips and ridges depicted in fig. 2).
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) 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of Luh (US 2019/0090670 A1).
Regarding claim 2, Weber discloses the medical device of claim 1.
However, Weber fails to disclose wherein the first portion of the main body pivots relative to the second portion of the main body to transition from the open configuration to the closed configuration.
Luh teaches (para. [0070]; figs. 7-16), in the same field of endeavor, a medical device comprising a first portion of a main body (110a) pivoting relative to a second portion of the main body (110b, pivots via 130a and 130b) to transition from an open configuration to a closed configuration (see figs. 1-2a depicting open and closed configurations), for the purpose of allowing substantially uninhibited movement of at least one arm relative to the other arm, allowing for differing degrees of separation (paras. [0057]-[0058] and [0066]).
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 first and second portions of body member 24 of Weber to be pivotable relative to each other via hinges, in order to allow for differing degrees of separation of the arm portions when desired, allowing substantially uninhibited movement of at least one arm relative to the other arm, and a greater degree of separation to provide a larger gap between the arm portions when needed, based on the suggestions and teachings of Luh (paras. [0057]-[0058] and [0066]).
Regarding claim 10, Weber discloses the medical device of claim 7.
However, Weber fails to disclose wherein the first portion of the distal tip is pivotally connected to the second portion of the distal tip to transition between the open configuration and the closed configuration of the distal tip.
Luh teaches (para. [0070]; figs. 7-16), in the same field of endeavor, a medical device comprising a first portion of a distal tip (tip of 110a) pivoting relative to a second portion of the distal tip (tip of 110b, pivots via 130a and 130b) to transition between an open configuration and a closed configuration of the distal tip (see figs. 1-2a depicting open and closed configurations), for the purpose of allowing substantially uninhibited movement of at least one arm relative to the other arm, allowing for differing degrees of separation (paras. [0057]-[0058] and [0066]).
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 first and second portions of the distal tip of Weber to be pivotable relative to each other via hinges, in order to allow for differing degrees of separation of the arm portions when desired, allowing substantially uninhibited movement of at least one arm relative to the other arm, and a greater degree of separation to provide a larger gap between the arm portions when needed, based on the suggestions and teachings of Luh (paras. [0057]-[0058] and [0066]).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of Ruiz Ortiz (US 2019/0008546 A1).
Regarding claim 6, Weber discloses the medical device of claim 1.
However, Weber fails to disclose wherein the first portion of the actuator pivots relative to the second portion of the actuator to transition from the open configuration to the closed configuration.
Ruiz Ortiz teaches (para. [0085]; fig. 19), in the same field of endeavor, a medical device comprising a first portion and a second portion pivotable relative to each other between open and closed configurations (192 and 194 pivot via hinge 196), for the purpose of providing a clam shell-like configuration that keeps each half connected (para. [0085]).
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 latching mechanisms of Weber to further include a hinge between each half of actuator 22, in order to provide the capability of opening and closing each half without completely separating the halves from each other, decreasing the chance of dropping or losing one of the halves during use, based on the suggestions and teachings of Ruiz Ortiz (para. [0085]).
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of Peine (US 2011/0112517 A1).
Regarding claim 16, Weber discloses (see abstract; col. 3 line 65-col. 6 line 20; figs. 1-12) a medical device (fig. 1), comprising:
a proximal component, including a handle (20, col. 4 lines 37-57; fig. 1) having a main body (24) and an actuator (22);
wherein the main body includes a first portion (include portion of 28a forming slot, fig. 5) and a second portion (includes portion of 28b forming slot) movable relative to the first portion of the main body to transition between an open configuration (figs. 2-3) and a closed configuration (figs. 4-5) of the main body;
wherein the actuator includes a first portion (23a, figs. 5-8) and a second portion (23b) movable relative to the first portion of the actuator to transition between an open configuration (figs. 6-7) and a closed configuration (assembled configuration, fig. 1) of the actuator, and the actuator translates relative to the main body in the closed configurations of the main body and the actuator (actuator 22 translates proximally and distally on body member 24, col. 4 lines 12-57; fig. 1); and
a distal component including a shaft (12, col. 4 lines 12-30; fig. 1) and a wire (control members 16 which are placed within tube 50, col. 5 lines 25-42; fig. 8).
However, Weber fails to explicitly disclose wherein the distal component is releasably coupled to the proximal component.
Peine teaches (paras. [0035] and [0058]; fig. 1), in the same field of endeavor, a medical device (fig. 1) comprising a distal component (14) releasably coupled to a proximal component (detachable, para. [0058]), for the purpose of allowing the shaft portion to be disposable such that the handle portion is re-usable and may be sterilized and reused numerous times, allowing for a higher quality instrument handle portion while keep the overall price of the instrument reasonable (para. [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a releasable connection between conduit 12 and body member 24 of Weber, in order to allow conduit 12 to be disposable such that the handle portion is re-usable and may be sterilized and reused numerous times, allowing for a higher quality instrument handle portion while keep the overall price of the instrument reasonable, based on the teachings of Peine (para. [0035]).
Regarding claim 17, Weber (as modified) teaches the medical device of claim 16. Weber further discloses wherein the proximal component includes a distal tip (portion of arms including clips 32a and 32b, fig. 2), wherein the distal tip includes a first portion (32a) and a second portion (32b) movable relative to the first portion of the distal tip to transition between an open configuration and a closed configuration of the distal tip (see figs. 2-5).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Weber in view of Luh and Ruiz Ortiz.
Regarding claim 20, Weber discloses (see abstract; col. 3 line 65-col. 6 line 20; figs. 1-12) a method of assembling a medical device (fig. 1), comprising:
placing a first actuator portion (23a) onto a first main body portion (28a, col. 5 lines 16-25; fig. 5);
inserting a wire (control members 16 which are placed within tube 50, col. 5 lines 25-42; fig. 8) into a wire opening (formed by 54a and 54b, col. 5 lines 43-64; fig. 8) of the first actuator portion and a wire channel (39) of the first main body portion (col. 5 line 65-col. 6 line 2);
closing a first main body portion (28a) with a second main body portion (28b, figs. 4-5); and
closing the first actuator portion with a second actuator portion (23b, assembled configuration considered to be closed configuration, fig. 1).
However, Weber fails to disclose wherein the first main body portion and the second main body portion are configured to be closed by pivoting the first main body portion relative to the second main body portion, wherein the first actuator portion and the second actuator portion are configured to be closed by pivoting the first actuator portion relative to the second actuator portion.
Luh teaches (para. [0070]; figs. 7-16), in the same field of endeavor, a medical device comprising a first portion of a main body (110a) pivoting relative to a second portion of the main body (110b, pivots via 130a and 130b) to transition from an open configuration to a closed configuration (see figs. 1-2a depicting open and closed configurations), for the purpose of allowing substantially uninhibited movement of at least one arm relative to the other arm, allowing for differing degrees of separation (paras. [0057]-[0058] and [0066]).
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 first and second portions of body member 24 of Weber to be pivotable relative to each other via hinges, in order to allow for differing degrees of separation of the arm portions when desired, allowing substantially uninhibited movement of at least one arm relative to the other arm, and a greater degree of separation to provide a larger gap between the arm portions when needed, based on the suggestions and teachings of Luh (paras. [0057]-[0058] and [0066]).
Weber (as modified) still fails to teach wherein the first actuator portion and the second actuator portion are configured to be closed by pivoting the first actuator portion relative to the second actuator portion.
Ruiz Ortiz teaches (para. [0085]; fig. 19), in the same field of endeavor, a medical device comprising a first portion and a second portion pivotable relative to each other between open and closed configurations (192 and 194 pivot via hinge 196), for the purpose of providing a clam shell-like configuration that keeps each half connected (para. [0085]).
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 latching mechanisms of Weber (as modified) to further include a hinge between each half of actuator 22, in order to provide the capability of opening and closing each half without completely separating the halves from each other, decreasing the chance of dropping or losing one of the halves during use, based on the suggestions and teachings of Ruiz Ortiz (para. [0085]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2025/0090188 A1 to Sharma, disclosing a reusable handle.
US 2009/0299143 A1 to Conlon, disclosing an actuating and articulating surgical device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771