DETAILED ACTION
This action is in response to applicant's amendments filed 02/03/26.
The examiner acknowledges the amendments to the claims.
Claims 1, 5-6, 10-16 are pending in this application.
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 Arguments
Applicant's arguments filed 02/03/26 have been fully considered but they are not persuasive.
Applicant generally argues that “features A-E” (Remarks filed 02/03/26, page 7), which are currently incorporated in amended claim 1, serve as means to solve technical problems and are not obvious matters of design choice. However, none of the prior art rejections rely on design choice as a rationale, as maintained below.
Next, Applicant argues that in Doerr fails to disclose feature D (“the grip has a tapered shape of which a thickness decreases toward an open end from the connection end, and the open end being the other end of the grip that is on a side opposite to the connection end”), but rather the grip narrows towards the axial center from the connection end to the open end and then widens again in Doerr. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). While Doerr discloses a grip 11 having a shape that generally decreases towards an open end (see annotated Figure 2 below showing wider base end near connection end of grip 11 and narrower tapered shape at the open end of the grip), Zhu is relied upon for features D and E as discussed below.
Lastly, Applicant argues that one of ordinary skill in the art would not modify Doerr with the features D and E as taught by Zhu, since changing the grip shape to a truncated conical shape could limit the variety of gripping methods and would be rendered unsatisfactory for its intended purpose. It is noted that the grip “having a variety of gripping methods” is not recited and therefore not necessitated by the claims. Furthermore, one of ordinary skill in the art would still be motivated to modify the grip of Doerr to a tapered truncated conical shape, since Doerr acknowledges that obturator elements may include a different shape ([0047], [0077]), and the tapered truncated conical shape as taught by Zhu would facilitate gripping and conforming to the curvature of a user’s hand. The examiner asserts that the intended use would not be limited or rendered unsatisfactory and that the gripping methods as disclosed in Doerr (Figures 9-12) could still be carried out with the resulting grip in view of Zhu due to the wider bottom connection end, the recessed portions, and the tapered shape at the open end that would facilitate said gripping methods for a user/surgeon.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 recites “the first surface is a surface parallel to the axial direction”. However, the present application does not provide support for the first surface being parallel to the axial direction. Figure 4 and [0048] the instant specification publication provide support for the first surface 30 being “approximately parallel” to the axial direction “AD” instead of being “parallel”. For examination purposes, the limitation will be read as –the first surface is a surface approximately parallel to the axial direction--.
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.
Claims 1, 5-6, 10-11, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Doerr et al., hereinafter “Doerr” (U.S. Pub. No. 2019/0216497) in view of Zhu (U.S. Pub. No. 2019/0290321).
Regarding claim 1, Doerr discloses an obturator (Figures 1-15) comprising:
a shaft 13 that is configured to be inserted into a cannula (configured for insertion into a cannula 12) and of which a distal end 13 is sharp-pointed in a needle-like shape to be stuck into a body wall ([0005]);
a grip 11 to which a proximal end of the shaft is attached and that is gripped by an operator; and
at least two recessed portions (see annotated Figure 2 below) that are formed at the grip and on which fingers of the operator are hooked (Figures 9-10),
FIGURE 2 of DOERR
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wherein the at least two recessed portions are formed at opposite positions on the grip (Id.),
wherein one of the at least two the recessed portions includes at least
a first surface (Id.) that is formed along an axial direction of the shaft, and
a second surface (Id.) that is connected to the first surface on a connection end side and that intersects the first surface, the connection end being one end of the grip to which the proximal end of the shaft is attached,
wherein the first surface and the second surface are connected to each other by a curved surface (Id.),
Doerr further discloses including the grip 11 having a tapered shape of which a thickness decreases toward an open end, and a connection end being one end of the grip to which the proximal end of the shaft 13 is attached and the open end being the other end of the grip that is on a side opposite to the connection end (see annotated Figure 2 above), however does not teach the thickness decreasing from the connection end toward the open end, or wherein the grip has a shape that is obtained in a case where a portion of a prolate spheroid is cut along a short axial direction or has a truncated conical shape.
In the same field of art, namely obturators, Zhu teaches a grip 220 (Figure 6) having a tapered shape of which a thickness decreases from a connection end to an open end, or the shape that is obtained in a case where a portion has a truncated cone shape (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the grip of Doerr with a tapered shape or truncated cone shape as claimed, as taught by Zhu, in order to facilitate gripping and conforming to the curvature of a user’s hand and since Doerr teaches that the obturator elements may include a different shape ([0047], [0077]).
Regarding claim 5, Doerr discloses at least one of the first surface or the second surface includes a curved surface (Figure 2 of Doerr).
Regarding claim 6, Doerr discloses the first surface extends from a position near the connection end to the open end (Id.).
Regarding claim 10, Doerr as modified teaches the claimed invention, as discussed above, except does not expressly disclose a length of the grip in the axial direction of the shaft is 1.2 times or more and less than 1.5 times a length of the grip in a radial direction of the shaft, although the grip of Doerr is generally greater in length in the axial direction than the length in the radial direction of the shaft (Figures 1 and 5).
However, a skilled artisan would have acknowledged that modifying the length of the grip in the axial direction could be optimized relative to the length of the grip in the radial direction in order to facilitate handling by a surgeon. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the grip such that a length of the grip in an axial direction of the shaft is 1.2 times or more and less than 1.5 times a length of the grip in a radial direction of the shaft for the purpose of ease of handling, and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 11, Doerr as modified teaches the claimed invention, as discussed above, except wherein a length of the grip in the axial direction of the shaft is 40 mm or greater and smaller than 70 mm.
A skilled artisan would have acknowledged that modifying the length of the grip in the axial direction could be optimized to facilitate handling by a surgeon. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the grip such that a length of the grip in an axial direction of the shaft is 40 mm or greater and smaller than 70 mm for the purpose of ease of handling, and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, Doerr discloses the grip 11 includes a protrusion 16 or 18 (Figure 6A, [0065]) that is configured to be connected to the cannula and that is provided at a position corresponding to one of the at least two recessed portions in a circumferential direction of the shaft.
Regarding claim 14, Doerr discloses a trocar comprising: the obturator according to claim 1, as discussed above; and a cannula 12 (Figure 2) into which the obturator is attachably and detachably inserted (Figures 6A, 8A; [0065]).
Regarding claim 15, Doerr discloses the cannula 12 includes a cannula body (Figures 3-4) that has a tubular shape with an insertion hole into which the shaft is inserted (Figure 6), and a connecting portion 90 to which a proximal end of the cannula body is attached, to which the grip 11 is attachably and detachably connected, and of which a length in the axial direction of the shaft is shorter than a length of the grip in the axial direction (Figures 3-4, 6-6A, 8A; [0064]-[0065]).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Doerr (U.S. Pub. No. 2019/0216497) in view of Zhu (U.S. Pub. No. 2019/0290321), as applied to claim 1 above, and further in view of Delano et al., hereinafter “Delano” (U.S. Pub. No. 2009/0292259).
Regarding claim 12, Doerr as modified teaches the claimed invention, as discussed above, except for the grip including a notched portion in which at least a portion of a button for separation of the cannula is accommodated and that is disposed at a position different from a position of one of the at least two recessed portions in a circumferential direction of the shaft.
In Figures 1-9, [0051]-[0052], [0054] Delano teaches a grip 10 including a notched portion (see notch accommodating protrusions 16) in which at least a portion of a button (any of 16 that may be pushed or deflected) for separation of a cannula 22 is accommodated and that is disposed at a position different from a position of one of the at least two recessed portions in a circumferential direction of a shaft 26 (see two recessed or beveled edges on 10 on either side of protrusions 16).
It would have been obvious to one of ordinary skill before the effective filing date to modify the grip with a notched portion and button, as taught by Delano, to facilitate releasably engagement with an obturator and cannula by a user.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Doerr (U.S. Pub. No. 2019/0216497) in view of Zhu (U.S. Pub. No. 2019/0290321), as applied to claim 1 above, and further in view of Roche Rebollo et al., hereinafter “Roche Rebollo” (U.S. Pub. No. 2019/0159806).
Regarding claim 16, Doerr as modified teaches the claimed invention, as discussed above, except for the first surface being a surface parallel to the axial direction.
In Figures 2B and 4B and [0041], Roche Rebollo teach a grip with a first surface 230 that is formed along an axial direction (longitudinal axis) of a shaft 310, wherein the first surface is parallel (approximately parallel) to the axial direction.
It would have been obvious to one of ordinary skill before the effective filing date to modify the first surface of Doerr as modified to be a surface that is parallel (approximately parallel) to the axial direction, as taught by Roche Rebollo, in order to provide a surface that is easily held between the fingers of a user/surgeon ([0041] of Roche Rebollo).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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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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/DIANE D YABUT/Primary Examiner, Art Unit 3771