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
Claims 1, 2, 3, 5, 6, 8, 15, 16, 19, 20 are objected to because of the following informalities:
Claim 1 recites that “the slider connecting to wire” which should be corrected to “the slider is connected[ing] to the wire.”
Claims 1, 8, and 15 recite “a body” and “the main body.” The main body does not have antecedent basis. Examiner suggests correcting the claim to recite “a slider slidably attached to the body.”
Claim 2 recites “the spring is extended, the grasper is closed,” which should recite “the spring is extended [[,]] and the grasper is closed.”
The same issue occurs with compressed/opened or extended/open in claims 3, 5, and 6.
Claim 8 recites “A endoscopic treatment instrument” which should be “an endoscopic treatment instrument,” and “the treatment portion is a first state” which should read “the treatment portion is in a first state.”
Claims 9, 10, 12, and 13 contain grammatical errors. Claim 9 recites: “the treatment portion is…” should recite “the treatment portion is in [i.e., the relative state].”
Claim 15 recites “the needle is rotatable relative to grasper” which should recite “the needle is rotatable relative to the grasper”
Claims 16 and 19 recite “a tip of the needle is keep relative to the grasper,” which should recite “a tip of the needle is kept [[keep]] relative to the grasper.” Appropriate correction is required.
Claim 20 recites “wherein the tension of the wire, the grasper is opened when is larger than the elastic force of the spring,” should recite “wherein the tension of the wire, when the grasper is opened,
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 9-14 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 9 recites “the handle according to claim 8.” However, claim 8 does not previously recite a “handle.” It is unclear whether “the handle” refers to the endoscopic treatment instrument, the operation portion, or another component thereof. Therefore, the metes and bounds of claim 9 are unclear. Claims 10 and 11 are likewise indefinite by their virtue of their dependency from claim 9.
Claim 12 recites “the handle according to claim 5” and further refers to “the treatment portion.” However, claim 5 is directed to a needle holder and does not recite a “handle” or a “treatment portion.” It is unlear what claimed structure is being further limited by claim 12. Claims 13 and 14 are likewise indefinite by virtue of their dependency from claim 12.
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 8, 15, 16, 17, 18, 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ichikawa et al. (US 2017/0095249 A1)
Regarding claim 8, Ichikawa discloses a endoscopic treatment instrument (Figs. 1-17; paras. [0042]-[0143]) comprising: a sheath 10 (Fig. 1); an operation portion 50 located at a proximal end of the sheath (Fig. 1), the operation portion including: a body 51; a slider 52 slidably attached to the main body (para. [0065]); and a spring 24 located between the body and the slider (Fig. 2); a treatment portion 30 located at a distal end of the sheath (Fig. 1); a wire 40 configured to operate the treatment portion, (para. [0048]) wherein, when the spring is a natural length, the treatment portion is a first state (i.e., the open state as disclosed by paras. [0100]-[0101]).
Regarding claim 15, Ichikawa discloses a needle holder 1 for an endoscope comprising (Figs. 1-17; paras. [0042]-[0143]): a grasper 30; a wire 40 configured to operate the grasper (para. [0048]); an operation portion 50 located proximally relative to the grasper (Fig. 1), the operation portion including: a body 51; a slider 52 slidably attached to the main body (para. [0065]), the slider connecting to wire (Fig. 2); and a spring 24 located between the body and the slider (Fig. 2).
The device of Ichikawa is fully capable of performing when a tension of the wire and an elastic force of the spring are balanced, the grasper is configured to grasp a needle so that the needle is rotatable relative to grasper if one desired to do so- note that the limitations of claim 15 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
Regarding claim 16, Ichikawa discloses the needle holder according to claim 15. Ichikawa also discloses wherein the tension of the wire is larger than the elastic force of the spring (i.e., proximal movement of slider 52 pulls operation wire 40 against elastic force of spring 24 (paras. [0100]-[0103]), when the grasper grasps the needle (i.e., closed state (paras. [0100]-[0103]) so that a direction of a tip of the needle is keep relative to the grasper (i.e., in the closed state).
Regarding claim 17, Ichikawa discloses the needle holder according to claim 16. Ichikawa also discloses wherein when the elastic force of the spring is larger than the tension of the wire (i.e., when the force with which the surgeon pulls back slider 52 is loosened, the mechanism is moved distally by the elastic force of spring 24 (para. [0109])), the grasper is opened (para. [0109]).
Regarding claim 18, Ichikawa discloses the needle holder according to claim 17. Ichikawa also discloses wherein the spring is located distally relative to the slider (Figs. 2, 9, 12).
Regarding claim 19, Ichikawa discloses the needle holder according to claim 15.
The device of Ichikawa is fully capable of performing wherein the elastic force of the spring is larger than the tension of the wire, when the grasper grasps the needle so that a direction of a tip of the needle is keep relative to the grasper if one desired to do so- note that the limitations of claim 19 are merely functional limitations and do not affect the structure of the claimed invention - a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art).
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 1-7, 9-14, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ichikawa et al. (US 2017/0095249 A1) and alternatively in view of Hasson (US 5,628,757).
Regarding claim 1, Ichikawa discloses needle holder 1 for an endoscope comprising (Figs. 1-17; paras. [0042]-[0143]): a grasper 30; a wire 40 configured to operate the grasper (para. [0048]); an operation portion 50 located proximally relative to the grasper (Fig. 1), the operation portion including: a body 51; a slider 52 slidably attached to the main body (para. [0065]), the slider connecting to wire (Fig. 2 shows the slider connected to the wire); and a spring 24 located between the body and the slider (Fig. 2).
Ichikawa does not expressly disclose wherein, when the spring is a natural length, the grasper is closed. Rather, Ichikawa teaches the opposite operative relationship between the spring and the grasper. Specifically, Ichikawa teaches that proximal movement of slider 52 causes operation wire 40 to move proximally and brings grasping members 31,32 into a closed state (para. [0100]). In this closed state, coil spring is compressed more than when the coil spring has its natural length (para. [0101]), and further proximal movement of slider 52 further compresses coil spring 24 (para. [0103]). Conversely, when the pulling force applied by the surgeon is loosened, the elastic force of coil spring 24 moves the mechanism distally and brings grasping members 31, 32 into an open state (para. [0109]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse the operative relationship between the spring and the grasper of Ichikawa such that the natural length of the spring corresponds to the closed condition of the grasper rather than the open condition. Reversal of the operative relationship of the mechanical components to obtain the opposite but predictable operation is an obvious mechanical expedient where the modification yields no unexpected result. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955); MPEP 2144.04 expressly recognizes reversal of parts as supporting obvious rationale, while requiring that its applicability to the particular facts be explained.
Alternatively, in the same field of endeavor, namely surgical instrument for holding a needle, Hasson discloses a needle holder having jaws 12, 14 and a spring-biased actuator mechanism, wherein coil spring 110 acts between first member 104 and guide block 52 to urger guide block 52 and associated sleeve 32 toward a position corresponding to the closed position of jaws 12, 14 (Fig. 3; Col. 6 line 56-Col. 7 line 4)). Thus, Hasson teaches a needle holder in which the spring arrangement establishes the closed position of the jaws as the normally biased position of the grasping mechanism.
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 spring arrangement of Ichikawa in view of Hasson such that the natural length of the spring corresponds to the closed position of the grasper. Hasson teaches the desirability of a normally closed needle-holding arrangement whereby the jaws are biased towards the closed position for gripping and retaining a needle (Col. 3 lines 38-50). As such, one of ordinary skill in the art would have recognized that the relative spring length and positioning of the spring with respect to the movable actuator components may be selected such that the undeformed condition of the spring corresponds to the desired normally closed position of the grasper. Such a modification would have predictably provided the normally closed needle-holding arrangement taught by Hasson while retaining Ichikawa’s slider and wire actuation mechanism.
Regarding claim 2, Ichikawa and Hasson disclose the needle holder according to claim 1. Ichikawa further discloses that slider 52 is movable proximally from a first position to a second position, wherein proximal movement of slider 52 causes operation wire 40 to move proximally and brings grasping members 31,32 into the closed state (para. [0100]). Ichikawa further teaches that, in this proximally displaced position, coil spring 24 is compressed relative to its natural length (para. [0101]), and that further proximal movement of slider 52 further compresses coil spring 24 (para. [0103]).
As discussed above, it would have been obvious to one of ordinary skill in the art to reverse the operative relationship of Ichikawa’s spring relative to the slider such that proximal movement of slider 52 from the first position extends, rather than compresses spring 24. In the reversed arrangement, the spring at its natural length would correspond to the first slider position, and proximal movement of slider 52 to the second position would extend the spring while operation wire 40 would continue to place grasping members 31,32 in the closed state. Such a modification constitutes a reversal of the disclosed mechanical relationship and would have predictably produced the opposite spring deformation in response to the same proximal movement of the slider. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955); MPEP 2144.04.
Regarding claim 3, Ichikawa and Hasson disclose the needle holder according to claim 2. The resulting device of Ichikawa and Hasson as discussed above would also disclose wherein, when the slider is located at a third position located distally relative to the first position, the spring is compressed, the grasper is opened (i.e., at least since Ichikawa discloses the opposite configuration as disclosed in paras. [0100]-[0101], [0109] and further as modified above), and wherein the spring is located distally relative to the slider (i.e., at least since the spring is always distal to the slider; see Figs. 9 and 12).
Regarding claim 4, Ichikawa and Hasson disclose the needle holder according to claim 2. As discussed above, in the modified arrangement, when the spring 24 is the natural length, the grasper 31, 32 having a first closed state, and proximal movement of slider 52 extends spring24 while maintaining grasping members 31, 32 in a closed state. Ichikawa further teaches that continued proximal movement of slider 52 further deforms spring 24 while grasping members 31, 32 remain in the closed state and reliably grasp the suture needle (paras. [0100]-[0103]). Accordingly, in the reversed arrangement discussed above, extension of spring 24 from its natural length would increase the elastic force of spring 24 acting in the closing direction, thereby providing a second closed state having a greater grasping force than the first closed state at the natural length.
Regarding claim 5, Ichikawa and Hasson disclose the needle holder according to claim 1. Ichikawa further discloses that wherein, when the spring 24 is the natural length, the slider 52 is located at a first position (i.e., initial position of slider prior to movement as discussed in para. [0100]-[0101]), and wherein, when the slider 52 is located at a second position located proximally relative to the first position (i.e., slider 52 is pulled proximally from the initial position; para. [0100]), the spring 24 is compressed (para. [0101]), the grasper 31, 32 is closed (para. [0100]).
Regarding claim 6, Ichikawa and Hasson disclose the needle holder according to claim 5. Ichikawa further discloses that wherein, when the slider is located at a third position located distally relative to the first position (i.e., slider 52 is moved distally by the elastic force of spring 24; para. [0109]), the spring is extended (i.e., from its compressed state to its natural length as disclosed in paras. [0101], [0109]), the grasper is opened (para. [0109]).
Regarding claim 7, Ichikawa and Hasson disclose the needle holder according to claim 5. Ichikawa further discloses that wherein, when the spring is the natural length, the grasper having a first closed state (as modified above with respect to claim 1), wherein, when the spring is compressed, the grasper having a second closed state (paras. [0100]-[0103]), a grasping force of the first closed state is smaller than a grasping force of the second closed state (i.e., further proximal movement of slider 52 further compresses spring 24 while grasping members 31, 32 remain closed and reliably grasp the suture needle; paras. [0100]-[0103]). Accordingly, compression of spring 24 from its natural length would increase the elastic force of spring 24 acting in the closing direction, thereby providing the second closed state with a greater grasping force than the first closed state at the natural length.
Regarding claim 9, Ichikawa discloses the handle according to claim 8. Ichikawa further discloses when the spring is the natural length, the slider is located at a first position (i.e., initial position of slider prior to movement as discussed in paras. [0100]-[0101]), and wherein, when the slider is located at a second position located proximally relative to the first position (i.e., the slider is pulled proximally from the initial position; para. [0100]), the treatment portion is the first state (i.e., the open state as interpreted above).
Ichikawa does not directly disclose that the spring is extended when the slider is located at the proximal second position. Rather, Ichikawa discloses that proximal movement of the slider compresses the spring (paras. [0101], [0103]).
As discussed above with regard to claims 1-2, it would have been obvious to one of ordinary skill in the art to reverse the operative relationship of Ichikawa’s spring relative to the slider such that proximal movement of the slider from the first position extends, rather than compresses the spring. In the reversed arrangement, proximal movement of the slider to the second position would extend the spring. Such a modification constitutes a reversal of the disclosed mechanical relationship and would have predictably produced the opposite spring deformation in response to the same proximal movement of the slider. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955); MPEP 2144.04.
Regarding claim 10, Ichikawa and Hasson disclose the handle according to claim 9. The device of Ichikawa as modified by Hasson as discussed above would also disclose wherein, when the slider is located at a third position located distally relative to the first position, the spring is compressed and the treatment portion is in a second state different from the first state (i.e., the closed state, which is different from the first/open state as interpreted above).
Regarding claim 11, Ichikawa and Hasson disclose the handle according to claim 10. Ichikawa further discloses wherein the spring is located distally relative to the slider (Figs. 2, 9, 12).
Regarding claim 12, Ichikawa and Hasson disclose the handle according to claim 5. Ichikawa further discloses wherein, when the spring is the natural length, the slider is located at a first position (i.e., initial position of the slider prior to movement; paras. [0100]-[0101]), and wherein, when the slider is located at a second position located proximally relative to the first position (i.e., the slider is pulled proximally from the initial position; para. [0100]), the spring is compressed (para. [0101]), the treatment portion is the first state (i.e., the closed state para. [0100]).
Regarding claim 13, Ichikawa and Hasson disclose the handle according to claim 12. Ichikawa further discloses wherein, when the slider is located at a third position located distally relative to the first position (i.e., the slider moves distally; para. [0109], the spring is extended (i.e., the spring expands from its compressed state; para. [0109]), the treatment portion is a second state different from the first state (i.e., open state; para. [0109]).
Regarding claim 14, Ichikawa and Hasson disclose the handle according to claim 13. Ichikawa does not directly disclose wherein the spring is located proximally relative to the slider. Rather, Ichikawa discloses the opposite arrangement wherein the spring is located distally to the slider (Figs. 2, 9, 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse the relative positioning of the spring and slider such that the spring is located proximally, rather than distally relative to the slider. Such a modification constitutes a reversal of the disclosed mechanical arrangement and would have predictably provided the opposite relative positioning of the components. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955); MPEP 2144.04.
Regarding claim 20, Ichikawa discloses the needle holder according to claim 19. Ichikawa does not directly disclose wherein the tension of the wire, the grasper is opened when is larger than the elastic force of the spring. Rather, Ichikawa teaches the opposite operative relationship, wherein proximal movement of slider 52 causes operation wire 40 to move proximally and brings grasping members 31, 32 into the closed state (para. [0100]) while release of the pulling force permits the elastic force of spring 24 to move the mechanism distally and bring the grasping members into the open state (para. [0109]).
Hasson discloses that spring 110 biases guide block 52 and sleeve 32 to the position corresponding to the closed position of jaws 12, 14, and application of force to second member 106 against the force of the spring retracts sleeve 32 to the position of the jaws (Fig. 3; Col. 6 line 56-Col. 7 line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse the operative relationship of the wire and spring of Ichikawa as taught in Hasso, such that tension of the wire greater than the elastic force of the spring opens the grasper, since a mere reversal of the operating parts that achieves the expected opposite operation would have been an obvious modification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
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