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 .
Response to Arguments
New 35 U.S.C. 112(a) and 112(b) rejections necessitated by amendment.
Regarding prior art
Applicant's arguments filed 02/13/2026 have been fully considered but they are not persuasive.
For example, applicant argues “Crum discloses a laparascopic clamp instrument employing high-intensity ultrasound (HIU) emission and sensing for therapeutic purposes rather than for X-ray imaging. The device of Crum therefore is directed to ultrasound-based treatment and sensing and is not configured to generate an X-ray image, nor does Crum disclose any X-ray emission or X-ray sensing module configured for imaging” (REMARKS pg. 7).
In response to applicant's arguments against the references individually, 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).In this case, it is noted that applicant’s first argues that Crum does not teach a system which is configured to generate an X-ray image nor disclosing any X-ray emission or X-ray sensing module. Examiner notes that Crum is directed to ultrasound emission and reception and further discloses a configuration for generating an ultrasound image, however, the previous and current office action note that Crum is not relied upon for the features regarding the X-ray emission module and X-ray sensing module, but rather it is Graumann which is relied upon for such features.
Applicant further argues “Graumann teaches an imaging device in which the X-ray emitter and detector are components of an endoscopic imaging system that is not inserted into the body in the manner recited in claim 1, nor configured as part of a clamp module arranged to hold tissue while generating an X-ray image across opposed clamp bodies” (REMARKS pg. 7). In response to applicant's arguments against the references individually, 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). In this case it is noted that first, Graumann need not teach the specifics of the clamp module arranged to hold the tissue as this feature is taught by Crum and further that although the claim does not require holding the tissue while generating an X-ray image across opposed clamp bodies, it is noted that Crum teaches emitting and sensing energy while holding the tissue with the clamp module, therefore, when modified to include the X-ray emission module and the X-ray sensing module of Graumann on opposing clamp bodies in the same manner as the ultrasound emission module and ultrasound sensing module, that the system would function to generate an X-ray image accordingly. Finally, regarding applicant’s arguments that the X-ray emitter and detector are components of an endoscopic imaging system that is not inserted into the body, examiner respectfully disagrees in that it is known that and endoscope is for being inserted into the body and further [0008] of Graumann explicitly teaches that the x-ray emitter arrangement can be inserted into the examination object. It is therefore noted that applicant’s arguments against Graumann alone are not found persuasive as it is the combination of the clamp module of crum and the emission/sensing modules of Graumann which are relied upon to teach all of the elements of claim 1.
Applicant further argues “the cited references do not teach or suggest configuring opposed clamp bodies that both (i) hold tissue and (ii) include facing X-ray emission and sensing modules specifically arranged to generate an X-ray image between the clamp bodies as expressly required by claim 1. The Examiner’s proposed modification would require substantial structural redesign of the Crum device and is unsupported by a sufficient articulated rationale as required by MPEP 2141 and 2143” (REMARKS pg. 7). In response to applicant's argument that the proposed modification would require substantial structural redesign of the Crum device, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, it is noted that applicant’s arguments that the modification would require substantial structural redesign of the Crum device is merely conclusory without any evidence nor arguments as to why that is the case. Examiner notes that applicant arguments cannot replace evidence where evidence is necessary. Examiner further notes that Crum already teaches an emission module and a sensing module on opposite clamp modules for emitting and receiving data and further for generating image data, thus examiner notes that further including an X-ray emission module and an X-ray sensing module such as those taught by Graumann in the same corresponding clamp modules (i.e. the X-ray emission module on the same clamp module as the ultrasound emission module and the X-ray sensing module on the same clamp module as the ultrasound sensing module) would not require any redesign but merely an addition of the modules to the clamps or in an alternative to replace the ultrasound sensing modules. Either of which would have been readily recognized as a modification to the system of Crum without any “substantial redesign”. Furthermore, a person would have been motivated to include the X-ray emitting/sensing modules of Graumann in the system of Crum to provide further diagnostic value to the system of Crum by allowing for further imaging using x-ray to enable tissue discrimination or to examine sites closely with x-ray diagnostic capabilities. Thus Applicant’s arguments that the modification of Crum to include the features of Graumann is unsupported by sufficient rationale is unfounded and merely conclusory without any support via evidence nor further arguments. For at least these reasons applicant’s arguments against the combination of Crum and Graumann is not found persuasive and the rejection is maintained/updated in view of the amendments to the claims.
Applicant further argues “Neither Crum nor Graumann teaches clamp bodies arranged such that surfaces of opposed clamp bodies align in parallel while carrying X-ray emission and sensing modules facing each other to generate an image across a lesion held between the clamp bodies. Crum uses ultrasound transducers located on instrument arms for therapeutic energy delivery no opposed X-ray imaging modules arranged to capture an image through held tissue. Graumann likewise does not disclose clamp-body-mounted opposed emitter/detector elements configured for tissue gripping while imaging” (REMARKS pg 7-8). In response to applicant's arguments against the references individually, 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). As noted above, the rejection does not rely on Crum to teach X-ray imaging modules, but rather teaches ultrasound imaging modules which capture an ultrasound image and does not rely on Graumann to teach the opposed clamp-body opposed emitter-detector elements configured for tissue gripping while imaging as these features are already taught by the primary reference Crum. It is the combination of Crum which teaches clamp-body opposed emitter-detector elements configured for tissue gripping while imaging which is modified to include the x-ray imaging modules of Graumann that teaches the features of claim 1, where it is noted that a person having ordinary skill in the art would have recognized that when applied to the system of Crum the x-ray emission module and X-ray sensing module of Graumannwould be facing each other and attached to the surfaces of opposed clamp bodies aligned in parallel of Crum.
Applicant finally argues “because neither Crum nor Graumann, alone or in combination, teaches or suggests: (1) an X-ray emission module and an X-ray sensing module configured to generate an X-ray image and (2) the opposed clamp-body arrangement holding tissue while imaging across the clamp bodies, the combination fails to disclose every limitation of claim 1 as required for a prima facie obviousness case” (REMARKS pg 8). Examiner respectfully disagrees in that (1) is explicitly taught by Graumann and (2) is explicitly taught by Crum and it is the combination of Crum and Graumann which teaches the all of the elements of claim 1.
For at least the reasons listed above, applicant’s arguments against the teachings of Crum and Graumann are not found persuasive.
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.
Claims 1-5 are 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 1 recites the limitation “wherein the X-ray emission module and the X-ray sensing modules are configured to generate an X-ray image”. Examiner notes that the there is no textual support for the limitation nor is there any implicit support that the modules are configure to generate an x-ray image. Specifically it is noted that a person having ordinary skill in the art would understand that generating an x-ray image requires processing capabilities and there is no support that the modules positioned on the clamp bodies have such processing capabilities. Rather in [0042] it is disclosed that the sensing result by the X-ray sensing module 142 is transmitted to external control equipment through the signal cable, whereby it is possible to see an X-ray image. Thus its is noted that while the modules may be configured to acquire X-ray imaging data which may ultimately be used (e.g. by external control equipment) to generate an X-ray image, there is not sufficient support that the modules themselves are configured to generate said X-ray image. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing and the limitation therefore constitutes new matter.
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 1-5 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 1 recites the limitation “wherein the X-ray emission module and the X-ray sensing modules are configured to generate an X-ray image”. The limitation is unclear in light of the specification as to what constitutes an X-ray emission module and X-ray sensing module which are configured to generate an X-ray image and are located on the clamp bodies. In light of [0042] it has been interpreted that the X-ray emission module and the X-ray sensing module are capable of acquiring a sensing result (e.g. X-ray image data) which may be used to generate an X-ray image, however, clarification is required.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Crum et al. (US 20070004984 A1), hereinafter Crum in view of Foreign Graumann (DE 102010061880 A1), hereinafter Graumann.
Regarding claim 1,
Crum teaches an imaging device (at least fig. 3A (210) and corresponding disclosure in at least [0057]) for minimally invasive surgery ([0023] which discloses laparoscopic clamp and abstract which discloses minimally invasive surgical instrument)
the device (210) comprising:
a rod (see at least fig. 3) having a predetermined length and configured to be inserted into a human body (Examiner notes that the rod depicted necessarily has a predetermined length (i.e. a length which is predetermined for manufacturing purposes and [0023] which discloses the laparoscopic clamp that can be inserted through a trocar and into the body cavity)
a clamp module (see at least fig. 3A) including a first clamp body (at least fig. 3A (220a) and corresponding disclosure in at least [0057] and/or at least fig. 5B (402a) and corresponding disclosure in at least [0072]. See also [0057] which discloses it should be recognized that clamp 210 is intended to be exemplary, rather than limiting on the types of instruments that can be used, consistent with the present disclosure. Many other types of instruments having opposed jaws or arms upon which paired therapeutic transducers (or a therapeutic transducer paired with an acoustic reflector or acoustic absorber disposed on the opposing arm) can alternatively be used to implement the concepts disclosed herein. Examiner notes that the first clamp body may further include the spreader bars attached to element 220a/402a), a second clamp body (at least fig. 3A (220b) and corresponding disclosure in at least [0057] and/or at least fig. 5B (402b) and corresponding disclosure in at least [0072] Examiner notes that the first clamp body may further include the spreader bars attached to element 220b/402b) and a clamp support (see at least fig. 3A considered to be either the spreader bars or the bar from which the spreader bars extend. Furthermore, examiner notes that the spreader bars necessarily use clamp support for operating accordingly) supporting the first clamp body (220a/402a) and the second clamp body (220b/402b) such that a first end of the first clamp body and a first end of the second clamp body open and close ([0057] which discloses spreader bars 222 are coupled to the opposed jaws to initially enable the opposed jaws to be expanded after the clamp has been inserted into a body cavity. See also fig. 4C depicting the clamp bodies able to close as shown by arrows 414 and disclosure in at least [0073]);
an emission module disposed at the first end of the first clamp body ([0072] which discloses such a technique can be implemented where arm 402a comprises an array of therapeutic transducers (or a single transducer) to act as transmitters)
a sensing module disposed at the first end of the second clamp ([0072] which discloses arm 402b comprises an array of transducers (or a single transducer) configured to act as receivers for the ultrasound pulses emitted by the ultrasound transducers in the array on arm 402a)
and a manipulation module (at least fig. 3A (214 and 216) and corresponding disclosure in at least [0057]) disposed at a second end of the rod (see at least fig. 3A) and operating the clamp module to open and close the first end of the first clamp body and the first end of the second clamp body of the clamp module ([0057] which discloses the trigger enables the jaws of the clamp to be manipulated),
wherein the emission module and the sensing module are configured to generate an image ([0088] which discloses additional signal processing can enable either an ultrasound image and/or a Doppler ultrasound image to be displayed to a user, as is generally known in the art)
wherein with the first end of the first clamp body and the first end of the second clamp body open are emitted from the emission module and the signals pass through a lesion of the human body and are sensed by the sensing module ([0060] which discloses as noted above, the region of tissue to be treated can be part of an organ, part of a tumor, or part of a mass of tissue and [0061]-[0063] disclosing the therapy probe positioned such that ultrasound energy is transmitted to interrogate the target tissue. See also fig. 5B depicting the emission and sensing of signals through the tissue sample (406)),
and wherein when the first end of the first clamp body and the first end of the second clamp body are opened, a surface of the first end of the first clamp body and the second clamp body are aligned to be parallel and face each other, such that the emission module and the sensing module are aligned to face each other (see at least fig. 3B depicting the first end of the first clamp body and the second end of the clamp body are opened, and the surfaces are aligned to be parallel and face each other), such that the emission module and the sensing module are aligned to face each other, and wherein the first clamp body and the second clamp body are opened and closed by the clamp support (see at least fig. 3A and 5B), wherein the first and second clamp bodies are configured to hold a tissue having the lesion when closed ([0057] which discloses spreader bars 222 are coupled to the opposed jaws to initially enable the opposed jaws to be expanded after the clamp has been inserted into a body cavity, and later to enable the opposed jaws to be forced together to apply pressure on tissue disposed between the opposed jaws)
Crum fails to explicitly teach wherein the emission module and the sensing module include or are an X-ray emission module and an X-ray sensing module, respectively and wherein X-rays are emitted from the X-ray emission module with the first end of the first clamp body and the first end of the clamp body open are configured to position a lesion of a target organ therebetween in the human body, and x-rays travel through the lesion and is then sensed by the X-ray sensing module for X-ray imaging.
Graumann, in a similar field of endeavor involving medical imaging, teaches an X-ray emission module (at least fig. 1 (1) and corresponding disclosure in at least [0031]) disposed at a first end of a first rod ([0019]-[0020] which discloses the x-ray emitter arrangement attached to a distal end of an emitter endoscope or laparoscope) and an X-ray sensing module (at least fig. 1 (2) and corresponding disclosure in at least [0040]) disposed at a first end of a second rod ([0041] which discloses the x-ray detector integrated with a second endoscope or laparoscope),
Wherein the X-ray emission module and the X-ray sensing module are configured to generate an X-ray image ([0025] which discloses the X-rays which shine through the volume section and emerge for it, are detected by means of the X-ray detector in order to create the X-ray image data)
wherein the first rod and the second rod are configured to be inserted into the human body, such that the X-ray emission module and the X-ray sensing module are inserted into the human body ([0041]) and the x-ray emission module and the x-ray sensing module are aligned to face each other ([0044] which discloses the x-ray emitter 1 and x-ray detector 2 are aligned with one another)
And wherein x-rays travel through a volume of tissue and is then sensed by the x-ray sensing module for x-ray imaging ([0035] which discloses the x-rays emitted by the x-ray emitter illuminate the predetermined volume section and impinge on the x-ray detector and the x-rays shine through the volume section and are detected in order to create the X-ray image data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Crum to include the x-ray emission module and the x-ray sensing module of Graumann in order to generate X-ray image data (Graumann [0025]) of the tissue between the clamp bodies. Such a modification would provide for additional imaging of a small area using a miniaturized X-ray emitter/detector, such that x-ray imaging of small areas can be done intra-operatively to enable tissue discrimination or to examine sites more closely (Graumann [0029]). Thus such a modification would allow for enhanced evaluation of the target tissue by providing additional imaging capabilities of the tissue between the clamp bodies of Crum.
Examiner notes that in the modified system, the system functions such that the X-rays are emitted from the X-ray emission module of Graumann with the first end of first clamp body and the first end of the second clamp body and the lesion positioned therebetween in the human body as taught by Crum and the X-rays thus pass through the lesion and are sensed by the X-ray sensing module accordingly.
Regarding claim 2,
Crum further teaches wherein the clamp support supports the first clamp body and second clamp to be rotatable such that the first clamp body any one of the first clamp body and the second clamp body moves toward and away from the other one ([0057] which discloses spreader bars 222 are coupled to the opposed jaws to initially enable the opposed jaws to be expanded after the clamp has been inserted into a body cavity, and later to enable the opposed jaws to be forced together to apply pressure on tissue disposed between the opposed jaws. Examiner notes that a person having ordinary skill in the art would have recognized that such expansion and closing of the jaws would require rotation of the clamp bodies at least including the spreader bars which would necessarily rotate in order to expand or pull together the clamp bodies)
The first clamp body and the second clamp body is rotated by the manipulation module (([0057] which discloses the trigger enables the jaws of the clamp to be manipulated)
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Crum and Graumann, as applied to claim 1 above, and further in view of Johnson et al. (US 20070078459 A1), hereinafter Johnson.
Regarding claim 3,
Crum, as modified, teaches the elements of claim 1 as previously stated.
Crum, as modified, fails to explicitly teach wherein the clamp support elastically supports the first clamp body and the second clamp body to open the first end of the first clamp body and the first end of the second clamp body, and the manipulation module operates the clamp module to move the clamp module between an insertion position, where the first end of the first clamp body and the first end of the second clamp body are closed and inserted in the rod from the first end of the rod, and an image position where the clamp module is exposed outside the rod with the first end of the first clamp body and the first end of the second clamp body open by elasticity of the clamp support.
Johnson, in a similar field of endeavor involving minimally invasive procedures, teaches a device comprising:
A rod (at least fig. 1 (12) and fig.3 (304) and corresponding disclosure in at least [0084])
A clamp module (at least fig. 3 (300) and corresponding disclosure in at least [0083]) disposed at a first end of the rod (304a) and including a first clamp body (at least fig. 3 (310) and corresponding disclosure in at least [0083]), a second clamp body (at least fig. 3 (320) and corresponding disclosure in at least [0083]), and a clamp support (at least fig. 5 (103) and corresponding disclosure in at least [0083]) supporting at least one of the first clamp body and the second clamp body such that a first end of the first clamp body and a first end of the second clamp body open and close ([0083] which discloses as central shaft 302 is withdrawn into outer sleeve 304 a distal edge 304 of outer sleeve 304 abuts against movable jaw member and forces movable jaw member towards fixed jaw member 320);
A manipulation module (at least fig. 1 (302 and 40) and corresponding disclosure in at least [0069] and [0083]) disposed at a second end of the rod (see at least fig. 1) and operating the clamp module to open and close the first end of the first clamp body and the first end of the second clamp body of the clamp module ([0034] which discloses actuation of the movable handle relative to the housing results in movement of the movable jaw members relative to the shaft. Examiner thus notes the manipulation module 40 and 302 would operate the clamp module to open and close the first end of the first clamp body and the first end of the second clamp body),
wherein the first end of the second clamp body open are configured to position a tissue of a target organ therebetween in the human body ([0083] which discloses wherein tissue may be positioned between jaw members 320, 310)
wherein the clamp support (103) elastically supports the first clamp body and the second clamp body to open the first end of the first clamp body and the first end of the second clamp body ([0083] which discloses the jaw members are biased to the open condition by a biasing member (e.g. spring or the like). Examiner notes a biasing member/spring would elastically support the first and second clamp body)
The manipulation module (302) operates the clamp module to move the clamp module between an insertion position, where the first end of the first clamp body and the first end of the second clamp body are closed and inserted in the rod from the first end of the rod ([0090] which discloses the jaw members are advanced through the lumen of the outer sleeve 304 in a closed condition) and an image position where the clamp module (300) is exposed outside the rod with the first end of the first clamp body and the first end of the second clamp body open by elasticity of the clamp support (See at least fig. 3 and corresponding disclosure in [0083])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Crum, as currently modified to include a clamp module and manipulation module as taught by Johnson in order to provide a variable-ratio mechanical advantage for manipulating the jaw members and clamping tissue, such that, for example, the jaw members can be closed on tissue, easier, quicker and with less user force than previously envisioned to clamp the tissue (Johnson [0017]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Crum and Graumann, as applied to claim 1 above, and further in view of Johnson and Pennybacker et al. (US 5637110 A), hereinafter Pennybacker.
Regarding claim 4,
Crum, as modified, teaches the elements of claim 1 as previously stated.
Crum, as modified, fails to explicitly teach wherein the clamp support is configured to support second ends of the first clamp body and the second clamp body to be rotatable such that the first end of the first clamp body and the first end of the second clamp body open and close, wherein the manipulation module operates the clamp module to move the clamp module between an insertion position, where the first end of the first clamp body and the first end of the second clamp body are closed and inserted in the rod from the first end of the rod, and an image position where the clamp module is exposed outside the rod, and the first end of the first clamp body and the first end of the second clamp body are opened by pulling wires connected to the first clamp body and the second clamp body, respectively, at the imaging position.
Johnson, in a similar field of endeavor involving minimally invasive procedures, teaches a device comprising:
A rod (at least fig. 1 (12) and fig.3 (304) and corresponding disclosure in at least [0084])
A clamp module (at least fig. 3 (300) and corresponding disclosure in at least [0083]) disposed at a first end of the rod (304a) and including a first clamp body (at least fig. 3 (310) and corresponding disclosure in at least [0083]), a second clamp body (at least fig. 3 (320) and corresponding disclosure in at least [0083]), and a clamp support (at least fig. 5 (103) and corresponding disclosure in at least [0083]) supporting at least one of the first clamp body and the second clamp body such that a first end of the first clamp body and a first end of the second clamp body open and close ([0083] which discloses as central shaft 302 is withdrawn into outer sleeve 304 a distal edge 304 of outer sleeve 304 abuts against movable jaw member and forces movable jaw member towards fixed jaw member 320);
A manipulation module (at least fig. 1 (302 and 40) and corresponding disclosure in at least [0069] and [0083]) disposed at a second end of the rod (see at least fig. 1) and operating the clamp module to open and close the first end of the first clamp body and the first end of the second clamp body of the clamp module ([0034] which discloses actuation of the movable handle relative to the housing results in movement of the movable jaw members relative to the shaft. Examiner thus notes the manipulation module 40 and 302 would operate the clamp module to open and close the first end of the first clamp body and the first end of the second clamp body),
wherein the first end of the second clamp body open are configured to position a tissue of a target organ therebetween in the human body ([0083] which discloses wherein tissue may be positioned between jaw members 320, 310)
wherein the clamp support (103) supports second ends of the first clamp body and the second clamp body to be rotatable such that the first end of the first clamp body and the first end of the second clamp body open and close (see at least figs. 3 and 4),
The manipulation module (302) operates the clamp module (103) to move the clamp module between an insertion position, where the first end of the first clamp body and the first end of the second clamp body are closed and inserted in the rod from the first end of the rod (See at least fig. 5 and [0090]), and an image position where the clamp module is exposed outside the rod (See at least fig. 6 and corresponding disclosure in at least [0091]), and
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Crum, as currently modified, to include a clamp module and manipulation module as taught by Johnson in order to provide a variable-ratio mechanical advantage for manipulating the jaw members and clamping tissue, such that, for example, the jaw members can be closed on tissue, easier, quicker and with less user force than previously envisioned to clamp the tissue (Johnson [0017]).
Crum, as currently modified, fails to explicitly teach wherein the first end of the first clamp body and the first end of the second clamp body are opened by pulling wires connected to the first clamp body and the second clamp body.
Pennybacker, in a similar field of endeavor involving minimally invasive surgical clamps, teaches wherein a first end of the first clamp body (at least fig. 20 (170) and corresponding disclosure in at least Col. 9 lines 47-67) and a first end of a second clamp body (at least fig. 20 (170) and corresponding disclosure in at least Col. 9 lines 47-67) are opened by pulling wires (at least fig. 20 (146 and 50) and corresponding disclosure in at least Col. 6 lines 45-49, Col. 15 lines 14-22, and Col. 11 lines 5-21 which disclose pulling on the links 200 pivots the jaws in the opposite direction toward their open position in at least fig. 24. Examiner notes that the links are pulled by pulling the wires 146 which are part of actuating rod 50 as disclosed in Col. 15 lines 14-22) connected to the first clamp body (170) and the second clamp body (170), respectively (See at least exploded fig. 20 which depicts the connection of the wires 146/50 to the jaws via links 200).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Crum, as currently modified, to include pulling wires as taught by Pennybacker in order to improve the strength and control in opening and closing the jaws (Pennybacker Col. 2 lines 15-17)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Crum, Graumann, Johnson, and Pennybacker as applied to claim 4 above further in view of Kawai et al. (US 20010021859 A1), hereinafter Kawai.
Regarding claim 5,
Crum, as modified, teaches the elements of claim 4 as previously stated. Crum, as currently modified, fails to explicitly teach wherein the clamp module includes a stopper stopping the first clamp body and the second clamp body with a predetermined distance therebetween when the wires are pulled.
Kawai, in a similar field of endeavor involving minimally invasive surgical clamps, teaches wherein a clamp module further includes a stopper stopping a first clamp body and a second clamp body with a predetermined distance therebetween ([0082] which discloses a stage-like stopper 123 for preventing the member 41 from being opened at an angle being equal to or greater than 90 degrees).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Crum, as currently modified, to include a stopper as taught by Kawaii in order to prevent the clamp module from being opened to an undesired angle (Kawaii [0082]) , thus ensuring the safety of the clamps and preventing damage to the tissue which could occur if the clamp module opens undesirably.
Examiner notes that in the modified system, the stopper would stop the first clamp body and the second clamp body with the predetermined distance therebetween when the wires as taught by Pennybacker are pulled accordingly.
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached on Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797