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
Regarding 35 U.S.C. 112(a)
Applicant's arguments filed 09/09/2026 have been fully considered but they are not persuasive. For example, applicant argues “the specification repeatedly conveys that the device - through the cooperative operation of the X-ray emission module and the X-ray sensing module - obtains an X-ray
image of the lesion. The X-ray emission module emits X-rays and the X-ray sensing module senses the X-rays that have passed through the lesion ([0037], [0042]-[0043]), and the device "takes an X-ray image" (1 [0032]) such that "it is possible to take an X-ray image" ([0045]) and "to obtain an X-ray image in minimally invasive surgery" (T [0046]). Refer to the published application (US 2024/0023910 A1).”, “The claim attributes image generation to the two modules collectively - i.e., to the X-ray imaging subsystem - not to a single module performing all downstream monitor-display processing. Read in that light, "configured to generate an X-ray image" means the emission and sensing modules are arranged and operable such that an X-ray image is produced from the emitted and sensed X-rays, which the specification expressly supports ([0037], [0042]-[0043]). Refer to the published application (US 2024/0023910 A1). The Examiner's reading imports a narrower requirement - that the modules alone perform all image reconstruction -that neither the claim nor § 112(a) requires” (REMARKS pg. 6). Examiner respectfully disagrees in that the claim does not recite that the device – through cooperative operation of the X-ray emission module and the X-ray sensing module -obtains an X-ray image of the lesion as argued by applicant, but rather the claim is more narrow and positively recites that the X-ray emission module and X-ray sensing module are configured to generate the x-ray image. The paragraphs and citations provided by applicant only provide support that the device takes an X-ray image, that it is possible to take an X-ray image and further provide explicit support of that the X-ray emission module emits X-rays and the X-ray sensing module senses X-rays, however, none of the cited paragraphs nor any other paragraphs in the originally filed specification provide support that the X-ray emission module and the X-ray sensing module are configured to generate an x-ray image. As noted in the previous Office Action generation of an X-ray image is understood by a person having ordinary skill in the art to include processing capabilities such that an image is generated and would not recognize that a mere emission module and sensing module which are disclosed as being capable of emitting and sensing X-rays would perform such image generation.
Applicant further argues “The Applicant respectfully submits that the Examiner's own § 103 analysis confirms this reading. In rejecting claim 1, the Examiner finds that the modified system "would function to generate an X-ray image" based on the cooperative emission and sensing of X-rays across the held tissue (Office Action, pp. 3-4, 12), using Graumann's teaching that the emitter and detector "create the X-ray image data" (1 [0025]). The same system-level, cooperative sense of "generate an X-ray image" that the Examiner applies to the prior art is fully supported by the present specification. No new matter is introduced” (REMARKS pg. 6). Examiner respectfully disagrees in that the prior art has been interpreted based on the clarity issue/lack of support for the limitation in the claim and is interpreted in the same manner as disclosed by applicant such that the emitter and detector create/sense X-rays or X-ray imaging data accordingly.
For at least the reasons listed above, applicant’s arguments against the 112(a) written description rejection are not found persuasive and the 112(a) rejection is maintained. Examiner recommends amending the claims to more clearly specify the functions/configurations of the X-ray emission module and X-ray sensing module (e.g. the X-ray emission module is configured to emit X-rays and the X-ray sensing module is configured to sense the X-rays emitted by the X-ray emission module or similar) such that the claim is consistent with the originally filed specification (see for example [0030], [0037], and [0043]) in order to advance prosecution.
Regarding 35 U.S.C. 112(b)
Applicant's arguments filed 09/09/2026 have been fully considered but they are not persuasive.
For example, applicant argues “read in light of [0037] and [0042]-[0043], a skilled artisan understands the limitation with reasonable certainty: the X-ray emission module emits X-rays toward the opposed clamp body, and the X-ray sensing module senses the X-rays after they pass through the lesion held between the clamp bodies, so that an X-ray image of the lesion is produced. Indeed, the Examiner articulated a definite construction - that the modules are "capable of acquiring a sensing result (e.g. X-ray image data) which may be used to generate an X-ray image" (Office Action, p. 8) - which itself demonstrates that the claim conveys its scope with reasonable certainty. The claim is therefore definite” (REMARKS pg. 7). Examiner respectfully disagrees in that the claim is recited in a manner which is inconsistent with applicant’s originally filed specification and that a person having ordinary skill in the art would not readily recognize that the limitation as currently recited is understood to be more broad such that it encompasses merely emitting and sensing X-ray images so that an X-ray image of the lesion is produced as disclosed in the originally filed specification and cited by applicant. For this reason, in light of applicant’s specification, examiner has provided an interpretation of the limitation which is consistent with applicant’s own specification. For at least these reasons, applicant’s arguments are not found persuasive and as noted above, examiner recommends amending the claims to be more consistent with the originally filed specification.
Regarding prior art
Applicant's arguments filed 09/09/2026 have been fully considered but they are not persuasive.
For example, applicant argues “Neith Crum nor Graumann, alone or in combination, teaches or suggests the arrangement in which an X-ray emission module carried on a first clamp body and an X-ray sensing module carried on the opposed second clamp body of a single tissue-holding clamp module are ‘configured to generate an X-ray image when the first clamp body and the second clamp body are inserted into the human body’ with the lesion-bearing tissue held between those opposed clamp bodies” (REMARKS pg. 9) and specifically argues I. Graumann does not place its X-ray emitter and detector on the opposed bodies of any clamp. Graumann’s X-ray emitter is caried on one endoscope/laparoscope ([0019]-[0020], [0040]-[0041]) – two independent instruments that are separately inserted and separately aligned ([0044]). Graumann says nothing about a clamp, opposed clamp bodies, or holding a lesion between opposed bodies while imaging. Graumann therefore supplies only a generic X-ray emitter/detector pair; it does not supply the claimed integration of the X-ray emission and X- ray sensing modules onto the two opposed bodies of a single clamp that grips the tissue being imaged” (REMARKS pg. 9).
Examiner first notes that the claim does not require a “single-tissue holding clamp module”, but rather recites a clamp module comprising a first clamp body, a second clamp body, and a clamp support supporting at least one of the first clamp body and the second clamp body. Nonetheless, even if such a single-tissue holding clamp module were required by the claims, it is noted that this feature is taught by Crum. 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. 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. Furthermore, although the claim require that the emission module and sensing module are configured to generate an X-ray image when the first clamp body and the second clamp body are inserted into the human body, such a limitation does not require generation of the x-ray image with the lesion bearing tissue held between those opposed clamp bodies. Nonetheless, as noted above, when the teachings of Graumann are applied to the teachings of Crum, the system would function to generate an X-ray image when the first clamp body and the second clamp body are inserted into the human body with the lesion-bearing tissue held between those opposed clamp bodies in the same manner that the emission module and sensing module of Crum are configured to generate an image when the first clamp body and the second clamp body are inserted into the human body with the lesion-bearing tissue held between those opposed clamp bodies. Finally, although Graumann teaches the X-ray emission module and the X-ray sensing module on two separate endoscopes, nothing of record indicates that such an X-ray emission module and X-ray sensing module are incapable of being applied to other insertable devices such as the clamp system of Crum. Since Crum teaches a clamp having an emission module on one clamp body and a sensing module on a second clamp body, a person having ordinary skill in the art would have recognized the ability and motivation of supplying other emission/sensing modules in the same manner, especially when such emission/sensing modules are disposed on opposing rods/elements and are desired to be aligned with one another as argued by applicant and disclosed by Graumann in at least [0014] and [0044]. 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 modified to include the emission/sensing modules of Graumann which are relied upon to teach all of the elements of claim 1.
Applicant further argues “Crum does not supply the missing integration for X-ray imaging. Crum's opposed arms carry ultrasound transducers for high-intensity ultrasound therapy and ultrasound sensing (11 [0072], [0088]) - a contact-based, acoustic modality fundamentally different from X-ray transmission imaging. The Examiner uses Crum only for the clamp structure and Graumann only for "X-ray," and then presumes the two combine to yield the claimed X-ray-imaging clamp. That presumption is precisely the hindsight reconstruction that KSR and MPEP § 2142 forbid: the only place the claimed integration appears is Applicant's own disclosure.” (REMARKS pg. 10). 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 Crum is not require to teach the missing integration for X-ray imaging as the X-ray imaging features are relied upon by Graumann. It is thus the combination of Crum and Graumann which teach the clamp structure including the X-ray emission module and X-ray sensing module.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Examiner notes that since Crum teaches the opposed arms carrying ultrasound transducers to perform therapy and sensing and that such sensing is capable of being used to generate a medical image of the tissue disposed between the clamps that applying other emitters/sensers to the clamp body to perform additional imaging/diagnosis of the tissue therebetween would have been an obvious modification. Since Graumann teaches opposed and aligned X-ray emission module and X-ray sensing modules inserted into the human body, a person having ordinary skill in the art would have recognized applying such modules to the system of Crum which already provides such emitting modules and sensing modules which are opposed and aligned by being provided on opposing clamp bodies accordingly.
Applicant further argues “a conclusion of obviousness by substitution requires that combining the known elements yield predictable results. MPEP 2143(I)(B), (D). The examiner’s assertion that mounting Graumann’s X-ray emitter/detector on Crum’s opposed arms requires ‘no substantial redesign’ and is ‘merely an addition’ (Office Action, pg. 4). Is itself conclusory and unsupported by evidence, the same deficiency the Examiner attributes to Applicant. Graumann keeps its emitter and detector on independently-positioned scopes to control the source-object-detector geometry; the Office Action does not explain why a skilled artisan would expect that transplanting those modules onto the closely-spaced, tissue compressing jaws of Crum’s ultrasound therapy clamp would predictably generate a usable X-ray image across the held tissue. Absent that articulated reasoning, the combination lacks the rational underpinning required by KSR and MPEP 2141, 2143 (REMARKS pg. 10). Examiner respectfully disagrees for a plurality of reasons. First it is noted that the combination is not noted as a substitution, therefore any arguments against the obviousness by substitution under MPEP 2143 (I)(B), (D) are not found persuasive as the motivation to combine does not rely on such rationale. Rather the motivation to combine is explicitly provided by examiner in that applying the emission module and sensing module to the clamp body (i.e. an additional emission module and sensing module) would provide for additional imaging measurements/diagnosis of the tissue between such emission modules/sensing modules. Furthermore, regarding applicant’s arguments that the Office Action does not explain why a skilled artisan would expect that transplanting those modules onto the closely-spaced, tissue compressing jaws of Crum’s ultrasound therapy clamp would predictably generate a useable X-ray image across the held tissue. Examiner first notes that generation of a “useable” X-ray image across the held tissue is not a requirement of the claimed invention, nonetheless, examiner further notes that Graumann explicitly discloses in [0041] that the x-ray detector can be arranged as closely as possible from another side to the volume section to be examined, depending on the position and location of the x-ray emitter and in [0023] that since the X-ray detector arrangement can also be inserted into the examination object, the distance between the x-ray emitter arrangement inserted into the examination object and the x-ray detector arrangement can advantageously be significantly reduced compared to an x-ray detector located outside of the examination object, thus explicitly provide a desire for closely spaced x-ray emitter and x-ray detector for providing a higher-quality X-ray image that can be recorded with significantly lower patient dose. Furthermore, Graumann explains that the emitter and detector are opposing and aligned, thus a person having ordinary skill in the art would have recognized that applying the X-ray emission module and X-ray sensing module to the clamp bodies of Crum would yield predictable results and would have reasonable success of generating an X-ray image of the tissue held therebetween.
Regarding applicants arguments on pg. 10-11 that the emphasized limitation is not met by the combination as a whole, Examiner respectfully disagrees in that as noted above, when combined, the system would function such that the X-ray emission and sensing modules of Graumann are carried on the opposed bodies of the single clamp holding the lesion in the same manner as the emission and sensing modules of Crum. The arguments that Graumann images across two separate scopes and does not include a clamp or held tissue and that Crum holds tissue by images with ultrasound are found to be attacks on the references individually and do not take into account the modification of Crum to include the X-ray emission module and X-ray sensing module of Graumann applied to the clamp of Crum.
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 when the first clamp body and the second clamp body are inserted into the human body ([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 when the x-ray emission module and x-ray sensing module are inserted into the human body ([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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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
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