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 .
In view of the appeal brief filed on May 26th, 2026, PROSECUTION IS HEREBY REOPENED. A new grounds of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JOANNE M RODDEN/ Supervisory Patent Examiner, Art Unit 3794
Response to Arguments
Applicant’s arguments, see pages 2-4, filed May 26th, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive in view of the interpretation of the Jang reference with respect to the blade retraction and the Weber reference. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art the teaches the claim’s limitations.
In response to applicant's argument on pages 2-3 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Applicant describes Walsh’s distances that the transducer and instrument are both variable, such that in the invention the transducer and instrument are fixed and/or static) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument on page 3 that the rationale does not account for how the combination would actually be implemented, 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).
In response to applicant’s argument on page 3 that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Walsh explicitly describes the benefits of the claimed arrangement.
In response to applicant's arguments against the references individually on pages 2-5, 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 response to applicant's argument on pages 4-5 that such combination, 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).
The previous 112(b) and 112(d) rejections have not been independently addressed in the response and therefore the rejections are maintained.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because they are hand drawn numerical labels (Figs. 1-11) and comprise written descriptions (Figs. 2-14). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1, line 17: “module adapted” should read --module is adapted--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “feedback module” in claim 1.
In reference to the Specification, [0025] recites: “The electrocautery device and system of the present invention may optionally include: (i) a computer adapted to accept data from the ultrasonic transponder through the data transmission module and to process the data and signal the feedback module so as to cause the feedback module to either (1) signal the user of the electrocautery device (or any other cutting and dissecting device) or (2) change or interrupt the current provided by the source of current” and [0095] recites: “It will be also be appreciated that the mechanical and electromechanical arrangements in the device and the nature and distribution of the associated software within the electrocautery device and system of the present invention” such that the feedback module may be software.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 6, 28-29 & 31-33 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.
Regarding claim 1, the claim recites “wherein the signal to the user of the electrocautery device is an audiovisual warning” in lines 10-11 and there is no direct support in the Specification for this feature. The following paragraphs recite: [0024]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, [0028]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, and [0093]: “may provide visual and tactile feedback to and through the computer system to the electrocautery device” but these do not provide any direct support for an audiovisual warning.
Claims 6, 28-29 & 31-33 are also rejected by virtue of their dependency on claim 1.
Regarding claim 28, the claim recites “wherein the signal to the user of the electrocautery device is a vibration” and there is no direct support in the Specification for this feature. The following paragraphs recite: [0024]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, [0028]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, and [0093]: “may provide visual and tactile feedback to and through the computer system to the electrocautery device” but these do not provide any direct support for a vibration.
Claim 29 is also rejected by virtue of its dependency on claim 28.
Regarding claim 29, the claim recites “wherein the feedback module activates the vibration” and there is no direct support in the Specification for this feature. The following paragraphs recite: [0024]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, [0028]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, and [0093]: “may provide visual and tactile feedback to and through the computer system to the electrocautery device” but these do not provide any direct support for a vibration.
Regarding claim 32, the claim recites “wherein the signal to the user of the electrocautery device is an audio warning” and there is no direct support in the Specification for this feature. The following paragraphs recite: [0024]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, [0028]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, and [0093]: “may provide visual and tactile feedback to and through the computer system to the electrocautery device” but these do not provide any direct support for a vibration.
Claim 33 is also rejected by virtue of its dependency on claim 32.
Regarding claim 33, the claim recites “wherein the feedback module activates the audio warning” and there is no direct support in the Specification for this feature. The following paragraphs recite: [0024]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, [0028]: “a computer system to provide visual or tactile feedback to the electrocautery device handle”, and [0093]: “may provide visual and tactile feedback to and through the computer system to the electrocautery device” but these do not provide any direct support for a vibration.
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, 6, 28-29 & 31-33 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.
Regarding claim 1, the claim recites “a feedback module” in line 9 and based on the 112(f) section above, it is unclear whether this is to be interpreted as hardware or software. For examination purposes, the feedback module will be interpreted as software.
Regarding claim 1, the claim recites “position and acceleration data” in lines 22-23 and it is unclear if this is the same position and acceleration data as that recited in lines 17-18 or is different position and acceleration data. For examination purposes, these are the same position and acceleration data and the limitation will be interpreted as “the position and acceleration data”.
Regarding claim 1, the claim recites “a microprocessor and RAM/ROM memory” in lines 24-25 and it is unclear if this is separate or part of the computer system recited in line 21. For examination, these will be interpreted as components that may be part of a same computer system.
Claims 6, 28-29 & 31-33 are also rejected by virtue of their dependency on claim 1.
Regarding claim 6, the claim recites “an associated computer system” in line 3 and it is unclear if this is computer system is the same as the computer system recited in claim 1, from which claim 6 depends or is a separate computer system. For examination purposes, these are a same computer system and the limitation will be interpreted as “the computer system”.
Regarding claim 28, the claim recites “a proximity” in line 3 and it is unclear if this is the same proximity or a different proximity as recited in claim 1, from which claim 28 depends. For examination purposes, these are the same proximities and the limitation will be interpreted as “the proximity”. Claim 29 is also rejected by virtue of its dependency on claim 28.
Regarding claim 32, the claim recites “a proximity” in line 3 and it is unclear if this is the same proximity or a different proximity as recited in claim 1, from which claim 28 depends. For examination purposes, these are the same proximities and the limitation will be interpreted as “the proximity”.
Claim 33 is also rejected by virtue of its dependency on claim 32.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 32-33 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 32, the claim recites “wherein the signal to the user of the electrocautery device is an audio warning to the operator of positioning of the electrocautery device in a proximity to anatomical tissue whose cutting or damage is to be avoided” and it is unclear how this further narrows the subject matter of claim 1, which recites “wherein the signal to the user of the electrocautery device is an audiovisual waring to the user of positioning of the electrocautery device in a proximity to anatomic tissue whose cutting or damage is to be avoided”.
Claim 33 is also rejected by virtue of its dependency on claim 32.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 6 & 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (U.S. Pub. No. 20200008880, previously cited), herein referred to as “Jang” in view of Walsh et al. (U.S. Pub. No. 20200360054, previously cited), herein referred to as “Walsh”, Ludwin et al. (EP 2862536 A1), herein referred to as “Ludwin”, and Iannitti et al. (U.S. Pub. No. 20180177390, previously cited), herein referred to as “Iannitti”.
Regarding claim 1, Jang discloses an electrocautery device (ultrasonic probe 100; [0087]: the incision unit 110 is constituted by an electrode of the electric scalpel, the incision unit 110 may solidify the object … the region coagulates), the electrocautery device comprising:
(a) a handle portion (lower housing 122, upper housing 124 and cover housing 126) having a distalmost end along is longitudinal axis (rounded distalmost end of cover housing 126);
(b) an electrocautery unit (incision unit 110) having a surgical electrode extending from the distalmost end of said handle portion ([0084]: the incision unit 110 may be provided with an electrode; see Fig. 2);
(c) an ultrasonic transponder (ultrasonic image acquisition unit 40) so as to be adapted to detect differences in anatomical tissue distally of said surgical electrode ([0069]: the ultrasonic image acquisition unit 40 for generating an internal image of the object, the adjustment unit 50 for adjusting the incision unit 110, the power supply unit 60 for supplying power to each configuration of the ultrasonic probe 100, the display unit 70 for outputting an adjustment result of the incision unit 110; wherein device control based off of an image is seen as detecting differences in the tissue distally of the probe);
(d) a source of current (power supply unit 60) to said surgical electrode ([0086]: the incision unit 110 receives electric power from the power supply unit 60);
(e) a feedback module (controller 90) adapted to, based on the detection of differences in anatomical tissue ([0057]: The incision unit 110 is adjusted based on the inside of the object determined by the ultrasonic signal received by the ultrasonic probe 100; [0080]: the controller 90 may determine that it is possible to avoid a hazardous object or a region of interest that should not be incised in the direction of the movement of the incision unit 110),
(1) signal a user of the electrocautery device, wherein the signal to the user of the electrocautery device is a warning to the user of positioning of the electrocautery device in a proximity to anatomic tissue whose cutting or damage is to be avoided ([0108]: the ultrasonic probe 100 irradiates ultrasonic wave to an object 200 and determines the interior of the object 200 through the reflected ultrasonic signal; [0113]: Meanwhile, FIGS. 4A and 4B are merely examples of the operation of the disclosed ultrasonic probe 100. As another example, if the user is set to insert the incision unit when there is another dangerous object such as a blood vessel in the incision object, the ultrasonic probe 100 may stop the incision by inserting the incision unit 110 completely into the inside of the incision part; wherein the retraction of the blade is seen as a warning since a user can see the blade being retracted); and
(f) a data transmission module (communication unit 80) for transmitting data from said ultrasonic transponder, and for transmitting data to said feedback module ([0069]: the ultrasonic image acquisition unit 40 for generating an internal image of the object, the adjustment unit 50 for adjusting the incision unit 110, the power supply unit 60 for supplying power to each configuration of the ultrasonic probe 100, the display unit 70 for outputting an adjustment result of the incision unit 110 … a communication unit 80 for exchanging data with the ultrasonic diagnostic apparatus 10; [0095]: communication unit 80 transmits ultrasonic signals to the ultrasonic diagnostic apparatus 10 or transmits the generated ultrasonic signals to the ultrasonic probe 100. The communication unit 80 may also receive a control command of the ultrasonic probe 100 from the ultrasonic diagnostic apparatus 10).
(h) a three-dimensional spatial data module adapter to transmit three-dimensional spatial data to a computer system ([0069]: a communication unit 80 for exchanging data with the ultrasonic diagnostic apparatus 10; [0131]: the ultrasonic probe 100 detects the depth of the region of interest based on the ultrasonic image within the object (330); [0138]: The ultrasonic probe 100 detects the shape of the object, that is, the shape of the region of interest based on the generated image (420); wherein detection of the shape and depth of a region of interest is seen as a three-dimensional spatial data module),
(i) a display adapted to display a surgical site ([0050]: a processor for controlling the overall operation of the ultrasonic diagnostic apparatus 10. The processor generates an ultrasonic image and controls the main body display unit 4 to output an image),
wherein the data transmission module adapted to transmit electrocautery unit status data ([0069]: the ultrasonic image acquisition unit 40 for generating an internal image of the object, the adjustment unit 50 for adjusting the incision unit 110, the power supply unit 60 for supplying power to each configuration of the ultrasonic probe 100, the display unit 70 for outputting an adjustment result of the incision unit 110 … a communication unit 80 for exchanging data with the ultrasonic diagnostic apparatus 10; [0095]: communication unit 80 transmits ultrasonic signals to the ultrasonic diagnostic apparatus 10 or transmits the generated ultrasonic signals to the ultrasonic probe 100. The communication unit 80 may also receive a control command of the ultrasonic probe 100 from the ultrasonic diagnostic apparatus 10; [0043]: the ultrasonic probe 100 and the ultrasonic diagnostic apparatus 10 exchange signals through wireless communication. However, this is merely an example, and the ultrasonic diagnostic apparatus 10 and the ultrasonic probe 100 may be connected through a wired communication).
But Jang fails to disclose (c) an ultrasonic transponder extending from the distalmost end of said handle portion and disposed adjacent and parallel to said surgical electrode,
wherein the surgical electrode and ultrasonic transponder extend approximately equal distances from the distalmost end of said handle portion.
However, Walsh discloses an electrocautery device (modular assembly 100; [0030]: the second endoscopic instrument 150 of the present disclosure is not limited to a biopsy needle, but may include a variety of medical instruments configured to manipulate a target tissue within a body passage, including, for example, electrocautery knives), the electrocautery device comprising: (a) a handle portion (main body 110; [0022]: main body 110 (e.g., housing, ergonomic handle, etc.)); (b) an electrocautery unit ([0030]: the second endoscopic instrument 150 of the present disclosure is not limited to a biopsy needle, but may include a variety of medical instruments configured to manipulate a target tissue within a body passage, including, for example, electrocautery knives); and (c) an ultrasonic transponder (ultrasound transducer 142) extending from the distalmost end of said handle portion (distal end of dual-lumen catheter 112; [0024]: an ultrasound transducer 142 disposed at a distal end of the first endoscopic instrument 140 extends beyond a distal end of the dual-lumen catheter 112) and disposed adjacent and parallel to said surgical electrode ([0026]: a distally extended position with the sharpened distal end 152 of the second endoscopic instrument in the second position (FIG. 4B); [0027]: the sharpened distal end 152 of the second endoscopic instrument 150 may be substantially adjacent to or extend slightly distally beyond the ultrasound transducer 142 such that the pulmonary nodule 160 and sharpened distal end 152 may be imaged simultaneously; see Fig. 4B),
wherein the surgical electrode and ultrasonic transponder extend approximately equal distances from the distalmost end of said handle portion ([0027]: the sharpened distal end 152 of the second endoscopic instrument 150 may be substantially adjacent to or extend slightly distally beyond the ultrasound transducer 142 such that the pulmonary nodule 160 and sharpened distal end 152 may be imaged simultaneously; see Fig. 4B and wherein “approximately” is broad such that substantially adjacent is seen as extending approximately the same distance from the distalmost end of the handle portion).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrocautery device of Jang to have the positioning of the ultrasonic transponder, as taught by Walsh, for the purpose of enabling the target tissue and distal end of the electrocautery unit to be imaged simultaneously (Walsh: [0027]).
But Jang in view of Walsh fail to disclose:
(e) a feedback module adapted to, based on the detection of differences in anatomical tissue,
(1) signal a user of the electrocautery device, wherein the signal to the user of the electrocautery device is an audiovisual warning to the user of positioning of the electrocautery device in a proximity to anatomic tissue whose cutting or damage is to be avoided,
(2) cease the current provided by said source of current to prevent cutting or damaging anatomical tissue.
However, Ludwin discloses (e) a feedback module (processor 42) adapted to, based on the detection of differences in anatomical tissue ([0034]; processor 42 uses at least the force and displacement measurements performed by sensors 38 and 48 to assess the risk of tissue perforation),
(1) signal a user of the electrocautery device, wherein the signal to the user of the electrocautery device is an audiovisual warning to the user of positioning of the electrocautery device in a proximity to anatomic tissue whose cutting or damage is to be avoided ([0034]: Processor 42 presents audiovisual indications and alerts regarding the estimated risk on display 46, to enable operator 30 to take suitable measures, in advance, to prevent tissue perforation),
(2) cease the current provided by said source of current to prevent cutting or damaging anatomical tissue ([0050]: processor 42 automatically reduces or shuts down the RF energy upon entering the perforation and/or perforation-risk zones).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the feedback module of Jang in view of Walsh to be the feedback module of Ludwin, for the purpose of the indications and alerts regarding the estimated risk enabling the operator to take suitable measures in advance to prevent tissue perforation ([0034]).
But Jang in view of Ludwin and Walsh fail to disclose:
(g) an accelerometer, wherein the data transmission module adapted to transmit position and acceleration data from the electrocautery unit,
(i) a display adapted to display a surgical site and further incorporate position and acceleration data from the electrocautery unit,
wherein said data transmission module also contains a microprocessor and RAM/ROM memory for managing a short-range wireless or wired interface and converting voltage data from the accelerometer into digitized data.
However, Iannitti discloses (g) an accelerometer ([0041]: Sensors may optionally include and/or be coupled to one or more accelerometers), wherein the data transmission module adapted to transmit position and acceleration data from the electrocautery unit ([0041]: Sensors may optionally include and/or be coupled to one or more accelerometers used to estimate the movement, position, and location of the medical device and/or portions thereof; [0026]: In some aspects, the spatial location of the device is determined using real-time data received from an ultrasound device (e.g., ultrasound wand); where real-time data acquisition is seen as a short-range wireless or wired data connection),
(i) a display adapted to further incorporate position and acceleration data from the electrocautery unit ([0041]: Sensors may optionally include and/or be coupled to one or more accelerometers used to estimate the movement, position, and location of the medical device and/or portions thereof; [0052]: In some embodiments, position sensing units are used to track the sensors disposed on the medical device and the ultrasound wand. The position data is sent to the imaging platform, which processes or combines the data with the volumetric data obtained from the 3D ultrasound transducer and provided on a display),
wherein said data transmission module also contains a microprocessor and RAM/ROM memory for managing a short-range wireless or wired interface and converting voltage data from the accelerometer into digitized data ([0041]: Sensors may optionally include and/or be coupled to one or more accelerometers used to estimate the movement, position, and location of the medical device and/or portions thereof; [0052]: In some embodiments, position sensing units are used to track the sensors disposed on the medical device and the ultrasound wand. The position data is sent to the imaging platform, which processes or combines the data with the volumetric data obtained from the 3D ultrasound transducer and provided on a display; [0054]: In some cases, the imaging platform includes at least one processor and memory. The processor may be a physical hardware processor including a single core or multiple cores. The processor may also be a virtual processor that runs on a hypervisor layer that control access to underlying processor hardware; wherein in a system utilizing accelerometer(s) and processors, this is seen as being capable of converting voltage data from the accelerometer into digitized data).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to include the accelerometer, microprocessor and position/acceleration data of Iannitti to the system of Jang in view of Ludwin and Walsh for the purpose of improving the ease and ability to target structures and navigate solid organ tissue intra-operatively, in part, by modeling the surgeon's actions while using the device and/or the device's spatial location relative to the patient and/or the patient's organ and so that a surgeon has improved visualization of the surgical trajectory and vital structures within a solid organ (Iannitti: [0026], [0051]).
Regarding claim 6, Jang discloses (j) a three- dimensional spatial detection system and associated tactile feedback system contained within the electrocautery device and an associated computer system ([0131]: the ultrasonic probe 100 detects the depth of the region of interest based on the ultrasonic image within the object (330); [0138] The ultrasonic probe 100 detects the shape of the object, that is, the shape of the region of interest based on the generated image (420); [0113]: if the user is set to insert the incision unit when there is another dangerous object such as a blood vessel in the incision object, the ultrasonic probe 100 may stop the incision by inserting the incision unit 110 completely into the inside of the incision part; wherein detection of the shape and depth of a region of interest is seen as a three-dimensional spatial detection system & retraction of the blade is seen as a tactile feedback).
Regarding claim 31, Jang in view of Ludwin discloses wherein the feedback module varies the current based on the acceleration and/or position data (Ludwin: [0050]: processor 42 automatically reduces or shuts down the RF energy upon entering the perforation and/or perforation-risk zones).
Regarding claim 32, Jang in view of Ludwin discloses wherein the signal to the user of the electrocautery device is an audio warning to the user of positioning of the electrocautery device in a proximity to anatomical tissue whose cutting or damage is to be avoided (Ludwin: [0034]: Processor 42 presents audiovisual indications and alerts regarding the estimated risk on display 46, to enable operator 30 to take suitable measures, in advance, to prevent tissue perforation).
Regarding claim 33, Jang in view of Ludwin discloses wherein the feedback module activates the audio warning based on the acceleration and position data (Ludwin: [0034]: Processor 42 presents audiovisual indications and alerts regarding the estimated risk on display 46, to enable operator 30 to take suitable measures, in advance, to prevent tissue perforation).
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jang in view of Walsh, Ludwin and Iannitti as applied to claim 1, above, and further in view of Weber (U.S. Pub. 20140188095, previously cited), herein referred to as “Weber”.
Regarding claim 28, Jang in view of Walsh, Ludwin and Iannitti fail to disclose wherein the signal to the user of the electrocautery device is a vibration to warn the user of positioning of the electrocautery device in a proximity to anatomical tissue whose cutting or damage is to be avoided.
However, Weber discloses wherein the signal to the user of the electrocautery device is a vibration to warn the user of positioning of the electrocautery device in a proximity to anatomical tissue whose cutting or damage is to be avoided ([0044]: the feedback means may be configured to notify the surgeon when the TDM has been positioned in a particular location within the target region for a particular time period …. Examples of tactile feedback means include vibration). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrocautery device of Jang in view of Walsh, Ludwin and Iannitti to include a signal to the user, as taught by Weber, for the purpose of providing information to a user to avoid excess energy delivery to tissues (Weber: [0044]).
Regarding claim 29, Jang in view of Walsh, Ludwin and Iannitti fails to disclose wherein the feedback module activates vibration based on the acceleration and position data.
However, Weber discloses wherein the feedback module activates vibration based on the acceleration and position data ([0044]: the feedback means may be configured to notify the surgeon when the TDM has been positioned in a particular location within the target region for a particular time period …. Examples of tactile feedback means include vibration).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrocautery device of Jang in view of Walsh, Ludwin and Iannitti to include an accelerometer and feedback module, as taught by Weber, for the purpose of providing information to a user to avoid excess energy delivery to tissues (Weber: [0044]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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