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
1. Applicant's arguments filed 06/27/2025 have been fully considered but they are not persuasive.
While the Examiner appreciates the Applicant’s amendments and arguments, the U.S.C 112a rejection is still applied. It is unclear how the data is supplemented with capacitance and compression data to determine thermal impacts of tissue. Specifically, it is not understood how capacitance and/or compression data have to do with thermal impacts. There are currently no examples in applicant’s arguments or specification that explain how compression and capacitance are specifically used with the imaging data to determine thermal effects of tissue. The examples provided by applicant relate to: A) using polarization/refractivity (from imaging alone) to determine thermal damage (while this may determine thermal impact, it does not use capacitance or compression data in any way to make this determination); B) using impedance (as the second parameter) and visualizing movement, creep or compression (as the first parameter from the imaging) to determine subsurface irregularity - even if capacitance and impedance are interchangeable, this in no way accounts for compression (as a second parameter from a sensor, i.e. not the imaging) and has nothing to do with determining thermal impacts.
Further, the claims still remain broad enough to encompass any/all surgical instruments and controlling these surgical instruments in any manner imaginable. While there are examples of increasing or decreasing power level within the specification, the claims are much broader than what is disclosed.
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.
2. Claims 1-20 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.
With respect to claims 1, 6, and 14, the claims require gathering imaging data and a combination of capacitance and viscoelastic compression data and then comparing the imaging data to the supplementation of capacitance/compression data to determine fluid flow of the tissue. However, these steps have not been explained. For example, it is not clear how this is achieved (see arguments presented above). The Applicant has not explained their claims, but rather they just broadly/generally say you compare any of these parameters to determine any state/condition. While these parameters and conditions are disclosed, they are never really discussed together, as to how these parameters are used to determine fluid flow.
Additionally, the claims are currently written broad enough to control (in any way) a surgical instrument (any/all surgical instruments imaginable); however, the specification does not support this breadth.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement."Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Claims 2-5, 7-13, and 15-20 are rejected by virtue of their dependency.
3. Claims 1-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant is claiming gathering imaging data and a combination of capacitance and viscoelastic compression data and then comparing the imaging data to the supplementation of capacitance/compression data to determine fluid flow of the tissue. However, one skilled in the art would not be able to predict/determine fluid flow based on comparing these types of data without having to perform experiments. In fact, there would be an undue amount of experimentation put on one skilled in the art in order to determine this since the Applicant gives no working examples as to how these data points are compared and used to determine fluid flow. Therefore, given the state of the art, it does not appear that one skilled in the art would be knowledgeable about how compare imaging data and a combination of capacitance and viscoelastic compression data to make a determination on fluid flow in the subject.
Allowable Subject Matter
4. Claims 1-20 currently do not have an art rejection. The claims contain subect matter that is not found in the art. Such subject matter includes “control, in real time with the determination of the state of the tissue, the surgical instrument acting on the tissue, based on the result of the comparison of the first tissue parameter with the second tissue parameter, wherein the second parameter comprises a capacitance and a viscoelastic compression of the tissue.” The U.S.C. 112a rejections would need to be addressed before determining allowance.
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.
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/S.L.C./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796