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 .
Remarks
This action is in response to the Remarks filed 12/04/2025.
Claims 1, 2, 8, 9, 11, 13, 15-20, 22, 23, and 25 are pending.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
Rejection of claims 1-3, 7-13, and 15-24 under 35 U.S.C. 101
Independent claims 1, 13, and 18 have been amended to recite determining an energy level for the suggested surgical instrument and wherein the control program update is configured to operate the surgical instrument at the determined energy level. Applicant argues (see Remarks, pages 10-13) that the amended claims are not directed towards an abstract idea. Examiner respectfully disagrees.
First, Applicant argues (see pages 10-11) that the claims recite generating a control program update which is a feature that cannot be practically performed in the human mind. However, this is not found to be persuasive. It would be possible for a human to determine a control update to operate a surgical device using a computer. As explained in MPEP 2106.04(a)(2)(III), courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer.
Second, Applicant argues (see pages 11-12) that the claims are tied to a particular machine and any judicial exception is integrated into a practical application. However, this is not found to be persuasive. As recited, the claims require a processor for receiving the biomarker measurement, determining a threshold based on a temperature differential, determining that the biomarker measurement exceeds the threshold, determining a blood perfusion difficulty when the biomarker measurement data exceeds the threshold, selecting a surgical instrument that has an improved access capability, determining an energy level for the selected surgical instrument, generating a control message for a display device that indicates the selected surgical instrument, generating a control program update configured to operate the selected surgical instrument, and sending the update to the selected surgical instrument. These limitations are directed towards steps of data collection, analysis, and output. As best understood, the crux of the invention is the data processing performed to determine the energy level and surgical instrument, which is an abstract idea. An abstract idea cannot provide a practical application or significantly more. The amended limitation of generating a control program update is understood to be a further data output step. As best understood, the additional elements are the processor and sensor (claim 18). The processor is recited at a high level of generality (i.e., as a generic processor performing the basic steps of data gathering, analysis, and output; see MPEP 2106.05(h)) and the sensor is generic structure for the insignificant, extra-solution activity of data gathering.
Third, Applicant argues (see pages 12-13) that the claims are not directed to an abstract idea because they recite a specific technological improvement to the functioning of a surgical instrument. However, this is not found to be persuasive. Any alleged improvement is within the abstract idea itself. As explained above, an abstract idea cannot provide significantly more or a practical application.
Therefore, there is no further description, in the claims or the specification, of any particular technology for performing the steps recited in the claim other than generic computer components used in their ordinary capacity as tools to apply the abstract idea. Nor does the claimed invention use a particular, or special, machine. In other words, the claims “are not tied to any particular novel machine or apparatus” capable of rescuing them from the realm of an abstract idea. Further, these components are being used to perform the extra-solution activity of data gathering, analysis, and displaying (i.e. an insignificant extra-solution activity, see MPEP 2106.05(g)).
Therefore, the claims do not recite any additional elements that: (1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. Please See MPEP § 2106.05(a)(c), (e)-(h). Therefore, the rejection of the claims under 35 U.S.C. 101 is maintained.
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, 2, 8, 9, 11, 13, 15-20, 22, 23, and 25 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.
Independent claims 1, 13, and 18 require the limitation of the control program update “configured to operate the selected surgical instrument at the determined energy level to address the blood perfusion difficulty by reducing collateral tissue effects at the surgical site”. This limitation is not supported by the instant specification. The specification at pars. [0411] and [0413] discloses generating a control signal configured to control a surgical energy device and adjusting surgical instrument selection to select a tool that minimizes collateral damage, which is not the same as the claimed limitation of operating the selected surgical instrument at the determined energy level to address the blood perfusion difficulty by reducing collateral tissue effects.
Claims 2, 8, 9, 11, 15-17, 19, 20, 22, 23, and 25 are rejected based on their dependency on claims 1, 13, and 18.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 8, 9, 11, 13, 15-20, 22, 23, and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system and method for minimizing blood perfusion difficulty complications. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claims 1 and 18 are directed towards a system, and claim 13 is directed towards a method, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 and 18 are directed towards a system and claim 13 recites a method for minimizing blood perfusion difficulty complications comprising a sensor for measuring a biomarker, a processor for receiving the biomarker measurement, determining a threshold based on a temperature differential, determining that the biomarker measurement exceeds the threshold, determining a blood perfusion difficulty when the biomarker measurement data exceeds the threshold, selecting a surgical instrument that has an improved access capability, determining an energy level for the selected surgical instrument, generating a control message for a display device that indicates the selected surgical instrument, generating a control program update configured to operate the selected surgical instrument, and sending the update to the selected surgical instrument.
The limitation of predicting blood perfusion difficulty complications, as drafted in claims 1-3, 7-13, and 15-24, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper or a generic computer. For example, predicting blood perfusion difficulty complications in the context of this claim encompasses a user obtaining biomarker data, determining thresholds, determining a blood perfusion difficulty based on the thresholds and biomarker measurement data, selecting a surgical instrument, determining an energy level for that surgical instrument, generating a control message for a display device that indicates the selected surgical instrument, generating a control program update configured to operate the selected surgical instrument, and sending the update to the selected surgical instrument. Other than reciting a sensor and processor, nothing in the elements of the claims precludes the steps from practically being performed in the mind or using pen and paper.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
As recited, the step of receiving the biomarker measurement data is considered to be a data collection step, the steps of determining a threshold based on a temperature differential, determining that the biomarker measurement exceeds the threshold, determining a blood perfusion difficulty when the biomarker measurement data exceeds the threshold, selecting a surgical instrument that has an improved access capability, determining an energy level for the selected surgical instrument, generating a control message for a display device that indicates the selected surgical instrument, and the steps of generating a control program update configured to operate the selected surgical instrument, and sending the update to the selected surgical instrument are considered to be a data output step. These are considered to be insignificant extra-solution activity, see MPEP 2106.05(g).
The additional elements are a sensor and processor. The processor is recited at a high level of generality (i.e., as a generic processor performing the basic steps of data gathering, analysis, and output; see MPEP 2106.05(h)) and the sensor is generic structure for the insignificant, extra-solution activity of data gathering.
Further, the processor claimed and described in the Specification appear to function in a generic manner using commercially available equipment (pars. [0267]-[0268] of the published specification: “The processor 20102 may be any single-core or multicore processor such as those known under the trade name ARM Cortex by Texas Instruments.”).
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional element of a processor amounts to no more than mere instructions to apply the exception using generic computer components. The sensor provides generic structure for the insignificant, extra-solution activity of data gathering. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible. 1, 2, 8, 9, 11, 13, 15-20, 22, 23, and 25
Claims 2, 8, 9, 11, 15-17, 19, 20, 22, 23, and 25 depend on claims 1, 13, and 18 and recite the same abstract idea as claims 1, 13, and 18 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2, 19 and 25 (i.e. specifying what the surgical instrument can be) are simply providing options for the surgical instrument selection. The limitations of claims 8, 9, 11, 16, 17, 22, and 23 (i.e. providing details about the adjustment) are considered to be further data output steps. The limitations of claim 15 (i.e. providing details about the adjustment, obtaining a planned energy level, and determining an adjusted energy level) are further data output, data gathering, and data analysis steps. The limitations of claim 20 (i.e. determining the predicted complication based on a calculated probability) are further data analysis steps. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHREYA ANJARIA/Examiner, Art Unit 3796
/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
Prosecution Insights