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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 November 2024 has been entered.
This Office Action is responsive to the amendment filed with the RCE filed on 27 November 2024. As directed by the amendment: Claims 1, 2, 3, 6, 9, 10, 11, 12, 13, 14, 15, 16, 18, 2, 22, 23, and 24 have been amended, Claims 4 and 8 have been cancelled, and no claims have been added. Claims 7, 19, and 20 were previously withdrawn due to a Restriction Requirement. Thus, Claims 1-3, 5, 6, 9-18, and 21-24 are presently under consideration in this application.
Specification
The title of the invention is not descriptive, and does not appear to relate to the currently claimed invention. A new title is required that is clearly indicative of the invention to which the claims are directed.
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, 5, 6, 9-15, 17, 18, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1, 2, 5, 9, 10, and 24 recite a surgical system (machine) and Claims 11, 12, 13, 14, 15, 17, 18, 21, 22, and 23 recite a surgical method (process), each of which are within the four statutory categories.
Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 are directed to an abstract idea as described below.
Step 2A, Prong One:
Independent Claim 1 is directed to a surgical system comprising a controller configured to:
obtain first image data via a first surgical device configured to resurface a mucosal surface of a tissue in a patient, wherein the first image data comprises an intraluminal visualization of the tissue;
obtain second image data via a second surgical device, wherein the second image data comprises an extraluminal visualization of the tissue from inside the patient;
determine, based on the first and second image data, a monitored parameter associated with the tissue;
adjust, based on the monitored parameter, a control parameter for intraluminally and extraluminally altering the patient's sensing of food relative to the tissue;
and generate a control signal based on the adjusted control parameter.
Claims 11, 12, 13, 14, 15, 17, 18, 21, 22, and 23 recite similar methods that are implemented by the system of Claims 1, 2, 5, 9, 10, and 24.
These limitations, under their broadest reasonable interpretation, are merely a mental process than can be performed by a person using a pen and paper by viewing images/signal data, because these are steps are akin to having a doctor or other human actor performing a medical diagnosis of a patient and mathematically evaluating sensed data, and graphically “displaying” (i.e. a “control signal”) the output for analysis. Therefore, these steps may be performed mentally by a human actor and implemented by drawing objects/graphs, or verbally providing instructions/formulating a treatment plan, based on the evaluation by hand using a pen and paper.
Claims 2, 5, 6, 9, 10 and 24 depend from Claim 1, and Claims 12, 13, 15, 17, 18, 21, 22, and 23 depend from Claims 11 and 14. These dependent claims only recite additional features of mathematically evaluating, analyzing, controlling, and determining steps.
For example, Claim 11 recites “instructing the second surgical device to helically wrap an implant around the tissue”. However, the claim does not explicitly recite performing the “helically wrapping” step, only that instructions are provided.
Claim 2 recites, “cause a medicant-eluting implant to extraluminally alter the patient’s sensing of food”. Claim 15 recites similar limitations. However, the claim does not explicitly recite actually administering the medicant (or providing specific treatment output based on the analysis), and may be interpreted as additionally providing instructions, as with a human actor/doctor.
Dependent Claims 5, 6, 9, 10, 13, 17, 18, and 21-24 recite additional limitations merely with respect to “determining”, “analyzing”, “monitoring” or “controlling” steps.
These limitations and other limitations of the dependent claims are also merely processes to evaluate a sensed signal which may be performed mentally by a human actor, such as by comparing data/images, performing calculations, and/or simply by drawing objects using a pen and paper. Therefore, these steps may be performed mentally by a human actor and implemented by drawing objects/graphs, or verbally providing instructions/formulating a treatment plan, based on the evaluation by hand using a pen and paper.
If claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two:
The judicial exception is not integrated into a practical application.
Claims 1, 11, and 14 only recites the additional limitations “a controller”, “a first surgical device”, “a second surgical device”, and “an implant”.
Dependent Claims 2, 5, 6, 9, 10, 11, 13, 17, 18, and 21-24 recite the only additional structure of “a surgical hub”, “a robotic surgical system”, “a first implant” and “a second implant”.
These elements merely use generic computer component to evaluate a sensed signal and provide images. It is noted that no direct therapy or treatment initiation is explicitly claimed. Providing imagining during medical diagnostics is a well-known and conventional technique that uses some type of generic imaging system to record data from a patient. This analysis includes merely acquiring a signal/data from a user using a generic imaging components, and is considered an insignificant pre-solution activity of gathering data for use in a claimed process (see MPEP 2106.05(g)). This pre-solution activity of data gathering and then performing calculations/analyses/diagnoses is well-known and typical in the field of medical sensing and computing technology.
These additional elements are recited at a high-level of generality (i.e. most generic computer and medical systems would be known to have these components for general computation, imaging/sensing, processing, and output of sensed data), and they amount to no more than mere pre-solution activity of data gathering from a known sensing or imaging device, and outputting generic ‘controlling’ steps. This pre-solution activity of data gathering using electrodes/sensors and imaging devices is known the field of medical sensing and computing technology. As found in MPEP 2106.05(f), “the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”.”
For example, see the Ben-Oren et al. (US Publication No. 2015/0359594), Altschul et al. (US Publication No. 2018/0256208), and Drozdzal et al. (US Publication No. 2015/0016700) references described in detail below which describe known imaging and surgical medical systems. Therefore, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Thus the claims are directed to an abstract idea. As described above, Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 are merely directed to a mental process, because these are steps are akin to having a doctor or other human actor performing a medical diagnosis of a patient and mathematically evaluating sensed and image data, and determining treatment/diagnosis , which may be done mentally by a human actor and implemented by drawing objects/graphs based on the evaluated by hand using a pen and paper.
Furthermore, the limitations of “adjust a control parameter” in Claims 1, 11, and 14, “cause a medicant-eluting implant to alter the patient’s sensing of food” in Claims 2 and 12, and “instructing the second surgical device to helically wrap an implant around the tissue” limitations in Claims 10 and 11 are not defining a “particular treatment” as required to be considered a practical application, since the claims are directed to merely providing instructions. According to MPEP 2106.04(d)(2), “The treatment or prophylaxis limitation must be “particular,” i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).” Therefore, the limitations as defined by Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 is considered generic and therefore does not integrate the abstract idea into a practical application, since the claims do not specify a particular treatment or that the treatment is directly applied to the patient.
It is noted that Claims 3 and 16 recite explicit particular treatment/therapy protocols (i.e. causing a medicant-eluting implant to extraluminally alter the patient’s sensing of food relative to the tissue by eluting a medicant, and intraluminally by resurfacing the mucosal surface of the tissue) that are implemented by the surgical system and thus specifically provides therapy based on the imaging/sensing analysis, and therefore these claims would be considered to be integrated into a practical application and not be directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the judicial exception into a practical application (Step 2A - Prong Two), the additional elements of using “a controller”, “a first surgical device”, “a second surgical device”, “an implant”, “a surgical hub”, “a robotic surgical system”, “a first implant” and “a second implant” to perform the imaging and data analysis of sensed signals amounts to no more than mere instruction to apply the exception using known and generic elements, and then outputting the results using known computing elements and providing generic and well-known “instructions”/diagnosis that may be performed by a human actor, such as providing treatment advice or a verbal treatment plan.
The only structural elements recited in the claims are “a controller”, “a first surgical device”, “a second surgical device”, “an implant”, “a surgical hub”, “a robotic surgical system”, “a first implant” and “a second implant”. These additional elements are recited at a high-level of generality (i.e. most generic computer and medical systems would be known to have these components for general computation, sensing/imaging, processing, and output of sensed data), and only provide conventional, routine, and well-known sensing and computing functions that do not add meaningful limits to practicing the abstract idea.
The imaging and analysis steps as defined by Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 amount to no more than mere pre-solution activity of data processing, and this pre-solution activity of processing data using known sensing/imaging systems is well-understood, routine, and conventional in the field of computing and medical technology. For example, see the Ben-Oren et al. (US Publication No. 2015/0359594), Altschul et al. (US Publication No. 2018/0256208), and Drozdzal et al. (US Publication No. 2015/0016700) references described in detail below which describe known imaging and surgical medical systems.
Therefore, the evaluations steps of Claims as defined by Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 do not recite any additional structural elements or limitations on practical applications (e.g. specific treatment).
Therefore, the claims are not patent eligible.
Therefore, Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is noted that Claims 3 and 16 recite explicit particular treatment/therapy protocols (i.e. causing a medicant-eluting implant to extraluminally alter the patient’s sensing of food relative to the tissue by eluting a medicant, and intraluminally by resurfacing the mucosal surface of the tissue) that are implemented by the surgical system and thus specifically provides therapy based on the imaging/sensing analysis, and therefore these claims would be considered to be integrated into a practical application and not be directed to an abstract idea.
It is recommended by the Examiner that explicit treatment types as recited in Claims 3 and 16 be added to Claims 1, 11, and 14 in order to overcome the rejections under 35 USC 101.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Ben-Oren et al. (US Publication No. 2015/0359594) discloses a medical surgical system and method (Abstract) comprising multiple imaging devices (Paragraph 0073, 0146, 0169, 0172, 0242; see Fig. 6) which control a surgical system to provide nerve treatment (Paragraph 0015-0017, 0026, 0041, 0042) to tissue to alter the sensing/absorption of food (Paragraph 0133, 0180, 0190, 0304; Claim 72).
Altschul et al. (US Publication No. 2018/0256208) discloses an in-vivo imaging surgical system and method (Abstract, Paragraph 0032, 0034, 0035) which include multiple imaging modalities (Paragraph 0065, 0067-0069, 0076, 0088, 0093, 0095; Claim 7) including analyzing digestive function and motility of metabolites (Paragraph 0036, 0037, 0054; Claim 21).
Drozdzal et al. (US Publication No. 2015/0016700) discloses an in-vivo imaging surgical system and method (Abstract, Paragraph 0006, 0008) which include multiple imaging modalities (Paragraph 0038, 0045, 0150; Fig. 12) including analyzing digestive function and motility of food (Paragraph 0137, 0148, 0002-0004).
Allowable Subject Matter
Claims 3 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 are directed to an abstract idea under 35 USC 101 as described in detail above. It is noted that Claims 3 and 16 recite explicit particular treatment/therapy protocols (i.e. causing a medicant-eluting implant to extraluminally alter the patient’s sensing of food relative to the tissue by eluting a medicant, and intraluminally by resurfacing the mucosal surface of the tissue) that are implemented by the surgical system and thus specifically provides therapy based on the imaging/sensing analysis, and therefore these claims would be considered to be integrated into a practical application and not be directed to an abstract idea. It is recommended by the Examiner that explicit treatment types as recited in Claims 3 and 16 be added to Claims 1, 11, and 14 in order to overcome the rejections under 35 USC 101.
Response to Arguments
The Examiner has withdrawn the previous 35 USC 112(f) interpretations of “a second surgical device” due to the Applicant’s amendments filed in the RCE filed 27 November 2024 to Claims 1, 2, 3, 6, 9, 10, 11, 12, 13, 14, 15, 16, 18, 2, 22, 23, and 24 further defining this element, as well as the Applicant’s persuasive explanation/arguments filed in the RCE (see Page 9 of RCE).
It is noted that the current TITLE of the invention is objected to. The title of the invention is not descriptive, and does not appear to relate to the currently claimed invention. A new title is required that is clearly indicative of the invention to which the claims are directed.
The Applicant’s arguments (Pages 9-10) filed in the RCE filed 27 November 2024 with respect to the previous 35 USC 102(a)(2) and 35 USC 103 rejections of Claims 1-3, 5, 6, 9-18, and 21-24 as made in the previous Final Rejection Office Action mailed 28 August 2024 have been fully considered and are persuasive. The Examiner agrees that none of previously cited Rajagopalan et al. (US Publication No. 2022/0184339), Mantri et al. (US Publication No. 2021/0401522), nor Jones et al. (US Publication No. 2023/0312700) explicitly teaches or suggests the surgical system and surgical methods as defined in Claims 1-3, 5, 6, 9-18, and 21-24 as amended. Therefore, the previous 35 USC 102(a)(2) and 35 USC 103 rejections of Claims 1-3, 5, 6, 9-18, and 21-24 have been withdrawn.
However, new 35 USC 101 rejections have been made above. Claims 1, 2, 5, 6, 9-15, 17, 18, and 21-24 are directed to an abstract idea as described in detail above. It is noted that Claims 3 and 16 recite explicit particular treatment/therapy protocols (i.e. causing a medicant-eluting implant to extraluminally alter the patient’s sensing of food relative to the tissue by eluting a medicant, and intraluminally by resurfacing the mucosal surface of the tissue) that are implemented by the surgical system and thus specifically provides therapy based on the imaging/sensing analysis, and therefore these claims would be considered to be integrated into a practical application and not be directed to an abstract idea. It is recommended by the Examiner that explicit treatment types as recited in Claims 3 and 16 be added to Claims 1, 11, and 14 in order to overcome the rejections under 35 USC 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796