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 .
Claim Status
Claims 1-20 are pending and under examination.
Claims 1-20 are rejected.
Claims 1 and 11 are objected to.
Claims 1 and 11 are independent.
No claims are new, canceled, or withdrawn.
Office Action Outline
Rejections applied
Abbreviations
X
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
X
112/b "Means for"
BRI
Broadest Reasonable Interpretation
X
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
X
112 Other
IDS
Information Disclosure Statement
X
102, 103
JE
Judicial Exception
X
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
X
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 10/25/2022 filing receipt, this application a 371 of PCT/US2020/063897 filed 12/09/2020, which claims priority to PRO 62/952,803 filed 12/23/2019.
Claim Objections
Claims 1 and 11 is objected to because of the following informalities:
The recitations "based on an output" and "based on an output of the artificial intelligence learning system" are recited respectively in the "providing an indication" and "providing adjusted control" elements of claim 1. To recite consistent claim language, it is suggested to amend the elements to recite the same recitation, either "based on an output" or "based on an output of the artificial intelligence learning system."
Claim 11 is objected to similarly as claim 1 above.
Appropriate correction is required.
Claim Interpretation – 112(f)
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.
Instant claim limitations interpreted as PROPERLY invoking 112(f)
The following claim limitations are interpreted as invoking 112(f):
• A "generator configured to provide" recited in claims 1 and 11, recites means (or an equivalent nonce term, here a "generator") and function and/or result (here "to provide energy based on control parameters") without reciting steps or structure to prevent invoking. The specification does disclose sufficient structure, material, or acts, and not just desired results, as exemplified at [0051-0052], and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
• A "artificial intelligence learning system configured to provide" recited in claims 7 and 17, recites means (or an equivalent nonce term, here a "system") and function and/or result (here "to provide the output relating to configuration of the control parameters") without reciting steps or structure to prevent invoking. The specification does disclose sufficient structure, material, or acts, and not just desired results, as exemplified at [0012], [0052], and [0056], and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
• An "image capturing device configured to capture" recited in claim 11, recites means (or an equivalent nonce term, here a "device") and function and/or result (here "to capture an image of tissue of a patient") without reciting steps or structure to prevent invoking. The specification does not disclose sufficient structure, material, or acts, but just desired results, despite specification [0038], and as such, is indefinite under 112(b) after properly invoking 112(f). MPEP 2181.III-IV pertain.
• A "generator configured to execute" recited in claim 11, recites means (or an equivalent nonce term, here a "generator") and function and/or result (here "to execute instructions to perform a method") without reciting steps or structure to prevent invoking. The specification does disclose sufficient structure, material, or acts, and not just desired results, as exemplified in the specification [0051-0052] and [0059]; and at Fig. 6 and 7 (which show generator 160 comprises a controller 500 which comprises a processor 520); and as such, is definite under 112(b) as properly invoking 112(f). MPEP 2181.III-IV pertain.
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(b)
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 2 and 10-20 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. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
112(b) rejections (corresponding to 112(f) above) for structure not clearly linked:
The limitation “image capturing device configured to capture an image” recited in claim 11 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 11 recites means (or an equivalent, nonce term, here "image capturing device") and function and/or result (here "to capture an image") without specifying steps or structure to prevent invoking, and it is not clear that the specification (especially at [0038]) discloses sufficient structure, material, or acts rather than just function and results for capturing an image, noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112(b). While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. MPEP 2181 pertains, and MPEP 2187, FP 7.34.23 lists options for overcoming the rejection.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
112(b) rejections for indefiniteness:
Claim 2 recites "the control parameter values" in the recitation "a predicted outcome of applying the energy based on the control parameter values to the tissue." It is not clear if the "control parameter values" recited in claim 2 refer to the "adjusted control parameter values" of claim 1 or to the accessed control parameter values of claim 1. Possibly amending claims 1 and 2 to distinguish the different control parameter values, e.g., possibly "current control parameter values" and "adjusted control parameter values," (and make necessary changes throughout the dependent claims as necessary) may help to overcome the rejection. Claim 12, which depends from claim 11, is rejected similarly.
In claims 10 and 20 the connection is unclear between the "control parameter values" (of the preamble) and the "control parameters" in the recitation "wherein providing the adjusted control parameter values for the generator includes: automatically adjusting the control parameters...and providing an indication to the clinician that the control parameters have been automatically adjusted," which is unclear as to if the "control parameters" themselves or the "control parameter values" are being adjusted. Specification [0041] discloses the generator control parameters 904 may include, but are not limited to, for example, duration, power, ramp rate, frequency, or other generator parameters. The intention of the invention appears to be to adjust the control parameter values, not the actual control parameters themselves. For examination purposes, the "control parameters" of claims 10 and 20 will be interpreted as "control parameter values."
Claim 11 recites "instructions to perform a method including: accessing...," but the structural relationship is unclear between the claimed "system" and these "instructions." Claim 11 is to a 101 machine or manufacture, i.e. a "system" interpreted strictly according to its recited structure so that, in order for the recited process steps to be limiting, their corresponding structure must be clear. This rejection might be overcome, for example, by amending to recite such structure, e.g. a storage device comprised by the "system" and itself comprising the instructions, as supported at, for example, [58-59] of the specification. For compact examination, it is assumed that the claims will be amended in this manner or equivalently.
Claim Rejections - 35 USC § 112(a)
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.
Claim 11-20 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. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
112(a) rejection (for invoking 112(f) without adequate description in the disclosure):
The limitation "image capturing device to capture an image" recited in claim 11 invokes 35 U.S.C. 112(f) as identified above in the section "Claim Interpretation – 112(f)" above. Specification paragraph [0038] was considered, however, the specification fails to disclose and describe sufficient structure of “image capturing device to capture an image.” The limitations are considered to recite a mean-plus-function limitation for which the structure needs to be described.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a)). Note, the MPEP at 2106.04(a)(2) & 2106.04(b) further explains that abstract ideas and laws of nature are defined as:
• mathematical concepts, (mathematical formulas or equations, mathematical relationships and mathematical calculations);
• certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people);
• mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information);
• laws of nature and natural phenomena are naturally occurring principles and/or relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1:
Claims 1-10 are directed to a 101 process, here a method. Claims 11-20 are directed to a 101 machine or manufacture, here a system. As such, claims 1-20 are directed to a related method and system, and therefore to categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
Step 2A, Prong One:
The claims are found to recite abstract ideas in the form of mental processes and mathematical concepts as follows:
Independent claims 1 and 11 recite mental processes and mathematical concepts for:
• processing an image and control parameter values by an artificial intelligence learning system to provide an output.
Claims 6 and 16 recite mental processes and mathematical concepts for:
• processing the information from the clinician to provide a tag for training the artificial intelligence learning system;
• training the artificial-intelligence learning system.
Claims 9 and 19 recite a mathematical concept for:
• a convolutional neural network for image processing.
Step 2A Prong One Summary: The claims recite mental processes and mathematical concepts. When considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in the claims (e.g., "processing an image and values"; "processing the information") are directed to processes that may be performed in the human mind, or with pen and paper, as there are no particular limitations recited in the claims which would prevent the mental processes from being performed in the human mind or with pen and paper. The claims recite inherent mathematical processes in e.g., an artificial intelligence learning system, training the artificial intelligence learning system, and a convolutional neural network, details of which are not explicitly shown, but are discussed in the Specification at [0036] and [0056]. Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea.
Therefore, the claims recite elements that constitute a judicial exception in the form of an abstract idea(s). (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
41. MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps: Claims 1 and 11 recite additional elements for accessing data (images and parameter values). Claims 1, 10, 11, and 20 recite an additional element of providing output (an indication to the clinician and/or adjusted control parameter values). Claims 3 and 13 recite an additional element of receiving information from the clinician. Claims 6 and 16 recite an additional element of storing data.
Claims which further limit the data gathering additional elements of claims 1 and 11: Claims 2 and 12 further limit the output of the artificial intelligence learning system. Claims 4, 5, 14, and 15 further limit the information from the clinician. Claims 7 and 17 further limit the accessing of patient information. Claims 8 and 18 further limit the patient information.
Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps are considered insignificant extra-solution activity, and are not sufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed, nor do they provide an improvement to technology (see MPEP § 2106.04(d)(I)).
Additional elements of computer components and surgical equipment: Claim 1 recites a computer; claims 1 and 11 recite a generator; claims 3 and 13 recite an energy-based surgical instrument; claim 11 recites an energy based surgical system and an image capturing device; claim 13 recites a user-interface and a voice recorder. The claims require only generic computer components, generators, surgical systems and instruments, and image capture devices, which do not improve computer or surgical technology, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Additional elements of providing energy and applying the energy to tissue: Claims 3 and 13 recite providing the energy, claim 3 recites applying the energy to the tissue. These additional elements are generically claimed elements of electrosurgery, and do not integrate the recited judicial exception into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Additional element of automatically adjusting control parameters: Claims 10 and 20 each recite the additional element of automatically adjusting the control parameters (interpreted in the 112(b) section as control parameter values). When considering each claim as a whole, claims 10 and 20 do not yet recite a transformation, nor is there an improvement to technology shown. Several issues are discussed below which are pertinent to a transformation and/or an improvement to technology:
(i) In general, to help overcome the 101 rejection, the claims may be amended to recite a link between an energy based surgical procedure performed on a patient, and the automatic adjusting (or maintaining) of control parameters of that energy based surgical procedure. This may help to overcome the 101, whether a transformation or an improvement to a technical field (or both) is claimed. In the instant claims, the only recitation concerning the patient in claim 1 is the accessing, processing, etc., of an image of the patient's tissue; there is not surgery performed in claims 1 and 11. To establish a clear link between the procedure on the patient, and the adjusted control parameters based on the AI system, it may help to possibly amend claims 1 and 10 to recite a first element of "performing an energy-based surgical procedure on a patient" and then amending the next element to "accessing an image of tissue of the[[a]] patient" with a final element, e.g., of actively performing electrosurgery on the patient, the electrosurgery informed by the adjusted parameter values from the AI learning system. If amendments are made such as suggested with appropriate assertion of an improvement to technology, the 101 might possibly be withdrawn.
(ii) Claims 1 and 11 recite contingent language in "providing adjusted control parameter values... if the indication indicates not to maintain the control parameter values," such that there is an embodiment in which the control parameters values would not be adjusted when the indication indicates to maintain the control parameter values. As the transformation likely hinges on the adjusting of control parameter values, the contingent language would likely need to be removed if transformation is asserted as the reason for patent eligibility. However, if an improvement to a technology is asserted in future remarks, the contingent claim language is likely acceptable as long as Applicant amends claims 1 and 11 to connect the real-world electrosurgical procedure (in an active step) performed on the patient with the adjusted control parameter values based on the AI system.
(iii) It is noted claims 10 and 20 recite active steps of automatically adjusting the control parameter values; it may help to move these recitation into claims 1 and 11, respectively.
(iv) It is noted the method is not repeated. That is, the identified JE is performed, but it is not clear that the results of the JE are used in a practical application to affect the real world, e.g. to control further application of energy. Amending such that the elements are repeated and the control parameters continuously maintained or adjusted may possibly be a step toward a transformation (as long as new matter is not added).
(iv) Regarding showing an improvement to technology, a detailed explanation of a technical improvement may help to overcome a 101 rejection, (see MPEP 2106.04(d) and (d)(1), as well as MPEP 2106.05(a)). The explanation might include a concise statement of the improvement, including improvement over the previous state of the technology field; identification of the technology field; explanation of how the claims deliver the improvement and that reasonably all embodiments within the claim scope also will result in the asserted improvement, and extension of the explanation to persuasively demonstrate the nexus of integration of the judicial exceptions into a practical application. As further examples, argument may clearly and adequately explain cause and effect leading to improvement or, for example when such cause and effect explanation is not possible, then may include evidence (e.g. experimental data) comparing a claimed result to conventional results. Also, arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim.
Applicant is encouraged to request an interview if it would be helpful.
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of: (1) an improvement, (2) a treatment, (3) a particular machine, or (4) a transformation is yet clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement. (Step 2A, Prong Two: No).
Step 2B:
Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of accessing data (claims 1 and 11), providing output (claims 1, 10, 11, 20), receiving information (claims 3 and 13), and storing data (claims 6 and 16) do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory, [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity.
Additional elements of computer components and surgical equipment: The additional elements of a computer (claims 1-10), a generator (claims 1 and 11), an energy based surgical system (claims 11-20), an image capturing device (claim 11), a user-interface (claim 13), and a voice recorder (claim 13) do not cause the claims to rise to the level of significantly more than the judicial exception; these are conventional elements of a computer, generator, energy based surgical systems, image capturing device, user interface, and voice recorder, generically claimed and which do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept.
Additional elements of providing energy and applying the energy to tissue (claim 3 and 13); and the additional element of automatically adjusting control parameters (claims 10 and 20) do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept. Additionally, these elements are shown to be conventional by the following reference:
Taheri, (Journal of the American Academy of Dermatology, vol. 70(4):607-e1, pp. 1-12 (2014); cited on the attached form PTO-892), presents a review on electrosurgery, and shows electrosurgical unit generators delivering energy to patient's body (p.3-4, fig.1-3, and discussed throughout entire document). Taheri shows automatically adjusting power in electrosurgical generators (p.6, col.1, ¶ 3-4).
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claim 1-11 and 13, which are interpreted to recite conventional computer components.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The recited computer components and surgical equipment do not impose meaningful limitations on the claims.
• The courts have recognized “receiving or transmitting data over a network”, “performing repetitive calculations”, and “storing and retrieving information in memory”, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The accessing, receiving, outputting, and storing of data in the claims is recited in a generic manner.
All limitations of claims 1-20 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO.)
Therefore, claims 1-20, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shen (WO 2019/089919 A2, published 05/09/2019; cited in the 08/23/2022 IDS), in view of Zhang, (IEEE Journal of Biomedical and Health Informatics, 24(4), pp.965-973 (Sept. 2019); cited on the attached form PTO-892), in view of Mohr, (US 2010/0228249 A1, published 09/09/2010; cited in the attached form PTO-892).
Emphasis has been added to some claim elements below to promote clear communication; this emphasis is not recited in the instant claims.
Regarding the following elements:
• accessing control parameters of a generator configured to provide energy (claims 1 and 11 ),
• processing control parameters by artificial intelligence to provide an output (claims 1 and 11),
• providing adjusted control parameters (claims 1 and 11),
• providing energy, applying energy, receiving information from the clinician (claims 3 and 13),
• input from a clinician indicates outcome of applying energy (claims 4 and 14)
• information from the clinician includes a user-interface selection (claims 5 and 15)
• artificial intelligence learning system configured to output (claims 7 and 17)
• and automatically adjust control parameters (claims 10 and 20):
Shen teaches a system and method for characterizing tissue during surgical procedures such as cutting and/or coagulating tissue by selective application of energy [002], [007]. Shen shows user interface 250 is configured to provide information (e.g. TCI 400 and/or other information) to an operator of system 10 and/or to receive information from an operator of system 10 [124]. Shen shows the system provides an intelligent action function... to affect (e.g. in a feedback mode performed manually by the operator, or automatically by system 10) the action being performed on the tissue ... based on the feedback provided, the system 10 and/or the operator may avoid treating (e.g. avoid cutting) specific tissue and/or only treat a limited amount of tissue (e.g. treat specific tissue). System 10 can be configured such that the therapeutic function (e.g. energy delivery) is automatically enabled and/or disabled... The intelligent action function can also be configured to "tune" a tissue treatment, (e.g. tune delivery of treatment energy 500 for cutting, cauterization, ligation, and the like), such as by adjusting to levels of energy-delivery... Examples of relevant parameters to be adjusted include waveform, power, frequency, voltage, phase, duty cycle, depth of treatment, and/or temperature...[189]. Shen shows the clinician or other operator of system 10 receives TCI 400 and/or other information from one or more feedback indicators or other user interfaces, UI 250 shown, which can include information about the tissue proximate probe electrodes 151, such as information for use in making decisions during a surgery or other clinical procedures [0195].
Regarding the claims 8 and 18 element of patient information, Shen shows patient information other patient information (e.g. ...age,...hydration level,... and/or other biological characteristics) [136].
Shen does not show:
• accessing image of tissue of a patient of claims 1 and 11 (taught by Zhang below).
• processing images by artificial intelligence of claims 1 and 11 (taught by Zhang below).
• providing an indication to the clinician of claims 1, 10-11, and 20 (taught by Mohr below).
• the predicted outcome of claims 2 and 12 (taught by Zhang below).
• providing a tag for training, storing training data, and training the artificial intelligence system of claims 6 and 16 (taught by Zhang below).
• the convolutional neural network of claims 9 and 19 (taught by Zhang below).
Regarding the following elements:
• accessing an image of tissue of a patient (claims 1 and 11),
• processing images by artificial intelligence (claims 1 and 11),
• the predicted outcome (claims 2 and 12)
• providing a tag for training, storing training data, and training the artificial intelligence system (claims 6 and 16),
• and the convolutional neural network (claims 9 and 19):
Zhang shows an ultrasound (US) imaging based on a convolutional neural network (CNN) architecture for the detection and monitoring of thermal lesions induced by microwave ablation (MWA) (p.965, abstract and entire document). Zhang shows training and testing samples and corresponding spatio-temporal optical images as the criteria of the sample label (i.e., tags) were extracted (p.966, col.2, ¶ 2). Zhang shows optical images of tissue sections were used as the ground truth for training of the CNN and US 2-D RF data backscattered from the ablated region after envelope detection were used as the input (p.967, col.1, ¶ 2). Zhang shows training samples with positive or negative labels were used as input layers (p.967, col.2, ¶ 2). Zhang shows the trained network was used to classify testing samples to predict the thermal lesion (bridging p.967-968).
Regarding to following element:
• providing an indication to a clinician (claims 1, 10-11, and 20)
Mohr shows a minimally invasive surgical system that includes an endoscope to capture video images of a surgical site and at least one robotic surgical tool; this includes a video display device of a surgeon console to display video images and information to a user, and a processor coupled to the endoscope and the video display device [0041]. Mohr shows an enhanced visual display through a graphical user interface (GUI) that is displayed to the surgeon at the surgeon's console. The GUI may provide persistent, and/or a momentary indication of an electrosurgical instrument having the capability of being activated. This indication may be associated with or overlaid upon the image of the instrument itself. The GUI may also provide a momentary visual indication whenever energy is activated [0161].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method for adjusting electrosurgical parameters of Shen, and the image processing in electrosurgery using a convolutional neural network (CNN) of Zhang, with the method for providing indications in electrosurgery of Mohr, to come to a method for an artificial intelligence system in electrosurgery because Zhang states CNNs have been applied to medical image analysis with significant performance improvement (Zhang, p.966, col.1, ¶ 2), while Mohr discloses a graphical user interface may provide a persistent visual indication that is easier to notice (Mohr [0161]). One would have had a reasonable expectation of success in doing so because Shen, Zhang, and Mohr are generally drawn to related teachings in electrosurgery, and one of ordinary skill in the art would have understood how to and would have been motivated to apply the teaching of Zhang and Mohr to the related teachings of Shen, and as such, the combination would have been obvious.
Nonstatutory double patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine to prevent the improper timewise extension of the "right to exclude" granted by a patent and to prevent multiple suits against an accused infringer by different assignees of the same invention (MPEP 804.II.B, 1st para.). A nonstatutory double patenting rejection is appropriate where the conflicting claims (instant v. reference) are not identical, but an examined-application claim (instant claim) is not patentably distinct from a reference claim because the instant claim is either anticipated by, or would have been obvious over, the reference claim (MPEP 804.II.B, 2nd para.).
In cases of double patenting rejections versus reference claims of pending applications, as opposed to claims of an issued patent, the rejections are provisional because the reference claims have not been patented. Presently, no rejections are provisional.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the application or patent of the reference claim either is shown to be commonly owned with the instant application or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must comply fully with 37 CFR 3.73(b).
Applicant may wish to consider electronically filing a terminal disclaimer (MPEP 1490.V pertains, along with https://www.uspto.gov/patents-application-process/applying-online/eterminal-disclaimer). Electronic filing may lead to faster approval of the disclaimer. Also, if filing electronically, Applicant is encouraged to notify the examiner by telephone so that examination may resume more quickly.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Double patenting rejections of instant claims 1-20
Instant claims 1-20 are rejected on the grounds of nonstatutory double patenting as unpatentable over one or more claims in reference application 18/277,417 (NOA mailed 2/10/2026) in view of over Shen (WO 2019/089919 A2, published 05/09/2019; cited in the 08/23/2022 IDS), Zhang, (IEEE Journal of Biomedical and Health Informatics, 24(4), pp.965-973 (Sept. 2019); cited on the attached form PTO-892), and Mohr, (US 2010/0228249 A1, published 09/09/2010; cited in the attached form PTO-892).
Although the reference claims are not identical to the instant claims, in a BRI they also are not patentably distinct from the instant claims: either (i) because the instant claims recite obviously equivalent or broader limitations in comparison to the reference claims or (ii) because the instant claims recite limitations which are obvious over the cited art. It is not clear that the instant claims recite limitations which are narrower than limitations in the reference claims.
The reference application recites claims which involve the use of artificial intelligence in the control of energy-based surgery (e.g. 18/277,417 claim 10). The instantly recited "tissue" would have been prima facie obvious in view of the cited art.
It would have been obvious in view of the cited art to modify reference claims to arrive at the rejected instant claims. Either the instant limitations are interpreted as reading on a reference limitation, or the instant limitations would have been obvious in view of the cited art. That is, to the extent that any instant claims are narrower than reference claims, then any such narrowing would have been obvious over the cited art.
Conclusion
No claims are allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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