Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In 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.
Joint Inventors
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 7th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The Office maintains production requirements for examiners based on the average anticipated time it takes to examine applications within their technological field and at their experience level, so it should be noted that when far greater than normal time is allocated to merely correct claim construction and/or claim drafting issues, rather than for prior art searching, the overall quality of the prior art searching may be impacted or may not even be feasible given the potential for the applied prior art to change completely following corrective amendments. As such, Examiner urges Applicant and/or their attorney/agent to ensure a bona fide effort and due diligence in improving the quality of the claim set prior to further correspondence with the Office.
Upon initial review of the claims as currently presented, it is clear that there are highly indefinite claims that can be interpreted many possible different ways, particularly, indefinite claim limitations that are dependent upon other indefinite claim limitations, dependent claims and/or limitations drawn to elements that either do not have antecedent basis or are drawn to external elements that are not definitively claimed as part of the claimed system, claims with clearly incorrect dependencies that lead to even more significant antecedent basis issues, limitations clearly drawn to purely optional elements, limitations drawn to potentially previously described elements while describing those potentially previously described elements with differing terminology, and/or limitations drawn to the entire system being described rather than individual components of the system. When this amount of indefiniteness occurs, the Examiner may in the course of examination determine that claims as currently written have meaning far too open to interpretation to warrant prior art searching until the definitive understanding of said limitations are clear. This is currently true for the instant application’s claims and thus any new prior art rejections made by the Examiner after any amendment by the Applicant and/or their attorney/agent to attempt to eliminate the indefinite nature of such claims/limitations, will not be construed as a new ground of rejection, and will not result in a second non-final action being issued. However, not including prior art rejections in the instant Office action avoids the possibility of the Examiner merely applying arbitrary and/or non/less-applicable prior art and then using “election by original presentation” following a corrective amendment based on the need for completely new prior art and/or new prior art searching.
Based on the highly indefinite nature of the claims (with examples given in the 112(b) rejections section below) and the significant amendments necessary to the claims, claim limitations that may be interpreted under 35 U.S.C. 112(f) will not be discussed in this instant Office action (i.e. this will occur after Applicant can bring the claims into a more definitive state).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
Examiner notes the claims as currently submitted are replete with errors and as such it may be possible that there are more issues present than those presented in this section. Examiner urges the Applicant to properly review and edit as necessary the entirety of the claims to ensure these common errors are avoided since they create an unnecessary burden on the Examiner for proper interpretation and consideration. Applicant should ensure that each claim is both grammatically proper and definite before filing their response to this Office action.
Similarly, Examiner also encourages Applicant to correct their specification where necessary based on the issues presented in these sections, which are equally applicable to the specification. Due to the large number of errors present, Examiner only did a cursory review of the specification, and thus the specification has not been checked to the extent necessary to determine the presence of all possible errors. Applicant's cooperation is requested in correcting any errors of which Applicant may become aware in the specification. 35 U.S.C. 112(a) requires the specification to be written in “full, clear, concise, and exact terms”, and as currently written, the specification too is replete with portions which are not clear, concise, and exact, for the same reasons as discussed in regards to the current claims. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a). Examiner reminds Applicant that when amending the specification, no new matter may be added. Any submitted substitute specification must include markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. When filing a substitute specification, it is further required to submit an accompanying clean version (without markings) and a statement saying that the substitute specification contains no new matter. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
The reasons for indefiniteness are outlined below. Note the following: (a) this list may not be all-inclusive as these claims are replete with errors and the meaning of several limitations may have been incorrectly interpreted by the Examiner due to one or more indefinite issues that warrant clarification from the Applicant in their reply, especially when indefinite limitations are dependent on indefinite limitations and then those are dependent on further indefinite limitations, etc., (2) due to the significant number of indefiniteness issues present, some issues pointed out here may be better classified as just objections but due to the heavy uncertainty within the claims, even these will be included in this section as well for the sake of brevity, (3) all of the issues with each claim will be discussed one-by-one rather than by grouping claims together according to the type of issues present.
Regarding Claim 1, the limitation(s) proceeding “processing the received data to […]” are indefinite as it is unclear to the examiner which data is being referred to (the real-time data “indicative or tissue mechanical properties” or the “interoperative context data”), and what exactly is processing the data. In a similar fashion, the limitation(s) proceeding “generating real-time output signals comprising […]” also does not include what exactly is generating the signals. The “AI engine” doesn’t seem to have any involvement in the data processing steps. Furthermore, numerous phrases lack antecedent basis, and the manner in which the subject matter is presented makes it unclear to the examiner how to interpret the claim limitations including the said phrases. This includes “the AI output” when there is no mention of any AI output, which this limitation makes it further unclear to the examiner the exact role of the AI engine since it is never mentioned again in the claim. The limitations “expected tissue response”, “predicted safe thresholds”, “anomaly thresholds”, “force thresholds”, “safe tissue engagement”, “force modulation”, “predicted surgical maneuvers”, “biomechanical force adaptions”, “prior trajectories” and “image-based models” also lack antecedent basis. The limitation preceded by the term “optionally” is also indefinite, since this entire limitation is optional, it is unclear to the examiner why it is being claimed. The terms “patient-specific properties”, “response profiles”, “deviations”, “anomaly thresholds”, “refining”, “online learning”, “optimize tissue interaction”, “reduce damage”, “ensure precision”, “risk being exceeded”, “force levels”, “safety margins”, “tissue compliance”, “fine-tuned”, “safe tissue engagement”, “synchronize” and “predicted surgical maneuvers” in this claim are also all relative terms which render the claims indefinite. The terms “improved”, “precise” and “critical” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 3, the limitation of “intraoperative model updates” lacks antecedent basis, as it is there is no prior claim or mention of any intraoperative model, much less the ability for updating said model. It is also unclear what is being updated, and what the updates are based upon. The terms “hybrid federated”, “online learning”, “employing”, “privacy-preserving” and “aggregation” are also highly indefinite and not defined by the claim or specification. The limitation of “excluding visual, task-based, or historical procedural data” lack antecedent basis. Furthermore, the term “mechanical signal deviations” also lacks antecedent basis.
Regarding Claim 4, the limitation of “tissue deformation predictions” lacks antecedent basis. This limitation seems to refer to the previous limitation of claim 1 involving “predict tissue-specific safe force thresholds”, but it is unclear to the examiner what is being claimed in these limitations as written, as there is no consistency in terminology. The terms “derived” and “time-resolved” in this claim are relative terms which render the claim indefinite. The terms “derived” and “time-resolved” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, the limitation “viscoelastic modeling parameters” both lack antecedent basis and is highly indefinite, since it is unclear to the examiner what these parameters are and the claim or specification do not define them
Regarding Claim 5, the limitations of “predictive force profiles” and “detected physiological signals” lack antecedent basis. There was no prior mention or claim involving any predictive force profiles or detection of physiological signals. These terms are also highly indefinite since there is no definition for what these profiles and signals are, or what is predicting the profiles and detecting these signals.
Regarding Claim 7, the limitations of “autonomous force modification”, “multiple actuators” and “tissue stress” lack antecedent basis. Furthermore, the terms “adjusting”, “coordinated”, “minimize” and “overall” are relative terms which render the claim indefinite. The terms “adjusting”, “coordinated”, “minimize” and “overall” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 8, the limitations of “AI processing unit”, “prior case history”, “behavioral metrics”, “real-time performance” and “feedback signals” all lack antecedent basis. It is unclear to the examiner what is being claimed and what these limitations are referring to, as there was no prior mention of these limitations. Furthermore, the terms “personalized”, “prior”, “tailor” and “dynamically” are relative terms which render the claim indefinite. The terms “personalized”, “prior”, “tailor” and “dynamically” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 9, the limitation of “haptic feedback device”, “surgeon console”, “tissue resistance”, “visual imaging”, “anatomical segmentation”, “raw sensor data”, “virtual compliance modeling”, “tissue behavior”, “haptic feedback parameters”, “surgeon-specific thresholds”, “instrument characteristics” and “sensor drift” all lack antecedent basis. The examiner notes none of these limitations are defined or mentioned in the base claim, and it is unclear how any of these limitations are acquired, measured or utilized at all. Furthermore, the terms “integrated”, “renders”, “compliance differentials”, “adaptive”, “raw”, “tailoring”, “behavior”, “surgeon-specific”, “characteristics” and “drift” are relative terms which render the claim indefinite. The terms “integrated”, “renders”, “compliance differentials”, “adaptive”, “raw”, “tailoring”, “behavior”, “surgeon-specific”, “characteristics” and “drift” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Lastly, claim 9 introduces an AI engine that “generates adaptive haptic signals […]”, which seems to be a different AI engine from what was introduced in the base claim. It is unclear to the examiner the relationship between the two AI engines, or if the intention of the applicant is to refer to a single AI engine (the same one from claim 1), thus further rendering the claim indefinite.
Regarding Claim 10, the limitations of “haptic feedback system”, “haptic settings”, “intraoperative haptic and force data”, “multiple procedures”, “predictive feedback models”, “tissue interactions”, “haptic signals” and “surgical skill development” all lack antecedent basis. It is unclear to the examiner what is being claimed and what the intended scope of the invention is. There is no clear boundary for what a haptic feedback system encompasses in this claim. Furthermore, the terms “enabling”, “secure”, “personalized”, “federated”, “improve”, “simulate”, “synthesized” and “skill development” are relative terms which render the claim indefinite. The terms “enabling”, “secure”, “personalized”, “federated”, “improve”, “simulate”, “synthesized” and “skill development” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding Claim 11, the limitations of “temporal fidelity”, “haptic rendering”, “local and telesurgical operations”, “audiovisual cues”, “intraoperative awareness” and “predefined safety limits” all lack antecedent basis. It is unclear to the examiner what is being claimed and what the intended scope of the invention is. There is no clear boundary for what purpose this newly claimed algorithm serves and how haptic feedback is related in the data processing step for alerting the surgeon. It is also unclear what the alert is exactly. Furthermore, the terms “temporal”, “fidelity”, “local”, “optionally”, “enhance” and “awareness” are relative terms which render the claim indefinite. The terms “temporal”, “fidelity”, “local”, “optionally”, “enhance” and “awareness” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Lastly, the limitation preceded by the term “optionally” is also indefinite, since this entire limitation is optional, it is unclear to the examiner why it is being claimed
Regarding Claim 12, the limitations of “surgeon console”, “haptic device”, “tactile sensations”, “mechanical compliance differentials”, “tissue resistance”, “image recognition”, “visual synchronization”, “raw sensor data”, “virtual compliance”, “force simulations”, “historical data”, “behavior metrics”, “real-time performance”, “anatomical structures”, “safety zones”, “haptic parameters”, “surgeon thresholds”, “tool differences”, “sensor drift”, “user-specific customization”, “intraoperative haptic and sensor data”, “across procedures”, “tissue interactions”, “haptic signals”, “skill development”, “haptic rendering”, “local and remote (telesurgical) operations”, “audiovisual cues” and “situational awareness” all lack antecedent basis. Examiner notes the bulk of this claim has almost no concrete definition or structure into any of its components. It is extremely unclear to the examiner what is being claimed, and how the various components are related. The limitation preceded by the term “optionally” is also indefinite, since this entire limitation is optional, it is unclear to the examiner why it is being claimed. Furthermore, the terms “integrated”, “renders”, “compliance differentials”, “optionally”, “adaptive”, “scaling”, “filtering”, “augmenting”, “personalized”, “near”, “enables”, “secure”, “user-specific”, “customization”, “federated”, “across”, “simulates”, “synthesized”, “development”, “temporal”, “fidelity”, “enhanced” and “awareness” are relative terms which render the claim indefinite. The terms ““integrated”, “renders”, “compliance differentials”, “optionally”, “adaptive”, “scaling”, “filtering”, “augmenting”, “personalized”, “near”, “enables”, “secure”, “user-specific”, “customization”, “federated”, “across”, “simulates”, “synthesized”, “development”, “temporal”, “fidelity”, “enhanced” and “awareness” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Lastly, the claim introduces a new AI unit, which seems to differ in role, scope and function to the AI engine in the base claim. Examiner is confused why there seems to be three separate AI-related components that all seem to merely represent a vague, generic processing unit that seems unnecessary to perform the proceeding claimed limitations.
As stated in the beginning of this section, this list may not be all-inclusive as these claims are replete with errors and the meaning of several limitations may have been incorrectly interpreted by the Examiner due to one or more indefinite issues that warrant clarification from the Applicant in their reply, especially when indefinite limitations are dependent on indefinite limitations and then those are dependent on further indefinite limitations. Examiner notes there may be 101 issues within these claims based on how broadly the additional limitations are written, along with the majority of potential judicial exceptions being written in a manner which, under broadest reasonable interpretation, merely encompasses mental processes. Furthermore, as previously stated in the Claim Interpretation section of this Office Action, the Examiner may in the course of examination determine that claims as currently written have meaning far too open to interpretation to warrant prior art searching until the definitive understanding of said limitations are clear. This is currently true for the instant application’s claims and thus any new prior art rejections made by the Examiner after any amendment by the Applicant and/or their attorney/agent to attempt to eliminate the indefinite nature of such claims/limitations, will not be construed as a new ground of rejection, and will not result in a second non-final action being issued. However, not including prior art rejections in the instant Office action avoids the possibility of the Examiner merely applying arbitrary and/or non/less-applicable prior art and then using “election by original presentation” following a corrective amendment based on the need for completely new prior art and/or new prior art searching.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bryant Tang whose telephone number is (571)270-0145. The examiner can normally be reached M-F 8-5 CST.
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, Thomas Worden can be reached at (571)272-4876. 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.
/BRYANT TANG/Examiner, Art Unit 3658
/JASON HOLLOWAY/Primary Examiner, Art Unit 3658