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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) and under 35 U.S.C. 120 is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 21-27, 35-40) in the reply filed on November 25, 2025 is acknowledged. Claims 28-34 are hereby withdrawn as being directed towards a non-elected invention.
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 21-23, 35-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: YES - The claim 21 recites robotic system and, therefore, is a device. The claim 35 recites a non-transitory computer readable storage medium and is therefore a device.
Step 2A, Prong 1, Judicial Exception: YES - The claims recite the limitation of comparing at least one image feature with a second image feature to determine movement of a medical instrument, determining an inactive driving state of the robotic component, and determining if the movement of the medical instrument is a result of physiological motion if the drive state is inactive. These limitations, as drafted, are a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “one or more processors” and “at least one computer-readable memory” (claim 21) and “non-transitory computer readable storage medium” (claim 35) nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “one or more processors”, “at least one computer-readable memory”, and “non-transitory computer readable storage medium” language, the claim encompasses a user simply taking the difference between viewable points in the image, checking the status of the robot drive, and comparing the difference and robot drive status to verify the movement was not caused by the robot drive but rather from physiological motion (i.e. a simple deduction process). The mere nominal recitation of a generic computer processor and memory/storage medium does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “receive first image data and second image data from an image sensor associated with a medical instrument, the medical instrument being configured to be controlled by a robotic component”, “one or more processors” and “at least one computer-readable memory” and “non-transitory computer readable storage medium”. The memory/storage and receive step are recited at a high level of generality (i.e., as a general means of storing and acquiring data), and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The processing circuitry that performs the receiving, tracking, determining steps is also recited at a high level of generality, and merely automates the steps. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry).
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry). Accordingly, even in combination, 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. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. Here, the initial “receive first image data and second image data…” step was considered to be extra-solution activity in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification does not provide any indication that the processor and memory is anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here), i.e. receiving generic “first image data” and “second image data”. Accordingly, a conclusion that the receiving step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
The features of claim 22-23 remain abstract because they can be performed by a person looking at the image data and making mental determinations.
Claims 36, 37, 38 are considered to be additional elements but do not take the abstract idea out of the mental process grouping, since the additional element of providing an alert is generic, specifying the medical instrument is a scope with image sensor is not positively claimed and generic, and the robotic component is not positively claimed and generic.
The features of claim 39 remain abstract because they can be performed by a person looking at the image data and making mental determinations.
The features of claims 24, 25, 26, 27, and 40 are considered patent eligible because they are a specific way of tracking that cannot be readily performed in the mind by looking at the images.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-23, 35-39 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.
Regarding Claim 21, the step of “based on the determination that the medical instrument moved and the determination that the robotic component is in the inactive driving state, determine that the movement of the medical instrument was caused by physiological motion” is not sufficient to arrive at a determination of physiological motion because as claimed, there is no way to separate physiological motion from other motions such as non-physiological body movements (patient twitch or rolled over) or surgeon bumping the instrument. All that can be determined is relative movement between the medical instrument and the image features but it cannot be determined what caused the movement. Additional information is needed. For example, the location sensor of claim 26 provides for differential determination of body movements or physiological movements and the frequency analysis of claims 24 or claim 25 would allow for reasonably determining that the signal is physiological in origin (i.e., it is cyclical). As such, Applicant has not demonstrated possession of the full breadth of the claim 21 and claim 35; they are impermissibly broad for differential determination of physiological motion, specifically.
Claims 22-23, 36-39 do not resolve the scope issue because distances between two images is insufficient to discriminate between the type of motion and conclude it is physiological or not. However, if the image features were specified to be on the diameter of bronchus, of which correlates with physiological respiratory motion, then it could be determined to be physiological in origin (as opposed to other body lumens such as urethra or feature points along the length of the lumen). However, the claim lacks the specificity to limit to image features that actually correlate with physiological motions.
Claims 24-27 and 40 are not rejected under 112(a), since the frequency analysis or location sensor provide for sufficient signal discrimination to conclude the signal is physiological in origin or not.
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 21-27 and 35-40 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.
Regarding Claim 21, “determine that the medical instrument moved” is undefined with respect to a frame of reference. It is assumed this is meant as movement with respect to the image features, but clarification is required.
For claim interpretation, examiner is interpreting “first image data and second image data from an image sensor associated with a medical instrument” as the first and second image data are from the perspective of a medical instrument, i.e. endoscope images taken at different timepoints.
For claim interpretation, examiner is interpretation “image features” as visible landmarks in the first image data and the second image data.
Regarding Claim 22, “detect a first point of interest and a second point of interest in the first image data” and “detect the first point of interest and the second point of interest in the second image data” are confusing because they lack antecedent basis with the claim 21 “image features”. These are assumed to be the same thing but clarification is needed.
Regarding Claim 24, “scale change in image data” is confusing because it lacks antecedent basis with the “image data” from claim 21. These are assumed to be the same thing but clarification is needed. It is further confusing because only two images have been defined by the claim and it doesn’t seem like frequency can be determined from only two images. Are more time points needed? Clarification is requested.
Regarding Claim 25, “determine a first physiological movement frequency….based on the first image data and….the second image data” is confusing because only two images have been defined by the claim and it doesn’t seem like frequency can be determined from only two images. Are more time points needed? Clarification is requested.
Regarding Claim 26, “location sensors” is confusing because it is unclear what location they are measuring. It is assumed to be location of the patient, e.g. placed on the patient’s torso.
Regarding Claim 27, it is not understood how “robot command data” can be a location sensor type. Further, Markush groups should not use “comprise” language because it is not a closed grouping and therefore indefinite. Rather, the form “…sensors selected from the group consisting of A, B, and C” is suggested. See MPEP 2117(I).
Claim 35 is rejected for the same reasons as Claim 21 above.
Claim 39 is rejected for the same reason as for Claim 22 above.
Claim 40 is rejected for the same reasons as for Claim 26 above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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.
Claims 21 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 20 of U.S. Patent No. 11503986.
The patented claims are narrower in scope than the instant claims and therefore anticipate most of the features, except the patented claim 1 does not teach determination that the movement of the medical instrument was caused, specifically, by physiological motion. Rather, patent claim 7, dependent on claim 1, teaches the determination of physiological movement frequency. As such, the patented claim 1+7 anticipates the instant claim 21. Similarly, patented claim 14+20 anticipates instant claim 35.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The claims avoid the prior art because the prior art does not teach determination of physiological motion imparted on the endoscope based on robotic component being in an inactive driving state, based on image features in the first image data and the second image data using either frequency analysis as in claims 24, 25 or additional location sensor as in claim 26, in order to provide a more accurate position determination of the endoscope and understanding if recalibration is needed. Examiner interprets the image data as endoscope images taken at different time points.
Prior art US 11857149 (and US 12458453) to Forsyth teaches determination of physiological motion while a robot is inactive (robot is locked in place, i.e. inactive, step 2309, Figure 23 and then deviations based on physiological motion are detected in step 2313). However, Forsyth does not rely upon feature analysis in an endoscope image as part of the determination of physiological motion. Rather, Forsyth is tracking a surgical tool, not a diagnostic/imaging tool. Global motion of the patient and surgical tool are tracked separately.
Prior art US 20160184032 to Romo teaches tracking motions/positions with an endoscope using diameter landmarks detected from the images (Figure 28A). However, these landmarks are not utilized to detect physiological motions imparted on the endoscope; rather, they are utilized to detect global positioning of the centerline path traversed by the endoscope.
Prior art US 20230277250 to Belkind Shafir and US 20220031406 (and US 12263043) to Hufford all teach identifying landmark features in endoscope images. However, the landmark features are not utilized to track physiological motions imparted on the endoscope. Instead, they are utilized to help guide the user to the target area.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Closely related but not available as prior art is US 20250302332 to Shen for motion compensation of endoscopes, including motions caused by physiology.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/ Primary Examiner, Art Unit 3799