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 .
Response to Amendment
Examiner acknowledges the amendment filed 08 January 2026 wherein: claims 1-3, 7, 10-11, 14-16, and 19-20 are amended; claim 9 is canceled; claims 1-8 and 10-20 are pending.
Response to Arguments
Applicant’s arguments filed 30 July 2025 (“Arguments”) have been fully considered.
Examiner acknowledges 35 U.S.C. § 112(f) is no longer invoked due to amendment.
The remainder of Applicant’s arguments are not persuasive.
Applicant’s arguments with respect to the rejections of claims 1-8 and 10-20 under 35 U.S.C. §§ 101 and 102, and are moot in part due to the amended claims. Arguments still relevant in view of the amended claims are responded to below.
Claim 1
Regarding claim 1, the claim has been amended to recite “an abnormal factor” instead of “any abnormal factor”. The claim has further been amended to include limitations previously in claim 9, namely “wherein identifying the abnormal factor or event comprises: calculating a probability of a particular factor or event adversely impacting the scan”. The claim has further still been amended to recite the identifying further comprises:
obtaining a threshold value, wherein the threshold value is a preset level where a factor or event is considered the abnormal factor or event that potentially adversely impacts the scan; determining whether the probability that is calculated for the particular factor or event meets or exceeds the threshold value; and identifying the particular factor or event as an identified abnormal factor or event that potentially adversely impacts the scan when the probability that is calculated does not meet or exceed the threshold value[.]
Rejection under 35 U.S.C. § 101
Applicant argues the rejections under 35 U.S.C. § 101 are improper because the claims are directed to eligible subject matter, and that utility is not the test for patent-eligible subject matter.
Examiner acknowledges utility is not the test for a patent-eligible subject matter grounds of rejection under 35 U.S.C. § 101, as Applicant argues. However, there is a separate and distinct utility grounds for rejection under 35 U.S.C. § 101. See MPEP § 2107.01(II), which describes that an invention which recites an incredible or non-credible utility, i.e., one that does not operate to produce the results claimed by the patent applicant, is grounds for a utility rejection under 35 U.S.C. § 101. It is on these grounds the initial 35 U.S.C. § 101 rejection was made, and on which it is maintained, as Applicant has submitted no arguments against this basis.
Rejections under 35 U.S.C. § 112(a)
Applicant argues the amended claim overcomes the prior enablement and written description. Examiner respectfully disagrees. Examiner acknowledges the claim is amended to recite identifying “an abnormal factor” instead of “any abnormal factor”. However, the specification still describes the incredible utility of detecting any abnormal factor, so the full scope of the claimed invention would be selecting one abnormal factor from any possible abnormal factor, which as described in the Non-Final Rejection (issued 10 October 2025) is not enabled. Further, while the claim amendments include further steps, these steps are not described in the specification in such a manner as to enable one of ordinary skill in the art to practice the claimed invention. For example, the claim recites “calculating a probability of a particular factor or event adversely impacting the scan”. However, nowhere does Applicant’s specification describe how to actually calculate the probability. A similar issue exists for “obtaining a threshold value”. As described in the Non-Final Rejection, Applicant’s disclosure reads as if one considered the wanted results (being able to detect any abnormal event and the calculating probability of adverse impact) and user interface design (see, e.g., Fig. 11, showing the detection of an abnormal event and displaying the probability of adverse impact), but without sufficiently describing how to actually achieve those results. For these reasons, the enablement and written description rejections are maintained.
Claims 10 and 20
Regarding claims 10 and 20, similar reasoning to that described above regarding claim 1 applies, for one or more of calculating a probability, obtaining a threshold value, and comparing surveillance image data to reference data.
Claims 2-9 and 11-19
Regarding claims 2-9 and 11-19, see the above responses regarding claims 1, 10, and 20.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections — 35 U.S.C. § 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
Claims 1-20 are rejected under 35 U.S.C. § 101 because the claimed invention is not supported by either a credible asserted utility or a well-established utility.
Claims 1, 10, and 20
Regarding claims 1, 10, and 20, with reference to representative claim 1, the claim recites “identifying, via the processor, an abnormal factor or event within the environment that potentially adversely impacts a scan of a subject with the medical imaging scanner based on the surveillance image data”. Applicant’s specification states “The computer-implemented method also includes identifying, via the processor, any abnormal factor or event within the environment that potentially adversely impacts a scan of a subject with the medical imaging scanner based on the surveillance image data” (¶ 5; emphasis added by Examiner). While Applicant’s specification describes some abnormalities (¶ 25), the specification does not describe how to identify abnormal factors beyond those listed. The scope of “an abnormal factor” thus includes any abnormal factor, including abnormal factors beyond those listed in paragraph 25. Further, even for those abnormal factors described in the specification, the actual identification is only described with a high level of generality (obtaining a threshold by undisclosed means and determining whether a calculated probability calculated by undisclosed means exceeds the threshold; see, e.g., ¶¶ 50-51). The specification does not describe how comparing surveillance image data to reference data is performed. The entire specification reads as if the inventor contemplated a desired outcome (i.e., being able to detect any abnormal factor) and a user interface (see, e.g., ¶¶ 63-64, Figs. 11-12), but did not actually perform the claimed method (or actually make a system or write code to perform the full scope of the claimed method). While one of ordinary skill in the art would have reasonably expected credible utility if the claim recited identifying a specific abnormal factor (e.g., one of the factors identified in Applicant’s specification), one of ordinary skill in the art would not have expected credible utility for identifying any abnormal factor. Either all possible abnormal factors would need to be programmed, or some means for determining abnormal factors beyond those listed in the specification would need to be provided. No such disclosure is present in Applicant’s specification. While claims 1, 10, and 20 recite one or more of calculating a probability and obtaining a threshold, as described above, Applicant’s specification does not describe how to actually determine the probability or threshold. For example, does not describe how one would calculate a probability based on the surveillance image data. Accordingly, claims 1, 10, and 20 are rejected.
Claims 2-9 and 11-19
Regarding claims 2-9 and 11-19, the claims are rejected due to their dependence.
Claim Rejections — 35 U.S.C. § 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.
Written Description: Claims 1-20
Claims 1-20 are rejected under 35 U.S.C. § 112(a), 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, at the time the application was filed, had possession of the claimed invention.
Claims 1, 10, and 20
Regarding claims 1, 10, and 20, with reference to representative claim 1, the claim recites “identifying, via the processor, an abnormal factor or event within the environment that potentially adversely impacts a scan of a subject with the medical imaging scanner based on the surveillance image data”. Applicant’s specification states “The computer-implemented method also includes identifying, via the processor, any abnormal factor or event within the environment that potentially adversely impacts a scan of a subject with the medical imaging scanner based on the surveillance image data” (¶ 5; emphasis added by Examiner). While Applicant’s specification describes some abnormalities (¶ 25), the specification does not describe how to identify abnormal factors beyond those listed. The scope of “an abnormal factor” thus includes any abnormal factor, including abnormal factors beyond those listed in paragraph 25. Further, even for those abnormal factors described in the specification, the actual identification is only described with a high level of generality (obtaining a threshold by undisclosed means and determining whether a calculated probability calculated by undisclosed means exceeds the threshold; see, e.g., ¶¶ 50-51). The specification does not describe how comparing surveillance image data to reference data is performed. The entire specification reads as if the inventor contemplated a desired outcome (i.e., being able to detect any abnormal factor) and a user interface (see, e.g., ¶¶ 63-64, Figs. 11-12), but did not actually perform the claimed method (or actually make a system or write code to perform the full scope of the claimed method). While one of ordinary skill in the art would have reasonably expected credible utility if the claim recited identifying a specific abnormal factor (e.g., one of the factors identified in Applicant’s specification), one of ordinary skill in the art would not have expected credible utility for identifying any abnormal factor. Either all possible abnormal factors would need to be programmed, or some means for determining abnormal factors beyond those listed in the specification would need to be provided. No such disclosure is present in Applicant’s specification. While claims 1, 10, and 20 recite one or more of calculating a probability and obtaining a threshold, as described above, Applicant’s specification does not describe how to actually determine the probability or threshold. For example, does not describe how one would calculate a probability based on the surveillance image data.
Accordingly, claims 1, 10, and 20 are rejected.
Further, the recitation of identifying only one abnormal factor (“an abnormal factor”) is new matter. The specification is clear that Applicant’s invention is to identify any abnormal factor (see, e.g., ¶ 5), and this is what was originally claimed (see claims 1, 10, and 20 as originally filed). Nowhere does Applicant’s disclosure as originally filed disclose identifying only one abnormal factor.
Claims 2-9 and 11-19
Regarding claims 2-9 and 11-19, the claims are rejected due to their dependence.
Enablement: Claims 1-20
Claims 1-20 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Specifically, for each claim, because the claimed invention is not supported by either a credible asserted utility or a well-established utility for the reasons set forth in the 35 U.S.C. § 101 rejections above, one skilled in the art clearly would not know how to use the claimed invention.
According to the approach used by the court in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (See MPEP § 2164), There are many factors (“Wands factors”) to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Claims 1, 10, and 20
Regarding claims 1, 10, and 20, with reference to representative claim 1, the broadest reasonable interpretation of the claim includes identifying any abnormal factor. As described in the 35 U.S.C. § 101 rejections above, the recitation of an abnormal factor is not limited to those specific examples provided in Applicant’s specification, but any factor which can be considered abnormal. The state of the art at the time of filing shows that identifying an abnormal factor (i.e., one for which a processor is programmed to identify) was generally known in the art, but not identifying any abnormal factor. Identifying any abnormal factor is an incredible function, and would require either listing all possible abnormal factors, or a means for identifying all possible abnormal factors beyond those listed in Applicant’s specification. No such disclosure is present. Further, even for those abnormal factors described in the specification, the actual identification is only described with a high level of generality (obtaining a threshold by undisclosed means and determining whether a calculated probability calculated by undisclosed means exceeds the threshold; see, e.g., ¶¶ 50-51). The specification does not describe how comparing surveillance image data to reference data is performed. The entire specification reads as if the inventor contemplated a desired outcome (i.e., being able to detect any abnormal factor) and a user interface (see, e.g., ¶¶ 63-64, Figs. 11-12), but did not actually perform the claimed method (or actually make a system or write code to perform the full scope of the claimed method). While one of ordinary skill in the art would have reasonably expected credible utility if the claim recited identifying a specific abnormal factor (e.g., one of the factors identified in Applicant’s specification), one of ordinary skill in the art would not have expected credible utility for identifying any abnormal factor. Either all possible abnormal factors would need to be programmed, or some means for determining abnormal factors beyond those listed in the specification would need to be provided. No such disclosure is present in Applicant’s specification. While claims 1, 10, and 20 recite one or more of calculating a probability and obtaining a threshold, as described above, Applicant’s specification does not describe how to actually determine the probability or threshold. For example, does not describe how one would calculate a probability based on the surveillance image data. Taking these factors into account, undue experimentation would be required by one of ordinary skill in the art to practice the full scope of claim 1. Thus, claim 1 is not enabled by the disclosure. Accordingly, claims 1, 10, and 20 are rejected.
Claims 2-9 and 11-19
Regarding claims 2-9 and 11-19, the claims are rejected due to their dependence.
35 U.S.C. § 112(b) Rejections: Claims 1-20
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: Identifying any abnormal factor, as recited for example in paragraph 5 of Applicant’s specification and claims 1, 10, and 20 as originally filed. This element is essential because it permits identifying any factor which may impact scans, not just one factor.
Claim Considerations — 35 U.S.C. §§ 102-103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. §§ 102–-----103 (or as subject to pre-AIA 35 U.S.C. §§ 102–103) 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 the appropriate paragraphs of 35 U.S.C. § 102:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. § 103:
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20
Claims 1-20 are not rejected under 35 U.S.C. §§ 102-103.
Claims 1, 10, and 20
Regarding claims 1, 10, and 20, Soderholm (US 10,285,629 B1) discloses a computer-implemented method for monitoring an environment within a scan room having a medical imaging scanner (110), comprising: receiving, at a processor (150), surveillance image data of the scan room from an optical imaging system comprising one or more cameras (cameras 140) disposed within the scan room; identifying, via the processor (150), an abnormal factor or event (physical motion) within the environment that potentially adversely impacts a scan of a subject with the medical imaging scanner (119) based on the surveillance image data, wherein identifying the abnormal factor or event comprises: obtaining a threshold value, wherein the threshold value is a preset level where a factor or event is considered the abnormal factor or event that potentially adversely impacts the scan; and identifying the particular factor or event as an identified abnormal factor or event that potentially adversely impacts the scan when the threshold value is exceeded; causing, via the processor, a notification of the identified abnormal factor or event to be provided to an operator of the medical imaging scanner; and recording, via the processor, the identified abnormal factor or event to an event log file (col. 3, l. 51 - col. 5, l. 38; col. 9, ll. 39-45; Figs. 1-2).
While Soderholm discloses identifying an abnormal factor (i.e., motion the processor is configured to detect via one or more camera), Soderholm does not disclose: calculating a probability of a particular factor or event adversely impacting the scan, determining whether the probability that is calculated for the particular factor or event meets or exceeds the threshold value; and identifying the particular factor or event as an identified abnormal factor or event that potentially adversely impacts the scan when the probability that is calculated does not meet or exceed the threshold value, obtaining reference image data of the scan room, and comparing the surveillance image data to the reference image to identify a particular factor or event in the surveillance image data as an identified abnormal factor or event that potentially adversely impacts the scan. Accordingly, claims 1, 10, and 20 are not rejected under 35 U.S.C. §§ 102-103.
Claims 2-9 and 11-19
Regarding claims 2-19 and 11-19, the claims are not rejected due to their dependence.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zelnik (US 2007/0053486 A1) discloses a computed tomography system including a camera to confirm system alignment (¶¶ 16, 25-28).
Mercer (US 2011/0121969 A1) discloses using cameras to monitor a medical diagnostic environment to detect abnormal events such as smoke from a failed component (¶ 52).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE RIDDICK whose telephone number is (571)270-1865. The examiner can normally be reached M - Th 6:30 am - 5:00 pm ET, with flexible scheduling.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-2995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Blake C. Riddick, Ph.D.
Primary Examiner
Art Unit 2884
/BLAKE C RIDDICK/Primary Examiner, Art Unit 2884
Prosecution Insights