DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/20/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/20/2026 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Regarding the arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that the claims are directed to a technology improvement not a method of organizing human activity. Examiner asserts that, under broadest reasonable interpretation, the steps recite instructions for a user for use of a ventilation status meeting an image acquisition criterion to acquiring medical images for the management of the subject’s ventilation, and therefore recite managing interactions between people. The acquiring of images for ventilation management of the subject is analogous to a person receiving instructions for performing these steps for the management of the care of the subject, and thus recites managing interactions between people. Thales recites a specific improvement in a technical field. The instant application recites claims for triggering acquisition and controlling the medical imaging device, however there is not indication of specific technical steps to demonstrate a technology improvement for the medical system beyond the abstract idea. Because of the generic configuration of the overall computing system, the improvements of the patient safety and image quality are not demonstrated. The steps for “acquiring the image” and “adjusting dose” recite instructions to perform adjustments to the devices, not a specific technology improvement.
Applicant further argues that the elements of the mechanical ventilator and medical imaging device with the processor recites a technology improvement. Examiner asserts that these are devices that are used in the instruction for controlling these devices. The use of the devices, including the processor, recites a generic configuration of these devices. There is no indication or limitation in the claim recite a technology improvement related to medical imaging quality. Applicant further argues that the claims are analogous to Example 37. Examiner asserts that the instant application does not recite steps of at technology increase that are recited in Example 37. CardioNet demonstrates the use of “specific” sensors for the specific improvement to imaging, however the instant application there is no such specific configuration of the components to demonstrate a technology improvement. The claimed steps for physically transforming the X-ray detector, as demonstrated in the claim, recites general steps or instructions to perform the adjustment of the devices, not specific transformations of data.
Applicant further argues that the claims qualify as significantly more that the judicial exception. Examiner further asserts that the connections of devices or mutual exchange of information and technical improvement related to those devices is not recited in the claims. The improvement of the “real time” coordination is merely the result of the use of the generic computing components, see MPEP 2106.05(f), specifically” "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).” Related to Berkheimer, See MPEP 2106.05(d)(I), specifically “Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018). However, this does not mean that a prior art search is necessary to resolve this inquiry. Instead, examiners should rely on what the courts have recognized, or those in the art would recognize, as elements that are well-understood, routine, conventional activity in the relevant field when making the required determination.” See rejection under Step 2B in the updated rejection below.
Regarding the arguments against the rejection of claims under 35 USC 103, Examiner agrees and therefore thus rejection is withdrawn.
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, 3-14, and 16 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 1, 3-14 are related to a system, and claim 16 is also related to a method (i.e., a process). Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Representative independent claim 1 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 1 recites:
A medical system for ventilation and imaging, comprising:
a mechanical ventilator, configured to be operated to cause a ventilation status at a subject,
a medical imaging device; and
at least one processor is configured to:
obtain, from the mechanical ventilator, a ventilation status information associated with the ventilation status of the subject,
trigger acquisition, by the medical imaging device, of a first image if the ventilation status meets a first image acquisition criterion,
trigger acquisition, by the medical imaging device, of at least one subsequent image if the ventilation status meets a second image acquisition criterion, and
control the medical imaging device to adjust a radiation dose to be used for acquisition of the first and/or subsequent image depending on the respective image acquisition criterion and/or ventilation status information,
wherein the images are acquired at a desired moment of ventilation to reduce image artifacts.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations are related to use of a ventilation status meeting an image acquisition criterion to acquiring medical images for the management of the subject’s ventilation:
“trigger acquisition” of a first image if the ventilation status meets a first image acquisition criterion, which is an abstract limitation related to considering the ventilation status meeting a criterion and generating an instruction for acquiring an image for the ventilation management of the subject,
“trigger acquisition” of at least one subsequent image if the ventilation status meets a second image acquisition criterion, which is an abstract limitation related to considering the ventilation status meeting a criterion and generating an instruction for acquiring an image for the ventilation management of the subject,
“control” the medical imaging device to adjust a radiation dose to be used for acquisition of the first and/or subsequent image depending on the respective image acquisition criterion and/or ventilation status information, which are abstract limitations related to the analysis of the previous criterion or ventilation status to generate an instruction for adjusting the radiation dose when controlling the medical imaging device,
The images are acquired at a desired moment of ventilation to reduce image artifacts, which is an abstract limitation of an instruction for the management of image acquisition for the subject to reduce artifacts.
The claim limitations as a whole recite steps or instructions to ben given for use of a ventilation status meeting an image acquisition criterion to acquiring medical images for the management of the subject’s ventilation, and therefore recite managing interactions between people. The acquiring of images for ventilation management of the subject is analogous to a person receiving instructions for performing these steps for the management of the care of the subject, and thus recites managing interactions between people.
The abstract idea recited in claim 16 is similar to that of claim 1.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., processor) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 3 recites abstract limitations further describing the image acquisition criterions as being the same or deviate within a tolerance window, further describing the abstract idea. Claim 4 recites instructions for “controlling” adjustment of ventilation parameters on the mechanical ventilator if it is “determined” that the ventilation status has changed compared to the acquisition of the first image; these steps can be performed by a person for the management of the ventilation of the subject, thus further describing the abstract idea. Claim 5 recites abstract limitations further describing the image criteria as differing from each other, thus further describing the abstract idea. Claims 6 and 7 recite abstract limitations further describing the image acquisition criterion as either being a maximum expiration or inspiration of a ventilated subject, further describing the abstract idea. Claim 8 recites abstract limitations of “generating” a ventilation image by “displaying” the first or second image acquired at maximum expiration based on a histogram of the images acquired at maximum inspiration, further describing the abstract idea. Claim 9 recites the abstract limitation of “determining” one or more positions where the image acquisition at minimum inspiration or maximum expiration has higher brightness than indicated by the histogram of the image acquired at maximum inspiration, further describing the abstract idea. Claim 11 recites further abstract limitations of “generating” a respiratory image by subtracting the image acquired at minimum inspiration and the image acquired at maximum inspiration from each other, further describing the abstract idea. Claim 12 recites the abstract limitation of “determining” tidal volume information from the images assigned to a residual volume, and the other one of the images assigned to a tidal lung capacity, by “determining” a difference between the RV and the TLC, further describing the abstract idea. Claim 13 recites further abstract limitations of “including” the ventilation status information into image data assigned to the first or subsequent images, further describing the abstract idea. Claim 14 recites instructions for “controlling” the ventilator to pause or suspend ventilation of the subject during image acquisition; these steps can be performed by a person for the management of the ventilation of the subject, thus further describing the abstract idea.
Patent Subject Matter Eligibility Test: Step 2A- Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A medical system for ventilation and imaging, comprising:
a mechanical ventilator, configured to be operated to cause a ventilation status at a subject,(merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec)
a medical imaging device (invokes computers or other machinery merely as a tool to perform an existing process, see MPEP 2106.05(f)), and
at least one processor is configured to (invokes computers or other machinery merely as a tool to perform an existing process, see MPEP 2106.05(f)):
obtain, from the mechanical ventilator, a ventilation status information associated with the ventilation status of the subject (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec),
trigger acquisition, by the medical imaging device (invokes computers or other machinery merely as a tool to perform an existing process, see MPEP 2106.05(f)), of a first image if the ventilation status meets a first image acquisition criterion, and
trigger acquisition, by the medical imaging device (invokes computers or other machinery merely as a tool to perform an existing process, see MPEP 2106.05(f)), of at least one subsequent image if the ventilation status meets a second image acquisition criterion, and
control the medical imaging device to adjust a radiation dose to be used for acquisition of the first and/or subsequent image depending on the respective image acquisition criterion and/or ventilation status information,
wherein the images are acquired at a desired moment of ventilation to reduce image artifacts.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of the overall medical system comprising a processor used to perform steps and the use of a medical imaging device as a tool to acquire images, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using computers or other machinery merely as a tool (see MPEP § 2106.05(f)). [Page 2 lines 19-21, Page 3 lines 28-30] of the Applicant’s Specification recites the overall generic medical system for processing data. [Page 3 lines 8-9, Page 15 lines 15-18] reciters the use of generic processors. [Page 3 lines 4-6] recites the medical imaging device as an x-ray machine or other generic imaging device that is used as a tool for merely acquiring first and second images. The additional elements recite the use of generic computing components and tools with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Regarding the additional limitation of a mechanical ventilator, configured to be operated to cause a ventilation status at a subject, and wherein the at least one processor is configured to obtain, from the mechanical ventilator, a ventilation status information associated with the ventilation status of the subject, these are merely pre-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [Page 10 lines 19-34] of the Applicant’s Specification recites the use of the mechanical ventilator as a tool to acquire the ventilation status for the patient and how there is a communication with the processor or controller of the imaging device to obtain status information from the ventilator. The use of the mechanical ventilator device to acquire and forward ventilation status information to the processor recites data gathering for the abstract idea related to acquiring images, and thus recites insignificant pre-solution activities.
Claim 16 recites similar additional elements as claim 1.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to manage a subject’s ventilation, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use 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 not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claim 10 recites an additional element of controlling displaying the ventilation images at the mechanical ventilator, where there is the use of generic displaying technology on the ventilator to display part of the abstract idea, thus reciting mere computer implementation.
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding the additional limitation of the overall medical system comprising a processor used to perform steps and the use of a medical imaging device as a tool to acquire images, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using computers or other machinery merely as a tool (see MPEP § 2106.05(f)). [Page 2 lines 19-21, Page 3 lines 28-30] of the Applicant’s Specification recites the overall generic medical system for processing data. [Page 3 lines 8-9, Page 15 lines 15-18] reciters the use of generic processors. [Page 3 lines 4-6] recites the medical imaging device as an x-ray machine or other generic imaging device that is used as a tool for merely acquiring first and second images. The additional elements recite the use of generic computing components and tools with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception.
Regarding the additional limitation of a mechanical ventilator, configured to be operated to cause a ventilation status at a subject, and wherein the at least one processor is configured to obtain, from the mechanical ventilator, a ventilation status information associated with the ventilation status of the subject, these are merely pre-solution activities. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information)”). [Page 10 lines 19-34] of the Applicant’s Specification recites the use of the mechanical ventilator as a tool to acquire the ventilation status for the patient and how there is a communication with the processor or controller of the imaging device to obtain status information from the ventilator. The use of the mechanical ventilator device to acquire and forward ventilation status information to the processor recites data gathering for the abstract idea related to acquiring images, and thus recites insignificant pre-solution activities and does not recite significantly more than the judicial exception. The communication interface between the ventilator and imaging device as described in Page 10 to forward information related to ventilation status that is used to acquire the images recites well understood, routine, and conventional activities.
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 1, 3-14, and 16 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
The following references have been previously considered; however, they do not teach in the invention individually nor in combination:
US 2016/0367200 A1 to VOSKREBENZEV et al. teaches of obtaining ventilation images during expiration.
US 2022/0015733 A1 to Regensburger et al. teaches of a system for providing support for an anesthesia procedure by use of a ventilator and imaging device. For the reduction of artifacts of the medical image, there is consideration of the position of the patient
WO-2021231101-A1 to Damineni et al. teaches of a remote system to remotely control the ventilation of a subject based on sensor and image data.
NPL “Dynamic measures of regional lung air volume using phase contrast x-ray imaging” to Kitchen et al. teaches of tracking the progress of a patient’s ventilation by taking x-ray images of the lung and performing calculations of lung volume.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINE SIOZOPOULOS whose telephone number is (571)272-6719. The examiner can normally be reached Monday-Friday, 8AM-5PM EST.
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, Jason B Dunham can be reached at (571) 272-8109. 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.
/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686
