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 .
Election/Restrictions
Applicant's election with traverse of invention I in the reply filed on 02 October 2025 is acknowledged. The traversal is on the ground(s) that:
The kit itself is defined as including the system, and thus cannot exist independently of it. The method likewise cannot be carried out without the same system components and algorithmic functionality that are recited in the system claims. The system is the physical and functional platform, the kit is the practical embodiment that enables deployment and use, and the method is the operational mode by which the system and kit achieve their intended purpose. This tight integration makes them part of a single inventive concept.
The specification repeatedly supports this unity. It describes the invention as a unified point-of-care remote patient care system that allows patient input, diagnostic testing, and care provider communication to occur together as part of one platform. It explains that the mobile diagnostic support system and kit enable the execution of the diagnostic and treatment method, and that the method is implemented through the system’s processor, algorithm, database, and care provider interface. The system and kit cannot achieve their intended function without the steps of the method, and the method cannot be performed without the system and kit.
The interdependence of the claims further demonstrates that they are not patentably distinct. The method claims explicitly rely on the same structures, components, and functionalities recited in the system and kit claims. Likewise, the system and kit are designed and configured for use in performing the method. This mutual dependence confirms that they are directed to a single invention. As MPEP § 806.05(c) notes, apparatus and method claims that are used together to achieve a single disclosed purpose are considered a single invention and should not be subject to restriction.
This is not found persuasive because the inventions are patentably distinct for the previously cited reasons. The method does not require a mobile or portable device, nor has the Applicant offered information that the steps are necessarily tied to such a structure. The requirement is still deemed proper and is therefore made FINAL.
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 1-10 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. Claim 1 requires “BPM diagnosis interpretation (BPM-DI)” in line 18, without explaining what this term means in the claim. Based on the Specification (par. 0011), the Examiner will interpret this term to mean “blood pressure monitor” for the purposes of Examination, but this claim must be amended to either dispute or agree with this interpretation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson III et al (U.S. 2018/0296143). Anderson discloses (Figure 2) a mobile diagnostic support system for enhanced integration and involvement between a user and a care provider for provisioning medical care to said user comprising a plurality of user symptom reports (USR) (par. 0110), one of said plurality of USR comprising a first user health condition report, a plurality of exam devices (ED) (par. 0081), one of said plurality of ED comprising a vital sign monitor (VSM) having a first user exam result (UER), a plurality of lab tests (LT), one of said plurality of LT comprising a bodily fluid test (BFT) (par. 0033) having a first user test result (UTR), a database (par. 0032) comprising analysis data, said analysis data comprising a plurality of USR data, one of said plurality of USR data comprising a symptom report, a plurality of UER data, one of said plurality of UER data comprising a VSM exam result, a plurality of UTR data, one of said plurality of UTR data comprising a BFT test result, a plurality of diagnosis data (DD) one of said plurality of DD comprising a plurality of ED diagnosis interpretations (ED-DI) one of said plurality of ED-DI comprising a BPM (par. 0041) diagnosis interpretation (BPM-DI) dataset, a second of said plurality of ED-DI comprising an LT diagnosis interpretation (LT-DI) dataset, a plurality of treatment data (TD) (par. 0096), one of said plurality of TD comprising a plurality ED treatment interpretations (ED-TI), one of said plurality of ED-TI comprising a BPM treatment interpretation (BPM-TI) dataset, a second of said plurality of ED-TI comprising an LT treatment interpretation (LT-TI) dataset, and a plurality of prophylaxis data (PD) (par. 0079), one of said plurality of PD comprising a plurality of ED prophylaxis interpretations (ED-PI), one of said plurality of ED-PI comprising a BPM prophylaxis interpretation (BPM-PI) dataset, a second of said plurality of ED-PI comprising an LT prophylaxis interpretation (LT-PI) dataset, an algorithm (par. 0047), a user device, a processor, and a care provider device, wherein optionally said user inputs at least one user health condition report (par. 0031), wherein said user connects at least one of said plurality of ED and/or said plurality of LT, wherein said processor uses said algorithm via encryption secured electronic transmission (par. 0049) to connect to said plurality of ED and/or said plurality of LT, identify each of said plurality of ED and/or said plurality of LT, read a data from each of said plurality of ED and/or said plurality of LT, reformat/reorganize said data into a standard/consolidated formatted data-stream (par. 0065), and transmit said standard/consolidated data-stream into and/or attach to a patient record system (par. 0043), wherein said processor uses said algorithm to compare (par. 0065) said plurality of USR, said plurality of UER, and said plurality of UTR to said plurality of DD, said plurality of TD, and said plurality of PD and displays on said care provider device and/or said user device at least one of a diagnosis suggestion, a treatment suggestion, or a prophylaxis suggestion, wherein said care provider device is used by a care provider to offer onsite diagnostic support, and wherein said care provider device is used by a care provider to review, assess, comment on, and/or adjust any of said plurality of USR, said plurality of UER, said plurality of UTR, said diagnosis suggestion, said treatment suggestion, and said prophylaxis suggestion.
Regarding claim 2, Anderson discloses (par. 0122-0123) a plurality of medical billing data (MBD), one of said plurality of MBD comprising a medical device billing data (MDBD), and wherein said processor uses said algorithm via encryption secured electronic transmission to display a billing suggestion.
Regarding claim 3, Anderson discloses (par. 0099) a chatbot to review, assess, comment on, and/or adjust any of said plurality of USR, said plurality of UER, said plurality of UTR, said diagnosis suggestion, said treatment suggestion, and said prophylaxis suggestion.
Regarding claim 4, Anderson discloses (par. 0099) a chatbot to review, assess, comment on, and/or adjust said plurality of MBD and/or said billing suggestion.
Claims 15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cella et al (U.S. 2022/0108262). Cella discloses (par. 3223) a mobile diagnostic kit for implementing a method for enhanced integration and involvement between a user and a care provider during a provisioning of medical care to said user comprising: a backpack; a wheeled case (par. 2125); a stethoscope (par. 6838); a video camera (par. 0032); and a vital signs monitor comprising measurements for any combination of temperature, blood pressure, oxygen satiation, and heart rate.
Regarding claim 18, Cella discloses (par. 1093) an ultrasound analysis apparatus.
Regarding claim 19, Cella discloses (par. 2126) a rapid molecular test apparatus.
Regarding claim 20, Cella discloses (par. 2374) a recurring subscription fee.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson III et al (U.S. 2018/0296143) in view of Cella et al (U.S. 2022/0108262). Anderson discloses the claimed invention except for a backpack; a wheeled case; a stethoscope; a video camera; and a vital signs monitor comprising measurements for any combination of temperature, blood pressure, oxygen saturation, and/or heart rate. Cella, however discloses these elements (par. 3223, 2125, 6838, 0032).
Cella and Anderson both disclose mobile systems for collecting and displaying vital signs. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Anderson’s displayed reports with Cella’s backpack, wheeled case, and other components, in order to provide an easily carried system for increase patient compliance and comfort.
Regarding claim 6, Anderson discloses (par. 0006) at least a blood chemistry analysis apparatus.
Regarding claim 7, Cella and Anderson disclose the claimed invention but do not disclose expressly the urine analysis apparatus. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the mobile diagnostic kit as taught by Cella and Anderson, with the urine analysis apparatus, because the applicant has not disclosed the analysis of urine provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the measured vital signs as taught by Anderson and Cella, because Anderson and Cella are able to generate reports and create a diagnosis based on the vital signs collected. Therefore, it would have been an obvious matter of design choice to modify Cella and Anderson to obtain the invention as specified in the claim.
Regarding claim 8, Cella discloses (par. 1093) an ultrasound analysis apparatus.
Regarding claim 9, Cella discloses (par. 2126) a rapid molecular test apparatus.
Regarding claim 10, Cella discloses (par. 2374) a recurring subscription fee.
Regarding claim 16, Anderson discloses (par. 0006) a blood chemistry analysis apparatus; and/or a hematology analysis apparatus.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cella et al (U.S. 2022/0108262). Cella discloses the claimed invention but does not disclose expressly the urine analysis apparatus. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the mobile diagnostic kit as taught by Cella, with the urine analysis apparatus, because the applicant has not disclosed the analysis of urine provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the measured vital signs as taught by Cella, because Cella is able to generate reports and create a diagnosis based on the vital signs collected. Therefore, it would have been an obvious matter of design choice to modify Cella to obtain the invention as specified in the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792