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 .
This office action is in response to applicant’s communication of 3/4/2024. Currently claims 1-14 are pending and rejected or objected to below.
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)(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.
Claim(s) 1-3 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by REGMI, H.K. et al. "A System for Real-Time Syringe Classification and Volume Measurement Using a Combination of Image Processing and Artificial Neural Networks", Journal of Pharmaceutical Innovation (2019), pages 341-358, 22 October 2018 (22-10-2018), retrieved from https://link.springer.com/content/pdf/10.1007/s12247-018-9358-5.pdf
REGMI discloses a method for execution on a computing device to provide information on dosage of medication for administration to a patient using a syringe (see Abstract), comprising: receiving, from an image-capture device, an image of the syringe after the medication has been drawn but before being administered to the patient (a syringe image capture and analysis system is described in the last paragraph of col 2 of pg. 342, and the first two paragraphs of col 1 of pg. 343; also see fig. 1 on pg. 344); determining, from the image of the syringe, a capacity of the syringe (volume measurement is described in the last paragraph of col 1 of pg. 343; see also col 2 of pg. 345); locating, in the image of the syringe, a plunger head and a barrel head of the syringe (see figs. 1-2); and estimating the dosage of the medication contained in the syringe, using a mathematical model based on the capacity of the syringe and using the located plunger and barrel heads as inputs for the mathematical model (see the neural network in fig. 1, the description for syringe classification beginning on col 2 of pg. 343, and the volume measurement of col 2, pg. 345).
Concerning claim 2 note image processing and machine learning functionality is used to classify the type of syringe being used, and provide an approximation of the volume of medication present in the syringe as described in 2ⁿᵈ paragraph of col 1, pg. 343.
Concerning claim 3 and the predefined mathematical models, see an automated volume measurement capability of the system is accomplished using supervised machine learning and ANN's which are trained to measure the plunger depth in pixcls and corresponding volume to build a neural network model that is utilized for later volume calculation, as described in the 3ʳᵈ paragraph of col 1, pg. 343.
Concerning claim 13 see above disclosure concerning the rejection of claim 1 and similar operational and method steps.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 4-8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over REGMI, H.K. et al. "A System for Real-Time Syringe Classification and Volume Measurement Using a Combination of Image Processing and Artificial Neural Networks", Journal of Pharmaceutical Innovation (2019), pages 341-358, 22 October 2018 (22-10-2018), retrieved from https://link.springer.com/content/pdf/10.1007/s12247-018-9358-5.pdf in view of LIMAYE et al. (US 2020/0381106 A1).
With regards to claim 4, the REFMI is silent for a mathematical model comprising a regression model with a line of best fit relating to positional information of the plunger and barrel heads, and volume of the syringe. However, estimating volume or capacity of a syringe using a regression line of best fit in terms of plunger positional information (see the depth calculation as described in REGMI, col 2, pg. 345) along with other syringe parameters (see REGMI, eq'n 2) is an obvious method that a skilled person would intuitively know to apply in a straightforward manner, and is an implementation choice for calculating volume of fluid in a syringe. Hence, claim 4 lacks an inventive step in view of REGMI, LIMAYE and the common general knowledge.
Claims 5-8 and 14 refer to electronically sending pertinent image and dosage information for storage in patient medical health records; LIMAYE, paragraphs [0058]-[0061] disclose an image capture application to determine if a correct medication dose amount has been drawn and confirmed, in which case medical event data or informatics obtained via a captured image processing operation can be stored locally or remotely for access and use by the patient and/or other medical condition management stakeholders and can be automatically uploaded to a repository for inclusion in a patient's electronic record. It would have been an obvious modification to make to REGMI to include recordation in a health record in order to create a history to more efficiently treat a patient and record the specifics of past procedures for safety and efficiency.
Concerning claims 6-8, and 14 it is examiner’s position that the electronic medical record as taught would include sending, recording, and storing images or an estimated dosage in LIMAYE to create a history to more efficiently treat a patient and record the specifics of past procedures for safety and efficiency.
Allowable Subject Matter
Claims 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. 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.
PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
Prosecution Insights