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 without traverse of Invention I (claims 1-21), in the reply filed on 07/16/2026, is acknowledged.
Claims 22-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2026.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 4/4/2024, 4/24/2024, 5/24/2024, 8/9/2024, 10/22/2024, 8/22/2025, 9/5/2025, 2/13/2026, and 06/30/2026, have been considered by the examiner.
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 15 and 16 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 15] The claim recites the limitation of “a software application” in the 4th and 5th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the “software application” recited in claim 15 is the same or different limitation “software application” recited in independent claim 1. For purposes of examination, it is interpreted that the “software application” limitation of claim 15 is the same as the “software application” limitation of claim 1.
[Claim 16] The claim is rejected based upon its dependency from claim 15.
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)(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.
Claims 1-3 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yarger et al. (PGPub 2023/0166047).
[Claim 1] Yarger teaches a system (figure 5) for verifying dosage accuracy of a medicinal fluid (paragraph [0002]), the system comprising:
a syringe (figure 5, item 10) comprising a barrel (figure 3, item 30), a fluid chamber (figure 3, unlabeled; chamber comprising stopper 32) formed inside the barrel (figure 3, item 30), a plunger (figure 3, items 32/34) slidably engaging the fluid chamber (figure 3, unlabeled), and a needle (figure 3, item 36), the syringe (figure 5, item 10) configured to draw an actual dosage of the medicinal fluid into the fluid chamber (figure 3, unlabeled) by movement of the plunger (figure 3, items 32/34) rearwardly in the fluid chamber (figure 3, unlabeled) (figure 3; paragraphs [0002], [0066], [0073]); and
a first data set (“image capture” of indicia 80/88; via item 102) comprising pre-determined volumetric proportions of the fluid chamber (figure 3, unlabeled) between a substantially full volume when the plunger (figure 3, items 32/34) is in a fully extended position relative to the barrel (figure 3, item 30) and a substantially empty volume when the plunger (figure 3, items 32/34) is in a fully inserted position relative to the barrel (figure 3, item 30), the first data set (“image capture” of indicia 80/88; via item 102) configured to be saved to a processor (figure 7, item 100) or accessed by the processor (figure 7, item 100) for use in a software application (figure 7, item 114) to determine a volume of the actual dosage based on a digital image of at least a portion of the syringe (figure 5, item 10) after the actual dosage is drawn into the fluid chamber (figure 3, unlabeled) and a position of the plunger (figure 3, items 32/34) relative to the barrel (figure 3, item 30) is between the fully extended position and the fully inserted position (figures 5, 7, and 8; paragraphs [0059]-[0061], [0066], and [0072]-[0075]).
[Claim 2] Yarger teaches the limitations of claim 1, upon which claim 2 depends. In addition, Yarger discloses the barrel (figure 3, item 30) is non-transparent (paragraph [0050]).
[Claim 3] Yarger teaches the limitations of claim 2, upon which claim 3 depends. Yarger also teaches there are no volumetric markings (figure 5) on the barrel (figure 3, item 30).
[Claim 15] Yarger teaches the limitations of claim 1, upon which claim 15 depends. Yarger further discloses a second data set (“image capture” of indicia 82/84; via item 102), the second data set (“image capture” of indicia 82/84; via item 102) comprising a predetermined dosage volume based on at least one of medicine records, medical histories, insurance reporting, billing, a biometric reading, and prescriptions (“drug type”) (paragraphs [0052], [0066]), the second data set (“image capture” of indicia 82/84; via item 102) configured to be saved to the processor (figure 7, item 100) or accessed by the processor (figure 7, item 100) for use in a software application (see 112b interpretation above) (figure 7, item 114) to compare to the volume of the actual dosage to determine the accuracy of the actual dosage (paragraphs [0052], [0066]).
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.
The factual inquiries 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.
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.
Claims 7-11, 18, and 19, are rejected under 35 U.S.C. 103 as being unpatentable over Yarger et al. (PGPub 2023/0166047), in view of Broselow (PGPub 2018/0154088).
[Claim 7] Yarger teaches the limitations of claim 1, upon which claim 7 depends. Yarger does not specifically disclose first and second portions of the syringe comprising a first and second color, respectively.
However, Broselow teaches a system and method for verifying dosage accuracy of a syringe (figure 3, item 16; figure 6, item 40) via digital image analysis (figure 3), wherein a first portion of the syringe (figure 6, item 40) has a first color (figure 6, item 42), wherein a second portion of the syringe (figure 6, item 40) has a second color (figure 6, item 42), and wherein the first color (figure 6, item 42) and the second color (figure 6, item 42) in the digital image are distinguishable by the processor (via device 10) from other portions of the syringe (figure 6, item 40) to determine the position of the plunger (figure 6, item 46) (figure 6; paragraph [0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Yarger, with the use of a multi-colored syringe, as taught by Broselow, in order to provide increased functionality and versatility, by allowing for a means by which an alternative, yet equivalent method, for analyzing plunger placement might be utilized.
[Claim 9] Yarger and Broselow teach the limitations of claim 7, upon which claim 9 depends. In addition, Broselow teaches the first portion (figure 6, item 42) is disposed on or near a forward end of the barrel (figure 6, item 44) and the second portion (figure 6, item 42) is disposed on or near a rearward end of the barrel (figure 6, item 44) (the examiner notes that the “array of colors” taught by Broselow extends along the length of the barrel).
[Claims 8, 18, and 19] Yarger and Broselow teach the limitations of claims 7 and 9, upon which claims 8, 18, and 19, depend. Yarger and Broselow do not specifically disclose the utilized colors for the first and second portions of the syringe.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Yarger and Broselow, with the use of a claimed colors and color combinations, as applicant has placed no criticality on the claimed colors. As such, where the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, the particular arrangement is deemed to have been a design consideration within the skill of the art. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
[Claim 10] Yarger and Broselow teach the limitations of claim 9, upon which claim 10 depends. Yarger further disclose the barrel (figure 3, item 30) is sufficiently transparent to allow the medicinal fluid in the fluid chamber (figure 3, unlabeled) to be viewed through the barrel (figure 3, item 30) (figure 3; paragraph [0066]) (the examiner notes that Yarger teaches the plunger stopper 32 is visible through the barrel; as such, any medicinal fluid would also be visible).
[Claim 11] Yarger and Broselow teach the limitations of claim 10, upon which claim 11 depends. The embodiment taught by Yarger, relied upon in the rejection above, does not disclose the syringe comprises a plurality of volumetric markings disposed on an outer surface of the barrel.
However, Yarger teaches an alternative embodiment which utilizes a plurality of volumetric markings (figure 6b, item 74) disposed on an outer surface of the barrel (figure 6b; paragraphs [0068], [0069]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the structure taught by Yarger and Broselow, with the use of a plurality of volumetric markings, as taught by the alternative embodiment of Yarger, in order to provide increased functionality and versatility, by allowing for a user to visually discern a volume of fluid within the barrel of the syringe (Yarger; paragraph [0068]).
Allowable Subject Matter
Claims 4-6, 12-14, 17, 20, and 21, 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.
Claim 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 09/16/2026
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