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 Group I (claims 1-26); Species A (cellular telephone); and Species C (application software), in the reply filed on 11/10/2025, is acknowledged.
Claims 4 and 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
Claims 8, 15, and 21, have been cancelled. As such, claims 1-3, 5-7, 9-14, 16-20, and 22-26, are pending for examination.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 10/07/2022, 02/17/2023, 09/26/2023, 01/19/2024, 03/26/2024, 04/26/2024, 05/24/2024, 08/09/2024, 10/18/2024, and 09/05/2025, have been considered by the examiner.
Claim Rejections - 35 USC § 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 5-7, 9, and 10, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
[Claim 5] The claim recites the limitation of “wherein the application software is configured to determine whether the dosage drawn into the medical syringe is within a permissible range of deviations from a predetermined value” The originally filed specification does not provide support for this limitation (The examiner notes the specification only supports the “comparator” as having this functionality; there is no indication that the “comparator” is a part of the “application software”). As such, the limitation is considered new matter.
[Claims 6, 7, 9, and 10] The claims are rejected based upon their dependency from claim 5.
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 1-3, 5-7, 9-13, and 23, 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] The claim recites the limitation of “the elongate cylindrical fluid chamber” in the 8th line of the claim. There is a lack of antecedent basis for this limitation in the claim. Further, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “cylindrical fluid chamber” in the 4th line of the claim, or if a new structure is being introduced into the claim limitations. For purposes of examination, it is interpreted that the limitation refers to the previously recited “cylindrical fluid chamber.”
[Claim 1] The claim recites the limitation of “the full volumetric scale” in the 12th line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to the previously recited “volumetric scale,” or if an additional scale is intended to be claimed. For purposes of examination, it is interpreted that “the full volumetric scale” refers to the previously recited “volumetric scale.”
[Claim 1] The claim recites the limitation of “the full volumetric scale” in the 12th line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear how the term “full” is intended to be interpreted. Specifically, it is unclear if this refers to an internal liquid volume or the printed scale itself. Further, if referring to the scale itself, it would be unclear what determines “a full scale.” For purposes of examination, it is interpreted that any volumetric scale meets the limitations of the claims.
[Claim 23] The claim recites a dependency on cancelled claim 21. The examiner is unable to determine the metes and bounds of the claim, since it is unclear which limitations the claim is intended to incorporate. In order to provide proper antecedent basis for the limitation “the alert generation device” in the 2nd line of the claim, it is interpreted that claim 23 depends directly from claim 16.
[Claims 2, 3, 5-7, and 9-13] The claims are rejected based upon their dependency from independent claim 1.
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 14, 16-20, and 22-24, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yarger et al. (PGPub 2023/0166047).
[Claim 14] Yarger teaches a syringe dosage verification system (figures 6a and 6b) for use prior to administering an injection of a medicinal fluid (paragraphs [0060], [0070]), the system comprising:
a medical syringe (figure 6a, item 18) having a barrel (figure 6a, item 64) with a volumetric scale (figure 6b, item 74) (paragraph [0068]), an inwardly facing wall defining a cylindrical fluid chamber (figure 6b, item 72) disposed inside the barrel (figure 6a, item 64) (paragraph [0068]), a plunger having a plunger seal (“stopper) (figure 6b, item 78)(paragraphs [0035], [0069]) disposed inside and slidably engaging an inwardly facing wall of the cylindrical fluid chamber (figure 6b, item 72) of the barrel (figure 6a, item 64) and a plunger handle (“drive mechanism”) (figure 6b, item 76) (paragraph [0068]) projecting rearwardly from the barrel (figure 6a, item 64), and a forwardly projecting hypodermic needle (figure 6b, item 68) (paragraph [0068]); and
an imaging device (figure 6b, item 20) configured to view and selectively capture, store or transmit a digital image (via figure 6b, item 102) of a position of the plunger handle (figure 6b, item 76) relative to the barrel (figure 6a, item 64) when a dosage of the medicinal fluid is drawn into the fluid chamber (figure 6b, item 72) of the barrel (figure 6a, item 64) prior to an injection (paragraphs [0059], [0060], [0068]-[0070]).
[Claims 16 and 23] Yarger teaches the limitations of claim 14, upon which claims 16 and 23 depend (see 112b interpretation above). In addition, Yarger discloses an alert generation device ((figure 7, item 110) or (figure 6b, item 104)) configured to notify a user of an incorrect fluid dosage drawn into the medical syringe and generate at least one of an audio alert, a visual alert, and a tactile alert (paragraphs [0058], [0059], [0075]).
[Claims 17 and 18] Yarger teaches the limitations of claim 14, upon which claims 17 and 18 depend. Yarger further teaches the imaging device (figure 6b, item 20) is a cellular telephone (figure 6b; paragraph [0059]).
[Claims 19, 20, and 22] Yarger teaches the limitations of claim 14, upon which claims 19, 20, and 22, depend. Yarger also teaches the imaging device (figure 6b, item 20) is configured by downloading and installing application software (figure 7, item 114) on the imaging device (figure 7; paragraph [0058]); wherein the application software (figure 7, item 114) is configured to generate an audio, visual, or tactile alert to notify a user of an incorrect fluid dosage drawn into the medical syringe (figure 6a, item 18) (paragraphs [0058], [0059], [0075]).
[Claim 24] Yarger teaches the limitations of claim 14, upon which claim 24 depends. In addition, Yarger teaches the medical syringe (figure 6a, item 18) comprises at least one needle safety device (figure 6a, item 65) configured to protect a user or a third party from an accidental needle stick (paragraph [0068]).
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 1-3, 5-7, 9-13, 25, and 26, are rejected under 35 U.S.C. 103 as being unpatentable over Yarger et al. (PGPub 2023/0166047), in view of Shaw et al. (PGPub 2019/0298929).
[Claims 1-3] Yarger teaches a syringe dosage verification system (figures 6a and 6b) for use prior to administering an injection of a medicinal fluid (paragraphs [0060], [0070]), the system comprising:
a medical syringe (figure 6a, item 18) having a transparent (paragraph [0054]) barrel (figure 6a, item 64), a plunger handle (“drive mechanism”) (figure 6b, item 76) with a plunger seal (“stopper”) (figure 6b, item 78) (paragraphs [0035], [0068], [0069]) slidably engaging an inwardly facing wall of a cylindrical fluid chamber (figure 6b, item 72) disposed inside the barrel (figure 6a, item 64) (paragraph [0068]), and a forwardly projecting hypodermic needle (figure 6b, item 68) (paragraph [0068]), the barrel (figure 6a, item 64) further comprising an outwardly facing wall unitarily molded with the inwardly facing wall (figure 6b; the examiner notes this merely describes the structure of a “barrel”), the outwardly facing wall having a volumetric scale (figure 6b, “lines” of item 74) and numeric indicia (figure 6b, “numbers” of item 74) disposed on an indicia display surface (figure 6b) longitudinally coextensive with the elongate cylindrical fluid chamber (figure 6b, item 72) (see 112b interpretation above) so that a full volumetric scale (see 112b interpretation above) and the numeric indicia (figure 6b, item 74) disposed on the indicia display surface are viewable visible in relation to the plunger seal (figure 6b, item 78) as positioned inside the barrel (figure 6a, item 64) (paragraphs [0068], [0069]); and
an imaging device (cellular telephone) (figure 6b, item 20; paragraph [0059]) configured to view and selectively capture, store, or transmit a digital image (via figure 6b, item 102) of the full volumetric scale and the numeric indicia (figure 6b, item 74) disposed on the indicia display surface (figure 6b) in relation to the plunger seal (figure 6b, item 78) as positioned inside the barrel (figure 6a, item 64) when a dosage of the medicinal fluid is drawn into the fluid chamber (figure 6b, item 72) of the barrel (figure 6a, item 64) (paragraphs [0059], [0060], [0068]-[0070]).
Yarger does not specifically disclose the indicia display surface is flat.
However, Shaw teaches a medical syringe (figure 1, item 20) with a flat indicia display surface (figure 1, item 23) (paragraph [0049]).
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 indicia display surface of Yarger, to be flat, as taught by Shaw, in order to provide increased functionality, versatility, and ease of use, by allowing for a means by which mutable indicia might more easily applied to the syringe body, as well as for allowing easier viewing of the indicia surface by a user (Shaw; paragraphs [0003] and [0006]).
[Claims 5-7, 9, and 10] Yarger and Shaw teach the limitations of claim 2, upon which claims 5-7, 9, and 10, depend. In addition, Yarger teaches the imaging device (figure 6b, item 20) is configured by downloading and installing application software (figure 7, item 114) on the imaging device (figure 7; paragraph [0058]); wherein the application software (figure 7, item 114) is configured to determine whether the dosage drawn into the medical syringe (figure 6a, item 18) is within a permissible range of deviations from a predetermined value (paragraph [0058]) and configured to generate (via an alert generation device) ((figure 7, item 110) or (figure 6b, item 104)) an audible, visual, or tactile alert, to notify a user if the fluid dosage drawn into the medical syringe is not correct (figure 6a, item 18) (paragraphs [0058], [0059], [0075]).
[Claim 11] Yarger and Shaw teach the limitations of claim 1, upon which claim 11 depends. Yarger also discloses the medical syringe (figure 6a, item 18) comprises at least one needle safety device (figure 6a, item 65) configured to protect a user or a third party from an accidental needle stick (paragraph [0068]).
[Claims 12 and 13] Yarger and Shaw teach the limitations of claim 11, upon which claims 12 and 13 depend. Yarger does not specifically disclose a mechanism that selectively retracts the hypodermic needle or a safety shield that is forwardly moveable to cover the needle tip.
However, Shaw teaches a medical syringe (figure 1, item 20) comprising a mechanism (figure 11, item 50) which selectively retracts a hypodermic needle (figure 11, item 34) (paragraph [0033]), as well as a safety shield (figure 16, item 232) that is forwardly moveable to cover a needle tip (figures 15 and 16; paragraph [0065]).
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 safety features of Yarger and Shaw, with the use of a needle retraction mechanism and a forwardly moveable safety shield, as taught by Shaw, in order to provide increased functionality, control, and safety, in order to prevent accidental needle sticks, as such safety mechanisms are well known in the art.
[Claims 25 and 26] Yarger teaches the limitations of claim 24, upon which claims 25 and 26, depend. Yarger does not specifically disclose a mechanism that selectively retracts the hypodermic needle or a safety shield that is forwardly moveable to cover the needle tip.
However, Shaw teaches a medical syringe (figure 1, item 20) comprising a mechanism (figure 11, item 50) which selectively retracts a hypodermic needle (figure 11, item 34) (paragraph [0033]), as well as a safety shield (figure 16, item 232) that is forwardly moveable to cover a needle tip (figures 15 and 16; paragraph [0065]).
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 safety features of Yarger, with the use of a needle retraction mechanism and a forwardly moveable safety shield, as taught by Shaw, in order to provide increased functionality, control, and safety, in order to prevent accidental needle sticks, as such safety mechanisms are well known in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5, 11-14, 16-20, and 22-26, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 11-14, and 18-26, of U.S. Patent No. 12,458,761. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 1 of the patent. The difference between claim 1 of the instant application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 1 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
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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/JASON E FLICK/Primary Examiner, Art Unit 3783 11/21/2025