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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e)/120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/199210 and 16/588947, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application fails to disclose a biological fluid specimen collector. As such, claims 1-9 and 17-18 are examined with a filing date of 12/14/2021.
Response to Amendment
This office action is responsive to the amendments filed on October 30, 2025 and February 10, 2026. As directed by the amendment: claims 1 and 10 have been amended and claims 19-20 been added. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, filed February 10, 2026, with respect to the rejection(s) of claim(s) 1 and 10 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive, specifically in regards to the Chen and Hagen references not teaching or disclosing the newly added claim limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
With regards to the rejection to claim 1 using Shippert. The examiner notes that the “proximal end” is not defined in the claim. As such, it is the examiner’s opinion that Shippert is capable of being used in a 102(a)(1) rejection to the newly amended claim. However, for the sake of compact prosecution, the term “proximal” is interpreted to mean the end of the injector closest to the cartridge nest. Applicant is advised to further define the term “proximal” and/or “distal” in the claim.
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 4 and 5 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.
Regarding claim 4, the claim recites “a flexible application injector” in line 1. It is unclear if this injector is the same injector as recited in claim 1 or a different. For examination purposes, the injector of claim 4 is the same injector as recited in claim 1.
Claim 5 is also rejected by virtue of being dependent on claim 4.
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.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makower (US 20050245906).
Regarding claim 1, Makower discloses a secure device for delivering medications (fig. 2A), the device comprising:
a syringe body (see below);
a cartridge nest (see below; the examiner notes that absent any further structural or functional limitations, the luer tip of the syringe is equated to the “cartridge nest”);
an injector (tube 20 in fig. 2);
a plunger actuator (see below); and
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a biological fluid specimen collector attached to the injector at a proximal end of the injector (porous matrix 20 in fig. 2a is shown to extend along the entire length of the tube 20 so as to be attached to a proximal end of the tube 20; the porous matrix 20 is functionally capable of collecting biological fluid, for example, by injecting the biological fluid through the syringe and into the porous matrix).
Regarding claim 2, Makower discloses the biological fluid specimen collector is a nasal fluid specimen collector (the porous matrix 20 is capable of collecting nasal fluid).
Regarding claim 3, Makower discloses the biological fluid specimen collector is adapted for at least one of nasopharyngeal and oropharyngeal sampling (the porous matrix is capable of sampling fluid from either region).
Regarding claim 4, Makower discloses a flexible application injector (tube 20 in fig. 2a; paragraph 85 discloses that the tube can be made from porous silicone rubber so as to be flexible) extending from an application tip of the cartridge nest (needle of syringe in fig. 2a), and wherein the biological fluid specimen collector is an absorbent material located at least partially around the application injector (paragraph 85 discloses matrix 24 can be made from cotton).
Regarding claim 6, Makower discloses the biological fluid specimen collector is adapted for removal from the device and transported to a laboratory for analysis (the matrix 24 is removable from the syringe by removing the needle from the device 12a).
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.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower, as applied to claims 1 and 4 above, and further in view of Pinczower (US 6306084).
Regarding claim 5, Makower discloses the absorbent material is a cotton swab (paragraph 85 discloses the matrix 20 is made from “cotton wadding” and is thus capable of acting as a swab). However, Makower does not explicitly teach or disclose the cotton swab is sterile.
Pinczower is directed towards a device which comprises a sterile cotton applicator (9:11-19) configured to be inserted into a nasal passage (fig. 10). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the absorbent cotton swab of Shippert to be sterile, as taught by Pinczower, to ensure bacteria or other germs do not enter the nasal passage during treatment.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower, as applied to claim 1 above, and further in view of Hagen (US 20180279918).
Regarding claim 7, Makower discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose an integrated electronics subassembly configured for collecting vital signs information.
As discussed above, Hagen teaches an integrated electronics subassembly configured for collecting vital signs information (housing unit 105 in fig. 2; paragraph 43 discloses the unit includes temperature sensors for collecting patient temperature data) which is connectable/usable with a syringe (paragraph 62). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Makower to include the integrated electronics subassembly configured for collecting vital signs information of Hagen for the purpose of evaluating patient skin temperature before administration of the pharmaceutical to obtain a baseline temperature reading.
Regarding claim 8, in the modified device of Makower, Hagen discloses the electronics subassembly comprises a temperature sensor for taking a patient's temperature (temperature sensors 115 in fig. 2).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower in view of Hagen, as applied to claims 1, 7, and 8 above, and further in view of Castellano (US 6156008).
Regarding claim 9, modified Makower teaches all of the claimed limitations set forth in claims 1, 7, and 8, as discussed above, but does not teach or disclose the temperature sensor is an infrared proximity temperature sensor.
Castellano is directed towards a device (fig. 1) having a temperature sensor (temperature sensor 202 in fig. 5) which is configured to measure the temperature of skin and is an infrared proximity temperature sensor (5:66-6:17). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the temperature sensor of modified Makower to be an infrared proximity temperatures sensor, as taught by Castellano, since Castellano teaches that these types of sensors are quicker and more accurate (6:10-15).
Claim(s) 10-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ulrich (GB 2534469) in view of Hagen (US 20180279918).
Regarding claim 10, Ulrich discloses a secure device for delivering medications, the device (fig. 1) comprising:
a syringe body (see below);
a cartridge nest (see below);
a plunger actuator (piston rod 14 in fig. 1); and
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an the integrated electronics subassembly including a first extendable and retractable locking portion and a second extendable and retractable locking portion which extend and retract in the same direction relative to one another (locking pin 122 and spring 123 in fig. 2A work together to lock the position of the piston rod; figs. 2A and 2B shows the portions 122/123 extending/retracting in the same direction).
However, Ulrich does not teach or disclose the integrated electronics subassembly configured for collecting vital signs.
Hagen teaches a device (unit 105 in fig. 2) usable with a syringe (paragraph 62) and comprising an integrated electronics subassembly configured for collecting vital signs (paragraph 43 discloses fingertip temperature sensors 115 which can be used to monitor the temperature of a user’s skin before or during administration).
Since Ulrich teaches that the device is actuated by placing a user’s fingers on the plunger-actuating means (15 in fig. 1; pg. 8, lines 21-24), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Ulrich to have the fingertip temperature sensors of Hagen (115 in fig. 2) on the plunger-actuating means on Ulrich (15 in fig. 1). Hagen teaches these sensors are useful in monitoring a temperature of a patient’s skin before, during, and/or after pharmaceutical injection to evaluate efficacy and any potential side effects.
Regarding claim 11, modified Ulrich teaches all of the claimed limitations set forth in claim 10, as discussed above, but does not teach or disclose the electronics subassembly is adapted for interfacing with a peripheral sensor capable to detect and transmit the patient vital signs information data.
Hagen teaches the electronics subassembly is adapted for interfacing with a peripheral sensor capable to detect and transmit the patient vital signs information data (paragraph 61 discloses that data can be detected and wirelessly transmitted to a “variety of memory storage and data processing devices”).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Ulrich so that the electronics subassembly is adapted for interfacing with a peripheral sensor capable to detect and transmit the patient vital signs information data, as taught by Hagen, in order to evaluate more general patient trends (paragraph 61).
Regarding claim 12, in the modified device of Ulrich, Hagen discloses the peripheral sensor is included in a wearable device (paragraph 61 discloses transmitting to a watch).
Regarding claim 13, modified Ulrich teaches all of the claimed limitations set forth in claim 10, as discussed above, but does not teach or disclose the electronics subassembly is adapted for notifying at least one of a patient, healthcare provider and administrator when at least one vital sign parameter meets a predetermined threshold.
Hagen teaches the electronics subassembly is adapted for notifying at least one of a patient, healthcare provider and administrator when at least one vital sign parameter meets a predetermined threshold (paragraph 86 discloses an alarm when a user’s biometrics are outside a certain usage range).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Ulrich so that the electronics subassembly is adapted for notifying at least one of a patient, healthcare provider and administrator when at least one vital sign parameter meets a predetermined threshold, as taught by Hagen, to improve patient safety.
Regarding claim 14, in the modified device of Ulrich, Hagen discloses the electronics subassembly comprises a temperature sensor for taking a patient's temperature (temperature sensors 115 in fig. 2).
Regarding claim 16, modified Ulrich teaches all of the claimed limitations set forth in claim 10, as discussed above, but does not teach or disclose the electronics subassembly is configured for transmitting a patient's collected vital signs information to a database for storage.
Hagen teaches the electronics subassembly is configured for transmitting a patient's collected vital signs information to a database for storage (paragraph 61 discloses uploading biometric data to a variety of memory storage devices).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of modified Ulrich so that the electronics subassembly is configured for transmitting a patient's collected vital signs information to a database for storage, as taught by Hagen, in order to evaluate more general patient trends (paragraph 61).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ulrich in view of Hagen, as applied to claims 10 and 14 above, and further in view of Castellano.
Regarding claim 15, modified Ulrich teaches all of the claimed limitations set forth in claims 10 and 14, as discussed above, but does not teach or disclose the temperature sensor is an infrared proximity temperature sensor.
Castellano is directed towards a device (fig. 1) having a temperature sensor (temperature sensor 202 in fig. 5) which is configured to measure the temperature of skin and is an infrared proximity temperature sensor (5:66-6:17). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the temperature sensor of Hagen to be an infrared proximity temperatures sensor, as taught by Castellano, since Castellano teaches that these types of sensors are quicker and more accurate (6:10-15).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ulrich in view of Hagen, as applied to claim 10 above, and further in view of Zelten (US 853525).
Regarding claim 17, Hagen discloses all of the claimed limitations set forth in claim 10, as discussed above, but does not teach or disclose a biological fluid specimen collector.
Zelten teaches a syringe (syringe 20 in fig. 5) which comprises a biological fluid specimen collector (the entirety of invention 10 in fig. 3 is equated to the “specimen collector” absent any further structural limitations regarding the collector). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Hagen to include the biological fluid specimen collector of Zelten attached to the syringe of Hagen. This modification would able the biological fluid specimen collector to stop bleeding after an injection (4:63-65).
Regarding claim 18, in the modified device of Ulrich, Zelten discloses the biological fluid specimen collector is a nasal fluid specimen collector (the device 10 is capable of collecting nasal fluid).
Regarding claim 19, in the modified device of Ulrich, Ulrich discloses an injector (needle 11 in fig. 1).
Regarding claim 20, in the modified device of Ulrich, Zelten discloses the biological fluid specimen collector is attached to the injector at a proximal end of the injector (fig. 1 shows a portion of device 10 attached to a needle 60 at a proximal end of the needle).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM 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, 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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/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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