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 .
Response to Amendment
The examiner acknowledges the reply filed on 11/24/2025 in which claims 16, 17, 19, 22, 27, 30, and 33-35, were amended. Claims 24 and 25 are cancelled. New claims 36 and 37 have been added. Currently, claims 16-23 and 26-37 are pending for examination in this application.
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 29, 30, 32, 34, and 35, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Despa et al. (PGPub 2016/0213853).
[Claims 29, 34, and 35] Despa teaches a system and method comprising:
determining of at least one of a size of a dose or of an operational status of a handheld injection device (figure 1b, item 100) (paragraphs [0060], [0064]), the handheld injection device (figure 1b, item 100) comprising a click noise generator (“click-wheel”; dose dial mechanism; figure 1a, item 104) configured to generate a mechanical vibration or an acoustic noise during operation of the handheld injection device (paragraph [0025]), the method comprising:
attaching a wearable electronic device (figure 1a, item 110) to one of a wrist, a hand, or an arm, of a user (this limitation would be met by the user holding the injection device in hand),
bringing the handheld injection device (figure 1b, item 100) in mechanical contact with the body of the user (again, this limitation would be met by the user holding the injection device in hand),
detecting at least one of a mechanical vibration or an acoustic noise caused or generated by the click noise generator (“click-wheel”; dose dial mechanism; figure 1a, item 104) by at least a first sensor (figure 2, item 212) of the wearable electronic device (figure 1a, item 110) (paragraph [0052]), and
determining or deriving at least one of a size of a dose and an operational status of the handheld injection device (figure 1b, item 100) based on signals obtained from the at least first sensor (figure 2, item 212) in response to the detection of mechanical vibration or acoustic noise (paragraphs [0060], [0064]),
wherein the wearable electronic device (figure 1a, item 110) comprises a housing (figure 1b, main body of 110 (not labeled)), a processor (figure 2, item 205) arranged inside the housing (paragraph [0050]), and at least the first sensor (figure 2, item 212) connected to the processor (figure 2, item 205) (paragraph [0050]) and configured to detect the at least one of the mechanical vibration or the acoustic noise (paragraph [0052]).
[Claims 30 and 32] Despa teaches the limitations of claim 29, upon which claims 30 and 32 depend. In addition, Despa discloses the wearable electronic device (figure 1a, item 110) comprises a wristband (figure 1b, item 114) fixedly attached to the housing (figure 1b) and configured to attach the housing to the portion of the body of the user (again, this limitation would be met by the user holding the injection device in hand) (paragraphs [0044], [0045]).
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 31 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Despa et al. (PGPub 2016/0213853), in view of Arrington et al. (USPN 11,311,232).
[Claims 31 and 33] Despa teaches the limitations of claim 30, upon which claims 31 and 33 depend. Despa does not specifically disclose the wearable electronic device (figure 1a, item 110) is implemented as a bracelet.
However, Arrington teaches an apparatus and method comprising a wearable electronic device (figure 7b, item 700) that is implemented as a bracelet (column 3, lines 53-58), having a wristband (figure 7b, item 708) that is wrapped around a portion of a body of the user (figure 7c).
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 Despa, to utilize the structure of a bracelet, as taught by Arrington, in order to provide increased functionality and versatility, by allowing for a means by which the detection device could be used with multiple injection devices without requiring attachment to multiple structures.
Allowable Subject Matter
Claims 16-23, 26-28, and 36-37, are allowed over the prior art of record as amended by the applicant on 11/24/2025.
The following is an examiner’s statement of reasons for allowance: The claims in this application have been allowed because the prior art of record fails to disclose or render obvious the structure recited in independent claim 16.
The closest prior art of record is Despa et al. (PGPub 2016/0213853); and Arrington et al. (USPN 11,311,232).
The claims in this application have been allowed because the closest prior art of record fails to teach among all the limitations or render obvious a structure comprising a wearable electronic device comprising:
a housing,
a processor arranged inside the housing, and
at least a first sensor connected to the processor and configured to detect at least one of a mechanical vibration or an acoustic noise caused or generated by a click noise generator of a handheld injection device.
Specifically, regarding independent claim 16, the prior art to Despa and Arrington, either alone or in combination, fails to disclose or render obvious the specific structural and/or functional features, as claimed;
wherein the at least first sensor is capable to detect or to measure at least one of:
i) a vibration of a skin of a user caused or generated by the click noise generator and
ii) a sound wave caused or generated by the click noise generator and
transmitted through a portion of a body of a user when the handheld injection device is in mechanical contact with the user while operated.
Response to Arguments
Applicant's representative’s arguments, filed 11/24/2025, with regards to claims 29-35, have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s representative’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
Regarding independent claims 29 and 35, applicant’s representative asserts the claimed “first sensor element” is not taught by the prior art due to the fact that the sensor element taught by Despa is not “capable of detecting: a vibration of a skin of a user caused or generated by the click noise generator and a sound wave caused or generated by the click noise generator and transmitted through a portion of a body of a user.” Although these arguments are convincing relative to the amended claim language of independent claim 16, the amended functionality of the sensor has not been incorporated into the independent claims 29 and 35. Thus, applicant’s representative’s arguments, relative to independent claims 29 and 35, are not reflective of the currently recited claim limitations and are found to be unconvincing.
In response to applicant's argument that Arrington is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Applicant’s representative’s arguments relative to the field of endeavor of each piece of art is overly narrowed in view. Both Despa and Arrington are directed toward therapeutic treatments; thus, are found within the same field of endeavor. Given this, applicant’s representative’s arguments are unconvincing.
In light of the remarks and standing rejection above, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 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.
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.
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.
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/27/2026