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 .
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.
Claim(s) 27 is/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 27, Applicant recites the limitation “wherein the accelerometer is…” However, no “accelerometer” has been previously introduced in Claim 27 or parent Claim 19. It is unclear if this “accelerometer” is the same or different from the accelerometer introduced in other claims (e.g. Claim 21) or if reference to the “accelerometer” was made in error and the claim was intended to recite a different component positively recited in Claim 19 (e.g. the gyroscope or the “mode sensing arrangement” in general).
Claim Rejections - 35 USC § 102
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) 19-26, 28, 30-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/185516 (“Toporek”).
Regarding Claims 19, 33, and 35, Toporek discloses a system and method of its use comprising:
a data collection apparatus (Abstract) for measuring a dose of medicament, the data collection apparatus comprising:
A gyroscope (21 – Par. 20) configured to detect rotation of a dose dialing component during at least one of a dose dialing operation or a dose dispensing operation (Par. 13, 61, 64, 71); and
A mode sensing arrangement configured to output a second signal indicative of whether the dose dialing operation or the dose dispensing operation is being performed on the drug delivery device (Par. 10, 12, 22); and
A computer device, wherein the computing device is configured to determine the dose based upon the first signal outputted by the gyroscope and the second signal outputted by the mode sensing arrangement (Par. 13, 16, 61, 67).
Regarding Claim 20, Toporek discloses the data collection apparatus is configured to determine the dose based at least in part on the first signal outputted by the gyroscope and the second signal outputted by the mode sensing arrangement (Par. 13, 16, 61, 67).
Regarding Claim 21, Toporek discloses the mode sensing arrangement comprises an accelerometer (Par. 20, 61, 72), and wherein the data collection apparatus is configured to determine the dose based on a first dose determined using the gyroscope and a second dose determined using the accelerometer (Par. 20 – re: the dose size determination is made by the “detector unit” which is integrated as “one or more sensors integrating a gyroscope and at least one accelerometer” whereby the dose size determination is made by the combined signals from the two sensors).
Regarding Claim 22, the accelerometer of Toporek is configured to detect vibrations of the dose dialing component (Par. 61).
Regarding Claim 23, Toporek discloses at least one of the gyroscope or the accelerometer is a microelectromechanical system (MEMS) (Par. 20, 61, 72).
Regarding Claim 24, Toporek discloses the mode sensing arrangement comprises an accelerometer configured to detect vibrations during the dose dialing operation or dose dispensing operation (Par. 12, 22).
Regarding Claims 25 and 36-37, Toporek discloses the data collection apparatus is configured to process a third signal outputted by the accelerometer to distinguish between a first type of vibration and a second type of vibration, wherein the first type of vibration corresponds to the dose dialing operation and the second type of vibration corresponds to the dose dispensing operation (Par. 12, 22).
Regarding Claims 26 and 34, Toporek discloses a communication interface, wherein the data collection apparatus is configured to use the communication interface to transmit data corresponding to the first signal outputted by the gyroscope to a computing device for determining the dose (Par. 27, 67).
Regarding Claims 28 and 38, Toporek discloses the mode sensing arrangement comprises an actuation sensor configured to detect that the dose dispensing operation is being performed. (Par. 29).
Regarding Claim 30, Toporek discloses that the drug delivery device is an injection pen (see Fig.1)
Regarding Claims 31 and 32, Toporek discloses the apparatus may either be contained within the drug delivery device or provided as a supplementary add-on module attachable to the drug delivery device (Par. 25, 26).
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) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/185516 (“Toporek”) as applied above, and further in view of U.S. Publication No. 2018/0207366 (“Marcoz”).
Regarding Claim 27, Toporek discloses the invention substantially as claimed except that that the accelerometer is configured to detect linear translation of the dose dialing component during the dose dispensing operation. Rather, Toporek limits consideration of an accelerometer, expressly, only to use in the first detector for detecting rotational movement. However, Toporek does disclose that the second detector unit may be used to detect “relative axial movement of the button” (Par. 23, 24, 68), i.e. linear translation of the dose dialing component during the dose dispensing operation and that this “second detector” may be “of the same type as the first detector or may be a different type of detector (Par. 21). Marcoz discloses that it is known to use accelerometers to detect relative axial/linear translation/displacement of a dose dialing knob during a dose dispensing operation to identify the administration of a dose of medicament (Par. 34-36, 109). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Toporek to include an accelerometer as part of as second detector unit for the purposes of detecting linear movement of the dose dialing component incident to the initiation of a dose dispensing operation, as disclosed by Marcoz, in order to provide the system with useful identifying signal data which can be used to determine the precise mode and manner in which the device is being used so that the data can collectively be analyzed to determine accurate dosing and dispensing information for categorizing and logging use activity.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/185516 (“Toporek”) as applied above, and further in view of U.S. Publication No. 2011/0270219 (“Friedli”).
Regarding Claim 29, Toporek discloses that the actuation sensor may comprise a “capacitive sensor” (Par. 21) although Toporek fails to specifying exactly how this “capacitive sensor” will be particularly integrated so as to determine actuation data. However, Friedli discloses a drug administration device wherein the administration button comprises a capacitive “touch sensor” to “generate an activation signal” (Par. 11). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the dose dispensing button of the invention of Toporek with a capacitive touch sensor, as disclosed by Friedli, in order to generate an activation signal which provides a determining signal that the button has been pushed and the injection device has been activated so that the second detector can determine that the device is being used to dispense a dose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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, KEVIN SIRMONS can be reached at (571) 272-4965. 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.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/29/2026
Prosecution Insights