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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/1/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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 2-21 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.
In regard to claim 2, the claims are indefinite because it is unclear if the applicant is trying to positively recite the processor of the claim. It appears that the processor is needed to analyze the data of the injection and output the warning so the examiner is interpreting the claims as requiring the processor. It is suggested that the applicant amend the claim accordingly. A possible suggestion is (starting line 7 of claim 2):
“predetermined target location;
a processor; and
one or more sensors coupled to the syringe, the one or more sensors configured to measure data indicative of a position and an orientation of the syringe relative to anatomy of the live patient;
wherein the one or more sensors are configured to be in communication with the processor and output data of the injection to the processor, and
wherein the processor is configured to:
receive and analyze data of the injection; and
output a warning in response to detecting an error in the accuracy of the injection based at least in part on the data of the injection.”
In regard to claim 16, a similar amendment is requested.
The dependent claims are rejected by virtue of their dependency on the rejected independent claims.
Allowable Subject Matter
Claims 2-21 will be considered allowable upon resolution of the 112 rejection above.
The following is an examiner’s statement of reasons for allowance: The closest prior art made of record can be considered to be Baker et al. (US 2016/0367766), Boyden et al. (US 2014/0121637), Hoendervoogt et al. (US 2009/0234302), and Bartlett (US 2011/0202012). These references all fail to disclose the recited injection systems on claim 2 and claim 16 including the recited syringe, sensors, and processor.
Hoendervoogt discloses an orientation device 112 having an accelerometer that measures relative orientation between at least a portion of the implanted medical device and the medical instrument, which includes the syringe 46. Hoendervoogt does not disclose that the orientation device 112 and the processor have information of the relative position or orientation between the IMD and anatomy of the patient.
Bartlett teaches a position sensor 30 wherein the output from sensor 30 can be used to provide user feedback via the user feedback unit 22 to indicate when the desired insertion location has been reached. However, Bartlett does not disclose a sensor that can measure data indicative of a position and an orientation of the syringe relative to anatomy of the live patient and a processer configured to receive and analyze the data of the injection.
Baker discloses an injection system (700; see Figure 7) comprising a syringe (12') with one or more sensors (70 and 79) for providing position and tilt information to an external device (45), wherein the external device can provide warnings to the user (see par. [0072] and [0082]). However, there is no disclosure in Baker that the one or more sensors are configured to measure data indicative of a position and orientation of the syringe relative to anatomy of the live patient. At best it appears that the system provides feedback on the correct angle of the syringe but does not consider anatomy of the live patient.
Boyden discloses an injection system (900) comprising a syringe (935) with one or more sensors (945, 950), in the form of photo-sensors, that send a signal to microprocessor (955) when illuminated by light (915) positioned at the target location. While features of the patient's face are considered by other elements of the system, the photo-sensors are only configured to detect light. They are not disclosed as being configured to measure data indicative of a position and an orientation of the syringe relative to anatomy of the live patient.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 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, Michael Tsai can be reached at 571-270-5246. 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.
THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights