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 10/14/2025 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 § 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) 1-3, 5-10, 13-14 and 17-18 are rejected under 35 U.S.C. 102a1 as being anticipated by Maxwell et al. (US 2009/0177085 A1 – hereafter ‘085).
‘085 (Dayton) a system for using metastable perfluorocarbon nanodroplets for ultrasonic lysis (Abstract) that includes the following limitations for claim 1:
“A testing and observation device”: ‘085 discloses a method for performing non-invasive thrombolysis (Abstract) that is being interpreted as the testing and observation device of the instant application.
“for simulation of traumatic injury testing of laboratory subjects”: It should be noted that preamble statements reciting the purpose or intended use of the invention rather than any distinct definition of any of the claimed invention's limitations is not considered to structurally define the claimed invention over the prior art. See also MPEP 2111.02 II and 2114.
“a test containment adapted for containing a plurality of test subjects”: ‘085 discloses an LDPE tube (Fig. 1; [0019]) that is being interpreted as test containment system that is fully capable of containing a plurality of test subjects.
“an injury inducement medium operable for inducing an injury of similar magnitude to each of a plurality of test subjects in the test containment”: ‘085 discloses a therapy transducer ([0037]; Fig. 1) that supplies ultrasonic waves to the sample where the ultrasonic waves are being interpreted as the injury inducement medium that is fully capable of inducing an injury of a similar magnitude to each of a plurality of test subjects.
“an actuation circuit configured for energizing the injury inducement medium for a predetermined interval selected based on a target injury stimuli directed at each of the plurality of test subjects.”: ‘085 discloses a RF amplifier ([0068]; Fig. 1) that is being the interpreted as the actuation circuit of he instant application that is fully capable of energizing the injury inducement medium.
‘085 discloses the following limitations for claim 13:
“A method for testing and treatment of neurological injury”: a method for performing non-invasive thrombolysis (Abstract) that includes treating blood clots (i.e. a neurological injury if it is in the brain) and for testing the clots ([0065]).
“disposing a plurality of test subjects in a test containment”: ‘085 disclose placing a plurality of clots in the tube (Fig. 1; [0065]).
“providing an injury inducement medium operable for inducing an injury of similar magnitude to each of the plurality of test subjects”: ‘085 discloses applying an injury inducement medium such as ultrasonic waves ([0050]) that would induce an injury. Also, the transducer can operate at the same frequency which reads on the term “similar magnitude”.
“energizing the injury inducement medium for a predetermined interval selected based on a target injury stimuli directed at each of the plurality of test subjects”: ‘085 uses an amplifier (Fig. 1; [0068]) that supplies the stimuli at predetermined intervals directed at the clots.
For claim 2, ‘085 discloses that the ultrasonic waves can be emitted form a phased array ([0037]) which would be a plurality of surfaces.
For claim 3, the tube of ‘085 would have a plurality of surfaces for testing blood clots.
Claim 5 appears to be drawn to the manner in which the claimed device is operated which does not structurally define the claimed invention over the prior art. See MPEP §2114.
For claim 6, the transducer of ‘085 provides sonication energy to the target and does this for a duration and frequency from each emitting surface ([0037]; [0068]).
For claim 7, a plurality of samples are loaded into the tube and the ultrasonic transducer is fully capable of creating a reproducible injury across all of the clots ([0068]; [0065]).
Claim 8 appears to be drawn to the manner of operation of the claimed device which does not structurally define the claimed invention over the prior art. See MPEP §2114.
For claim 9, ‘085 discloses using an ultrasonic imager (Fig. 1; [0054]; i.e. the visualization medium) that renders a reaction observable and includes a video recorder (Fig. 1 ) that records the image.
For claim 10, ‘085 discloses that the RF amplifier and function generator (Fig. 1) have an interface and that the RF amplifier and function generator are fully capable of generating an actuation signal with a duration and a periodic interval ([0068]).
For claim 14, the transducer of ‘085 provides sonication energy to the target and does this for a duration and frequency from each emitting surface ([0037]; [0068]).
For claim 17, the transducer of ‘085 provides sonication energy to the target and does this for a duration and frequency from each emitting surface ([0037]; [0068]). This would be done for the plurality of surfaces in the tube.
For claim 18, ‘085 discloses applying an injury inducement medium such as ultrasonic waves ([0050]) that would induce an injury. Tis would be done in response to the actions by the function generator (Fig. 1).
Therefore, ‘085 meets the limitations of claims 1-3, 5-10, 13, 14, 17 and 18.
Allowable Subject Matter
Claims 4, 11, 12, 15, 16, 19 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: For claim 4, the prior art fails to teach or fairly suggest where the plurality of surfaces include a post array having a plurality of pylons, each pylon responsive to the injury inducement medium for emitting an injury signal.
Claims 11 and 12 would be allowable for the same reasons as claim 4.
For claim 15, the prior art fails to teach or fairly suggest arranging a plurality of surfaces in the test containment for disposing each of the plurality of test subjects within a predetermined distance from a surface of the plurality of surfaces.
Claim 16 would be allowable for the same reasons as claim 15.
For claim 19, the prior art fails to teach or fairly suggest the method that includes introducing a chemical agent for inhibiting the ability of calcium influx channels in the test subjects for mitigating an effect of the injury inducement medium and observing the test results.
Claim 20 would be allowable for the same reasons as claim 19.
The closest prior art is Maxwell et al. (US 2009/0177085 A1) that discloses a method for performing non-invasive thrombolysis, but Maxwell does not teach the limitations of claims 4, 11, 12, 15, 16, 19 and 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dayton et al. (US 2020/0405258 A1) discloses a system for using metastable perfluorocarbon nanodroplets for ultrasonic lysis on a blood vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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 Marcheschi can be reached at 571-272-1374. 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.
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
Prosecution Insights