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 .
This action is in response to papers filed 10/07/2025.
Claims 2-8, 11-15, 29-35 are pending. Claims 1, 9-10, 16-28 have been cancelled.
The following rejections are newly applied necessitated by amendment.
The following action is FINAL.
Withdrawn Rejections
The 35 USC 112b, 35 USC 102, and 35 USC 103 rejections made in the previous office action are withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-8, 11-15, 29-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2-8, 15, 32-35 are rejected based upon the new claim of 32. Upon review of the specification for new matter, the specification does not appear to provide support for the recitation of the steps of claim 32. The specification does not appear to teach “one or more soluble biomarkers” collected in the pre or post therapy. In particular although the specification teaches measuring levels of cfDNA (para 30), the specification does not recite “biomarkers” or “soluble biomarkers”.
Claims 11-14 are rejected based upon review of the newly added amendments of “detecting a level of cfDNA molecules that have traversed through the permeabilized barrier into a first blood sample”. The recitation is considered new matter as the specification teaches detection of cfDNA of a first blood sample after uses of ultrasound and microbubbles, however, there is no teaching of only detecting in this sample “a level of cfDNA molecules that have traversed through the permeabilized barrier”. In particular this sample would be all the cfDNA molecules in the blood including but not limited to cfDNA molecules that have traversed.
Claims 29-31 are rejected based upon the new claim of 29. Upon review of the specification for new matter, the specification does not appear to provide support for the recitation of “biomarkers” in claim 29. The specification does not appear to teach “one or more soluble biomarkers” collected in the pre or post therapy. In particular although the specification teaches measuring levels of cfDNA (para 30), the specification does not recite “biomarkers” or “soluble biomarkers”. Further although paragraph 30 teaches mechanical oscillation, the specification does not teach the recitation “causes a relaxation and obtaining of a BBB and/or BTB of the patient and the relaxation and opining enable…..”.
These amendments to the claims, therefore, constitute new matter.
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 2-8, 11-15, 29-35 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.
Claims 2-8, 15, 32-35 are indefinite over “biomarkers secreted by a biological specimen” in claim 32. The claims appear to require determination of levels of a biomarker secreted by a particular biological specimen, however, the claims only require samples of blood. As such the detection would be the biomarker from any location that has been shed into the blood and not a particular specimen. Further, the claims do not requrie3 that the patient recites therapy and as such it is not clear how to performed a post therapy blood sample. The claims require “determining an effectiveness of the first therapy”, however, the patient is not required to be given a first therapy. Furhtermore, the claims only require detection of biomarkers, it is not clear how this detection provided effectiveness of the therapy.
Claims 11-14 are indefinite over the detection steps. The first sample requires detection of a level of cfDNA that have traversed through the permeabilized barrier, however the second and third sample only requires detection of “the level of cfDNA”. As such it is not clear if the claim intends any cfDNA molecule levels or the level of cfDNA molecules that have traversed through the permeabilized barrier. Further, it is not clear if the injection and the ultrasound is performed before each of the sample detection (first, second, third) or if these steps only need to be applied once.
Claims 29-31 are indefinite over the injecting of the fluid in claim 29. The claims require injecting a fluid comprising microbubbles, however, the claims further require localized ultrasound in the brain. The claim is unclear as it appears that any injection site can be used for the fluid, however, it is not clear how a localized ultrasound will interact with microbubbles injected in any region of the patient when the ultrasound and the microbubble injection are simultaneous.
Claim 31 is indefinite. The claims are drawn to a relative increase in biomarker concentration or unvaried or decrease, however, claim 29 does not require a measurement of concentration. Further the recites multiple steps in the wherein clause. It is not clear if the claims are intending to require these steps or if the claim only requires the effective step of “determining an effectiveness”.
Conclusion
No claims are allowed.
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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. 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.
/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682