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.
Claims 1-24 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.
The term “sufficient” in claim 1 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim fails to set forth a minimum threshold to satisfy the sufficient amount condition.
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) 1-3, 17-22, and 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feistel (US 2017/0261510).
Feistel discloses a method of obtaining prostatic cells from a subject comprising: insonating a prostate of the subject with an amount of ultrasonic energy effective to elicit exfoliation of cells into a prostatic duct ([0068]); and collecting one or more body fluids containing at least a portion of said exfoliated cells with a sufficient amount for detecting abnormalities ([0052]; [0069]).
With respect to claim 2, Feistel discloses wherein said collecting comprises collecting one or both of said urine and an ejaculate of the subject ([0052]).
With respect to claim 3, Feistel discloses wherein said collecting comprises collecting said urine over a plurality of collections ([0061]; [0069]).
With respect to claims 17-19, Feistel discloses fragments of epithelia cells ([0022]; [0024]).
With respect to claim 20, Feistel discloses collecting ([0065-0067]).
With respect to claim 21, Feistel discloses comprising promoting prostate secretion by stimulating the prostate ([0068]).
With respect to claim 22, Feistel discloses wherein the stimulating comprises one or more of electroejaculation, prostatic massage, and sexual stimulation ([0033]; [0052]).
With respect to claim 24, Feistel discloses comprising analyzing the sample of the prostatic secretion obtained so as to determine if the sample contains prostatic cancer cells or prostatic dysplasia cells, or is non-pathological ([0036]; [0069-0071]).
With respect to claim 25, Feistel discloses an ultrasound device programmed to isonate a prostate, comprising at least one probe for isonating the prostate, wherein the at least one probe comprises: one or more of a transrectal ultrasound probe, a transperineal ultrasound probe and a ultrasound catheter probe (Fig. 5; 100; [0068]); and a prostate stimulator (Fig. 5; 120; [0068]), wherein the at least one probe is configured to cause exfoliation of one or both cells and tissue fragments from the walls of the prostate follicles ([0068]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 4-5 and 7-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feistel (US 2017/0261510) in view of Angelsen (US 2014/0135681).
With respect to claims 4-5, Feistel discloses the subject matter substantially as claimed except for a high energy mechanical index at a level greater than 0.4. However, Angelsen teaches in the same field of endeavor a MI greater than 0.5 is useful for breakage of particles with drugs encapsulated or dispersed, to release the active drug molecules within the diseased tissue, and also to stimulate transport of particles across biological membranes such as the cell wall ([0022]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Feistel with a MI greater than 0.5 in order to stimulate transport of particles ([0022]).
With respect to claims 14-15, Feistel discloses the subject matter substantially as claimed except for microbubble-containing agent. However, Angelsen teaches in the same field of endeavor administering microbubble-containing agent ([0006]; [0022]; [0078]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Feistel with microbubble-containing agent as taught by Angelsen as substation of one agent for another is well within the skill level of one of ordinary skill in the art.
With respect to claims 7-13, Feistel discloses the subject matter substantially as claimed except for a first and second intensity level. However, Angelsen teaches in the same field of endeavor adjusting MI level based on cavitation level and/or based on tissue temperature ([0035]; [0022]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Feistel with adjustable MI as taught by Angelsen in order to adjust the cavitation level and/or tissue temperature ([0035]) and optimization of ranges is well within the skill level of one of ordinary skill in the art (MPEP 2144.04).
With respect to claim 16, Angelsen discloses wherein the ultrasound energy does not exceed a MI of 1.3 (MI≈0.5; [0078]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feistel (US 2017/0261510) in view of Cioanta et al. (US 2005/0054994).
Feistel discloses the subject matter substantially as claimed except for wherein collecting comprises a catheter. However, Cioanta et al. teaches in the same field of endeavor using a catheter to collect a biosample through the urethra ([0023]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Feistel with a catheter to collect a sample as taught by Cioanta et al. as it is well known to collect a biosample using a catheter inserted through the urethra ([0023]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feistel (US 2017/0261510) in view of Shahar et al. (US 2008/0312538).
Feistel discloses the subject matter substantially as claimed except for promoting urination. However, Shahar et al. teaches in the same field of endeavor instructing the patient to drink lots of fluids so he has a full bladder and a strong urge to urinate ([0009]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Feistel instructing the patient to drink lots of fluids as taught by Shahar et al. as it is well known to promote urination during a procedure ([0009]).
Allowable Subject Matter
Claim 6 is 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: the prior art of record fails to disclose or render obvious the claimed combination of subject matter particularly the combination of parameters of the ultrasound beam: MI in a range between 0.4 and 1.8; beam width in a range between 2 mm and 10 mm; pulse width in a range between 100 ms and 800 ms; and pulse repetition rate in a range between 4 Hz and 20 Hz.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
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, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/ Primary Examiner, Art Unit 3797
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