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 64, 65, 67-69 and 72-74 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 regards to claims 64, 65, 67 and 68, the limitations drawn to the impedance or conductivity “is increased” or “is lowered/decreased” are vague. There is no basis of comparison set forth (i.e., increased or decreased compared to what?). Further, the limitations are recited in the passive voice, rendering it unclear whether provision of the nanoparticle increases or decreases impedance or conductance; or whether this is setting forth a new method step (i.e., a step of increasing or decreasing impedance or conductance in addition to providing a nanoparticle, and if so, what that step might entail).
In regards to claim 69, similar to above, the “is altered” language is vague. It is unclear whether this is an additional method step or whether provision of the nanoparticle (of claim 62) alters current density and/or power loss density.
In regards to claims 72 and 73, similar to above, the “is increased” language is vague. It is unclear whether this is an additional method step or whether provision of the nanoparticle (of claim 62) increases the efficacy or magnitude of the current density.
In regards to claim 74, “the increased efficacy” lacks antecedent basis. It appears that this claim should depend from claim 72 instead of claim 73.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 59-61, 70 and 76-78 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Wardak et al. (US 2020/0121728, hereinafter “Wardak”).
In regards to claim 59, Wardak discloses a method of preventing or disrupting mitosis of a pluripotent stem cell (abstract, “eliminating residual pluripotent stem cells”) comprising:
a. exposing the pluripotent stem cell to an alternating electric field for a period of time, the alternating electric field having a frequency and field strength (pars. 0009-0010),
wherein the frequency and field strength of the alternating electric field prevents or disrupts mitosis of the pluripotent stem cells (par. 0047, “eliminating the rapidly dividing pluripotent stem cells”).
In regards to claim 60, the pluripotent stem cell is in a target site of a subject (par. 0014, “the exposing step is performed in vivo”).
In regards to claim 61, the pluripotent stem cell is a fetal stem cell, embryonic stem cell or induced pluripotent stem cell (par. 0014, “the pluripotent stem cells comprise one or more of induced pluripotent stem cells, embryonic stem cells”).
In regards to claim 70, the alternating electric field is a tumor-treating field (pars. 0048-0051, “TTFields”).
In regards to claim 76, preventing or disrupting mitosis prevents or disrupts division of the pluripotent stem cell (par. 0047, “eliminating the rapidly dividing pluripotent stem cells”).
In regards to claim 77, the frequency is 25 kHz to 1 MHz (par. 0010, “a frequency between 50 kHz and 500 kHz”).
In regards to claim 78, the field strength is at least 1 V/cm (par. 0010, “a field strength of at least 1 V/cm”).
Allowable Subject Matter
Claims 62, 63, 66, 71 and 75 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.
Claims 64, 65, 67-69 and 72-74 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: Wardak is the closest prior art. While disclosing exposing pluripotent stem cells to an alternating electric field to prevent or disrupt mitosis of the cells, Wardak does not disclose introducing nanoparticles to the target site of the subject. The general concept of providing nanoparticles to a target site in conjunction with electrical fields is known (see US 2021/0321916 to Kendall et al.), this teaching is drawn to measuring analytes. The references taken alone or in combination with the remaining prior art fail to reasonably suggest introducing nanoparticles to a target site of a subject for the purposes of preventing or disrupting mitosis of a pluripotent stem cell, as required by the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
