DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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.
Claim 16 is 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.
Regarding claim 16:
The claim limitation “wherein the patient” in line 1 of the claim is unclear. It’s not clear what this claim requires since the claim is incomplete. However, for the sake of examination, the office has assumed that the limitation requires a patient.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190091350 A1 to Peyman in view of US 20060210798 A1 to Burda and WO 9627327 A1 to Eggers et al. (Eggers).
Regarding claim 1:
Peyman discloses:
A kit (figure 3) for electrocatalytically treating a tumor or a diseased tissue (58/50), the kit comprising: nanoparticles (¶0030 and ¶0079); a voltage generator (46); and at least one electrode pair consisting of an anode and a cathode (48 and 52; ¶0079), the electrode pair for electrical communication with the voltage generator (see the electrical connection as shown in figure 3 between 46 and 48/52).
Peyman fails to disclose:
Nanoparticles selected from the group consisting of copper-doped titanium dioxide nanoparticles, chromium-doped titanium dioxide nanoparticles, manganese-doped titanium dioxide nanoparticles, cobalt-doped titanium dioxide nanoparticles, nickel-doped titanium dioxide nanoparticles and substantially iron oxide free titanium dioxide nanoparticles;
a voltage generator, which includes a dial for adjusting the voltage and a voltmeter for displaying the voltage.
Burda teaches:
A method for treating cancer (¶0017) that includes nanoparticles including nitrogen-doped titanium dioxide nanoparticles (see ¶0090) and further teaches that the nanoparticles can be doped with transition metals (¶0072) and these transitional members can include ruthenium, rhodium, nickel, palladium, platinum, copper, gold, silver (¶0074).
Eggers teaches:
A method for treating tumors that includes a voltage generators (40) and an electrode (23). The reference further teaches the voltage generator can include a dial (42; page 7, lines 20-25) for adjusting the voltage and a voltmeter/display (45; page 7, lines 25-35).
Regarding the limitation “Nanoparticles selected from the group consisting of copper-doped titanium dioxide nanoparticles, chromium-doped titanium dioxide nanoparticles, manganese-doped titanium dioxide nanoparticles, cobalt-doped titanium dioxide nanoparticles, nickel-doped titanium dioxide nanoparticles and substantially iron oxide free titanium dioxide nanoparticles”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman to replace the nanoparticles in Peyman with the copper-doped titanium dioxide nanoparticles as taught by Burda. This is a simple substitution of one known element (nanoparticles in Peyman) for another (copper-doped titanium dioxide nanoparticles as taught by Burda) to obtain predictable results (to treat cancer or tumor cells).
Regarding the limitation “a voltage generator, which includes a dial for adjusting the voltage and a voltmeter for displaying the voltage”:
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman to add the voltage display and dial for controlling the voltage as taught by Burda in order to control and measure the amount of voltage supplied to the patient (Burda, page 7, lines 25-35).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190091350 A1 to Peyman, US 20060210798 A1 to Burda and WO 9627327 A1 to Eggers et al. (Eggers) as applied to claim 1 above, and further in view of WO 2009120702 A2 to Hadjipanayis et al. (Hadjipanayis).
Regarding claim 2:
Peyman fails to disclose:
The kit of claim 1, wherein the nanoparticles are substantially iron oxide free titanium dioxide nanoparticles.
Hadjipanayis teaches:
A nanoparticle used for treatment of cancer cells (page 4, lines 20-25). The reference further teaches that the oxidation of the nanoparticles reduces detection (page 1, lines 5-10) and a process for producing iron oxide free nanoparticles (page 1, lines 20-25).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman to produce iron oxide free nanoparticles as taught by Hadjipanayis in order to increase the detection of the nanoparticles (Hadjipanayis, page 1, lines 5-10).
Claim(s) 3, 4, 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190091350 A1 to Peyman, US 20060210798 A1 to Burda, WO 9627327 A1 to Eggers et al. (Eggers) and WO 2009120702 A2 to Hadjipanayis et al. (Hadjipanayis) as applied to claim 2 above, and further in view of WO 2018114945 A1 to Meyre et al. (Meyre).
Regarding claim 3:
Peyman, Burda, Eggers and Hadjipanayis fail to disclose:
The kit of claim 2, wherein the voltage generator is configured to provide a voltage of about 3 volts to about 40 volts.
Meyre teaches:
A nanoparticle method that uses a volt generator (DBS; page 3, lines 34-36). Further, the DBS can be operated with 2-5 volts (page 12, line 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman, Burda, Eggers and Hadjipanayis to generate a voltage of 2-5 volts as taught by Meyre to stimulate or activate the nanoparticles (page 12, lines 15-20).
Regarding claim 4:
Peyman, Burda, Eggers and Hadjipanayis fail to disclose:
The kit of claim2, wherein the voltage generator is configured to produce an amperage of about 1 to about 4 milliamps.
Meyre teaches:
A nanoparticle method that uses a volt generator (DBS; page 3, lines 34-36). Further, the DBS can be operated with 0.5-2mA (page 18, line 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman, Burda, Eggers and Hadjipanayis to generate an amperage of 0.5-2 mA as taught by Meyre to stimulate or activate the nanoparticles (page 18, lines 15-20).
Regarding claim 6:
Peyman discloses:
The kit of claim 4, wherein the anode and the cathode are electrode pads (48 and 52).
Regarding claim 7:
Peyman discloses:
The kit of claim 6, further comprising an electrode gel (see gel mentioned in ¶0061).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190091350 A1 to Peyman, US 20060210798 A1 to Burda, WO 9627327 A1 to Eggers et al. (Eggers), WO 2009120702 A2 to Hadjipanayis et al. (Hadjipanayis) and WO 2018114945 A1 to Meyre et al. (Meyre) as applied to claim 4 above, and further in view of US 20140277324 A1 to DiUbaldi et al. (DiUbaldi).
Regarding claim 5:
Peyman, Burda, Eggers, Hadjipanayis and Meyre fail to disclose:
The kit of claim 4, wherein the anode and cathode are ear clips.
DiUbaldi teaches:
A transdermal electrical stimulation located on a head (see figure 3a-3b). The system includes ear clips (300) located on each ear which include and electrodes (325).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman, Burda, Eggers, Hadjipanayis and Meyre to replace the electrodes/anodes and cathodes on the body with ear clips with electrodes (anode and cathodes) as taught by DiUbaldi. This is a simple substitution of one known element (anode and cathodes as pads located on the body as taught by Peyman) for another (anode and cathodes as ear clips located on the ears as taught by DiUbaldi) to obtain predictable results (to pass energy through the body).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190091350 A1 to Peyman, US 20060210798 A1 to Burda, WO 9627327 A1 to Eggers et al. (Eggers), WO 2009120702 A2 to Hadjipanayis et al. (Hadjipanayis), WO 2018114945 A1 to Meyre et al. (Meyre) as applied to claim 4 above, and further in view of US 20140039489 A1 to Davalos et al. (Davalos).
Regarding claim 9:
Peyman, Burda, Eggers, Hadjipanayis and Meyre fail to disclose:
The kit of claim 4, further comprising a potable liquid, an edible gel or an edible cream that includes the nanoparticles.
Davalos teaches:
A method for ablating brain tissue with first and second electrodes (see abstract). Further, the reference makes use of a bioactive agent that can include nanoparticles (¶0020 and ¶0084). The reference further indicates the bioactive agent/nanoparticles can be administered a variety of ways including an inert diluent, or with an assimilable edible carrier, or they may be enclosed in hard or soft shell capsules, or they may be compressed into tablets, or they may be incorporated directly with the food of the diet. For oral therapeutic administration, the bioactive agents may be incorporated with excipients and used in the form of tablets, capsules, elixirs, suspensions, syrups, and the like (¶0088).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peyman, Burda, Eggers, Hadjipanayis and Meyre to administer the nanoparticles either by diluent or potable liquid (elixirs, suspensions, syrups) taught by Davalos in order to get the nanoparticles to the desired location in the body (Davalos, ¶0088).
Regarding claim 10:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 10 by Peyman, Burda, Eggers, Hadjipanayis, Meyre, and Davalos:
The kit of claim 8, further comprising a diluent that includes the nanoparticles (see the nanoparticle/bioactive agent within a diluent as taught by Davalos incorporated into Peyman).
Allowable Subject Matter
Claims 12 and 13 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.
Claim 16 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.
Response to Arguments
Applicant’s arguments, see remarks, filed 12/3/25, with respect to the rejection(s) of claim(s) 1-7 and 9-10 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20190091350 A1 to Peyman in view of US 20060210798 A1 to Burda and WO 9627327 A1 to Eggers et al. (Eggers).
Regarding the 35 USC 103 rejection of claim 12:
The applicant’s amendments to the claims are persuasive and for this reason the previous rejections were withdrawn.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims are persuasive and for this reason the previous rejections were withdrawn.
Conclusion
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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 on (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.
/WESLEY G HARRIS/Examiner, Art Unit 3783