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 .
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.
Claim Objections
Claim 6 is objected to because of the following informalities: “or a combination thereof” in lines 5-6 is superfluous and should be removed since the claim ends in “or any combination thereof”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: “the one additional oxide” should be amended to --the at least one additional oxide--. Appropriate correction is required.
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 1-2, 4-6, 13-22, 24 and 28-31 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.
Claim 1 recites the limitation "the bioceramic composition" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the improved status of the autonomic nervous system". There is insufficient antecedent basis for this limitation in the claim.
Claims 2, 4-6, 13, 15-12, 24 and 28-31 are rejected since they are dependent an indefinite base claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-2, 4-6, 13-22, 24 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Vissman et al. (US 2016/0136452) in view of McEwan (US 2015/0005855).
Regarding claim 1, Vissman discloses a method of improving recovery in a subject (see [0154]-[0176]), comprising contacting an article (see [0114], [0176]) comprising a bioceramic with the subject's body (see [0064]), wherein when heated or exposed to heat, the bioceramic composition provides far infrared thermal radiation to the subject (see [0010]), thereby providing an improvement in recovery in the subject (see [0138]-[0141]). However, Vissman fails to disclose improving recovery in a subject who has undergone and/or is undergoing treatment for cancer.
McEwan teaches a method of improving recovery of a subject who has undergone and/or is undergoing treatment of cancer (see treatment of chemotherapy migraines, [0045]) via applying an article to a subject’s skin that emits far infrared radiation (see [0013]-[0014] and [0027]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of improving a subject’s recovery to include improving recovery in a subject who has undergone and/or is undergoing treatment for cancer in light of McEwan and the treatment of established cancer treatment side effects that the method of Vissman demonstrates, the motivation being to provide the additional advantage of providing relief for cancer treatment symptoms in cancer treatment patients via a non-invasive and non-pharmaceutical manner (see McEwan [0027] and [0036]-[0050]).
Regarding claim 2, Vissman in view of McEwan further teaches wherein the treatment for cancer comprises chemotherapy (see McEwan [0036]); and radiation therapy, immunotherapy, or any combination thereof (the treatment of cancer patients undergoing/that have undergone radiation therapy, immunotherapy, and/or combination therapies is further obvious under the same obviousness rationale as applied above in the rejection of claim 1).
Regarding claim 4, Vissman further discloses wherein the article comprising the bioceramic contacts skin of the subject (see [0114] and [0176]).
Regarding claim 5, Vissman in view of McEwan further teaches wherein the improvement comprises an improved quality of life (see Vissman [0138]), reduced fatigue (see Vissman [0138], Fig. 14), improved balance (see Vissman [0261]), improved hydration (see McEwan [0015]), an increase in total plasma antioxidants (see Vissman [0318]-[0320]), improved quality of sleep (see Vissman [0487], Fig. 15), improved status of the autonomic nervous system (see Vissman [0138], [0487]), or any combination thereof.
Regarding claim 6, Vissman further discloses wherein the improvement comprises (b) improved balance as measured by baropodometry analysis (see [0259] and [0261]); (d) an increase in total plasma antioxidants ([0318]-[0320]); (e) improved quality of sleep as measured by the Pittsburgh Quality of Sleep Index (see [0408], [0487]); (f) improved quality of life as measured using the World Health Organization Quality of Life Questionnaire; or any combination thereof (see [0408], [0487]).
Regarding claim 13, Vissman further discloses wherein the improvement comprises a reduced heart rate variability (HRV) (see [0484] and [0523], Fig. 40).
Regarding claim 14, Vissman further discloses wherein the improvement comprises an improved status of the autonomic nervous system that comprises decreased markers of sympathetic activity, increased markers of parasympathetic activity, or both (see [0138], [0487]).
Regarding claim 15, Vissman further discloses wherein the bioceramic comprises kaolinite and tourmaline (see [0092]).
Regarding claim 16, Vissman further discloses wherein the bioceramic comprises from about 20 wt % to about 80 wt % kaolinite and from about 1 wt % to about 30 wt % tourmaline (see [0011]).
Regarding claim 17, Vissman further discloses wherein the bioceramic comprises at least one additional oxide (see [0092]).
Regarding claim 18, Vissman further discloses wherein the at least one additional oxide comprises from about 1 to 20 wt % of the bioceramic (see [0011]).
Regarding claim 19, Vissman further discloses wherein the one additional oxide is selected from the group consisting of aluminum oxide, silicon dioxide, titanium dioxide, magnesium oxide, and zirconium dioxide (see [0092]).
Regarding claim 20, Vissman further discloses wherein the bioceramic composition comprises from about 40 wt % to about 60 wt % kaolinite to about 5 wt % to about 15 wt % tourmaline to about 15 wt % to about 25 wt % aluminum oxide to about 10 wt % to about 20 wt % silicon dioxide; and from about 1 wt % to about 20 wt % titanium dioxide; provided that the total amounts are by total weight of the composition (see claim 5).
Regarding claim 21, Vissman further discloses wherein the bioceramic composition comprises from about 40 wt % to about 60 wt % kaolinite to about 5 wt % to about 15 wt % tourmaline to about 15 wt % to about 25 wt % aluminum oxide to about 10 wt % to about 20 wt % silicon dioxide (see claim 5); provided that the total amounts are by total weight of the composition. Vissman fails to specifically disclose the bioceramic comprising from about 1 wt % to about 20 wt % magnesium oxide, however Vissman further discloses the proportion of minerals and oxides in a bioceramic composition can optionally be altered depending on a number of variables, including, for example, the amount of thermal radiation, more specifically far infrared radiation, to be emitted, the disease or condition to be treated, the mode of administration, the requirements of the individual subject, the severity of the disease or condition being treated, or the judgment of a practitioner (see [0102]), therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the 1 wt % to about 20 wt % titanium dioxide as disclosed with 1 wt % to about 20 wt % of magnesium oxide in light of Vissman, the motivation being to achieve the desired amount of thermal radiation, condition to be treated, or requirements of the individual subject.
Regarding claim 22, Vissman further discloses wherein the bioceramic composition comprises from about 40 wt % to about 60 wt % kaolinite to about 5 wt % to about 15 wt % tourmaline to about 15 wt % to about 25 wt % aluminum oxide to about 10 wt % to about 20 wt % silicon dioxide; and from about 1 wt % to about 20 wt % zirconium dioxide; provided that the total amounts are by total weight of the composition (see [0161]-[0166]).
Regarding claim 24, Vissman further discloses wherein the article comprises clothing or bedding (see [0135]).
Regarding claim 28, Vissman further discloses wherein the article comprising the bioceramic is applied to the body of the subject for at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours, or at least 8 hours (see [0146]).
Regarding claim 29, Vissman further discloses wherein the article comprising the bioceramic is applied to the body of the subject daily, wherein the article comprising the bioceramic is applied to the body of the subject for at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours, or at least 8 hours each day (see [0146], [0339], [0410], [0467], [0490]).
Regarding claim 30, Vissman further discloses wherein the article comprising the bioceramic is applied to the body of the subject daily over a period of time of at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 5 weeks, or at least 6 weeks (see [0146], [0339], [0410], [0467], [0490]).
Regarding claim 31, Vissman further discloses wherein the article comprising the bioceramic is applied to the body of the subject daily, wherein the article comprising the bioceramic is applied to the body of the subject for at most 1 hour, at most 2 hours, at most 3 hours, at most 4 hours, at most 5 hours, at most 6 hours, at most 7 hours, or at most 8 hours each day (see [0146], [0339], [0410], [0467], [0490]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794