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.
Claim 49-63 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.
Regarding claim 49 recites “wherein the treatment site is selected from the group consisting of superficial subcutaneous adipose tissue, deep subcutaneous adipose tissue, superficial subcutaneous adipose tissue and deep subcutaneous adipose tissue, visceral adipose tissue, visceral adipose tissue and superficial subcutaneous adipose tissue, visceral adipose tissue and deep subcutaneous adipose tissue, or visceral adipose tissue, superficial subcutaneous adipose tissue and deep subcutaneous adipose tissue” in line 2-5. It is unclear to the examiner which groups are required. The way the claim is constructed makes it hard to clearly understand the group. Claim 50-56 and 62 depend on claim 49 and therefore are rejected.
Regarding claims 57-61 and 63 the phrase “optionally comprises one or more suitable pharmacological agents" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 47-54 and 58-63 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Velis et al. (US 2018/0116868).
Regarding claim 47 and 48, Velis discloses a method for treating subcutaneous brown fat and/or subcutaneous beige fat (abstract) and/or visceral brown fat and/or visceral beige fat (abstract), said method comprising administering an effective amount of a cold solution to a treatment site of a subject, wherein the treatment site is superficial subcutaneous adipose tissue, deep subcutaneous adipose tissue or superficial subcutaneous adipose tissue and deep subcutaneous adipose tissue [0007], and wherein the cold solution comprises (a) liquid water and one or more additives [0047], (b) liquid water, one or more additives, and about 2% to about 70% solid ice particles [0050], or (c) liquid water, one or more additives, and about 71% to about 100% solid particles [0050].
Regarding claim 49, Velis discloses a method for activating brown fat, said method comprising administering an effective amount of a cold solution to a treatment site of a subject in need thereof, wherein the treatment site is selected from the group consisting of superficial subcutaneous adipose tissue, deep subcutaneous adipose tissue, superficial subcutaneous adipose tissue and deep subcutaneous adipose tissue [0007], visceral adipose tissue, visceral adipose tissue and superficial subcutaneous adipose tissue [0006], visceral adipose tissue and deep subcutaneous adipose tissue, or visceral adipose tissue, superficial subcutaneous adipose tissue and deep subcutaneous adipose tissue , wherein the cold solution comprises (a) liquid water and one or more additives, (b) liquid water, one or more additives, and about 2% to about 70% solid ice particles, or (c) liquid water, one or more additives, and about 71% to about 100% solid particles [0050], and wherein the method results in activation of brown adipocytes, proliferation of brown adipocytes, increased volume of brown adipocytes, cryolipolysis of white adipocytes, conversion of white adipocytes into beige or brown adipocytes, conversion of white precursors into beige adipocytes, conversion of beige precursors into beige adipocytes, and/or conversion of brown precursors into brown adipocytes [0105].
Regarding claim 50, Velis discloses the method for treatment of claim 49, further comprising imaging the treatment site of the subject to determine the presence of brown adipocytes, beige adipocytes, white adipocytes, and/or precursors of brown, beige and/or white adipocytes, prior to administering the effective amount of the cold solution ([0104]-[0105]).
Regarding claim 51, Velis discloses the method for treatment of claim 49, further comprising imaging the treatment site, to monitor the activation of brown fat, after administering the effective amount of the cold solution ([0104]-[0105].
Regarding claim 52, Velis discloses the method for treatment of claim 49, wherein the cold solution is administered in a single treatment, or in a series of treatments [0098].
Regarding claim 53, Velis discloses the method for treatment of claim 50, wherein the cold solution is administered in a single treatment, or in a series of treatments [0098].
Regarding claim 54, Velis discloses the method for treatment of claim 49, wherein the cold solution is administered via a device selected from the group consisting of a needle, an expandable needle, a needle comprising more than one tip, a fenestrated needle, a fenestrated cannula, and an implant [0060].
Regarding claim 58, Velis discloses the method of claim 48, further comprising, prior to administering the cold solution, imaging one or more potential treatment sites in the subject to determine the presence of brown adipocytes, and selecting one or more treatment sites which contain brown adipocytes [0104], wherein the cold solution optionally comprises one or more suitable pharmacological agents.
Regarding claim 59, Velis discloses the method of claim 47, further comprising, prior to administering the cold solution, imaging one or more of the superficial subcutaneous adipose tissue, deep subcutaneous adipose tissue or superficial subcutaneous adipose tissue and deep subcutaneous adipose tissue in the subject to visualize sympathetic innervation of adipose tissue, and administering the cold solution into a treatment site with sympathetic innervation, to treat the subcutaneous brown fat and/or subcutaneous beige fat [0104], wherein the cold solution optionally comprises one or more suitable pharmacological agents.
Regarding claim 60, Velis discloses the method of claim 48, further comprising, prior to administering the cold solution, imaging the visceral adipose tissue in the subject to visualize sympathetic innervation of adipose tissue, and administering the cold solution into a treatment site with sympathetic innervation, to treat the subcutaneous brown fat and/or subcutaneous beige fat [0104], wherein the cold solution optionally comprises one or more suitable pharmacological agents.
Regarding claim 61, Velis discloses a method for forming beige adipocytes in a subject, said method comprising: imaging one or more treatment sites of the subject to determine the presence of white precursors [0104], the imaging technics listed are cable of determining the presence of whiter precursors [0104] , administering a cold solution to one or more treatment sites containing white precursors and the surrounding area in order to form beige adipocytes from the white precursors ([0050] and [0104], wherein the cold solution comprises (a) liquid water and one or more additives, (b) liquid water, one or more additives, and about 2% to about 70% solid ice particles, or (c) liquid water, one or more additives, and about 71% to about 100% solid particles, and wherein the cold solution optionally comprises one or more suitable pharmacological agents [0050].
Regarding claim 62, Velis discloses the method of claim 61, wherein the method induces cryolipolysis of white adipocytes [0105].
Regarding claim 63, Velis discloses a system for treating brown adipose tissue, the system comprising: an imaging device, a delivery device for delivering a cold solution to a treatment site of a subject (abstract), and a cold solution supply source configured to supply the cold solution [0104], wherein the cold solution comprises (a) liquid water and one or more additives, (b) liquid water, one or more additives, and about 2% to about 70% solid ice particles [0050], or (c) liquid water, one or more additives, and about 71% to about 100% solid particles [0050], and wherein the cold solution optionally comprises one or more suitable pharmacological agents.
Allowable Subject Matter
Claim 55-57 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.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has failed to find any reference which alone or in any combination would disclose, fairly suggest or make obvious of , prior to administering the cold solution, topically cooling the skin of the subject at or near the treatment site; administering a β3 receptor agonist to the subject; and imaging the treatment site and surrounding area, wherein the cold solution is administered to the treatment site via injection to activate brown adipocytes while also teaching each and every limitation set forth in independent claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-2721213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794