DETAILED CORRESPONDENCE
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim set and remarks filed on 12/19/2023 are acknowledged.
Claims 3-5, 7, 10, 12, 16, 19, and 29-36 are cancelled.
Claims 1, 2, 6, 8, 9, 11, 13-15, 17, 18, and 20-28 are pending.
Claim Rejections - 35 USC §102/103
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.
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.
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.
Claims 1, 2, 6, 8, 9, 11, 13-15, 17, 18, and 20-28 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tong (US 2015265570 A1).
Anticipation
Regarding claims 1, 2, 6, 8, 9, 11, 13-15, 17, 18, and 20-28, Tong is drawn to pharmaceutical compositions formulated for transmucosal delivery, and in particular sublingual delivery, comprising at least one tocotrienol or derivative thereof together with one or more pharmaceutically acceptable excipients. The use of said compositions for treating or preventing post exercise muscle soreness, delayed onset muscle soreness, cardiac fibrosis, hypertension, inflammation, stroke, cancer, elevated cholesterol and/or triglycerides, baldness, hypertrophy, conditions resulting from radiation exposure, stabilizing and/or controlling blood glucose levels, and improving exercise endurance and capacity (abstract).
Tong discloses an essential nutrient for the body, vitamin E is made up of four tocotrienols (alpha, beta, gamma, delta) [0002]. Tong discloses administration of tocotrienols by a transmucosal delivery route provides for enhanced bioavailability when compared with orally administered tocotrienols [0023]. Tong discloses a pharmaceutical composition formulated for transmucosal delivery including at least one tocotrienol or derivative thereof together with one or more pharmaceutically acceptable excipients [0024].
Tong discloses method of treating or preventing a disease or condition amenable to treatment with a tocotrienol including transmucosal administration of at least one tocotrienol or derivative thereof [0029]. Tong discloses the disease or condition is selected from the group consisting of: post exercise muscle soreness, delayed onset muscle soreness, cardiac fibrosis, hypertension, inflammation, stroke, cancer, elevated cholesterol and/or triglycerides, baldness, and a condition resulting from radiation exposure [0032]. Tong discloses a method of stabilizing and/or controlling blood glucose levels in an animal including transmucosal administration of least one tocotrienol, or derivative thereof [0035].
Tong discloses the transmucosal pharmaceutical composition is in the form of a tablet, film, wafer, gum, powder, spray, solution or gel [0038].
Tong discloses use of at least one tocotrienol or derivative thereof in the preparation of a medicament for transmucosal administration [0045]. Tong discloses a tablet formulation was prepared containing a dose of 10 mg tocotrienol comprised of the actives: delta-tocotrienol 9 mg, gamma tocotrienol 1 mg; and the following excipients: dextrose, mannitol, marine gelatin, l-leucine, l-arginine, pre-gel starch, PEG-200, propylene glycol, talc, silica dioxide, magnesium stearate, carotenoids [0203].
Obviousness
Tong does not explicitly disclose each of the components of the composition in one single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Tong, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Tong discloses all the required components and Tong discloses pharmaceutical compositions formulated for transmucosal delivery, comprising at least one tocotrienol or derivative thereof together with one or more pharmaceutically acceptable excipients, and use of said compositions for treating or preventing post exercise muscle soreness, delayed onset muscle soreness, stabilizing and/or controlling blood glucose levels, and improving exercise endurance and capacity (abstract). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615