DETAILED ACTION
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 .
Claim 20 is cancelled.
Claims 1-19, 21, and 22 are included in the prosecution.
Claim Objections
Claims 5b and 6b are objected to because of the following informalities:
There are 2 instances of claim 5 and claim 6, therefore the second instance of each of claim 5 and claim 6 will be referred to as claim 5b and claim 6b.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 2, 3, 4, 6, 5b, 6b, 7-11, 17, and 21 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 pre-AIA the applicant regards as the invention.
Regarding claims 2, 4, 6, 5b, 8-11, 17, 21, the phrase "e.g.” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claims 2, 3, 5b, 6b, 7, 8, the phrase “for example” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claims 8 and 10, 11, 17, 21 are indefinite because the claims contain the trademark “EUXYL PE 9010”. Generally, trademarks are not appropriate claim language because the mark identifies the product but not its composition. The composition of trademarked products can change with no notice.
Claims 11, 17, 21 are indefinite because the claims contain the trademark “Transcutol”. Generally, trademarks are not appropriate claim language because the mark identifies the product but not its composition. The composition of trademarked products can change with no notice. Examiner requests applicant ensure all trademarked terms that might remain in the claim set are corrected.
Claims 11, 17, and 21 recite a table. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Appropriate correction is required.
Claim Rejections - 35 USC § 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6, 5b, 6b, 7-19, 21, and 22 are rejected under 35 U.S.C. 103 as being obvious over Goren et al. (US 20160220465 A1) hereinafter Goren in view of Cornelius et al. (US20030007941A1) hereinafter Cornelius.
Regarding claims 1-6, 5b, 6b, 7-19, 21, and 22, Goren is drawn to cosmetically pleasing topical formulations of minoxidil and methods of inducing hair growth (abstract and claims 1-16).
Goren discloses topical compositions for treating hair loss [0001].
Goren discloses formulations of minoxidil or a pharmaceutically acceptable salt thereof (minoxidil) [0005].
Goren discloses the formulations described herein may be used in methods of inducing hair growth or reducing the rate of hair loss of a subject in need thereof, comprising applying a therapeutically effective amount of the formulation at least once daily to the scalp of the subject [0006].
Goren discloses suitable minoxidil salts are a minoxidil acetate, lactate, or citrate salt (first ion is the salt is an alkalinizing agent and second ion of the salt is minoxidil) [0035]. A composition for treating hair loss comprising a salt of minoxidil would inherently induce expression of sulfotransferase in skin of a person.
Goren discloses an adjuvant such as a skin penetrating agent (penetration enhancer) [0048]. Goren discloses the minoxidil is encapsulated in liposomes (encapsulated to modify the water solubility of the composition) [0047].
Goren discloses applying a minoxidil composition at least once daily to a scalp of a subject (applying the composition at a predetermined frequency) [0041]. Goren discloses the minoxidil can be encapsulated in a pharmaceutically acceptable carrier (carrier) [0047]. Goren discloses formulations of minoxidil or a pharmaceutically acceptable salt thereof formulated as a gel (gel) [0005]. Goren discloses cosmetically pleasing topical formulations of minoxidil (abstract) having a non-therapeutic cosmetic purpose (cosmetic product) [0041]. Goren discloses the compositions as a kit containing the composition and a device for administering the composition, such as a spray container or a dropper (kit and a dispenser) [0045].
Goren does not explicitly disclose wherein the alkalinizing agent is placed in a liposome containing lecithin.
However, Cornelius is drawn to methods and compositions for treating hair loss, including arresting and/or reversing hair loss and/or promoting hair growth, in mammals, such as humans, companion animals and livestock, using certain thyromimetic compounds (abstract).
Cornelius discloses the composition comprises agents that stimulate hair growth and/or arrest hair loss which cysteine (inorganic sulfur source) [0292].
Cornelius discloses preferred hair growth stimulants to be added to the compositions, with minoxidil being most preferred [0293].
Cornelius discloses the composition may be administered topically in the form of liposome delivery systems, such as small unilamellar vesicles, large unilamellar vesicles and multilamellar vesicles [0283].
Cornelius discloses the composition can comprise lecithin [0288].
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Goren, wherein the alkalinizing agent is placed in a liposome containing lecithin, as previously disclosed by Cornelius, and arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because both Goren and Cornelius are in the field of compositions for hair growth, comprising liposomes with minoxidil, and Cornelius discloses lecithin [0288] and that the composition may be administered topically in the form of liposome delivery systems [0283], thus combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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