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 .
DETAILED ACTION
Claim Rejections 35 USC 112(A)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for dissolving matrikine peptides, does not reasonably provide enablement for dissolving any active agent with which it is combined. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(1) The breadth of the claims; (2) The nature of the invention; (3) The state of the prior art; (4) The level of one of ordinary skill; (5) The level of predictability in the art; (6) The amount of direction provided by the inventor; (7) The existence of working examples; and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (reversing the PTO's determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement). In Wands, the court noted that there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The Court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known." 858 F.2d at 740, 8 USPQ2d at 1406. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention." Id., 8 USPQ2d at 1407.
(1) The nature of the invention and (5) The breadth of the claims:
The invention is drawn to a composition and method that uses any dimethyl silane with any monosaccharide ether to dissolve any active agent. This includes any active agent, which includes any chemical compound with some biological effect, as this is not defined in the specification with a limiting definition.
(2) The state of the prior art:
The art recognizes that not every active agent will be soluble in any solvent. The differences in peptide structure vs. small molecules, macromolecules without peptide bonds, and any other “active agent,” is known to have various reactions, and not every combination will penetrate skin or dissolve with the two claimed agents. The closest to a definition of “active agent” in the specification are the described embodiments: “The biologically active agent may be a vitamin, an antibiotic, a steroid, an immunosuppressant (e.g., a macrolide), a glycosaminoglycan (e.g., hyaluronic acid), a phenol (e.g., salicylic acid or hydroquinone), a peroxide, urea, lactic acid, or a peptide.” This does not provide any guidance for active agents that are not Palmitoyl-GHK, Pal-GPKG, Pal-LSDV.
The term “active agent” can include many insoluble agents, which have various factors that are beyond the scope of what is disclosed. There are more barriers to solubility than simply adding one of the two genera of solvents to any active agent, with no other claimed parameters, such as pH,. Hydrophilicity, ionization, types of formulations and administrations, among others (Acta Pharm Sin B. 2015 Aug 24;5(5):442–453). These parameters are integral to determining solubility, which is not established by the specification for any other active agent than lipo-matrikines.
(3) The relative skill of those in the art:
The relative skill of those in the art is high.
(4) The predictability or unpredictability of the art:
Applicant’s claims are based on predicting that the two broad classes of solvents, dimethyl silanes and monosaccharide ethers, will impart solubility, and from the disclosure of the specification, this implies skin penetration, as can be shown for Pal-GHK with the known solvent glycerol along with either of the claimed solvents. There is nothing in the specification to show that all peptides, let alone all active agents will be soluble in either of these alone, and nothing to show that active agents that are not already water-soluble will be more so with the addition of either claimed solvent. This renders the claims highly unpredictable, as there is nothing to limit the agent by chemical properties, structure, or use, for claims 1-12, and the methods of claims 13 and 14 are not clear as to what would be expected from the many combinations of active agents that may or may not be soluble with either claimed solvent.
(6) The amount of direction or guidance presented and (7) The presence or absence of working examples:
Applicant’s specification concludes that Methyl gluceth-20, bis-PEG-18 methyl ether and dimethyl silane produced theoretical increases in the amount of Pal-LSDV and Pal-GPKG delivered into the epidermis, yet the claims are drawn to any active agent being dissolved and deliverable to skin when combined with any dimethyl silane or monosaccharide ether. There is one ex vivo example to confirm two computer models, which only show support for the lipo-matrikine, Pal-GHK, and also require the main solvent to be glycerin and butylene glycol, which are not claimed. This does not enable the solubility with any active agent and the two claimed classes of possible solvents.
(8) The quantity of experimentation necessary:
Because it is uncertain to predict the many “active agents” that could be combined in a formulation with any dimethyl silane or monosaccharide ether, one of ordinary skill in the art would be burdened with undue “painstaking experimentation study” to determine how to use the claimed invention in a manner that can dissolve the agent, regardless of physical properties, how to deliver this broadly to skin or how to use the claimed solvent to create a homogenous formulation that has a practical use.
As such, the scope of active agents and the claimed solvents is not enabled.
Claim Rejections 35 USC 102(A)(1)
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(s) 1-14 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Yuerui Biotechnology (CN112120994A; hereinafter “Yuerui”).
Yuerui teaches a cosmetic composition comprising methyl glucitol polyether, glycerol polyether, 1, 2-pentanediol, bis-PEG-18 methyl ether dimethyl silane, 0.1-0.3% of the functional active substances, comprising mango extract, oligopeptide-1, biological carbohydrate gum-1, palmitoyl tripeptide-5 and crocus sativus extract (Abstract; Claim 1).
This meets the limitations of other agents, which are broadly construed to include any agent, as described above. As to the “which dissolve the biologically active agent,” this function is inherent to the claimed solvents themselves, as the composition contains the same components claimed. The MPEP states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id.
As such, a composition of an active agent with the same solvents will inherently behave in the same manner, absent any evidence to the contrary. The claimed composition is for the same use for skin rejuvenation in the same type of homogenous liquid mixture, with the same components. Claims 3, and 6-8 are met because this reference teaches that methyl gluceth-20 is used as a moisturizing agent, which adsorbs and retains moisture and maintains the skin barrier function while maintaining skin moisture (p. 3 of translation). Instant claims 2 and 4 are met because this reference teaches bis-PEG-18 methyl ether. Claims 9-12 are met because this reference teaches lipo-matrikines as active agents, including palmitoyl tripeptide-5. Claim 13 is met because the matrikine solvent mixture is applied to the skin (page 3, para. 2; example 3). Finally, claim 14 is met because claim it simply states “dissolving,” as the active step with no additional steps. As such, any method of combining these components in the same composition meets this limitation. Furthermore, claims 5-10 of Yuerui teach a method of preparing a homogenized mixture by stirring the components together (p. 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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