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
1. Applicant’s election of Group I (claims 1-12) without traverse in the reply filed on 4/28/26 is acknowledged.
2. Claims withdrawn:
Claims 13-16 & 24-27 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
3. Priority
Applicant’s claim for domestic priority under 35 U.S.C. 119(e), filed 3/8/21, is acknowledged.
4. IDS
The IDS filed on 9/7/23 are acknowledged. A signed copy is provided with this Office Action.
5. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
6. Abstract
*This application does not contain an abstract of the disclosure as required by 37 CFR 1.72(b). An abstract on a separate sheet is required.
*The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words [in length since the space provided for the abstract on the computer tape by the printer is limited]. The form and legal phraseology often used in patent claims, such as "means" and "said", should be avoided in the abstract. The abstract should sufficiently describe the disclosure to assist readers in deciding whether there is a need for consulting the full patent text for details. MPEP 608.01(b).
Line 2 of the abstract filed 9/7/23 recite legal phraseology “said” which must be deleted.
¶ 6.20 Trade Names, Trademarks, and Other Marks Used in Commerce
The use of the term [see paragraphs 0056-0057, for example], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trade marks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Examiner Note:
1. Capitalize each letter of the term in the bracket or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
2. Examiners may conduct a search for registered marks by using the Trademark Electronic Search System (TESS) which is available on the USPTO website to determine whether a mark identified in the patent application is a registered mark or not.
The use of the trademarks [0056] A peptide composition was prepared by combining 45.0 milligrams (mg) AC Marine Collagen, 4.5 mg BiPure, 0.9 mg Citric Acid, 0.0072 mg Copper Peptide GHK, 13.5 mg CytoRegulin, 13.5 mg Matrixyl 3000, 4.5 mg Microcare SB, 0.045 mg MiniHA, 13.5 mg Syn-Coll and 26.8 mL water to form 30 g of the peptide composition; have been noted in this application [See also paragraph (0057)] of the published application. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The Examiner suggests capitalizing each letter of the word or including a proper trademark symbol, such as TM or © following the word.
Appropriate correction is required. Applicant's cooperation is requested in correcting any trademark errors of which applicant may become aware in the specification.
7. Therapeutic Composition
Claims 1-12 are rejected under 35 U.S.C. § 112, first paragraph, as the disclosure is enabling only for claims limited to “skincare composition”.
Factors to be considered in determining whether undue experimentation is required, are summarized in re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988) [ Ex parte Forman [230 USPQ 546 (Bd. Pat. App. & Int. 1986)]. The Wands factors are: (a) the quantity of experimentation necessary, (b) the amount of direction or guidance presented, (c) the presence or absence of working example, (d) the nature of the invention, (e) the state of the prior art, (f) the relative skill of those in the art, (g) the predictability or unpredictability of the art, and (h) the breadth of the claim.
It is neither taught nor any data is provided for using “a peptide mixture; collagen; a first polyol; and a second polyol” in therapeutic compositions for the treatment of any of the any type of sensitive skin. There is no evidence presented that “a peptide mixture; comprising collagen; a first polyol; and a second polyol” is associated with any of the known skin disorders or can be treated by administering the peptide mixture. Without such a data or evidence, claims to therapeutic composition comprising any peptide mixture comprising any polyol and collagen, would amount to a composition or potential drug for treatment for any skin disorder or disease, which is not enabled. Given the lack of direction or guidance and the nature of the invention, obtaining such a composition for one of skill in the art would be highly unpredictable. This is because the peptide mixture when associated with a particular sensitive skin disease or disorder would be expressed differentially. Manipulating or controlling these levels depends upon the disease or disorder, and may not always be controlled by supplementing with such a peptide mixture composition. Further, no guidance in provided, pertaining to the fate of the administrated polypeptide in vivo.
Since it is not routine in the art to engage in de novo experimentation to prepare numerous compositions where the expectation "of success is unpredictable", the skilled artisan would require additional guidance, specific to individual sensitive skin disorder or disease, in order to make and use therapeutic compositions in a manner reasonably commensurate with the scope of the claims. Without such guidance, the experimentation left to those skilled in the art is undue.
8. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims.
1. A therapeutic composition for treatment of sensitive skin comprising: a peptide mixture; collagen; a first polyol; and a second polyol.
2. The therapeutic composition of claim 1, wherein the peptide mixture comprises one or more of acetyl heptapeptide 4, azeloyl bis-dipeptide 10, copper peptide, heptapeptide 34, hexapeptide 70, palmitoyl tripeptide 1, palmitoyl tripeptide 5, palmitoyl tetrapeptide 7, trifluoroacetyl tripeptide 2, collagen, and hyaluronic acid.
3. The therapeutic composition of claim 1, wherein the composition comprises: from about 0.3 to 5 weight percentage (% w/w) of the peptide mixture; from about 0.0005 to 0.1% w/w collagen; from about 3 to 35% w/w of the first polyol; and from about 0.3 to 25% w/w of the second polyol, wherein weight percentage is based on a total weight of the composition.
4. The therapeutic composition of claim 1, wherein the composition further comprises a combination of additives.
5. The therapeutic composition of claim 1, wherein the combination of additives is one or more of an extract, a thickening agent, an antimicrobial agent, an anti-foaming agent, a surfactant, an antioxidant a peptide, and a carboxylic acid.
6. The therapeutic composition of claim 1, wherein the combination of additives is one or more of Zea mays oil, retinyl palmitate, chlolecaliferol, Echinacea purpurea extract, Ocimum sanctum extract, dextran, hydroxyethylcellulose, simethicone, polysorbate 20, triethanolamine, aminopropyl ascorbyl phosphate, phenoxylethanol, ethylhexylglycerin, caprylyl glycol, benzyl alcohol, citric acid, salicylic acid and sorbic acid.
7. The therapeutic composition of claim 1, wherein the composition has a pH level ranging from 2.4 to 6.4.
8. The therapeutic composition of claim 1, wherein the composition has a viscosity ranging from 2.0 to 4.0 pascal seconds (Pa.Math.s).
9. The therapeutic composition of claim 1, wherein the composition has a density ranging from 0.93 to 1.09 grams per milliliter (g/mL).
10. The therapeutic composition of claim 1, wherein the sensitive skin comprises the genital area.
11. The therapeutic composition of claim 1, wherein the sensitive skin comprises vulvar tissue.
12. The therapeutic composition of claim 1, wherein the composition increases a collagen level of the sensitive skin.
The claims are described by broad limitations encompassing any therapeutic composition for treatment of sensitive skin comprising: any peptide mixture; any collagen; any first polyol; and any second polyol.
The claimed invention encompasses a genus of peptide mixtures not adequately described.
As per a google search (From Wikipedia) - Polyols may be classified according to their chemistry. Some of these chemistries are polyether, polyester, polycarbonate and also acrylic polyols. Polyether polyols may be further subdivided and classified as polyethylene oxide or polyethylene glycol (PEG), polypropylene glycol (PPG) and polytetrahydrofuran or PTMEG. These have 2, 3 and 4 carbon atoms respectively per oxygen atom in the repeat unit. Polycaprolactone polyols are also commercially available. There is also an increasing trend to use biobased (and hence renewable) polyols. Hence the broad terms – 1st and 2nd polyol(s) as employed in the instant claims remain undescribed.
The instant specification describes “A skincare composition comprising a peptide mixture, wherein the peptide mixture comprises [0056] and was prepared by combining 45.0 milligrams (mg) AC Marine Collagen, 4.5 mg BiPure, 0.9 mg Citric Acid, 0.0072 mg Copper Peptide GHK, 13.5 mg CytoRegulin, 13.5 mg Matrixyl 3000, 4.5 mg Microcare SB, 0.045 mg MiniHA, 13.5 mg Syn-Coll and 26.8 mL water to form 30 g of the peptide composition.
The additional elements added on to the claims are mere hypothetical and without any data, remain undescribed.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
9. 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 & 4-5 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 9408786 B2 (2016).
Instant claims are described above in paragraph 8. US 9408786 B2 (2016) teaches - A composition for the treatment of skin comprises a non-emulsified, aqueous suspension of retinol. The composition may further include at least one protein species, and some proteins used in the composition include collagen and elastin. The composition may also include hyaluronic acid. The composition may also include one or more of tocopheryl acetate, propylene glycol, and linseed extract. Also disclosed are methods for making the composition and use of the composition for the treatment of skin. (See abstract).
US 9408786 B2 teaches A method/composition for the treatment of skin, said method comprising applying to the skin a non-emulsified composition comprising, on a weight basis: 0.99% magnesium aluminum silicate; 8.00% soluble collagen; 2.00% hydrolyzed elastin; 1.00% sodium hyaluronate; 0.98% Linum usitatissimum (linseed) seed extract; 1.00% retinol/polysorbate 20 (50/50 mixture); 0.50% tocopheryl acetate; 0.80% octoxynol-9; 0.30% quatemium-15; 0.90% propylene glycol; 3.00% glycerin; 0.50% xanthan gum; and water; wherein said composition further includes, on a weight basis, at least one or more ancillary agent selected from the group consisting of: coloring agents, fragrances, thickening agents, buffers, and preservatives, wherein 0.90% propylene glycol & 3.00% glycerin being the first and second polyols and collagen being the peptide. (See claims 1-2 for example).
The reference further teaches a composition and a method for the treatment of skin, said method comprising applying to the skin a non-emulsified composition comprising, on a weight basis: 0.99% magnesium aluminum silicate; 8.00% soluble collagen; 2.00% hydrolyzed elastin; 1.00% sodium hyaluronate; 0.98% Linum usitatissimum (linseed) seed extract; 2.00% retinol/polysorbate 20 (50/50 mixture); 0.50% tocopheryl acetate; 0.80% octoxynol-9; 2.50% polysorbate 20; 0.30% quaternium-15; 0.90% propylene glycol; 3.00% glycerin; 0.50% xanthan gum; and water, wherein said composition further includes, on a weight basis, at least one or more ancillary agent selected from the group consisting of coloring agents, fragrances, thickening agents, buffers, and preservatives, wherein 0.90% propylene glycol & 3.00% glycerin being the first and second polyols and collagen being the peptide. (See claims 3-4 for example).
The reference anticipates the claims.
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940
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