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 Status
Claims 1-16 are pending and presently considered as filed 3/25/2024.
Election/Restrictions
An election/restriction requirement has not been set forth on record at this time. However, Applicant is directed to MPEP §§ 818, 818.02(a), 819, and 821.
Allowable subject matter has been identified (see section entitled “Allowable Subject Matter”, below), namely compositions consisting of SEQ ID NO: 1.
Claims 1-16 are considered below.
Priority
Priority to PCT/KR2022/014518 (filed 9/28/2022) is acknowledged.
Examiner notes that no certified translation of the Foreign Application KR10-2021-0130814 (filed 10/01/2021) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Information Disclosure Statement
The IDS filed 3/25/2024; 6/10/2025; and 4/14/2026 are each acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope and presently recites:
1. A peptide having the activity of preventing hair loss or promoting hair growth, comprising an amino acid sequence of SEQ ID NO: 1.
Accordingly, claim 1 is directed to a product, namely a peptide “comprising an amino acid sequence of SEQ ID NO: 1” (i.e., “GCGLFVAAC”)
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Claim 1 recite the phrase “comprising an amino acid sequence of SEQ ID NO: 1”. The usage of the indefinite article "an" rather than the definite article "the" impacts the pending claims scope as discussed below. Applicant is advised that the phrase
"A biopolymer comprising a sequence of SEQ ID NO: 1"
encompasses biopolymers comprising the full-length SEQ ID NO: 1 and also any subsequence of 2 or more units within SEQ ID NO: 1. However, the phrase
"A biopolymer comprising the sequence of SEQ ID NO: 1"
encompasses only biopolymers comprising the full-length of SEQ ID NO: 1. If the language is changed to closed, replacing "comprising” with “consisting of”, then the first example above would encompass any biopolymer sequence of two or more units fully contained within SEQ ID NO: 1, whereas the second example would be limited to the exact biopolymer as specified by SEQ ID NO: 1, and nothing more or less. If qualifying language is present (i.e., polynucleotide", "protein", "polypeptide", "oligopeptide", etc.), then the specification is consulted to determine whether or not an explicit definition is provided that imposes a lower limit on the size or composition of biopolymer encompassed by the qualifying terminology. For purposes of examining and interpreting the instant claim scope, Examiner notes that the originally filed disclosure describes a “peptide” as “two or more amino acids linked by a peptide bond” (see, e.g., Spec. filed 3/25/2024 at ¶[18]), wherein “[t]he peptide may include a variant peptide having a different sequence due to deletion… of amino acid residues” (see, e.g., Spec. filed 3/25/2024 at ¶[20]), and may have “20 or less” amino acids (see, e.g., Spec. filed 3/25/2024 at ¶[21]). Accordingly, the pending claims are reasonably understood to include any subsequence structures comprising any peptide subsequence of “two or more amino acids linked by a peptide bond” within SEQ ID NO: 1 (e.g., “GCGLFVAAC”, “CGLFVAAC”; “GCGLFVAA”; “GCGLFVA”; “GC”; “LF”; etc., etc.) that satisfies the intended use of “having the activity of preventing hair loss or promoting hair growth” as required by instant claim 1. If Applicant meant to claim sequences sharing or consisting of the consensus motif of “GCGLFVAAC”, then Applicant should amend the claims to recite “…comprising the amino acid sequence of SEQ ID NO: 1”, “…comprising SEQ ID NO: 1”, “…consisting of the amino acid sequence of SEQ ID NO: 1”, or “consisting of SEQ ID NO: 1”.
At claim 1, the phrase “having the activity of preventing hair loss or promoting hair growth” is understood to be a preamble reciting a functional limitation, wherein the
…term “prevention” means reducing the risk of developing a disease or disorder, and it refers to all actions that suppress or delay the onset of a disease by keeping it from progressing the development of one or more clinical symptoms of the disease in subjects who are easily exposed to or susceptible to the disease but do not yet have the disease or not show symptoms of the disease.
(see, e.g., Spec. filed 3/25/2024 at ¶[43]);
Or
The prevention or improvement of hair loss may be removing the cause of hair loss or suppressing the progression of hair loss, or may be promoting hair growth by suppressing hair loss or promoting hair formation
(see, e.g., Spec. filed 3/25/2024 at ¶[43]);
And the
….term "treatment" means alleviating a disease or disorder, and includes all actions that improve or beneficially change the symptoms of a disease by arresting or reducing the progression of the disease or one or more clinical symptoms thereof
(see, e.g., Spec. filed 3/25/2024 at ¶[44]).
Because “treatment” is defined to include “all actions that improve or beneficially change the symptoms of a disease”, “treatment” is understood to fully encompass “prevention” (see, e.g., Spec. filed 3/25/2024 at ¶¶[43]-[44]). This is pertinent because “treatment” and “prevention” explicitly include “actions” such as “suppress or delay the onset” of hair loss in “subjects who are easily exposed to or susceptible to” “hair loss due to burns and/or trauma”, among other things (see, e.g., Spec. filed 3/25/2024 at ¶¶[43]-[44], [46]). It is unclear how burns or trauma can be prevented suppressed or delayed. Accordingly, it is prima facie unclear if the phrase “having the activity of preventing hair loss or promoting hair growth” in the preamble of claim 1 and “for preventing hair loss or promoting hair growth” at claim 3-16, are non-limiting recitations of intended and expected results fully satisfied by all compounds that satisfy the positively recited structural limitations of instant claim 1 (see, e.g., MPEP § 2111.04(I), § 2111.03(II), e.g., including structures comprising a subsequence of SEQ ID NO: 1, such as Ala-Cys); or if such phrases are functional limitations corresponding to a structure/function relationship satisfied by some but not all compounds that satisfy the positively recited structural limitations of instant claim 1. This issue has been addressed under 35 USC § 112(b), below. For purposes of applying prior art, it is noted that zero structure/function guidance of any functional sequences lacking 100% sequence identity to instant SEQ ID NO: 1 appears to have been disclosed on record (see, e.g., Spec. filed 3/25/2024 at ¶¶[72]-[114], Figs. 1-7, noting that only a single peptide consisting of instant SEQ ID NO: 1, and lacking any modifications, was actually tested and shown to have any activity at all; but zero species had been tested and shown, in vivo, to actually “prevent hair loss or promote hair growth” as presently claimed). Therefore, the phrases at issue are not reasonably interpreted as functional limitations since there is no structure/function relationship disclosed on record commensurate in scope with the claim scope. Accordingly, unless otherwise stated, such preambles are treated as non-limiting recitations of a hoped-for and desired result satisfied by all structures that satisfy the structurally complete and positively recited limitations set forth within the body of instant claim 1 (e.g., all sequences and subsequences “comprising an amino acid sequence of SEQ ID NO: 1”, including sequences comprising dipeptide subsequences such as “Ala-Cys”).
Dependent claims 2 and 5-11 only appear to differ from the claims from which they depend by “wherein” clauses:
…wherein the peptide promotes the proliferation or activity of cells related to hair formation. (see, e.g., instant claim 2);
….wherein the composition induces the formation of hair by promoting the activity of one or more cells selected from the group consisting of dermal papilla cells, outer root sheath cells and germinal matrix cells. (see, e.g., instant claim 5);
….wherein the composition induces one or more phosphorylation selected from the group consisting of AKT and ERK in dermal papilla cells. (see, e.g., instant claim 6);
….wherein the composition induces the activation of β-catenin in dermal papilla cells. (see, e.g., instant claim 7);
….wherein the composition promotes one or more expressions selected from the group consisting of LEF-1 and cyclin Dl in dermal papilla cells. (see, e.g., instant claim 8);
….wherein the composition inhibits the expression of DKK-1 protein in dermal papilla cells. (see, e.g., instant claim 9);
….wherein the composition promotes one or more expressions selected from the group consisting of Ha3-II, Keratin 5, Keratin 14 and Keratin 19 in outer root sheath cells. (see, e.g., instant claim 10); and
….wherein the composition promotes the expression of MSX2 in germinal matrix cells. (see, e.g., instant claim 11);
Currently claims 2 and 5-11 appear to recite a method step in a product claim (e.g., see active step verbs such as “promotes”, “induces”, “induces”, “induces”, “promotes”, “inhibits”, “promotes” and “promotes” at claims 2 and 5-11, respectively), which render the claims indefinite (see, e.g., MPEP § 2173.05(p) and rejections under 35 USC 112(b), set forth below). However, to facilitate compact prosecution, it is noted that such “wherein” clauses may be subsequently amended to recite that the peptide (or composition thereof), is “capable of” either promoting, inducing or inhibiting such outcomes set forth in the “wherein” clauses –Applicant is advised that such potential amendments would raise additional issues under 35 USC §§112(a)/(b) as it would be necessary to consider if such limitations were non-limiting per MPEP § 2111.04(I) or otherwise further limiting functional limitations. However, as noted above, zero structure/function guidance of any functional sequences lacking 100% sequence identity to instant SEQ ID NO: 1 appears to have been disclosed on record (see, e.g., Spec. filed 3/25/2024 at ¶¶[72]-[114], Figs. 1-7, noting that only a single peptide consisting of instant SEQ ID NO: 1, and lacking any modifications, was actually tested and shown to have any activity at all; but zero species had been tested and shown, in vivo, to actually “prevent hair loss or promote hair growth” as presently claimed). Accordingly, such “wherein” clauses, even if amended to avoid a rejection under MPEP § 2173.05(p), would be objected to as substantial duplicates of the claims upon which they depend (see, e.g., MPEP § 608.01(m) and Form Paragraphs 7.05.05 and 7.05.06 set forth therein, discussing substantial duplicate claims).
A “composition”, a “pharmaceutical composition”, and a “cosmetic composition” are understood to differ as follows: The term “composition” broadly encompasses both “pharmaceutical compositions” and “cosmetic compositions”. Pharmaceutical compositions are understood to be formulated with pharmaceutically acceptable excipients, carriers, and manufactured in unit dosage forms (see, e.g., Spec. filed 3/25/2024 at ¶¶[48]-[53]), which may be administered topically or externally, but need not be so limited. Cosmetic compositions are understood to be formulated for external application, and may comprise adjuvants utilized in cosmetic or dermatological fields, including fats, fragrances, dyes, etc. (see, e.g., Spec. filed 3/25/2024 at ¶¶[60]-[63]).
“Cleansing foam” is understood to be a “foam” suitable for use in “cleansing” processes (e.g., hair or face washing), which is understood to be a cosmetic composition capable of foaming, wherein the foam must be suitable for cleansing.
“Cleansing water” is undefined on record, and it is unclear how “cleansing” modifies “water”. Water is an art-recognized solvent, and therefore “water” is necessarily “cleansing”. Accordingly, the term has been rejected as indefinite as it is unclear how “cleansing water” differs from “water”.
Additional claim interpretations are set forth below.
Claim Objections
Claim 16 is objected to because of the following informalities:
At claim 16, the term “Surfactant-containing cleansing” appears to be missing a noun (e.g., “product”) following the adjective “cleansing”. This is presumed to be a typographical error, but it is unclear if the proper noun is, for example, “product”, foam, gel, shampoo, conditioner, etc., etc.
Examiner notes that instant claims 2 and 5-11 differ from the claim from which they depend by a “wherein” clause. Examiner is advised that, following amendments removing indefinite language (see rejections below), that such claims may be subsequently objected to as substantial duplicates of the claims upon which they depend (see, e.g., MPEP § 608.01(m) and Form Paragraphs 7.05.05 and 7.05.06 set forth therein, discussing substantial duplicate claims), in the absence of clarification of how such language materially differentiates the structures of claims 2 and 5-11 from the structures of claims 1 and 3, respectively1.
Appropriate correction is required.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-16 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.
Claim 1 recites the preamble phrase “having the activity of preventing hair loss or promoting hair growth”, and claims 3-16 recite the “for preventing hair loss or promoting hair growth”, which renders the claims indefinite because it is unclear if such phrases are
Non-limiting recitations of intended and expected results, which are fully satisfied by all compounds that satisfy the positively recited structural limitations of instant claim 1 (e.g., if the preamble is satisfied by any and all sequences and subsequences “comprising an amino acid sequence of SEQ ID NO: 1”, wherein such language includes sequences comprising substructures of instant SEQ ID NO: 1, such as Ala-Cys2) (see, e.g., MPEP § 2111.04(I), § 2111.03(II)); or
A functional limitation that excludes some, but not all structures or subsequences “comprising an amino acid sequence of SEQ ID NO: 1” (e.g., if the preamble is satisfied by some but not all sequences and subsequences “comprising an amino acid sequence of SEQ ID NO: 1”, then sequences comprising, for example, only the subsequence of Ala-Cys may be excluded from the pending claim scope as lacking a requisite structure/function relationship required to satisfy the functional limitation).
Both interpretations are reasonable in view of the Specification, which explicitly discloses length variants, percent homology variants, chemical modification variants, and variants having groups attached to the N- and/or C-terminus (see, e.g., Spec. filed 3/25/2024 at ¶¶[20]-[21], [23]), and presumably many such variants are encompassed by the pending claim scope, because the usage of “an” rather than “the” is understood to potentially encompass numerous potential peptides comprising subsequences of instant SEQ ID NO: 1, such as “Ala-Cys” moieties3. Assuming for purposes of the instant rejection under 35 USC §112(b) that these phrases are functional limitations, the claim scope would be indefinite per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what compounds do or do not infringe upon the scope of claims 1 and 3-16. Although it is reasonably assumed that all claims are satisfied by a peptide consisting of SEQ ID NO: 1, the claim scope is not so limited4, which raises the material concern regarding the metes and bounds of the pending claim scope because it is unclear what minimal structure is required to achieve the functional limitation. Critically, zero structure/function guidance of any functional sequences lacking 100% sequence identity to instant SEQ ID NO: 1 or not consisting of instant SEQ ID NO: 1, appears to have been disclosed on record (see, e.g., Spec. filed 3/25/2024 at ¶¶[72]-[114], Figs. 1-7, noting that only a single peptide consisting of instant SEQ ID NO: 1, and lacking any modifications, was actually tested and shown to have any activity at all); however, zero species were tested and shown, in vivo, to actually “prevent hair loss or promote hair growth” as presently claimed. Furthermore, close prior art exists (the examples below are not exhaustive):
US2014/0309157A1 claims methods of promoting hair growth and production by administering SEQ ID NO: 2 (see, e.g., US’157 at claims 1, 4-6, 16, 22, and SEQ ID NO: 2); critically, SEQ ID NO: 2 of US’157 comprises a dipeptide subsequence of instant SEQ ID NO: 1, namely “Cys-Gly” (compare instant SEQ ID NO: 1 with US’157 at SEQ ID NO: 2).
US2019/0092821A1 claims peptides having an activity to stimulate hair production and hair follicle growth (see, e.g., US’821 at claims 1-8, 16-17, and SEQ ID NO: 1); critically, SEQ ID NO: 1 of US’821 comprises a dipeptide subsequence of instant SEQ ID NO: 1, namely “Ala-Cys” (compare instant SEQ ID NO: 1 with US’821 at SEQ ID NO: 1).
Accordingly, close prior art exists, and it is unclear if the functional limitations at issue do or do not exclude such close prior art since such prior art sequences comprise subsequences of instant SEQ ID NO: 1. Notably, the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Accordingly, because (i) it is unclear if the phrases at issue (e.g., “having the activity of preventing hair loss or promoting hair growth” at claim 1, and “for preventing hair loss or promoting hair growth” at claims 3-16) are limiting or non-limiting; and (ii) it is unclear, if the phrases are interpreted as functional limitations, what structures do or do not satisfy the functional limitations, an artisan would be unable to identify infringing from non-infringing compounds, claims 1 and 3-16 are rejected as indefinite.
Instant claims 2 and 5-11 are rendered indefinite because they currently recite “wherein” clauses within a product claim that include active method steps:
…wherein the peptide promotes the proliferation or activity of cells related to hair formation. (see, e.g., instant claim 2);
….wherein the composition induces the formation of hair by promoting the activity of one or more cells selected from the group consisting of dermal papilla cells, outer root sheath cells and germinal matrix cells. (see, e.g., instant claim 5);
….wherein the composition induces one or more phosphorylation selected from the group consisting of AKT and ERK in dermal papilla cells. (see, e.g., instant claim 6);
….wherein the composition induces the activation of β-catenin in dermal papilla cells. (see, e.g., instant claim 7);
….wherein the composition promotes one or more expressions selected from the group consisting of LEF-1 and cyclin Dl in dermal papilla cells. (see, e.g., instant claim 8);
….wherein the composition inhibits the expression of DKK-1 protein in dermal papilla cells. (see, e.g., instant claim 9);
….wherein the composition promotes one or more expressions selected from the group consisting of Ha3-II, Keratin 5, Keratin 14 and Keratin 19 in outer root sheath cells. (see, e.g., instant claim 10); and
….wherein the composition promotes the expression of MSX2 in germinal matrix cells. (see, e.g., instant claim 11);
Specifically, claims 2 and 5-11 appear to recite active method steps within a product claim (e.g., the claims recite “promotes”, “induces”, or “inhibits”), which render the claims indefinite per MPEP § 2173.05(p). The usage of an active method step within a product claim renders the claim scope indefinite because it is unclear when infringement occurs—before, during, or after the completion of the method step. Accordingly, claims 2 and 5-11 are rejected as indefinite. For purposes of applying prior art, the “wherein” clauses at claims 2 and 5-11 have been interpreted as non-limiting recitations of hoped-for and desired results that the peptides of instant claim 1 are all “capable of” achieving (e.g., “capable of promoting…”, “capable of inducing..”, or “capable of inhibiting…”) (see, e.g., MPEP § 2111.04(I)), and are therefore rejected for the reasons applicable to instant claim 1 and 35.
Claim 16 recites “cleansing water”, which is not defined on record, and “cleansing” appears to be utilized only as a relative term which renders the claim indefinite. The term “cleansing” and “cleansing water” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Water is an art-recognized solvent and therefore water can be used to remove water-soluble dirt. It is unclear how the addition of the adjective “cleansing” modifies “water” with respect to pH, temperature, solutes, etc., and no guidance is provided in the originally filed disclosure, which renders the claim scope indefinite. Applicant may overcome this rejection by amending claim 16 to remove “cleansing water”, presumably without altering the claim scope (i.e., claim 16 already recites all “solutions”, “suspensions”, “emulsions”, etc.).
Claim 16 recites “surfactant-containing cleansing”, which is not a noun, but an adjectival phrase, which therefore raises indefiniteness issues because it is unclear what specific noun the adjectival phrase is attempting to describe (e.g., it is unclear if the claim scope is directed to a “surfactant-containing cleansing foam”, “surfactant-containing cleansing product”, “surfactant-containing cleansing shampoo”, “surfactant-containing cleansing gel”, “surfactant-containing cleansing ointment”, etc.). Accordingly, the claim is indefinite by omission of the noun being described, and therefore it is unclear how an artisan could avoid infringement.
Claims 2-16 depend directly or indirectly from an indefinite base claim, and fail to reconcile the indefiniteness of the base claim; accordingly, claims 2-16 are rejected as indefinite for the reasons applied to the claim(s) upon which they depend.
Claims 1-16 are rejected as indefinite.
Claim Rejections - 35 USC § 112(a), Written Description
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 1-16 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Brief Statement of the Issue(s)
The issue is that the claims appear to recite functional limitations, but none of the recited functional limitations correspond to any clear structure/function relationship of record that reasonably permits artisans to identify or distinguish, a priori, claimed structures that can actually achieve the required functionality.
Claim Scope
Claim 1 is an independent claim, and is representative of the pending claims scope. The applicable claim interpretation has been set forth above in a separate section and in preceding rejections, and those interpretations are incorporated herein.
At claim 1, the phrase “comprising an amino acid sequence of SEQ ID NO: 1” has been interpreted in view of the usage of “an” to encompass any subsequence of two or more amino acids within instant SEQ ID NO: 1, which means that the instant claim scope may ostensibly include infinite numbers of products lacking any common structural motifs6 (e.g., note that “Ala-Ala”, “Leu-Phe”, “Gly-Cys-Gly”, etc., lack any common structural motif). Therefore, the claims may potentially read upon millions, billions, or trillions of different products, including length variants, percent homology variants, chemical modification variants, and variants having groups attached to the N- and/or C-terminus (see, e.g., Spec. filed 3/25/2024 at ¶¶[20]-[21], [23]), as well as any prior art peptide sequences comprising a common subsequence present within instant claim 1. Accordingly, the claim scope reasonably appears to be vast and highly varied.
Critically, the vast genus of >>billions of potential products is understood to be subject to functional limitations (e.g., claim 1 recites the preamble phrase “having the activity of preventing hair loss or promoting hair growth”, claims 3-16 recite the “for preventing hair loss or promoting hair growth”, and claims 2 and 5-11 recite “wherein” clauses presumably identifying a functional outcome a claimed structure must be able to achieve). However, none of these functional limitations correspond to any disclosed structure/function relationships of record or otherwise known in the prior art. Therefore, it is prima facie unclear if all compounds and subsequences within the scope of instant claim 1 satisfy the pending claims and functional limitations, or if perhaps only one or even zero species satisfy the functional limitations.
Actual Reduction to Practice
Zero examples of any peptide “preventing” or “treating” hair loss was disclosed on record, as zero in vivo tests showing statistically or practically significant results in any in vivo system were actually tested. It is pertinent to note that the
…term “prevention” means reducing the risk of developing a disease or disorder, and it refers to all actions that suppress or delay the onset of a disease by keeping it from progressing the development of one or more clinical symptoms of the disease in subjects who are easily exposed to or susceptible to the disease but do not yet have the disease or not show symptoms of the disease.
(see, e.g., Spec. filed 3/25/2024 at ¶[43]);
and
The prevention or improvement of hair loss may be removing the cause of hair loss or suppressing the progression of hair loss, or may be promoting hair growth by suppressing hair loss or promoting hair formation
(see, e.g., Spec. filed 3/25/2024 at ¶[43]);
And the
….term "treatment" means alleviating a disease or disorder, and includes all actions that improve or beneficially change the symptoms of a disease by arresting or reducing the progression of the disease or one or more clinical symptoms thereof
(see, e.g., Spec. filed 3/25/2024 at ¶[44]).
Accordingly, because “treatment” is defined to include “all actions that improve or beneficially change the symptoms of a disease”, “treatment” is understood to fully encompass “prevention” (see, e.g., Spec. filed 3/25/2024 at ¶¶[43]-[44]). This is pertinent because zero examples of record test or analyze “clinical symptoms”, “development of disease or disorder”, “removing the cause of hair loss”, etc. as hair is never directly assayed in vivo.
At best, the proffered data tests and shows that a single peptide, consisting of SEQ ID NO: 1, is capable of producing specific mRNA and protein level changes in an in vitro system:
(i) permitting proliferation, in vitro, of hair follicle dermal papilla cells (HHFDPC), after culturing for 72 hours and treatment with MTT solution and DMSO, wherein the change in proliferation in the specific system utilized is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[87]-[90], Fig. 1);
(ii) permitting increased expression of phosphorylated forms of AKT and ERK, in vitro, in hair follicle dermal papilla cells (HHFDPC), by western blotting using an unknown antibody of unknown specificity, wherein samples were assayed after 24 hours and cell washes, wherein the change in protein levels in the specific system utilized is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[91]-[94], Fig. 2);
(iii) permitting “activation” of β-catenin, in vitro, in hair follicle dermal papilla cells (HHFDPC), by western blotting and nuclear isolation, wherein samples were assayed after 24 hours and cell washes, wherein the change in protein levels in the specific system utilized relative to a positive control is not shown on record, and wherein the change in protein levels is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[95]-[96], Fig. 3);
(iv) permitting increased expression of LEF-1 and cyclin D1, presumably caused by activation of β-catenin, in vitro, in hair follicle dermal papilla cells (HHFDPC), by PCR (not QPCR), wherein samples were assayed after 24 hours and cell washes, wherein the change in mRNA levels in the specific system utilized relative to a positive control is not shown on record, and wherein the change in mRNA levels is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[97]-[98], Fig. 4);
(v) permitting inhibition of DKK-1 protein (dickkopf-related protein 1), in vitro, in hair follicle dermal papilla cells (HHFDPC) treated with dihydrotestosterone (DHT) and cultured in MSC complete media, assayed by western blotting, wherein the change in DKK-1 protein levels in the specific system utilized is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[100]-[103], Fig. 5); in addition, Figure 5 oddly appears to show that SEQ ID NO: 1 at higher concentrations showed increased DKK1 more similar to a negative control (see, e.g., instant Fig. 5 at 1 µM sample relative to 0.01µM and “NC” negative control), which raises concerns regarding experimental statistical and practical significance;
(vi) permitting increased expression of mRNAs of Ha3-II, Keratin 5, Keratin 14, and Keratin 19, in vitro, in human hair outer root sheath cells (HHORSC) grown in MSC complete media, assayed by PCR (not QPCR), wherein the proffered difference in expression levels of each mRNA is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[104]-[108], Fig. 6); in addition, Figure 6 oddly appears to show non-linear relationships between mRNA levels and SEQ ID NO: 1 concentrations (see, e.g., instant Fig. 6 at HA3-II showing no apparent difference among tested concentrations; see also Fig. 6 at Keratin 19, wherein the 0.1 µM sample is substantially brighter than either the 0.01 or 1 µM samples);
(vii) permitting increased expression of MSX2 mRNA, in vitro, in human hair germinal matrix cells (HHGMC) grown in MSC complete media subsequently replaced with serum free MSC media, assayed by PCR (not QPCR), wherein the proffered difference in expression levels of MSX2 mRNA is of unknown statistical and practical significance to the in vivo activity of “preventing hair loss or promoting hair growth” as claimed (see, e.g., Spec. filed 3/25/2024 at ¶¶[105]-[113], Fig. 7).
Accordingly, although a single peptide consisting of SEQ ID NO: 1, when administered to HHGMC, HHORSC, or HHFDPC cells, in vitro, was identified as being able to increase the expression of MSX2 mRNA, Ha3-II mRNA, Keratin 5 mRNA, Keratin 14 mRNA, Keratin 19 mRNA, phosphorylated form of AKT, phosphorylated from of ERK, activate β-catenin, and to inhibit DKK-1 protein levels to some extent, such proffered data is not equivalent or synonymous in scope with “preventing hair loss or promoting hair growth” as claimed, because “preventing hair loss or promoting hair growth” is explicitly defined as capable of treating alopecia and hair loss due to “hair loss due to burns and/or trauma”, among other things (see, e.g., Spec. filed 3/25/2024 at ¶¶[43]-[44], [46]).
Zero reduction to practice of “treating or preventing” hair loss due to hormonal imbalances (e.g., androgenic alopecia, hypothyroidism, hyperthyroidism), autoimmune disorders (e.g., alopecia areata, Lupus Erythematous), infection (e.g., tenia capitis, trichobacteriosis, syphilis, folliculitis), stress (e.g., telogen effluvium, anagen effluvium, traction alopecia), or scarring (e.g., burns, scarring alopecia or cicatricial alopecia), using any peptide at any concentration in any art-recognized model system for such hair loss, was tested at all.
In sum, although limited data pertaining to in vitro activity of a single peptide consisting of instant SEQ ID NO: 1 was provided, zero experimental data actually showing any sequence capable of “preventing hair loss or promoting hair growth” as presently claimed was reduced to practice and established with statistical or practical significance.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In this case, the claims encompass an essentially infinite number of peptides and products containing such peptides, but the originally filed disclosure provides zero embodiments reduced to practice that are actually capable of “preventing hair loss or promoting hair growth” as claimed; zero embodiments were reduced to practice showing “treating or preventing” hair loss due to hormonal imbalances (e.g., androgenic alopecia, hypothyroidism, hyperthyroidism); zero embodiments were reduced to practice showing “treating or preventing” hair loss due to autoimmune disorders (e.g., alopecia areata, Lupus Erythematous); zero embodiments were reduced to practice showing “treating or preventing” hair loss due to infection (e.g., tenia capitis, trichobacteriosis, syphilis, folliculitis); zero embodiments were reduced to practice showing “treating or preventing” hair loss due to stress (e.g., telogen effluvium, anagen effluvium, traction alopecia); zero embodiments were reduced to practice showing “treating or preventing” hair loss due to or scarring (e.g., burns, scarring alopecia or cicatricial alopecia).
Even assuming arguendo and in the light most favorable to the applicant that such limited in vitro data is pertinent to the claimed functionality, such data would at best apply only to the single embodiment consisting of instant SEQ ID NO: 1, as no structure/function relationship is provided on record, and zero evidence that peptides differing by even a single residue or charge retain activity has been placed on record.
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of two species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of one or zero functional embodiments of the claimed invention does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Identifying characteristics of the genus
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
The instant disclosure provides broad generalities of a genus of hoped-for and desired structures capable of achieving the desired functionalities at instant claims 1-16, including descriptions of length variants, percent homology variants, chemical modification variants, and variants having groups attached to the N- and/or C-terminus (see, e.g., Spec. filed 3/25/2024 at ¶¶[20]-[21], [23]). Zero such variants, other than the single compound consisting of SEQ ID NO: 1 were tested or reduced to practice in any way, or otherwise shown to be active.
Although the record provides limited in vitro data pertaining to the expression of some mRNAs and proteins following in vitro administration of the single peptide of SEQ ID NO: 1 (see, e.g., Spec. filed 3/25/2024 at ¶¶[87]-[113], Figs. 1-7), the disclosure provides zero explanation why an artisan would reasonably extend such limited data to any other species lacking 100% sequence identity with instant SEQ ID NO: 1 and lacking the same sequence composition, charge profile, and length, because zero structure/function relationships corresponding to any functional limitations set forth in the pending claims were actually explicitly addressed and identified on record. Therefore, an artisan would be unable to meaningfully identify and extrapolate any minimal shared consensus structure, charge, peptide length, etc. required to achieve the claimed functional limitations recited in the pending claims.
Accordingly, the functional limitations of the pending claims is reasonably understood to be utilized as a vague attempt to capture unknown and undisclosed structures, sufficient to achieve some functional result that Applicant hopes and desires that the disclosed invention is able to achieve. However, the disclosure but does not meaningfully disclose an unambiguous structure/function relationship permitting an artisan to identify, a priori, which exact structures do or do not satisfy the functional limitations at issue.
No underlying mechanism of action is identified that requires a minimal binding consensus sequence, secondary or tertiary structure, charger profile, etc., etc.
Accordingly, basic identifying characteristics pertinent to the claimed genus are left unanswered, including “which compounds can actually ‘prevent or treat’ hair loss as claimed, such as hair loss caused by hormonal imbalances (e.g., androgenic alopecia, hypothyroidism, hyperthyroidism), autoimmune disorders (e.g., alopecia areata, Lupus Erythematous), infection (e.g., tenia capitis, trichobacteriosis, syphilis, folliculitis), stress (e.g., telogen effluvium, anagen effluvium, traction alopecia), or scarring (e.g., burns, scarring alopecia or cicatricial alopecia)?”
Predictability in the Art
Although the level of skill in the art is high, the predictability in the art is low due to the complexity of biological systems, biochemistry, clinical challenges (e.g., patient age, sex, weight, health, and history), pharmaceutical challenges (e.g., delivery routes, pharmaceutical formulations permitting meaningful delivery of a therapeutically effective amount of a substance, substance half-life, uptake, stability, shelf-life, etc.), etc. Specifically, an artisan would not be able to predict or identify, a priori, and in the absence of any guidance or consensus structures exactly what compounds would be capable of ‘preventing or treating’, in vivo, hair loss as claimed, such as hair loss caused by hormonal imbalances (e.g., androgenic alopecia, hypothyroidism, hyperthyroidism), autoimmune disorders (e.g., alopecia areata, Lupus Erythematous), infection (e.g., tenia capitis, trichobacteriosis, syphilis, folliculitis), stress (e.g., telogen effluvium, anagen effluvium, traction alopecia), or scarring (e.g., burns, scarring alopecia or cicatricial alopecia).
The predictability of treating and preventing such diseases and conditions would not be deemed credible in the absence of objective evidence, because, for example, Filbrandt et al7. identifies that scarring alopecia
…encompasses a group of hair loss disorders in which the hair follicle is irreversibly destroyed and replaced by fibrous tissue. Hair regeneration is prevented because of destruction of epithelial stem cells . . . . Secondary cicatricial alopecia is also irreversible, though destruction of the hair follicle is incidental to a non-follicle-directed cause, such as thermal burns, metastatic cancer, trauma or radiation.
(see, e.g., Filbrandt at 1579 at col I, emphasis added).
Accordingly, although the specification alleges, without evidence, that the claimed invention can “prevent or treat” hair loss, including “hair loss due to burns and/or trauma”, among other things (see, e.g., Spec. filed 3/25/2024 at ¶¶[43]-[44], [46]), the relevant art, such as Filbrandt, reasonably informs artisans that such hair loss is “irreversible”, and that “hair regeneration is prevented” (see, e.g., Filbrandt at 1579 at col I, emphasis added). Accordingly, an artisan would not readily conclude that Applicant possessed such an invention in the absence of any statistically significant, objective, supporting evidence outweighing and addressing the doubts and concerns present in the prior art.
Accordingly, although the pending claim scope is vast and highly varied, and may ostensibly encompass zero, one, dozens, millions, or billions of species of peptides, in the complete absence of sufficient structure/function teachings permitting artisans to meaningfully identify, a priori, which structures are or are not capable of satisfying the functional limitations set forth in the instant claims, as required to practice the full scope of the claims, an artisan would not reasonably conclude that Applicant possessed the full scope of the broad and highly varied claim scope.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). In addition, the Courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is pertinent because, in the instant case, Applicants have claimed a broad and highly varied genus comprising an unknown number of species defined by reference to one or more functional limitations; however, the originally filed disclosure has failed to identify any common structure/function relationship sufficient to permit an artisan to identify what structures are included or excluded by the claim scope. This also means that it is prima facie unclear what structures are infringe or do not infringe upon the pending claim scope.
In conclusion, for the reasons discussed above, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claims 1-16 are rejected.
Claim Rejections - 35 USC § 102
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.
[Prior Art Rejection 01]
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US 9295629 B2 (March 29, 2016).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Claims 1-16 have been rejected under 35 USC §112(b) above. For purposes of the instant rejection, the preamble of claim 1 (i.e., “having the activity of preventing hair loss or promoting hair growth”) and the intended use statements of claims 3-16 (i.e., “for preventing hair loss or promoting hair growth”), are understood to be recitations of intended and expected results fully satisfied by all structures that satisfy the positively recited structural limitations set forth in the body of instant claim 1, including prior art structures comprising a subsequence of SEQ ID NO: 1, such as Ala-Cys) (see, e.g., MPEP § 2111.04(I), § 2111.03(II)). Furthermore, for purposes of the instant rejection, the “wherein” clauses at instant claims 2 and 5-11 are understood to either recite non-limiting intended and expected results fully satisfied by all structures that satisfy the positively recited structural limitations set forth in the body of instant claim 1, including prior art structures comprising a subsequence of SEQ ID NO: 1, such as Ala-Cys) (see, e.g., MPEP § 2111.04(I), § 2111.03(II)), or otherwise recite method steps wherein infringement is understood for purposes of the instant rejection to occur prior to performance of the active method step set forth in the “wherein” clause. Accordingly, claim 2 is rejected for reasons applied to claim 1; and claims 5-11 are rejected for reasons applied to claim 3. Additional claim interpretations are set forth below.
Regarding instant claims 1-16, and “an amino acid sequence of SEQ ID NO: 1”, the primary reference teaches and claims peptides capable of promoting β-catenin signaling, and “promoting hair growth or improving hair production” or “improving hair loss” by administering SEQ ID NOs: 1 or 2 (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9), wherein each peptide is comprises “an amino acid sequence of [instant] SEQ ID NO: 1”, namely the dipeptide subsequence of Cys-Gly (compare instant SEQ ID NO: 1 with US’629 at SEQ ID NOs: 1-2).
Regarding claims 1-16 and recitations of intended and expected use regarding treating hair loss, the primary reference explicitly claims methods of “promoting hair growth or improving hair production” or “improving hair lose” by administering SEQ ID NOs: 1 or 2 (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9).
Regarding instant claim 4 and a composition comprising such a peptide at a concentration range of 0.001 µM to 100 µM, an artisan would reasonably practice the claimed methods of treating or improving hair loss using the exemplified embodiments (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9). Notably, the primary reference teaches a “nutrient cream” (see, e.g., US’629 at col 13 at lines 1-40), a “nutrient liquid” (see, e.g., US’629 at col 13 at line 40 to col. 14 at line 30), and an “essence” (see, e.g., US’629 at col 14 at lines 4-30), which each comprise “peptide nanosome” at 2.5 wt%; the primary reference also teaches a “hair serum” and “hair toner” (see, e.g., US’629 at col 14 at lines 33 to col. 16 at line 10), which each comprise “peptide nanosome” at 1 wt% (see id). This is pertinent because SEQ ID NO: 1 has a MW of ~1543.8 (see US’629 at col. 10 at lines 20-25), and the primary reference explicitly teaches, discloses, and reduces to practice peptide nanosomes, which are disclosed as comprising “about 50 ppm” of peptide (see, e.g., US’629 at col 12 at lines 34-50). This means that the “nutrient cream”, “nutrient liquid”, and “essence” would comprise, 0.025 g nanosomes per gram of composition; wherein the nanosomes would comprise (50 x 10e-6) 0.00005 g peptide per gram of nanosome; which would mean 1.25x10-6 grams of peptide is present per gram of composition; assuming liquid density of approximately 1 g/mL, the mass concentration would be 1.25 mg/L; which would yield a molar concentration of (0.00125g/L) divided by 15.43.8 g/mol, which is approximately 0.81 µM of SEQ ID NO: 1. Using the same mathematical analysis described above, an artisan would readily infer that the “hair serum” and “hair toner” reduced to practice comprised approximately 0.324 µM of SEQ ID NO: 1. Therefore, the prior art is understood to clearly exemplify and direct artisans to compositions comprising a composition of such a peptide within the concentration range required by instant claim 4.
Regarding instant claims 3-16, “compositions”, “pharmaceutical compositions”, and “cosmetic compositions”, an artisan would reasonably practice the claimed products and methods of treating or improving hair loss using compositions acceptable for human administration (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9), which would include at least “nutrient creams” (see, e.g., US’629 at col 13 at lines 1-40), “nutrient liquids” (see, e.g., US’629 at col 13 at line 40 to col. 14 at line 30), “essences” (see, e.g., US’629 at col 14 at lines 4-30), “hair serums” and “hair toners” (see, e.g., US’629 at col 14 at lines 33 to col. 16 at line 10). Such compositions would readily be understood to be properly characterizable as both or either “pharmaceutical compositions” or “cosmetic compositions” (see, e.g., US’629 at col. 6 at lines 22-65, noting that such compositions are literally described as “pharmaceutical compositions” and as “cosmetic compositions”).
Regarding instant claims 13, 15, and formulation as “an external skin preparation”, an artisan would reasonably practice the claimed products and methods of treating or improving hair loss using compositions acceptable for human administration (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9), using “pharmaceutical compositions” or “cosmetic compositions” (see, e.g., US’629 at col. 6 at lines 22-65), wherein US’629 explicitly exemplifies topical administration (see, e.g., US’629 at col. 12 at lines 20-35), and therefore an artisan would at once envisage that topical administration necessarily required a formulation suitable for external skin application.
Regarding instant claim 16 and a cosmetic formulation such as a solution, suspension, essence, or cream, an artisan would reasonably practice the claimed products and methods of treating or improving hair loss using compositions acceptable for human administration (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9), using “cosmetic compositions” (see, e.g., US’629 at col. 6 at lines 22-65), including “nutrient creams” (see, e.g., US’629 at col 13 at lines 1-40), “nutrient liquids” (see, e.g., US’629 at col 13 at line 40 to col. 14 at line 30), “essences” (see, e.g., US’629 at col 14 at lines 4-30), “hair serums” and “hair toners” (see, e.g., US’629 at col 14 at lines 33 to col. 16 at line 10).
Accordingly, claims 1-16 are anticipated by the prior art.
[Prior Art Rejection 02]
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US 10238710 B2 (Mar. 26, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in the preceding rejection under 35 USC 102, above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-16 and recitations of intended and expected use regarding treating hair loss, the primary reference explicitly claims peptides and methods of “preventing hair loss or promoting hair growth” by administering SEQ ID NOs: 1-3 (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7-11, 13, and 18), wherein the peptides “promote[] the proliferation of hair follicle cells” (see id. at claim 8), increase phosphorylation of ERK (see id. at claim 9), increase expression of β-catenin (see id. at claim 10), reduce expression of DKK-1 (see id. at claim 11), increase expression of Ha3-II and Keratin 14 (see id. at col. 18 at lines 1-37), and wherein each of those sequences read upon the instant claims because they each comprise the dipeptide subsequence of Ala-Cys as present in instant SEQ ID NO: 1 (compare instant SEQ ID NO: 1 with US’710 at SEQ ID NOs: 1-3). Regarding instant claims 3-16 and “pharmaceutical” and “cosmetic” compositions, in view of the claimed peptides and methods (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7-11, 13, and 18), an artisan would review the specification for guidance regarding administration, and readily appreciate that the methods could be performed using compositions characterizable as pharmaceutical and/or cosmetic compositions (see, e.g., US’710 at col. 7 at line 1 to line 55). Regarding instant claim 4 and a composition comprising such a peptide at a concentration range of 0.001 µM to 100 µM, in view of the claimed peptides and methods (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7-11, 13, and 18), an artisan would review the exemplified embodiments, which include compositions comprising 1 µg/mL, 10 µg/mL, and 50 µg/mL of the peptides (see, e.g., US’710 at Example 3 at col. 16 at lines 9-39), which have a MW of approximately 1033.3, 1096.0, and 1036.9 (see, e.g., US’710 at Example 1 at Table 1 at col. 12 at lines 30-40). Examiner notes that a value of 1 µg/mL is 1 mg/L, which is 0.001g/L; divided by the mass (g/mol) and multiplied by 1x10e6 yields molarity in micromolar. Therefore, a 1 µg/mL of SEQ ID NO: 1 of US’710 is 0.968 µM, a 10 µg/mL of SEQ ID NO: 1 of US’710 is 9.68 µM, and a 50 µg/mL of SEQ ID NO: 1 of US’710 is 48.39 µM. Accordingly, it is readily understood that the disclosure directs and exemplifies concentrations falling within the range of claim 4. Regarding instant claims 13, 15, and “an external skin preparation”, the primary reference explicitly directs artisans to methods preventing hair loss or promoting hair growth using any form of local administration (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7 and 13), wherein the compositions are explicitly characterized as including pharmaceutical and/or cosmetic compositions (see, e.g., US’710 at col. 7 at line 1 to line 55), wherein such compositions are explicitly identified as understood to include administration to scalp, skin, and hair (see, e.g., US’710 at col. 3 at line 33 to line 60). Accordingly, an artisan would readily appreciate and interpret the claimed methods as including compositions formulated for external application. Regarding instant claim 16 and a cosmetic formulations such as solutions, suspension, essence, or cream, the primary reference explicitly directs artisans to methods preventing hair loss or promoting hair growth using any form of local administration (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7 and 13), wherein the compositions are explicitly characterized as including pharmaceutical and/or cosmetic compositions (see, e.g., US’710 at col. 7 at line 1 to line 55), and wherein cosmetic compositions are explicitly identified as encompassing solutions, suspensions, essences, creams, etc. (see, e.g., US’710 at col. 7 at line 34 to line 45).
Accordingly, claims 1-16 are rejected.
[Prior Art Rejection 03]
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US 10344061 B2 (Jul. 9, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in the preceding rejection under 35 USC 102, above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1-16 and recitations of intended and expected use regarding treating hair loss, the primary reference explicitly claims peptides and methods “for reducing hair loss” and “stimulating hair production or hair growth” by administering SEQ ID NO: 1 (see, e.g., US’061 at SEQ ID NO: 1, claims 1-18; see esp. id. at claims 1, 15, and 16), wherein the peptide “stimulates the growth of hair follicle cells” (see id. at claim 2), increase phosphorylation of ERK (see id. at claim 5), increase expression of β-catenin (see id. at claim 3), and increases the expression of MSX2 and Keratin-14 (see id. at claim 6), wherein SEQ ID NO: 1 reads upon the instant claim scope because it comprises the dipeptide subsequence of Ala-Cys as present in instant SEQ ID NO: 1 (compare instant SEQ ID NO: 1 with US’061 at SEQ ID NO: 1). Regarding instant claims 3-16, and “pharmaceutical” and “cosmetic” compositions prepared as “an external skin preparation”, such as a “solution”, “cream”, “spray”, or “essence”, in view of the claimed peptides and methods (see, e.g., US’061 at SEQ ID NO: 1, claims 1-18; see esp. id. at claims 1, 15, and 16), an artisan would review the specification for guidance regarding administration, and readily appreciate that the methods could be performed using compositions characterizable as pharmaceutical and/or cosmetic compositions (see, e.g., US’061 at col. 6 at lines 15 to line 40, col. 7 at lines 54-60), wherein such compositions may be administered by “topical skin administration” (see, e.g., US’061 at col. 8 at lines 8-10, col. 6 at lines 20-34 referring to massage creams, eye creams, soaps, foundations, etc.), which is understood to necessarily required the composition be “an external skin preparation”. Furthermore, an artisan would readily infer that the claimed methods could be practiced by utilizing solutions, creams, sprays, essence, massage creams, soaps, foundations, etc. (see, e.g., US’061 at col. 6 at lines 20-34). Regarding instant claim 4 and a composition comprising such a peptide at a concentration range of 0.001 µM to 100 µM, in view of the claimed peptides and methods (see, e.g., US’061 at SEQ ID NO: 1, claims 1-18; see esp. id. at claims 1, 15, and 16), an artisan would review the exemplified embodiments, which include compositions comprising 0.5 µg/mL, 5 µg/mL, and 50 µg/mL of the peptide of SEQ ID NO: 1 (see, e.g., US’061 at Figure 1a), wherein SEQ ID NO: 1 has a MW of approximately 1055.2 (see, e.g., US’061 at Example at Table 1 at col. 12 at lines 15-26). Examiner notes that a value of 1 µg/mL is 1 mg/L, which is 0.001g/L; divided by the mass (g/mol) and multiplied by 1x10e6 yields molarity in micromolar. Therefore, a 0.5 µg/mL of SEQ ID NO: 1 of US’061 is ~0.474 µM, a 5 µg/mL of SEQ ID NO: 1 of US’061 is ~4.74 µM, and a 50 µg/mL of SEQ ID NO: 1 of US’061 is ~47.38 µM. Accordingly, it is readily understood that the disclosure directs and exemplifies concentrations falling within the range of claim 4, and therefore an artisan would at once envisage the usage of such concentrations in the claimed methods.
Accordingly, claims 1-16 are rejected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
[NSDP Rejection 01]
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 8-9 of U.S. Patent No. 9295629 B2 (March 29, 2016). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection under 35 USC 102 using the same primary reference, above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis.
Regarding instant claims 1-16, and “an amino acid sequence of SEQ ID NO: 1”, the primary reference teaches and claims peptides capable of promoting β-catenin signaling, and “promoting hair growth or improving hair production” or “improving hair loss” by administering SEQ ID NOs: 1 or 2 (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9), wherein each peptide is comprises “an amino acid sequence of [instant] SEQ ID NO: 1”, namely the dipeptide subsequence of Cys-Gly (compare instant SEQ ID NO: 1 with US’629 at SEQ ID NOs: 1-2). Regarding claims 1-16 and recitations of intended and expected use regarding treating hair loss, the primary reference explicitly claims methods of “promoting hair growth or improving hair production” or “improving hair lose” by administering SEQ ID NOs: 1 or 2 (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9). Regarding instant claims 4, 3-16, pharmaceutical and cosmetic compositions, including liquids, creams, toners, and suspensions, wherein each may comprising a peptide at issue at a concentration range of 0.001 µM to 100 µM, an artisan would reasonably practice the claimed methods of treating or improving hair loss (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9) using the exemplified embodiments. This is permissible in a double-patenting rejection per MPEP § 804(II)(B)(1), which explains that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and is also permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”). Here, the primary reference exemplifies and describes both “pharmaceutical compositions” or “cosmetic compositions” (see, e.g., US’629 at col. 6 at lines 22-65, noting that such compositions are literally described as “pharmaceutical compositions” and as “cosmetic compositions”), including a “nutrient cream” (see, e.g., US’629 at col 13 at lines 1-40), a “nutrient liquid” (see, e.g., US’629 at col 13 at line 40 to col. 14 at line 30), an “essence” (see, e.g., US’629 at col 14 at lines 4-30), and a “hair serum” and “hair toner” (see, e.g., US’629 at col 14 at lines 33 to col. 16 at line 10); wherein each comprise a peptide as part of a “peptide nanosome” at either 1 wt% or 2.5 wt% (see id.). This is pertinent to instant claim 4, among others, because SEQ ID NO: 1 has a MW of ~1543.8 (see US’629 at col. 10 at lines 20-25), and the “peptide nanosomes” contain “about 50 ppm” of peptide (see, e.g., US’629 at col 12 at lines 34-50). This means that the “nutrient cream”, “nutrient liquid”, and “essence” (each 2.5 wt%) would comprise, 0.025 g nanosomes per gram of composition; wherein the nanosomes would comprise (50 x 10e-6) 0.00005 g peptide per gram of nanosome; which would mean 1.25x10-6 grams of peptide is present per gram of composition; assuming liquid density of approximately 1 g/mL, the mass concentration would be 1.25 mg/L; which would yield a molar concentration of (0.00125g/L) divided by 15.43.8 g/mol, which is approximately 0.81 µM of SEQ ID NO: 1. Using the same mathematical analysis described above, an artisan would readily infer that the “hair serum” and “hair toner” (1 wt%) reduced to practice comprised approximately 0.324 µM of SEQ ID NO: 1. Therefore, the prior art is understood to clearly exemplify and direct artisans to pharmaceutical and cosmetic compositions comprising a peptide as presently claimed within the concentration range required by instant claim 4. Regarding instant claims 13, 15, and formulation as “an external skin preparation”, an artisan would reasonably practice the claimed methods of treating or improving hair loss (see, e.g., US’629 at SEQ ID NOs: 1-2, claims 1, 5-6, 8-9) using the exemplified embodiments. This is permissible in a double-patenting rejection per MPEP § 804(II)(B)(1), which explains that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and is also permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”). Here, the primary reference explicitly exemplifies topical administration (see, e.g., US’629 at col. 12 at lines 20-35), and therefore an artisan would at once envisage and appreciate that the claimed methods necessarily encompassed formulations suitable for external skin application.
Anticipation analysis: MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the products and methods recited in the reference claims using one or more species within the scope of the instantly claimed products (see, e.g., MPEP § 804(II)(B)(2)).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the instant claims are directed to a named, claimed species set forth in the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the primary reference and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-16 are rejected.
[NSDP Rejection 02]
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11, 13, and 18 of U.S. Patent No. US 10238710 B2 (Mar. 26, 2019). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection under 35 USC 102 using the same primary reference, above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis.
Regarding instant claims 1-16 and recitations of intended and expected use regarding treating hair loss, the primary reference explicitly claims peptides and methods of “preventing hair loss or promoting hair growth” by administering SEQ ID NOs: 1-3 (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7-11, 13, and 18), wherein the peptides “promote[] the proliferation of hair follicle cells” (see id. at claim 8), increase phosphorylation of ERK (see id. at claim 9), increase expression of β-catenin (see id. at claim 10), reduce expression of DKK-1 (see id. at claim 11), increase expression of Ha3-II and Keratin 14 (see id. at col. 18 at lines 1-37), and wherein each of those sequences read upon the instant claims because they each comprise the dipeptide subsequence of Ala-Cys as present in instant SEQ ID NO: 1 (compare instant SEQ ID NO: 1 with US’710 at SEQ ID NOs: 1-3). Regarding instant claims 3-16 and “pharmaceutical” and “cosmetic” compositions, in view of the claimed peptides and methods (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7-11, 13, and 18), an artisan would review the specification for guidance regarding administration, and readily appreciate that the methods could be performed using compositions characterizable as pharmaceutical and/or cosmetic compositions (see, e.g., US’710 at col. 7 at line 1 to line 55)8. Regarding instant claim 4 and a composition comprising such a peptide at a concentration range of 0.001 µM to 100 µM, in view of the claimed peptides and methods (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7-11, 13, and 18), an artisan would review the exemplified embodiments, which include compositions comprising 1 µg/mL, 10 µg/mL, and 50 µg/mL of the peptides (see, e.g., US’710 at Example 3 at col. 16 at lines 9-39), which have a MW of approximately 1033.3, 1096.0, and 1036.9 (see, e.g., US’710 at Example 1 at Table 1 at col. 12 at lines 30-40)9. Examiner notes that a value of 1 µg/mL is 1 mg/L, which is 0.001g/L; divided by the mass (g/mol) and multiplied by 1x10e6 yields molarity in micromolar. Therefore, a 1 µg/mL of SEQ ID NO: 1 of US’710 is 0.968 µM, a 10 µg/mL of SEQ ID NO: 1 of US’710 is 9.68 µM, and a 50 µg/mL of SEQ ID NO: 1 of US’710 is 48.39 µM. Accordingly, it is readily understood that the disclosure directs and exemplifies concentrations falling within the range of claim 4. Regarding instant claims 13, 15, and “an external skin preparation”, the primary reference explicitly directs artisans to methods preventing hair loss or promoting hair growth using any form of local administration (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7 and 13), wherein the compositions are explicitly characterized as including pharmaceutical and/or cosmetic compositions (see, e.g., US’710 at col. 7 at line 1 to line 55) 10, wherein such compositions are explicitly identified as understood to include administration to scalp, skin, and hair (see, e.g., US’710 at col. 3 at line 33 to line 60) 11. Accordingly, an artisan would readily appreciate and interpret the claimed methods as including compositions formulated for external application. Regarding instant claim 16 and a cosmetic formulations such as solutions, suspension, essence, or cream, the primary reference explicitly directs artisans to methods preventing hair loss or promoting hair growth using any form of local administration (see, e.g., US’710 at SEQ ID NOs: 1-3, claims 7 and 13), wherein the compositions are explicitly characterized as including pharmaceutical and/or cosmetic compositions (see, e.g., US’710 at col. 7 at line 1 to line 55) 12, and wherein cosmetic compositions are explicitly identified as encompassing solutions, suspensions, essences, creams, etc. (see, e.g., US’710 at col. 7 at line 34 to line 45) 13.
Anticipation analysis: MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the products and methods recited in the reference claims using one or more species within the scope of the instantly claimed products (see, e.g., MPEP § 804(II)(B)(2)).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the instant claims are directed to a named, claimed species set forth in the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the primary reference and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-16 are rejected.
[NSDP Rejection 03]
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 10344061 B2 (Jul. 9, 2019). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection under 35 USC 102 using the same primary reference, above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis.
Regarding instant claims 1-16 and recitations of intended and expected use regarding treating hair loss, the primary reference explicitly claims peptides and methods “for reducing hair loss” and “stimulating hair production or hair growth” by administering SEQ ID NO: 1 (see, e.g., US’061 at SEQ ID NO: 1, claims 1-18; see esp. id. at claims 1, 15, and 16), wherein the peptide “stimulates the growth of hair follicle cells” (see id. at claim 2), increase phosphorylation of ERK (see id. at claim 5), increase expression of β-catenin (see id. at claim 3), and increases the expression of MSX2 and Keratin-14 (see id. at claim 6), wherein SEQ ID NO: 1 reads upon the instant claim scope because it comprises the dipeptide subsequence of Ala-Cys as present in instant SEQ ID NO: 1 (compare instant SEQ ID NO: 1 with US’061 at SEQ ID NO: 1). Regarding instant claims 3-16, and “pharmaceutical” and “cosmetic” compositions prepared as “an external skin preparation”, such as a “solution”, “cream”, “spray”, or “essence”, in view of the claimed peptides and methods (see, e.g., US’061 at SEQ ID NO: 1, claims 1-18; see esp. id. at claims 1, 15, and 16), an artisan would review the specification for guidance regarding administration, and readily appreciate that the methods could be performed using compositions characterizable as pharmaceutical and/or cosmetic compositions (see, e.g., US’061 at col. 6 at lines 15 to line 40, col. 7 at lines 54-60) 14, wherein such compositions may be administered by “topical skin administration” (see, e.g., US’061 at col. 8 at lines 8-10, col. 6 at lines 20-34 referring to massage creams, eye creams, soaps, foundations, etc.) 15, which is understood to necessarily required the composition be “an external skin preparation”. Furthermore, an artisan would readily infer that the claimed methods could be practiced by utilizing solutions, creams, sprays, essence, massage creams, soaps, foundations, etc. (see, e.g., US’061 at col. 6 at lines 20-34) 16. Regarding instant claim 4 and a composition comprising such a peptide at a concentration range of 0.001 µM to 100 µM, in view of the claimed peptides and methods (see, e.g., US’061 at SEQ ID NO: 1, claims 1-18; see esp. id. at claims 1, 15, and 16), an artisan would review the exemplified embodiments, which include compositions comprising 0.5 µg/mL, 5 µg/mL, and 50 µg/mL of the peptide of SEQ ID NO: 1 (see, e.g., US’061 at Figure 1a) 17, wherein SEQ ID NO: 1 has a MW of approximately 1055.2 (see, e.g., US’061 at Example at Table 1 at col. 12 at lines 15-26). Examiner notes that a value of 1 µg/mL is 1 mg/L, which is 0.001g/L; divided by the mass (g/mol) and multiplied by 1x10e6 yields molarity in micromolar. Therefore, a 0.5 µg/mL of SEQ ID NO: 1 of US’061 is ~0.474 µM, a 5 µg/mL of SEQ ID NO: 1 of US’061 is ~4.74 µM, and a 50 µg/mL of SEQ ID NO: 1 of US’061 is ~47.38 µM. Accordingly, it is readily understood that the disclosure directs and exemplifies concentrations falling within the range of claim 4, and therefore an artisan would at once envisage the usage of such concentrations in the claimed methods18.
Accordingly, claims 1-16 are rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20140309157 A1 shares a disclosure with US 9295629 B2, which has been addressed above, and is deemed redundant in view of US’629.
US 20160272679 A1 shares a disclosure with US 9295629 B2, which has been addressed above, and is deemed redundant in view of US’629.
US 20170049847 A1 shares a disclosure with US 10,238,710 B2, which has been addressed above, and is deemed redundant in view of US’710.
US 20190092821 A1 shares a disclosure with US 10344061 B2, which has been addressed above, and is deemed redundant in view of US’061.
Allowable Subject Matter
Examiner notes that sequence consisting of SEQ ID NO: 1 has been deemed free of the prior art.
The allowable subject matter could be claimed and the application placed in form for allowance by canceling claims 2, 5-11, and by amending claims 1, 3-4, and 12-16 as follows:
A peptide consisting of SEQ ID NO: 1.
3. A composition comprising the peptide of claim 1.
4. The composition according to claim 3, wherein the peptide is included in the composition at a concentration of 0.001 µM to 100 µM.
12. A pharmaceutical composition , comprising the peptide of claim 1.
13. The pharmaceutical composition according to claim 12, wherein the pharmaceutical composition is an external skin preparation.
14. A cosmetic composition , comprising the peptide of claim 1.
15. The cosmetic composition according to claim 14, wherein the cosmetic composition is an external skin preparation.
16. The cosmetic composition according to claim 14, wherein the cosmetic composition has any one formulation selected from the group consisting of solution, suspension, emulsion, gel, lotion, essence, cream, powder, soap, shampoo, conditioner, pack mask, , cleansing foam, oil, liquid foundation, cream foundation and spray.
The point of novelty is the novel sequence consisting of SEQ ID NO: 1.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 See, e.g., Nystrom v. TREX Co., Inc., 424 F. 3d 1136, 1143 (Fed. Cir. 2005), explaining that "When different words or phrases are used in separate claims, a difference in meaning is presumed".
2 See claim interpretation section, regarding the interpretation of “an amino acid sequence of SEQ ID NO: 1” compared to “the amino acid sequence of SEQ ID NO: 1”, incorporated herein.
3 See claim interpretation section, regarding the interpretation of “an amino acid sequence of SEQ ID NO: 1” compared to “the amino acid sequence of SEQ ID NO: 1”, incorporated herein. Instant SEQ ID NO: 1 is GCGLFVAAC.
4 See previous footnote.
5 Applicant is advised that if claims 2 and 5-11 are amended to have no cognizable structural difference relative to the structures of the claims from which they depend, such amendments may necessitate objections to claims 2 and 5-11 as substantial duplicates of the claims upon which they depend (see, e.g., MPEP § 608.01(m) and Form Paragraphs 7.05.05 and 7.05.06 set forth therein, discussing substantial duplicate claims).
6 See claim interpretation section, regarding the interpretation of “an amino acid sequence of SEQ ID NO: 1” compared to “the amino acid sequence of SEQ ID NO: 1”, incorporated herein. Instant SEQ ID NO: 1 is GCGLFVAAC.
7 Filbrandt et al., Primary cicatricial alopecia: diagnosis and treatment. CMAJ. 2013 Dec 10;185(18):1579-85. doi: 10.1503/cmaj.111570. Epub 2013 May 21. PMID: 23695609; PMCID: PMC3855115.
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
8 This is permissible in a double-patenting rejection per MPEP § 804(II)(B)(1), which explains that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and is also permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”).
9 See preceding footnote.
10 See preceding footnote.
11 See preceding footnote.
12 See preceding footnote.
13 See preceding footnote.
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
14 This is permissible in a double-patenting rejection per MPEP § 804(II)(B)(1), which explains that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and is also permissible to use the specification to identify obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”).
15 See preceding footnote.
16 See preceding footnote.
17 See preceding footnote.
18 See preceding footnote.
Prosecution Insights