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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 6/22/26 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/22/26.
Applicant's election with traverse of Group I, claims 1-10, in the reply filed on 6/22/26 is acknowledged. The traversal as to groups of inventions is on the ground(s) that there is no serious burden, and that all of Groups II and III claims depend back to claim 1 of Group I. This is not found persuasive because 1) the claim 11 first species (b) already is addressed in the rejection, and appears to be related to an error in depiction of the structure, and if claim 11 is not amended or cancelled would be reconsidered for examination via rejoinder under relevant circumstances, and 2) the claiming approach for claims 12 and 13 including the listing of multiple diverse conditions/diseases imparts an additional serious burden versus examination of Group I claims, and 3) the lack of unity was made clear and the 4/20/26 Restriction Requirement and clearly indicates a lack of unity due to no special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/22/26.
Applicant's election with traverse of the species election in the reply filed on 6/22/26 is acknowledged. The traversal is on the ground(s) that “the chemical penetration enhancer facilitates permeation of the active peptide composition, which the microneedle facilitates delivery of that composition through the skin barrier, so that, somehow per applicant, “they are linked by a single general inventive concept.” This is not found persuasive because these limitations are found in separate claims depending from claim 1, which lacks any reference to these limitations (if they were so linked, they could have been placed in the same claim).
The requirement is still deemed proper and is therefore made FINAL.
Notwithstanding the latter, and given applicant’s failure to properly respond to what was required to fulfill the election of species (applicant instead electing “Group I along with microneedle and chemical enhancer”), to advance prosecution on the merits, and considering a number of issues with the application and claims, the examiner is examining all of claims 1-10.
Claim Status
Claims 1-20 are pending.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/22/26.
Claims 1-10 are rejected.
Priority
The instant application, filed 04/18/2023 is a National Stage entry of PCT/US2021/055692 , International Filing Date: 10/19/2021
18249521 Claims Priority from Provisional Application 63094242 , filed 10/20/2020
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 7/18/23 Information Disclosure Statement, and provides a signed and dated copy of such herewith.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Fig. 1b’s chemical structure does not correspond to the description thereof, that its N-terminal was palmitoyolated, instead what appears in the figure is a pentadecanoic acid moiety attached to the N-termina. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. The amino acid sequence represented by FIG. 1A is an amino acid sequence that require a SEQ ID Number and sequence listing under ST.25.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the claims are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
PLEASE NOTE: Species (a) in Fig. 1A and claims 1 and 9 is an amino acid sequence meeting the sequence listing requirements. It does not comprise a D-form amino acid.
Specification
The disclosure is objected to because of the following informalities: Page 2, para 10 refers to Figure 1b as “palm-peptide”, however the chemical structure in Fig. 1b is not palm-peptide, rather the added fatty acid moiety is pentadecanoic acid.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-10 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.
There are two bases for rejection of all of claims 1-10.
FIRST:
The 6/22/26 claim set in claims 1 and 10 added a second (b) species:
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Applicant states on page 6 of Remarks of 6/22/26, “Applicant respectfully asserts that the amendments to the claims add no new matter.” The examiner recognizes that this second (b) species corresponds to adding a palmitoyl moiety, which is supported in the specification. However, it is unclear whether the first (b) species in claims 1 and 10:
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, which corresponds to adding a pentadecanoic acid, is still under examination, or whether applicant did not properly replace this first “(b)” species with the second “(b)” palmitoyl species when making the amendment.
Standard claiming practice does not identify different species/structures with the same letter or number.
Based on objections, it appears to the examiner that applicant made a typographical (as to structure) error in Fig. 1B, and this also appears in claims 1 and 10 under examination.
SECOND:
Claim 1 requires administering to a subject in need thereof, however the need is not stated. There is no disease or condition that is being treated, so it is unclear who that subject is. Stated another way, a person of ordinary skill in the art could not reasonably ascertain the metes and bounds of the claimed method because such person could not determine who is in such undefined/unspecified need.
ADDITIONALLY:
Claim 9 recites the limitation "the microneedle" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the chemical penetration enhancer" in its last two lines. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2008/0296456, published 10/18/18 (‘456).
The ‘456 teaches and evaluates the same peptides as instant (a) and the second (b) of claim 1, referenced as P4 (SEQ ID NO:9) and P4B (SEQ ID NO:11):
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The ‘456 teaches administering to a subject a composition comprising an effective amount of one or more peptides, wherein the one or more peptides consist of, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, or SEQ. ID NO: 12, para 24
Per para 19, “According to various method embodiments the skin cell is a keratinocyte, a melanocyte, a fibrocyte, a histiocyte, or a dendrocyte.”
The ‘456 evaluates peptide P4 and P4B in three human cell lines including epidermal progenitor and melanoblasts, so administered to such cells, these being mammalian (instant claim 2), skin (instant claim 3, epidermal progenitor cells and fibroblasts found in skin). Based on the above teachings and evaluations, the ‘456 teaches administering its compositions comprising P4 and P4B to a melanocyte (claim 4).
Based on the teachings and evaluations of the ‘456, the ‘456 teaches the same administering and permeation of the cells, and even beyond the data indicating permeation, administering the same product to the same cells must have the same properties. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Accordingly, the ‘456 anticipates claims 1-4.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0296456, published 10/18/18 (‘456).
The rejection of the second (b) peptide of claims 1-4 is set forth above and incorporated into this rejection.
The first (b) peptide of claim 1 lacks one CH3 on its N-terminus acyl chain relative to the second (b) peptide of claim 1. The ‘456 does not explicitly teach this species.
The level of ordinary skill in the art is high.
Based on close structural similarity, the first (b) peptide of claim 1 is rejected as similar in structure and function to the above-rejected second (b) peptide of claim 1.
Per MPEP 2144.09 “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
Claims 1-4 therefore would have been obvious based on the above and relevant dependent claim subject matter rejections to claims 2-4 set forth in the rejection in the previous section of this Office action.
This rejection is made for the sake of compact prosecution in case applicant does not remove this species, which appears to have been generated through an error in depicting the chemical structure.
Claim(s) 5-7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0296456, published 10/18/18 (‘456), as applied to claim 1 rejected under the above two rejections, in view of WO 2009/003034 A1, published 12/31/2008 (‘034), provided in 7/18/23 IDS.
The rejections of claim 1 are set forth above.
Claim 5, depending from claim 1, states “wherein the permeation is performed using a microneedle.”
Claim 9, depending from claim 1, limits the peptide to (a) of claim 1 and states that “the permeation is performed by the microneedle.”
Claim 6 depends from claim 1 and states, “wherein the permeation is facilitated using a chemical penetration enhancer,” and claim 7, depending from claim 6, lists among such enhancers propylene glycol and oleic acid.
Claim 10 depends from claim 1, limits the peptides to the two (b) species of claim 1, and states that “the permeation is facilitated by the chemical penetration enhancer.”
The ‘456 does not teach using a microneedle, nor specifically “enhancers” although it does teach a range of additives, see para 92.
The level of ordinary skill in the art is high.
The ‘034 teaches the same peptide as instant (a) of claim 1 and teaches using a microneedle in relation to increase skin permeability, see page 8 line 8, page 27, lines 9-12, and claim 31.
As to claims 6, 7 and 10, the ‘034 teaches adding propylene glycol to a topical administration of its peptides, page 10, lines 21-34, and oleic acid, page 11, line 2.
It would have been obvious to apply the same previously taught method to increase skin permeability by using a microneedle, as taught in the ‘034, for the same peptide, as well as a related peptide, as instantly taught, and the chemicals propylene glycol and oleic acid as clearly taught in the ‘034. Using the same device or chemical with the same or similar peptides would reasonably achieve the same result. The rationale is to combine prior art elements according to known methods to yield predictable results. Given the closely related teachings of these references, one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. There would have been a reasonable expectation of success given the respective teachings including of a microneedle to increase skin permeability.
Accordingly, claims 5-7, 9 and 10 are rejected as obvious.
Claim(s) 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0296456, published 10/18/18 (‘456), as applied to claim 1 under the above 35 USC 102 rejection and the first 35 USC 103 rejection, in view of Ho et al., Journal of Controlled Release 51 (1998) 301 –311 (Ho).
The rejections of claim 1 are set forth above.
Claim 6 depends from claim 1 and states, “wherein the permeation is facilitated using a chemical penetration enhancer,” claim 7, depending from claim 6, lists among such enhancers menthol, and claim 8, depending from claim 7, requires one or more peptides are present with menthol in a concentration of 5 percent (weight/volume).
Claim 10 depends from claim 1, limits the peptides to the two (b) species of claim 1, and states that “the permeation is facilitated by the chemical penetration enhancer.”
The ‘456 does not specifically teach “enhancers” in its administered compositions, although it does teach a range of additives, see para 92.
The level of ordinary skill in the art is high.
Ho teaches
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Ho also teaches that menthol, a cyclic monoterpene, has been used to enhance percutaneous absorption of its compound of interest, indomethacin, that the activities of penetration enhancers may also depend on the choice of cosolvent mixture, and postulated that increased solubility of drugs in solvent mixtures with menthol might play another important role in the promotion of permeation, page 302 left column.
Ho evaluated indomethacin in solvent systems that included 0-12% methanol, pages 302-310.
Ho found that menthol increased skin penetration with increasing concentrations of methanol increasing such penetration, this also depending on the amount of water in the solvent system, see Figures 3 and 4 and accompanying text.
Ho concludes that “The enhancement effect of the penetration of indomethacin due to menthol is mainly due to its effect on the skin,” page 310.
Based on the latter statement, even ignoring the possibility that the instantly claimed peptides also are hydrophobic, especially with the fatty acid acylation, but also given the constituent amino acid side chains, so in the same grouping as indomethacin in being not highly water soluble, one of ordinary skill in the art would have been motivated to utilize menthol to enhance skin penetration/permeation.
The prior art ‘456 contained "base" peptides and methods upon which the claimed invention can be seen as an "improvement;", the prior art Ho contained a "comparable" products with menthol that showed increased skin penetration properties and capabilities, although this is not the same as the ‘456 that has been improved in the same way as the claimed invention; and one of ordinary skill in the art could have applied the known "improvement" technique -adding menthol, in the same way to the ‘456 peptides and methods and the results would have been predictable to one of ordinary skill in the art. There would have been a reasonable expectation of success at least given the clear statement in Ho that the enhancement effect of the penetration of indomethacin due to menthol is mainly due to its effect on the skin.
As to the 5 percent limitation, this falls within the 0-12% concentrations of Ho and would have been obvious also. Per MPEP 2144.05 I, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Based on the above, claims 6-8 and 10 would have been obvious.
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.
Claims 1-6, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 9, 10 of U.S. Patent No. 7902329 (Reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the same peptide as instant claim 1’s peptide (a) is claimed in Reference patent claim 1, in a method that involves administering this “for lightening skin pigmentation”, so to the skin, its claim 2 specifically claiming this peptide, its claim 4 administering comprises a topical administration (so onto the skin), and its claim 9 claiming inter alia administering in conjunction with a physical treatment carried out by a microneedle. Please note that human skin satisfies claims 2-4 limitations. Please note that Reference patent claim 10’s aloe functions as a skin penetration enhancer absent evidence to the contrary.
Claims 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4 of U.S. Patent No. 7902329 (Reference patent), as applied to claim 1 above, in view of Ho et al., Journal of Controlled Release 51 (1998) 301 –311 (Ho).
The rejection of claim 1 is set forth above.
Claim 6 depends from claim 1 and states, “wherein the permeation is facilitated using a chemical penetration enhancer,” claim 7, depending from claim 6, lists among such enhancers menthol, and claim 8, depending from claim 7, requires one or more peptides are present with menthol in a concentration of 5 percent (weight/volume).
Claim 9 teaches the same species as the 329 claim 1 and with, as best understood, a chemical penetration enhancer.
The ‘456 does not specifically teach “enhancers” in its administered compositions, although it does teach a range of additives, see para 92.
The level of ordinary skill in the art is high.
Ho teaches
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Ho also teaches that menthol, a cyclic monoterpene, has been used to enhance percutaneous absorption of its compound of interest, indomethacin, that the activities of penetration enhancers may also depend on the choice of cosolvent mixture, and postulated that increased solubility of drugs in solvent mixtures with menthol might play another important role in the promotion of permeation, page 302 left column.
Ho evaluated indomethacin in solvent systems that included 0-12% methanol, pages 302-310.
Ho found that menthol increased skin penetration with increasing concentrations of methanol increasing such penetration, this also depending on the amount of water in the solvent system, see Figures 3 and 4 and accompanying text.
Ho concludes that “The enhancement effect of the penetration of indomethacin due to menthol is mainly due to its effect on the skin,” page 310.
Based on the latter statement, even ignoring the possibility that the instantly claimed peptides also are hydrophobic, especially with the fatty acid acylation, but also given the constituent amino acid side chains, so in the same grouping as indomethacin in being not highly water soluble, one of ordinary skill in the art would have been motivated to utilize menthol to enhance skin penetration/permeation.
The prior art ‘456 contained "base" peptides and methods upon which the claimed invention can be seen as an "improvement;", the prior art Ho contained a "comparable" products with menthol that showed increased skin penetration properties and capabilities, although this is not the same as the ‘456 that has been improved in the same way as the claimed invention; and one of ordinary skill in the art could have applied the known "improvement" technique -adding menthol, in the same way to the Reference patent claims’ peptide and methods and the results would have been predictable to one of ordinary skill in the art. There would have been a reasonable expectation of success at least given the clear statement in Ho that the enhancement effect of the penetration of indomethacin due to menthol is mainly due to its effect on the skin.
As to the 5 percent limitation, this falls within the 0-12% concentrations of Ho and would have been obvious also. Per MPEP 2144.05 I, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.”
Based on the above, claims 6-9 would have been obvious and are rejected under this section.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4 of U.S. Patent No. 7902329 (Reference patent), as applied to claim 1 above, further in view of US 2008/0296456, published 10/18/18 (‘456) and Ho et al., Journal of Controlled Release 51 (1998) 301 –311 (Ho).
The rejection of claim 1 is set forth above.
Claim 10 depends from claim 1, limits the peptides to the two (b) species of claim 1, and states that “the permeation is facilitated by the chemical penetration enhancer.”
The ‘329 does not specifically claim the species of instant claim 10 nor “chemical penetration enhancer”.
The level of ordinary skill in the art is high.
The ‘456 teaches and evaluates the same peptides as instant (a) and the second (b) of claim 1, referenced as P4 (SEQ ID NO:9) and P4B (SEQ ID NO:11):
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The ‘456 teaches administering to a subject a composition comprising an effective amount of one or more peptides, wherein the one or more peptides consist of, SEQ ID NO: 9, SEQ ID NO: 10, SEQ ID NO: 11, or SEQ. ID NO: 12, para 24.
One of ordinary skill in the art would recognize that P4B would readily be interchangeable with P4, and based on the results could be advantageously substituted for the species claimed in the ‘329 claim 1.
The ‘456 does not teach chemical penetration enhancers specifically, however Ho, see rejection above, teaches the advantages of menthol in improving penetration.
Particularly, Ho concludes that “The enhancement effect of the penetration of indomethacin due to menthol is mainly due to its effect on the skin,” page 310.
Based on the latter statement, and further considering the hydrophobic effect of the alkyl tails of the claim 10 species are contributing to the overall hydrophobic nature, and also given the constituent amino acid side chains, these species reasonably are in the same grouping as indomethacin in being not highly water soluble, one of ordinary skill in the art would have been motivated to utilize menthol to enhance skin penetration/permeation.
The Reference patent claim 1 as modified by the ‘456 resulted in "base" peptides and methods upon which the claimed invention can be seen as an "improvement;" the prior art Ho contained a "comparable" products with menthol that showed increased skin penetration properties and capabilities, and although this is not the same as the ‘329 further modified by the ‘456 that has been improved in the same way as the claimed invention; one of ordinary skill in the art could have applied the known "improvement" technique - adding menthol, in the same way to the Reference patent claims’ peptide and methods, as modified by the ‘456 as set forth herein, and the results would have been predictable to one of ordinary skill in the art. There would have been a reasonable expectation of success at least given the clear statement in Ho that the enhancement effect of the penetration of indomethacin due to menthol is mainly due to its effect on the skin.
Accordingly, claim 10 would have been obvious and is rejected under this section.
Conclusion
No claim is allowed.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
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