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 .
Claims Status
The remarks filed 11/04/2025 are acknowledged.
Claims 1-12 are amended and pending.
Applicant’s election without traverse of the following species in the reply filed on 11/04/2025 is acknowledged: skin dyschromia, a peptide of 14 amino acids having the sequence of SEQ ID NO: 1, acyl for the organic compound, pharmaceutically acceptable vehicles for the pharmaceutically acceptable excipient, and vitiligo for the specific type of skin dyschromia. Upon further consideration, the election of species requirement among Species Group B is withdrawn
Claims 11 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/04/2025.
Therefore, claims 1-10 are under examination.
Priority
The instant application is a 371 of PCT/IB2021/057631 and claims priority to Italian Republic Application IT102020000020287. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Priority is given to the Italian application with the earliest effective filing date of 08/20/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/30/2023, 12/12/2024, and 10/02/2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
The NPL documents lined through on the 12/12/2024 IDS were not considered because they are not in English. The foreign patent document lined through on the 10/02/2025 IDS was not considered because it is not in English.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Specification
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code (see page 5, line 16 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1-2 and 5 are objected to because of the following informalities: the claims contain internal periods (i.e. “sequence ID No. 1”). “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” MPEP 608.01(m)." Appropriate correction is required. The Examiner recommends amending the claims to recite “SEQ ID NO: 1” and to be consistent throughout the application with the sequence identifier.
Further, “the sequence ID No. 1” is grammatically awkward and the Examiner recommends amending the claims to remove “the” and recite “SEQ ID NO: 1”. Appropriate correction is required.
Claims 1-2 and 5-6 are objected to because of the following informalities: The claims recite the limitation “preferably.” MPEP 2173.05(d) states, “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.” The “preferably” should be removed entirely. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The claim recites “idiopathic and post-inflammatory guttata hypomelanosis”. The “guttata” is spelled incorrectly and should read as “guttate”. Appropriate correction is required.
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 1-10 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.
Claims 1 and 5 are drawn to a method for the treatment and/or prevention of skin dyschromia and/or de-innervation disease of the skin of a subject, the method comprising administering to the subject (a pharmaceutical composition consisting of, as required by claim 5): a peptide of 14 amino acids having the sequence of ID No. 1, a peptide of up to 16 amino acids having a sequence with at least 85%, preferably at least 90%, and preferably at least 95% identity with sequence ID No. 1, or a derivative and/or salt thereof, and as required by instant claim 5, at least one pharmaceutically acceptable excipient. Claim 3 adds the limitation of wherein said derivative or salt thereof includes an N and/or a C terminal of said peptide which is chemically modified or protected with an organic compound and claim 4 adds the limitation of wherein said compound is selected from the group consisting of phosphoryl, glycosyl, acyl, alkyl, carboxyl, hydroxyl, biotinyl, ubiquitinyl, and amide.
The specification states that a peptide of up to 16 amino acids with at least 85% sequence identity to SEQ ID NO: 1 comprises conservative amino acid substitutions which do not affect peptide activity. The specification also states that preferably, said derivative comprises an N and/or a C terminal of said peptide which is chemically modified or protected with an organic compound; more preferably, said organic compound is selected from the group consisting of phosphoryl, glycosyl, acyl, alkyl, carboxyl, hydroxyl, biotinyl, ubiquitinyl, and amido groups [page 7, lines 1-6]. Additionally, the derivative of the peptide is not limited to a chemically modified or protected N and/or C terminal. This is only a preferred example of the derivative may be and is not deemed predicative of all possible derivatives of the peptide, which could encompass the peptide with any number of modifications, substitutions, deletions, or insertions, so long as the resulting “derivative” peptide originates from the original peptide. The specification provides no example of what amino acid or where the amino acid can be substituted, deleted, or inserted while still retaining the function of the NGF(1-14) peptide, nor does the specification teach any functional NGF peptide comprising anything less than 100% sequence identity to SEQ ID NO: 1 (i.e. NGF(1-14)).
One means of providing adequate written description and evidence of
possession of a claimed genus is through providing sufficient distinguishing identifying
characteristics of the genus. The factors to be considered include disclosure of
complete or partial structure, physical and/or chemical properties, functional
characteristics, structure/function correlation, methods of making the claimed product,
or any combination thereof. In this case, the claim does not require that the modifications be made at specific amino acid residues or in a particular region of the sequences, and thus, the claims are drawn to a broad genus of a first fragment of the nCas9 protein with up to 156 substitutions or deletions in SEQ ID NO: 1 (SEQ ID NO: 1 consists of 1046 residues; 15% of 1046 is 156) and a second fragment of the nCas9 protein with up to 45 substitutions or deletions in SEQ ID NO: 2 (SEQ ID NO: 2 consists of 305 residues; 15% of 305 is 45).
Claims 1 and 5 are drawn to a variable sequence for the NGF peptide without any requirement for where these modifications occur within the sequence. Making deletions, insertions, or substitutions to a polypeptide sequence, while requiring the polypeptide to still maintain its function, is highly unpredictable. Bhattacharya et al., 2017 (instant PTO-892) teaches that the range of possible effects of even single variations at the protein level are significantly greater than currently assumed by existing software prediction methods, and that correct prediction of consequences remains a significant challenge [page 18, third paragraph]. Fenton et al., 2020 (instant PTO-892) teaches that while it is well known that most substitutions at conserved amino acid positions (which they call “toggle” switches) abolish function, it is also true that substitutions at nonconserved positions (which they call “rheostat” positions) are equally capable of affecting protein function, and that each substitution has a different functional outcome, and the set of substitutions spans a range of outcomes [see Abstract]. Further, Guo et al., 2004 (instant PTO-892) teaches that the effects of mutations on protein function are largely additive [page 9207, left column, third paragraph], supporting that when multiple mutations are introduced, there is even less predictability. Thus, it is clear that the structure of variable sequences of proteins does not predictably correlate with the function thereof.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must
describe an invention and does so in sufficient detail that one skilled in the art can
clearly conclude that "the inventor invented the claimed invention." Lockwood v.
American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re
Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he
description must clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed."). Thus, an applicant complies with the written
description requirement "by describing the invention, with all its claimed limitations, not
that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
A "representative number of species" means that the species, which are
adequately described, are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species
to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if
the disclosure "indicates that the patentee has invented species sufficient to constitute
the gen[us]. "See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.
Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir.
2004) "[A] patentee of a biotechnological invention cannot necessarily claim a genus
after only describing a limited number of species because there may be unpredictability
in the results obtained from species other than those specifically enumerated."). "A
patentee will not be deemed to have invented species sufficient to constitute the genus
by virtue of having disclosed a single species when ... the evidence indicates ordinary
artisans could not predict the operability in the invention of any species other than the
one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.
2004).
Thus, based on the lack of teachings in the specification and the teachings in the art, Applicant has failed to meet the written description of a peptide that has anything less than 100% sequence identity to SEQ ID NO: 1 for the NGF peptide. Therefore, one of skill in the art would not conclude that Applicant was in possession of an NGF peptide that has less than 100% sequence identity to SEQ ID NO: 1 and retains its function.
Claims 2-4 and 6-10, which depend from claims 1 and 5 respectively, are thereof deficient for the same reasons set forth above and do not meet the written description requirement.
Enablement
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating skin dyschromia, does not reasonably provide enablement for preventing skin dyschromia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and
Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v.
Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (5) The breadth of the claims:
The claims are drawn to a method for the treatment and/or prevention of skin dyschromia comprising administering to the subject a peptide of 14 amino acids having sequence ID No. 1, a peptide of up to 16 amino acids having a sequence with at least 85%, preferably at least 90%, and preferably at least 95% identity with sequence ID No. 1, or a derivative and/or salt thereof. Claim 9 adds the limitation wherein the skin dyschromia is selected from the group consisting of: vitiligo, bilateral vitiligo, acrofacial vitiligo, generalized vitiligo, focal vitiligo, segmental vitiligo, universal vitiligo, perinevic or Sutton's nevus vitiligo, leukoderma, skin dyschromia, piebaldism, pityriasis alba, pityriasis versicolor, idiopathic and post-inflammatory guttata hypomelanosis, acromic or depigmented nevi, progressive macular hypomelanosis, hypomelanosis caused by metabolic or nutritional or endocrine disorders, hypomelanosis caused by chemical, physical or pharmaceutical agents, infectious and post-infectious hypomelanosis, and inflammatory edipomelanosis. There is no support in the instant specification or in the prior or instant art that teaches or supports the ability to prevent any skin dyschromia related condition.
The term "preventing" is generally understood in the art to encompass a total protection from disease or injury. Thus, given the high level of required effect, a high level of evidence showing prevention is also required. As noted above, however, there are no working examples in the instant specification demonstrating any therapy using the claimed treatment, nor any examples directed to the palliative, preventative, or curative treatment of any skin dyschromia related condition. Therefore, the instant specification does not provide evidence or substantial guidance commensurate in scope with the broadly claimed method and how to use the method to prevent any skin dyschromia related condition.
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
Skin dyschromia can be caused by numerous underlying conditions and the state of the art with regards to preventing any skin dyschromia related condition is underdeveloped. The instant specification itself does not teach any method or treatment that would prevent any skin dyschromia related condition. One such condition that causes skin dyschromia encompassed by the claims is vitiligo. Shmerling, 2024 (instant PTO-892) teaches that vitiligo is an autoimmune disorder, in which the body’s immune system mistakenly targets and injures melanocytes [page 1], and that there is no way to prevent vitiligo, and that even treatment can be difficult [page 4]. Another condition that can cause skin dyschromia encompassed by the claims is Idiopathic Guttate Hypomelanosis (IGH). Williams, 2024 (instant PTO-892) teaches that the cause of IGH is unknown, tends to increase with age [page 2, second paragraph] and cannot be completely prevented [page 3, fifth paragraph].
Given the teachings above, the relevant art recognizes the unpredictability, and inability, of methods directed to treating any skin dyschromia related condition. Thus, the disclosure is not considered fully enabling for the claimed invention and the prior art does not compensate for the failings of the instant specification. This would require undue experimentation. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without such guidance, the changes which can be made and still maintain activity/utility is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Int. 1986).
(6) the amount of direction or guidance presented; (7) the presence or absence of working examples:
There is a lack of working examples in the specification for preventing any skin dyschromia related condition encompassed by the instant claims. Applicant has provided evidence of treating a mouse model of vitiligo using the claimed method [see Example 2]. However, Applicant has not provided any substantive evidence of preventing any skin dyschromia related condition using the claimed methods. Because the underlying cause of the skin dyschromia can vary, a demonstration of treatment or support of a given condition that can cause skin dyschromia does not support for the breath of the claim.
In conclusion, the claimed invention does not provide enablement for preventing any skin dyschromia related condition encompassed by the instant claims. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, and the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
Claims 2-4 and 6-10, which depend from claims 1 and 5, respectively, are rejected for the same reasons set forth above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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.
Claims 1-2 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO2013065078; 06/30/2023 IDS) in view of Travaglia et al., 2015 (instant PTO-892).
Regarding claims 1, 2, 5, 8, and 9, Liotta teaches that the topical administration to the skin of preparations containing Nerve Growth Factor (NGF) is effective in achieving an intensification of skin color, i.e. an increase in pigmentation, and improvement (treatment) of dermatological conditions involving skin achormias or hypochromias, such as in vitiligo [page 9, lines 14-20]. Liotta further teaches that a re-pigmentation of de-pigmentated areas was observed in patients suffering from vitiligo following treatment with a preparation of topical base cream containing NGF [page 9, lines 21-25]. Liotta also teaches that the solution, suspension or emulsion containing NGF according to the invention may contain various additional biologically active components, and/or NGF can be conjugated with carrier molecules or with molecules known to facilitate the permeation through the epidermis, or with cosmetically acceptable vehicles [page 13, lines 3-14]. Liotta additionally teaches that the NGF can be any NGF protein of human origin, murine origin, or a recombinant human NGF [page 12, lines 8-9].
However, Liotta does not specifically teach that the NGF is a peptide of 14 amino acids having the sequence of SEQ ID NO: 1. The Examiner notes that SEQ ID NO: 1 of the instant claims is disclosed as a NGF 1-14 peptide [see page 3, lines 8-10 of the instant specification].
Travaglia teaches a human NGF(1-14) peptide fragment that is the first monomer and linear N-terminal NGF peptide sequence that is able to activate the NGF signaling cascade, and the NGF(1-14) sequence is SSSHPIFHRGEFSV [page 1388, left column, fourth-fifth paragraphs].
The NGF(1-14) sequence of Travaglia has 100% sequence identity to the SEQ ID NO: 1 of the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the NGF protein of Liotta to specifically be the NGF(1-14) peptide of Travaglia. One would have been motivated to have used the NGF peptide of Travaglia because Liotta teaches that the NGF protein can be any NGF protein of human origin, murine origin, or a recombinant human NGF and Travaglia teaches that the NGF(1-14) is a human NGF peptide fragment and is able to activate the NGF signaling cascade. Further, one would have been motivated to use the specific NGF(1-14) sequence of Travaglia because it is a known sequence in the art, and it is obvious to use known variations in the prior art for predictable outcomes. See MPEP 2143 (F).
Claim 6 is included in this rejection because Liotta teaches that the preparation containing NGF contains 10 to 1000 ug/mL of NGF [page 18, lines 1-4]. MPEP 2144.05 (I) states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.”
Claim 7 is included in this rejection because Liotta teaches that that the preparation containing NGF is for topical application [page 11, lines 6-11] and can be in the form of a lotion, spray, cream, ointment, or gel [page 13, lines 23-25].
Claim 10 is included in this rejection because Liotta teaches that in that the method for therapy of dermatological dyschromic disorders by applying a preparation containing NGF on the skin are to be treated is combined with a topical steroid preparation [page 18, lines 21-25 and page 24; claims 10 and 13].
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Liotta (WO2013065078; 06/30/2023 IDS) in view of Travaglia et al., 2015 (instant PTO-892), as applied to claims 1-2 and 5-10 above, and further in view LifeTein, 2008 (instant PTO-892).
The teachings of Liotta and Travaglia are above.
However, Liotta and Travaglia do not teach chemically modifying or protecting the N and/or C terminal of the peptide with an acyl compound to create a peptide derivative.
Regarding claims 3 and 4, LifeTein teaches that N-terminal acetylation can increase the stability of the peptide, increasing the peptides ability to resist enzymatic degradation, and the N-terminal acetylation generates a closer mimic of the native protein, and thus, increases the biological activity of the peptide and increases its ability to enter cells [see pages 2-3].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the NGF peptide, as taught by Liotta and Travaglia, to comprise an N-terminal acetylation, as taught by LifeTein. One would have been motivated to make this modification because LifeTein teaches that N-terminal acetylation can increase the stability of the peptide, increasing the peptides ability to resist enzymatic degradation, and generates a closer mimic of the native protein, thus increasing the biological activity of the peptide and its ability to enter cells.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675