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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 44-57 in the reply filed on 10/1/25 is acknowledged. Election was made without traverse in the reply filed on a peptide comprising GGL (CNTF compound), the sequence YLGA (FAS inhibitor) and the FAS inhibitor and CNTF compound are covalently bonded.
Claims 47, 54 and 58-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 44-63 are pending.
Claims 44-46, 48-52 and 55-57 read on the elected Group I and species and are under consideration.
Claim Objections
Claims 46, 49-50 are objected to because of the following informalities: The claim should recite the amino acid sequence of the compounds. For example, according to the specification, peptide 6 is SEQ ID NO: 1, peptide 21 is SEQ ID NO: 2, MET 12 is SEQ ID NO: 3 and MET4-8 is SEQ ID NO: 5. The sequence identifier is claimed in claims 45, 48, however claims 46 and 49-50 do not. The claims should be consistent and claim the sequence identifier. Appropriate correction is required.
Claims 48 and 50 are objected to because of the following informalities: Claim 48 claims SEQ ID NO: 5 which is the same at Met4-8. The sequence identifier should be used instead of Met4-8.
Claim Rejections - 35 USC § 112
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 44-46, 48-52 and 55-57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. 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.
Scope of the claimed genus
Claim 44 is drawn to a drug delivery system comprising 1) a CNTF compound, a TNF-alpha/TNFR inhibitor, or a combination thereof; and 2) a FAS or FASL inhibitor. The USPTO provides claim terms with broadest reasonable interpretation in light of the specification. With respect to the “CNTF compound”, the instant specification states [0007]: With respect to a subject drug delivery system, a neurotrophic agent can include a CNTF compound or another neurotrophic agent, a CNTF compound includes any compound having a structure or activity similar to ciliary neurotrophic factor (CNTF), including CNTF, protein derivatives of CNTF, or a CNTF peptide. Examples include CNTF, a peptide containing part of the CNTF sequence, such as a neurotrophic peptide containing the sequence DGGL (SEQ ID NO: 18), e.g. Peptide 6 (P6; Ac-VGDGGLFEKKL-NH2 (SEQ ID NO: 1)) and Peptide 21 (P21; Ac-DGGLAG-NH2 (SEQ ID NO: 2)), recombinant CNTF (rhCNTF), or a neurotrophic peptide identified in U.S. Pat. No. 8,592,374, which is incorporated herein by reference for its disclosure related to neurotrophic peptides, including neurotrophic peptides having an adamantly group at the C- and/or N-terminal end, or any other peptide having similar biological activity to CNTF. Other neurotrophic agents include nerve growth factor (NGF), Brain-derived neurotrophic factor (BDNF), glial cell-derived neurotrophic factor (GDNF), etc.
Therefore, the broadest reasonable interpretation of “CNTF compound” includes any structure similar to CNTF, including derivatives, fragments etc. The claim also includes any compound that has “similar” activity to CNTF.
With respect to the limitation “a FAS or FASL inhibitor”, the instant specification states [0010]: Useful FAS or FASL inhibitors include bicyclol, FLIP; MET12 (HHIYLGAVNYIY (SEQ ID NO: 3), HHIYLGATNYIY (SEQ ID NO: 4), or H60HIYLGATNYIY71 (SEQ ID NO: 4)), or a shorter fragment thereof, such as a tetramer having a sequence YLGA (SEQ ID NO: 5), or a fragment having a sequence homology of at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, or at least about 90% sequence homology to MET12, including compound having a sequence shown in Table 1 below, such as compound 1, compound 2, compound 3, compound 4, compound 5, compound 6, compound 7, compound 8, compound 9, compound 10, or compound 11, MET4-8 (YLGA (SEQ ID NO: 5), YLGAV (SEQ ID NO: 7), IYLGA (SEQ ID NO: 6), HIYLGA (SEQ ID NO: 8), IYLGAV (SEQ ID NO: 9), YLGAVN (SEQ ID NO: 19), IYLGAVN (SEQ ID NO: 11), HIYLGAV (SEQ ID NO: 10), or HIYLGAVN (SEQ ID NO: 20)), MET8 (HIYLGAVN), MET4 (YLGA (SEQ ID NO: 5)), ONL1204 (e.g. a peptide comprising or consisting of a sequence HHIYLGATNYIY (SEQ ID NO: 4)); other MET12 derivatives such as a compound having a sequence: H60HIYLGATNYIY71-NH2 (SEQ ID NO: 4), FAS apoptotic inhibitory molecule [FAIM]; NOL3 [nucleolar protein 3 (apoptosis repressor with CARD domain [ARC]), etc.]; human decoy receptor 1 (DcR1); human decoy receptor 2 (DcR2); or human decoy receptor 3 (DcR3).
Therefore, the broadest reasonable interpretation of “a FAS or FASL inhibitor” includes SEQ ID NO: 3-5, fragments thereof and peptides having at least 10% homology thereto.
The instant specification states [0013]: Useful TNF-α or TNFR inhibitors include etanercept, infliximab, golimumab, certolizumab, adalimumab, TNFR1-selective antagonistic mutant TNF (R1antTNF), DMS5540, TNF Receptor-One Silencer (TROS), ATROSAB.
Please note that the paragraphs cited above are not specific definitions of the CNTF compound, FAS or FASL inhibitors and TNF-alpha or TNFR inhibitors.
Assessment of whether species are support in the original specification
The complete structure of the following species was disclosed: SEQ ID NOs: 1-22 as examples of CNTF compounds and FAS and FASL inhibitors. Paragraph [0015] lists specific TNF-alpha or TNFR inhibitors.
There was no disclosure of other peptide sequences that are CTNF compounds, TNF-alpha inhibitors, TNFR inhibitor, FAS inhibitor or FASL inhibitors.
In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of SEQ ID NO: 1-22 and the TNF-alpha or TNFR inhibitors of [0015] at the time the invention was filed.
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. 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 the instant case, the disclosure of SEQ ID NOs: 1-22 and [0015] are not representative of the genus. The disclosure of the sequences and compounds are not representative of the entire genus encompassed by a CNTF compound, TNF-alpha/TNFR inhibitor and a FAS or FASL inhibitor is not representative of the genus because the genus is enormous. The genus includes fragments, variants, derivatives etc. Therefore, a few examples is not representative of the enormous genus.
Identifying characteristics and structure/function correlation
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, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of a CNTF compound, TNF-alpha/TNFR inhibitor and a FAS or FASL inhibitor. The data do not suggest the physical basis for the claimed activity and therefore do not describe which substitutions, deletions or additions could be made while preserving function. This is an issue of written description. The specification does not make clear which compounds are in the genus and which are not because it does not describe the physical basis for the claimed activity.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession SEQ ID NOs: 1-22 as examples of CNTF compounds and FAS and FASL inhibitors and the TNF-alpha or TNFR inhibitors recited in paragraph [0015 PGPUB].
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 46, 53, 56 and 57 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 46 is indefinite because the sequence of peptide 21 does not match the sequence of peptide 21 in the specification. Peptide 21 is Ac-DGGLAG-NH2 (SEQ ID NO: 2) in the instant specification. However, SEQ ID NO: 2 in the sequence listing is DGGLG. It is unclear what the superscript “A” is.
Claim 53 recites the limitation "the implant". There is insufficient antecedent basis for this limitation in the claim because claim 44 does not recite an implant.
Claims 56 and 57 recite the limitation "the sustained delivery component". There is insufficient antecedent basis for this limitation in the claim because claim 44 does not recite a sustained delivery component.
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.
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 44-46, 48, 50-53 and 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Mossler et al. (US2011/0160141) and Zarnegar et al. (US2007/0184522).
Mossler et al. neurotrophic peptide having the sequence Ac-VGDGGLFEKKL-NH2 (peptide 6) (Fig. 11 [0092], Ex. 5 [0177] and claim 1). Mossler et al. also teach the peptide Ac-DGGLAG-NH2 (peptide 21) ([0092 Mossler et al. teach the peptide for treating neurodegenerative disease such as Alzheimer’s disease (claims 13-15 [0053, 0077, Ex. 5]. As evidenced by claim 46, peptide 6 and peptide 21 are CNTF compounds. Mossler et al. teach pharmaceutical compositions comprising the peptide [0040].
Mossler et al. does not teach the pharmaceutical composition comprises a FAS or FASL inhibitor. However, the teachings of Zarnegar et al. cure this deficiency.
Zarnegar et al. teach polypeptides that attenuate activation of FAS, TNFR1 or both. Zargenar et al. teach a peptide that attenuates the activation of Fas and TNFR1 comprises 4 contiguous amino acids having the sequence YLGA (claims 2-3). Zarnegar et al. teach the composition for treatment of Alzheimer’s disease [0022], claims 22 and 27). As evidenced by instant claim 48, YLGA is a FAS or FASL inhibitor.
With respect to claim 44, It would have been obvious to one or ordinary skill in the art at the time of the invention to combine the CNTF compound from Mossler et al. and the FAS/FASL inhibitor from Zarnegar et al. for a pharmaceutical composition to treat Alzheimer’s disease. MPEP 2144.06 states: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, Mossler et al. teach the CNTF compounds for treatment of AD and Zarnegar et al. teach the FAS/FASL inhibitors for treatment of AD, therefore the prior art teaches the compositions useful for the same purpose. A reasonable expectation of success is expected given that each component are treatments of the same disease.
With respect to claims 45 and 46. Mossler et al. teach peptide 6 and 21 which comprise DGGL sequence.
With respect to claims 48 and 50, Zarnegar et al. teach the sequence YLGA which is identical to SEQ ID NO: 5 and MET4-8.
With respect to claim 51, Mossler et al. teach the CNTF compound at 0.1 μg to 100 mg ([0049] and claim 11).
With respect to claim 52, Zarnegar et al. teach the FAS or FASL inhibitor at a concentration of 1 μg/ml-5 μg/ml [0008,0009,0011] of the peptides. Zargengar et al. claim the peptides in an amount to sufficiently attenuate cell death in the population of cells (claim 17), The concentration of the active agent in a composition is a result-effective variable and the determination of the optimum or workable ranges of said variable maybe characterized by routine experimentation (Please see MPEP 2144 II-Optimization of Ranges). It would have been obvious and routine experimentation to a person of ordinary skill in the art with a reasonable expectation of success to optimize the concentration of the FAS/FASL inhibitor, to arrive at the dose ranges of claim 52.
With respect to claim 55, the references do not teach the CNTF compound and FAS/FASL inhibitor are covalently bonded. However, it would have been obvious to covalently bond them because both peptides were know therapeutic agents for the same general purpose and covalently joining them into a single construct was a well-known design strategy to ensure co-delivery between the two components. Moreover, a person a person of ordinary skill in the art would have a motivation to covalently link them because it would provide a single therapeutic to administer rather than separately administering two peptides. There is a reasonable expectation of success given that methods of linking peptides is routine and well known in the art.
Claims 44-46, 48-53 and 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Mossler et al. (US2011/0160141) and Zarnegar et al. (US2007/0184522) in view of Jiang et al. (Journal of Neuroinflammation (2015) Vol. 12 article number 179).
The teachings of Mossler et al. and Zarnegar et al. are presented above in detail. The references do not teach the FAS or FASL inhibitor is MET12. However, the teachings of Krishnan et al. cure this deficiency.
Jiang et al. teach the sequence of Met12 which is a small molecular weight inhibitor of FAS (methods section). Jiang et al. teach Met 12, a 12-amino acid peptide containing the YLGA motif (HHIYLGAVNYIY) in the N-terminal region of the extracellular domain of the α chain of Met that binds to Fas and prevents its activation by sequestering it. The Met12 of Jiang et al. meets the limitation of Met12 of claim 49.
It would have been obvious to a person of ordinary skill in the art to use the FAS/FASL inhibitor of Jiang et al. in the method of Mossler et al. and Zarnegar et al. because it binds to Fas and prevents it activation by sequestering it. There is a reasonable expectation of success given its known function. Furthermore, Zarnegar et al. teach the method of using the FAS/FASL inhibitors for treating AD.
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 44-46, 48-53 and 55-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,147,855 Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN anticipates the instant claims.
The USPN claims a method of treating glaucoma or ocular hypertension comprising prostaglandin, wherein the drug delivery system further comprises peptide 6, 221 or contains the sequence YLGA, wherein the drug delivery further comprises MET4-8. Therefore, the drug delivery system of the USPN comprises a CNTF compound and FAS or FASL inhibitor.
Claims 44-46, 48-53 and 55-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,128,104 Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN anticipates the instant claims.
The USPN claims a drug delivery system comprising a CNTF compound and FAS/FASL inhibitor covalently linked. The USPN claims the claimed range of components (claims 2-3). The instant specification teaches the FAS/FASL inhibitor is Met12 and the CNTF compound is peptide 6 and 21. The MPEP states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In the instant case, the specification was used to properly construe FAS/FASL inhibitor and CNTF compound.
Claims 44-46, 48-53 and 55-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/893,848 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising FAS/FASL inhibitor and TNFalpha/TNFR inhibitor, wherein they are covalently bonded. The copending application also claims the claimed concentration. The instant specification teaches the FAS/FASL inhibitor is Met12 and the CNTF compound is peptide 6 and 21. The MPEP states: The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In the instant case, the specification was used to properly construe FAS/FASL inhibitor and CNTF compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 48-53 and 55-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/274,423 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising prostaglandin, peptide 21 (CNTF compound) and a FAS/FASL inhibitor (claims 1-4), wherein the FAS/FASL inhibitor is MetA, or MET5-8. The CNTF and FAS/FASL meets the limitations of instantly claimed CNTF compound and FAS/FASL inhibitor. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 48-53 and 55-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/238,317 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising a CNTF compound and FAS/FASL inhibitor, wherein they are covalently bonded. The copending Application claim the same concentration of compounds. The CNTF compound meets the limitation of the CNTF compound instantly claimed. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 48-53 and 55-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/238,317 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising a CNTF compound and FAS/FASL inhibitor, wherein they are covalently bonded. The copending Application claim the same concentration of compounds. The CNTF compound meets the limitation of the CNTF compound instantly claimed. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 44-46, 48-53 and 55-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 17/843,796 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending Application anticipates the claims. The copending application claims a drug delivery system comprising prostaglandin and CNTF compound and FAS/FASL inhibitor, wherein they are covalently bonded. The CNTF and FAS/FASL inhibitor are claimed as peptide 6, 21 and SEQ ID NO: 5, which meet the limitation of the CNTF compound and FAS/FASL inhibitor instantly claimed. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/TARA L MARTINEZ/ Examiner, Art Unit 1654