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 .
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 contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in claims 5 and 12.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
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) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on June 17, 2026, is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of the species SEQ ID NO: 4 in the reply filed on June 17, 2026, is acknowledged. The elected species was searched and prior art was found on SEQ ID NO: 4 and on SEQ ID NOs: 2-4. Therefore, the search was not extended further in accordance with MPEP § 803.02.
Claim Objections
Claim 14 is objected to because of the following informalities: the acronym PD should be defined the first time it appears in the claims to avoid confusion. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-10 and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
Regarding claims 9-10 and 14, BRI of the claims includes a pharmaceutical composition comprising the wild-type NEMO-binding domain (wtNBD) peptides SEQ ID NOs: 1 and 3. Instant SEQ ID NOs: 1 and 3 correspond to residues 735-745 and residues 737-743 of human IKKb protein, as evidenced by Figure 2B of May (NPL U, PTO-892).
Step 1: Claims 9-10 and 14-15 are to a composition of matter.
Step 2A, Prong 1: Claims 9-10 and 14-15 are directed to a product of nature, the wtNBD peptides SEQ ID NOs: 1 and 3. The closest counterpart to the nature-based product is the human IKKb protein. The claimed peptide has a different structural characteristic than the natural peptide, i.e., the natural peptide has covalent bonds on its ends that connect it to the rest of the protein whereas the claimed peptide lacks these bonds. However, the claimed peptide is otherwise structurally identical to the natural peptide, e.g., they had the same peptide backbone and amino acid sequence as human IKKb protein in nature. This difference is not a marked difference in view of MPEP § 2106.04(c)(II)(C)(2) and the Supreme Court decision in Myriad. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977. In addition, the function of the claimed peptide, slowing or inhibiting the progression of an a-synucleinopathy disorder or microglial activation disorder, is innate to the peptide itself, and was not created or altered by the inventor, including by gathering the peptide in an amount sufficient to carry out the function. See Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244. In sum, the claimed peptides are different, but not markedly different, from their naturally occurring counterparts and thus are natural phenomenon exceptions
Step 2A, Prong 2: The claim only recites the peptide, which is a natural phenomenon exception.
Because the limitation a pharmaceutical composition and therapeutically effective amount does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (MPEP § 2106.04(d)(2)).
Step 2B: Because the limitation a pharmaceutical composition and therapeutically effective amount does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, the claim does not amount to significantly more than the judicial exception (MPEP § 2106.05).
Therefore, claims 9-10 and 14-15 are patent ineligible.
Regarding claim 13, BRI of the claim includes a pharmaceutical composition comprising the wild-type NEMO-binding domain (wtNBD) peptides SEQ ID NOs: 1 and 3 in a carrier such as water. Instant SEQ ID NOs: 1 and 3 correspond to residues 735-745 and residues 737-743 of human IKKb protein, as evidenced by Figure 2B of May (NPL U, PTO-892).
Step 1: Claim 13 is to a composition of matter.
Step 2A, Prong 1: Claim 13 is directed to a product of nature, the wtNBD peptides SEQ ID NOs: 1 and 3 and the pharmaceutically acceptable carrier, which may be a nature-based product such as water. Because the peptide and water as claimed are not found together in nature, the closest counterpart to the nature-based products is human IKKb protein and water. As determined in the analysis of claims 9-10 and 14-15 above, the claimed peptide is different, but not markedly different from human IKKb protein. There is no evidence on record that mixing the claimed peptide with water changes the structure, function, or other properties of either the peptide or water in a marked way. Thus, for at least one embodiment of the claim with the BRI (e.g. wherein the carrier is water), the claimed mixture as whole does not display markedly different characteristics compared to the naturally-occurring counterparts. Instead, the peptide and water have the same characteristics in the mixture as the individual components, the same chemical structure and the same function of slowing or inhibiting the progression of an a-synucleinopathy disorder or microglial activation disorder and being a solvent. See Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948). Accordingly, each component, the peptide and the carrier, is a natural phenomenon exception.
Step 2A, Prong 2: The claim only recites the peptide and the carrier, which are natural phenomenon exceptions. Because there are no additional claim elements besides the judicial exceptions, the judicial exceptions are not integrated into a practical application (MPEP § 2106.04(d)(III)). In addition, because the limitation a pharmaceutical composition and therapeutically effective amount does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (MPEP § 2106.04(d)(2)).
Step 2B: Prior to applicant’s invention and at the time of filing the application, using a carrier for a peptide was well-understood, routine, and conventional, as evidenced by [0044] of the original specification. Because mixing the peptide with a carrier at this high level of generality does not meaningfully limit the claim, the claim does not amount to significantly more than the judicial exception (MPEP § 2106.05). In addition, because the limitation a pharmaceutical composition and therapeutically effective amount does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (MPEP § 2106.04(d)(2)).
Therefore, claim 13 is patent ineligible.
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.
Claims 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by May (US 2002/0156000 A1, hereafter “May”).
May teaches pharmaceutical compositions comprising a NEMO-binding domain ([0013]-[0014]), wherein the NEMO-binding domain peptide inhibits NF-kB activation ([0019], Figures 4-6). May teaches that the NEMO-binding domain may be from the wild type amino acid sequence of the NBD of IKKa or IKKb, LDWSWL (SEQ ID NO: 2) ([0061]), which is identical to instant SEQ ID NO: 3 (see also Figures 4F and 12A). May also teaches the peptide drqikiwfqnrrmkwkkTALDWSWLQTE (SEQ ID NO: 18) (Figure 5A), which is the peptide region from T735 to E745 of IKK fused with a sequence derived from the Antennapedia homeodomain that mediates membrane translocation and which is identical to instant SEQ ID NO: 2. Both of these peptides taught by May are species in the claimed genus “wtNBD peptide,” as evidenced by dependent claim 10.
May teaches that the compositions comprise a therapeutically effective amount of the peptide, e.g. an amount effective to treat an inflammatory disorder in a subject ([0115]). May teaches that the therapeutically effective amount may range from about 0.1 to 20 mg/kg body weight, and even more preferably about 1 to 10 mg/kg, 2 to 9 mg/kg, 3 to 8 mg/kg, 4 to 7 mg/kg, or 5 to 6 mg/kg body weight ([0116]), which is the same as the therapeutically effective amount presented in the instant specification ([0073]).
Therefore, May satisfies all of the structural limitations of claim 9 i.e. it comprises the same active agent in the same amount as claimed.
The limitation “for slowing or inhibiting the progression of an a-synucleinopathy disorder or a microglial activation disorder” in the preamble of claim 9 is an intended use limitation. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the composition satisfies all of the structural limitations of instant claims 9, i.e. it comprises the same active agent in the same amount as claimed. Because structure and function are linked, the prior art composition must be capable of performing the intended use.
Therefore, May anticipates claim 9.
Regarding claim 10, May teaches that the wtNBD peptide may be LDWSWL (SEQ ID NO: 2) ([0061]), which is identical to instant SEQ ID NO: 3 (see also Figures 4F and 12A), or drqikiwfqnrrmkwkkTALDWSWLQTE (SEQ ID NO: 18) (Figure 5A), which is identical to instant SEQ ID NO: 2. May also teaches that LDWSWL (SEQ ID NO: 2) can be fused to the Antennapedia homeodomain sequence ([0015], claims 16-19), shown in Figure 5A as drqikiwfqnrrmkwkk, which is a peptide identical to instant SEQ ID NO: 4.
Regarding claim 11, May teaches that the wtNBD peptide LDWSWL (SEQ ID NO: 2) may be fused to the membrane translocation domain ([0015], claims 16-19).
Regarding claim 12, May teaches that the membrane translocation domain may be of the third helix of the antennapedia homeodomain ([0015], claim 18). May also teaches the peptide drqikiwfqnrrmkwkkTALDWSWLQTE (SEQ ID NO: 18) (Figure 5A), which is the instantly claimed Antennapedia homeodomain sequence drqikiwfqnrrmkwkk fused to the wtNBD TALDWSWLQTE.
Regarding claim 13, May teaches the composition further comprises one or more pharmaceutically acceptable carriers ([0017], [0121]).
Regarding claim 14, the limitation “wherein the a-synucleinopathy disorder or a microglial activation disorder is selected from the group consisting of multiple system atrophy (MSA), dementia with Lewy bodies (DLB), PD, multiple sclerosis (MS), optic neuritis (ON), Huntington disease (HD), and Amyotrophic lateral sclerosis (ALS)” is an intended use limitation. The recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the composition satisfies all of the structural limitations of instant claim 14 and is therefore capable of performing the intended use.
Regarding claim 15, May teaches that the formulation may be intranasal ([0114]).
Claims 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rangasamy et al. (Intranasal Delivery of NEMO-Binding Domain Peptide Prevents Memory Loss in a Mouse Model of Alzheimer’s Disease. Journal of Alzheimer’s Disease, Volume 47, Issue 2, 24 July 2015, Pages 385-402, hereafter “Rangasamy”).
Rangasamy teaches a pharmaceutical compositions comprising a wild-type NEMO-binding domain, wherein the NEMO-binding domain peptide inhibits NF-kB activation (p. 391, col. 2, para. 2 - p. 393, col 1, para. 1). Rangasamy teaches that the NEMO-binding domain peptide is drqikiwfqnrrmkwkkLDWSWL (p. 388. col. 1, para. 1), which is the peptide region from 737-743 of IKKb (uppercase) fused with a sequence derived from the Antennapedia homeodomain that mediates membrane translocation (lowercase) and which is identical to the elected species instant SEQ ID NO: 4. This peptides is a species in the claimed genus “wtNBD peptide,” as evidenced by dependent claim 10.
Rangasamy teaches that the compositions comprise a therapeutically effective amount of the peptide, e.g. an amount effective to inhibit the induction of NF-κB activation, inhibit inflammation, reduce plaque formation in the hippocampus, suppress neuronal degeneration, restore plasticity-related molecules in the hippocampus, protect spatial learning and memory, and treat Alzheimer’s Disease (pp. 391-399; p. 401, col. 1, para. 2). Alzheimer’s Disease is a species in the genus “an a-synnucleinopathy disorder or a microglial activation disorder”, as evidenced by dependent claim 14.
Therefore, Rangasamy teaches all of the structural and functional limitation of and anticipates claims 9 and 14.
Regarding claims 10-12, Rangasamy teaches that the NEMO-binding domain peptide is drqikiwfqnrrmkwkkLDWSWL (p. 388. col. 1, para. 1), which is the peptide region from 737-743 of IKKb (uppercase) fused with a sequence derived from the Antennapedia homeodomain that mediates membrane translocation (lowercase) and which is identical to the elected species instant SEQ ID NO: 4.
Regarding claim 13, Rangasamy teaches that the pharmaceutical composition further comprises a pharmaceutically-acceptable carrier, normal saline (p. 388, col. 1, top).
Regarding claim 15, Rangasamy teaches that the pharmaceutical composition is administered intranasally (p. 388, col. 1, top).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 8:30 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTINA M MARCHETTI BRADLEY
Primary Examiner
Art Unit 1654
/CHRISTINA M MARCHETTI BRADLEY/ Primary Examiner, Art Unit 1654
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