DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 for the cited rejections 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.
3. Response to Election/Restriction filed on 6/8/2026 is acknowledged.
4. Claim filed on 6/8/2026 is acknowledged.
5. Claims 1-33 have been cancelled.
6. New claims 49-52 have been added.
7. Claims 34-52 are pending in this application.
8. Claims 47 and 48 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 35-43 are withdrawn from consideration as being drawn to non-elected species.
9. Claims 34, 44-46 and 49-52 are under examination.
Election/Restrictions
10. Applicant’s election without traverse of Group 1 (claims 34-46 and 49-52) and election without traverse of a fusion protein consisting of SEQ ID NO: 9 (DN-MAML) modified to introduce a maleimide group on the N-terminal residue, which is conjugated to SEQ ID NO: 16 (ANTP) comprising an additional cysteine at its C-terminus, via a thioether bond between the thiol of the additional cysteine at the C-terminus of SEQ ID NO: 16 and the maleimide linked to the N-terminal residue of SEQ ID NO: 9
as species of composition of matter in the reply filed on 6/8/2026 is acknowledged. The requirement is made FINAL in this office action.
Group 1 is drawn to a composition of matter selected from the group consisting of: (i) a cell-penetrating peptide (CPP) comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein; (ii) a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein; and (iii) a pharmaceutical composition comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) or a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 34; and prior art was found. Claims 35-43 are withdrawn from consideration as being drawn to non-elected species. Claims 34, 44-46 and 49-52 are examined on the merits in this office action.
Sequence Non-Compliance
11. This application contains sequence disclosures that are encompassed by 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 through 1.825 for the reason(s) set forth below. All sequences disclosed in the application must comply with the requirements of 37 C.F.R. 1.821-1.825, not only those recited in the claims.
In the instant case, the instant specification discloses the amino acid sequence (Gly)8 on page 21, line 9 of instant specification. However, this peptide is not disclosed in the filed sequence listing.
All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database.
Objections
12. The specification is objected to for the following minor informality: The specification discloses the amino acid sequence (Gly)8 on page 21, line 9 of instant specification. However, this peptide is not disclosed in the filed sequence listing; and it is missing the sequence identifier. Applicant is required to amend the specification to comply with 37 CFR 1.821(c) and 1.821(d).
13. The specification is objected to for the following minor informality: The specification recites “he origin of CPP can also vary” on page 9, line 7 of instant specification, There appears to be a typo in this recitation. Applicant is required to correct this error.
14. The specification is objected to for the following minor informality: The specification recites “https://www.rcsb.org/pdb/explore/explore.do?structureid=lSAN” on page 34, line 11 of instant specification. The embedded hyperlinks and/or other forms of browser-executable code are impermissible and require deletion. It is suggested that Applicant places a URL between these symbols “< >” to inactivate the hyperlinks. Applicant is required to correct these errors.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
15. The drawings are objected to for the following minor informality:
Figures 3, 8, 9, 14 and 17 contain multiple figures. For example, figure 3 contains figures 3A-3D; and each of these figures needs its individual description of the drawings.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
16. Claim 34 is objected to for the following minor informality: Applicant is suggested to amend claim 34 as “A composition of matter selected from the group consisting of: (i) a cell-penetrating peptide (CPP) comprising from 10 to 60 contiguous amino acids of an Antennapedia (ANTP) protein; (ii) a fusion protein comprising the CPP of (i) and a therapeutically useful protein; and (iii) a pharmaceutical composition comprising (i) or (ii)”.
17. Claim 44 is objected to for the following minor informality: Claim 44 contains the acronym “STAT3”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, signal transducer and activator of transcription 3 (STAT3). The abbreviation can be used thereafter.
Furthermore, Applicant is suggested to amend claim 44 as “The composition of matter according to claim 34, wherein the composition of matter is the fusion protein, and wherein the therapeutically useful protein is a dominant-negative (DN) protein; optionally wherein the DN protein is…”.
18. Claim 45 is objected to for the following minor informality: Claim 45 contains various acronyms, such as “EDC” and many others. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, for example, 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC). The abbreviations can be used thereafter.
Furthermore, Applicant is suggested to amend claim 45 as “The composition of matter according to claim 44, wherein the CPP is covalently linked to the DN protein via a zero-length crosslinker…”.
19. Claim 46 is objected to for the following minor informality: Applicant is suggested to amend claim 46 as “The composition of matter according to claim 34, wherein the composition of matter is the fusion protein, and wherein the CPP further comprises an additional cysteine at its N- or C-terminus; the therapeutically useful protein is DN-MAML, wherein the DN-MAML is conjugated to the CPP via a thioester bond formed with the cysteine thiol at the N or C terminus of the CPP sequence”.
20. Claim 49 is objected to for the following minor informality: Applicant is suggested to amend claim 49 as “The composition of matter according to claim 46, wherein the CPP comprises SEQ ID NO: 16 and/or the DN-MAML comprises SEQ ID NO: 9”.
21. Claim 50 is objected to for the following minor informality: Applicant is suggested to amend claim 50 as “The composition of matter according to claim 49, wherein the CPP comprises SEQ ID NO: 16 and the DN-MAML comprises SEQ ID NO: 9”.
22. Claim 51 is objected to for the following minor informality: Applicant is suggested to amend claim 51 as “The composition of matter according to claim 50, wherein the amino acid sequence of DN-MAML is modified to comprise a maleimide group”.
23. Claim 52 is objected to for the following minor informality: Applicant is suggested to amend claim 52 as “The composition of matter according to claim 51, wherein the additional cysteine is at the C-terminus of the CPP, and wherein the additional cysteine forms a thioether bond with the maleimide group in the DN-MAML”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
24. 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.
25. Claims 44-46 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 pre-AIA the applicant regards as the invention.
26. Claim 44 recites the limitation “optionally wherein the dominant-negative protein is a dominant-negative mastermind-like protein (DN-MAML), AKT-DN or STAT3; optionally wherein the DN-MAML comprises the sequence of SEQ ID NO: 9 or a sequence with 80% sequence identity thereto”. It is unclear whether the recited “optionally wherein the dominant-negative protein is a dominant-negative mastermind-like protein (DN-MAML), AKT-DN or STAT3; optionally wherein the DN-MAML comprises the sequence of SEQ ID NO: 9 or a sequence with 80% sequence identity thereto” further limits the dominant-negative protein to a DN-MAML comprises the sequence of SEQ ID NO: 9 or a sequence with 80% sequence identity thereto only or not. In the instant case, it appears such recitations are preferred embodiments. Therefore, the metes and bounds of instant claim 44 is vague and indefinite. Because claims 45 and 46 depend from indefinite claim 44 and they do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
27. Claim 45 recites both the optionally limitations and many parenthetical recitations. The metes and bounds of claim 45 is rendered vague and indefinite by the parenthetical recitations because it is unclear as to whether the limitations are part of the instantly claimed subject matter. Furthermore, it appears the recited optionally limitations are preferred embodiments. Taken all these together, the metes and bounds of instant claim 45 is vague and indefinite.
28. Claim 46 recites the limitation “optionally wherein the DN-MAML protein comprises the sequence of SEQ ID NO: 9 or a sequence with 80% sequence identity thereto; and/or the DN-MAML protein comprises a maleimide group”. It is unclear whether the recited “optionally wherein the DN-MAML protein comprises the sequence of SEQ ID NO: 9 or a sequence with 80% sequence identity thereto; and/or the DN-MAML protein comprises a maleimide group” further limits the DN-MAML to one comprising the sequence of SEQ ID NO: 9 or a sequence with 80% sequence identity thereto; and/or one comprising a maleimide group only or not. In the instant case, it appears such recitation is a preferred embodiment. Therefore, the metes and bounds of instant claim 46 is vague and indefinite.
Furthermore, for the purpose of this examination, the Examiner is interpretating the optional limitations and/or the parenthetical recitations recited in instant claims 44-46 do not further limit the composition of matter recited in these claims. Such interpretation applies to all the rejections set forth below.
Claim Rejections - 35 U.S.C. § 102(a)(1)
29. 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.
30. Claims 34, 44 and 45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Epenetos (WO 2019/038562 A1, filed with IDS).
The instant claims 34, 44 and 45 are drawn to a composition of matter selected from the group consisting of: (i) a cell-penetrating peptide (CPP) comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein; (ii) a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein; and (iii) a pharmaceutical composition comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) or a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein.
Epenetos teaches a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a cell penetrating peptide (CPP), (b) a second moiety derived from the Mastermind-like (MAML) protein, and (c) a connecting peptide (a hetero-bifunctional crosslinker); wherein the first region can be ANTP or its variants of SEQ ID NO: 2 or 3, or penetratin or its variants of SEQ ID NO: 4 or 5; wherein the second moiety is dominant negative MAML (dnMAML) of SEQ ID NO: 9, for example, page 1, lines 5-9; page 3, lines 22-23; page 5, lines 10-22; and page 21, line 4 to page 23, line 9. It meets the limitations of the fusion protein recited in instant claims 34, 44 and 45.
Since the reference teaches all the limitations of instant claims 34, 44 and 45; the reference anticipates instant claims 34, 44 and 45.
Claim Rejections - 35 U.S.C. § 103
31. 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 of this title, 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.
32. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
33. Claims 34, 44-46 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Epenetos (WO 2019/038562 A1, filed with IDS), and as evidenced by Epenetos (US 11357863 B2, US patent issued from US equivalent of WO 2019/038562 A1), and in view of Wei et al (CN 109420178 A, machine translation used and enclosed pages 1-81).
The instant claims 34, 44-46 and 49 are drawn to a composition of matter selected from the group consisting of: (i) a cell-penetrating peptide (CPP) comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein; (ii) a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein; and (iii) a pharmaceutical composition comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) or a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein.
Epenetos, throughout the patent, teaches a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a cell penetrating peptide (CPP), and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP can be ANTP or its variant of SEQ ID NO: 2 or 3, penetratin or its variants of SEQ ID NO: 4 or 5; and wherein the second moiety is dominant negative MAML (dnMAML) of SEQ ID NO: 9 consisting of the amino acid sequence LPRHSAVMERLRRRIELCRRHHSTCEARYEAVSPERLELERQHTFALHQR CIQAKAKRAGKH (identical to the DN-MAML of instant SEQ ID NO: 9), for example, page 1, lines 5-9; page 3, lines 22-23; page 5, lines 10-22; and page 21, line 4 to page 23, line 9. It meets the limitations of the fusion protein recited in instant claims 34, 44 and 45; and the limitation of DN-MAML recited in instant claim 49. And as evidenced by US 11357863 B2, SEQ ID NO: 2 in Epenetos is the amino acid sequence of an ANTP that is 60 amino acids in length; SEQ ID NO: 3 in Epenetos is variants of ANTP that that is 60 amino acids in length and include the CPP of instant SEQ ID NO: 16 as a species; SEQ ID NO: 4 in Epenetos is the amino acid sequence of penetratin consisting of RQIKIWFQNRRMK WKK; and SEQ ID NO: 5 in Epenetos is variants of penetratin that is 16 amino acids in length (see for example, columns 31-34, SEQ ID NOs: 2-5). Epenetos further teaches recombinant production of ANTP (a CPP)-fusion proteins is technically challenging, for example, page 4, lines 7-14; and page 37, line 23 to page 38, line 13. Epenetos also teaches the CPP is at either the N-terminal or the C-terminal region of fusion protein, and preferably the CPP is at the N-terminal region of the fusion proteins, for example, page 16, lines 20-24.
The difference between the reference and instant claims 34, 44-46 and 49 is that the reference does not teach the limitations of instant SEQ ID NO: 46.
However, Wei et al teach a one-step chemical reaction for synthesizing a conjugate comprising penetratin as a first moiety and polyethylene glycol maleimide derivative as a second moiety, wherein the penetratin is modified by adding a Cys residue at its N-terminus, for example, pages 39-41, paragraphs [0072] and [0073].
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Epenetos and Wei et al to develop a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a CPP, and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP is selected from ANTP or its variant and penetratin or its variants thereof; wherein the second moiety is dominant negative MAML (dnMAML) of instant SEQ ID NO: 9; and wherein a Cys residue is added to either the N-terminus or C-terminus, preferably the C-terminus, of the CPP, the dnMAML is modified to introduce a maleimide group; and wherein the fusion protein can be prepared by a one-step chemical reaction via a thioester bond formed between the CPP and the dnMAML.
One of ordinary skilled in the art would have been motivated to combine the teachings of Epenetos and Wei et al to develop a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a CPP, and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP is selected from ANTP or its variant and penetratin or its variants thereof; wherein the second moiety is dominant negative MAML (dnMAML) of instant SEQ ID NO: 9; and wherein a Cys residue is added to either the N-terminus or C-terminus, preferably the C-terminus, of the CPP, the dnMAML is modified to introduce a maleimide group; and wherein the fusion protein can be prepared by a one-step chemical reaction via a thioester bond formed between the CPP and the dnMAML, because Epenetos teaches recombinant production of ANTP (a CPP)-fusion proteins is technically challenging. Epenetos further teaches the CPP is at either the N-terminal or the C-terminal region of fusion protein, and preferably the CPP is at the N-terminal region of the fusion proteins. Wei et al teach a one-step chemical reaction for synthesizing a conjugate comprising penetratin as a first moiety and polyethylene glycol maleimide derivative as a second moiety, wherein the penetratin is modified by adding a Cys residue at its N-terminus.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Epenetos and Wei et al to develop a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a CPP, and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP is selected from ANTP or its variant and penetratin or its variants thereof; wherein the second moiety is dominant negative MAML (dnMAML) of instant SEQ ID NO: 9; and wherein a Cys residue is added to either the N-terminus or C-terminus, preferably the C-terminus, of the CPP, the dnMAML is modified to introduce a maleimide group; and wherein the fusion protein can be prepared by a one-step chemical reaction via a thioester bond formed between the CPP and the dnMAML.
34. Claims 34, 44-46 and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Epenetos (WO 2019/038562 A1, filed with IDS), and as evidenced by Epenetos (US 11357863 B2, US patent issued from US equivalent of WO 2019/038562 A1), and in view of Wei et al (CN 109420178 A, machine translation used and enclosed pages 1-81), and further in view of Tian (CN 111341387 A, machine translation used and enclosed pages 1-49).
The instant claims 34, 44-46 and 49-52 are drawn to a composition of matter selected from the group consisting of: (i) a cell-penetrating peptide (CPP) comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein; (ii) a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein; and (iii) a pharmaceutical composition comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) or a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein.
The rejection to claims 34, 44-46 and 49 under 35 U.S.C. 103 as being unpatentable over Epenetos (WO 2019/038562 A1, filed with IDS), and as evidenced by Epenetos (US 11357863 B2, US patent issued from US equivalent of WO 2019/038562 A1), and in view of Wei et al (CN 109420178 A, machine translation used and enclosed pages 1-81) has been set forth in Section 33 above.
The difference between the rejection set forth in Section 33 above and instant claims 34, 44-46 and 49-52 is that the rejection set forth in Section 33 above does not explicilty teach the CPP recited in instant claims 50-52.
However, Tian teaches an ANTP homeodomain consisting of the amino acid sequence MERKRGRQTYTRYQTLELEKEFHFNRYLTRRRRIEIAHALSLTERQIKIWFQ NRRMKWKKEN (comprising the amino acid sequence of instant SEQ ID NO: 16, underlined), for example, page 26, paragraphs [0040] and [0041].
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Epenetos, Wei et al and Tian to develop a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a CPP, and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP is selected from ANTP or its variant and penetratin or its variants thereof; wherein the second moiety is dominant negative MAML (dnMAML) of instant SEQ ID NO: 9; wherein the CPP comprises the amino acid sequence of instant SEQ ID NO: 16, and a Cys residue is added to either the N-terminus or C-terminus, preferably the C-terminus, of the CPP, and the dnMAML is modified to introduce a maleimide group; and wherein the fusion protein can be prepared by a one-step chemical reaction via a thioester bond formed between the CPP and the dnMAML.
One of ordinary skilled in the art would have been motivated to combine the teachings of Epenetos, Wei et al and Tian to develop a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a CPP, and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP is selected from ANTP or its variant and penetratin or its variants thereof; wherein the second moiety is dominant negative MAML (dnMAML) of instant SEQ ID NO: 9; wherein the CPP comprises the amino acid sequence of instant SEQ ID NO: 16, and a Cys residue is added to either the N-terminus or C-terminus, preferably the C-terminus, of the CPP, and the dnMAML is modified to introduce a maleimide group; and wherein the fusion protein can be prepared by a one-step chemical reaction via a thioester bond formed between the CPP and the dnMAML, because Tian teaches an ANTP homeodomain comprising the amino acid sequence of instant SEQ ID NO: 16. The fusion protein developed from the combined teachings of Epenetos, Wei et al and Tian is a simple substitution of one known element for another to obtain predictable results (see MPEP § 2143 I).
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Epenetos, Wei et al and Tian to develop a fusion protein comprising (a) a first moiety derived from Antennapedia (ANTP) homeodomain as a CPP, and (b) a second moiety derived from the Mastermind-like (MAML) protein as a therapeutic moiety; wherein the CPP is selected from ANTP or its variant and penetratin or its variants thereof; wherein the second moiety is dominant negative MAML (dnMAML) of instant SEQ ID NO: 9; wherein the CPP comprises the amino acid sequence of instant SEQ ID NO: 16, and a Cys residue is added to either the N-terminus or C-terminus, preferably the C-terminus, of the CPP, and the dnMAML is modified to introduce a maleimide group; and wherein the fusion protein can be prepared by a one-step chemical reaction via a thioester bond formed between the CPP and the dnMAML.
Obviousness Double Patenting
35. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
36. Claim 34 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of US patent 9145446 B2.
37. The instant claim 34 is drawn to a composition of matter selected from the group consisting of: (i) a cell-penetrating peptide (CPP) comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein; (ii) a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein; and (iii) a pharmaceutical composition comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) or a fusion protein comprising a CPP comprising from 10 to 60 contiguous amino acids selected from an Antennapedia (ANTP) protein and a therapeutically useful protein.
38. Claims 1-6 of US patent 9145446 B2 are drawn to a method for the treatment of cancer, comprising administering to a subject in need thereof, a conjugate comprising: a) a first region consisting of a protein having the amino acid sequence as set forth in SEQ ID NO: 1: b) a second region comprising the homeodomain of antennapedia; and c) a covalent linker.
The conjugate recited in claims 1-6 of US patent 9145446 B2 meets the limitations of the fusion protein recited in instant claim 34.
39. For the same/similar reasoning/rational as the rejection set forth in Sections 36-38 above, instant claim 34 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US patent 10259852 B2 (filed with IDS).
40. For the same/similar reasoning/rational as the rejection set forth in Sections 36-38 above, instant claims 34, 44 and 45 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US patent 11357863 B2.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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