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 9/4/2026 is acknowledged.
4. Claim filed on 9/4/2026 is acknowledged.
5. Claims 5, 6, 8, 10, 12, 13, 16 and 27-31 have been cancelled.
6. Claims 1-4, 7, 9, 11, 14, 15, 17-26 and 32 are pending in this application.
7. Claims 19-26 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.
8. Claims 1-4, 7, 9, 11, 14, 15, 17, 18 and 32 are under examination.
Election/Restrictions
9. Applicant’s election without traverse of Group 1 (claims 1-4, 7, 9, 11, 14, 15, 17, 18 and 32) and election of SEQ ID NO: 1 as species of compound for the elected Group 1 in the reply filed on 9/4/2026 is acknowledged. The requirement is made FINAL in this office action.
Please note: The elected species that are drawn to non-elected inventions in the response filed on 9/4/2026 would not be searched and examined in the current office action.
Group 1 is drawn to a compound represented by the formula (I): R1-Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6-Xaa7-Xaa8-R2 (I), or a pharmaceutically acceptable salt thereof; and a pharmaceutical composition comprising such compound of formula (I) and a pharmaceutically acceptable excipient. A search was conducted on the elected species; and prior art was found. Claims 1-4, 7, 9, 11, 14, 15, 17, 18 and 32 are examined on the merits in this office action.
Sequence Non-Compliance
10. 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 various peptides on page 16, part d) of instant specification. However, these peptides are 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
11. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
12. The specification is objected to for the following minor informality: The specification discloses various peptides on page 16, part d) of instant specification. However, these peptides are not disclosed in the filed sequence listing; and they are 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 discloses peptides of instant SEQ ID NOs: 1-41 throughout the specification. However, the amino acid sequences of SEQ ID NOs: 1-41 in the specification are inconsistent with what in the filed sequence listing, in that none of peptides of SEQ ID NOs: 1-40 in the filed sequence listing contains any D-amino acid, and SEQ ID NO: 41 in the filed sequence listing does not contain any amino acid sequence. Applicant is required to address these issues.
14. The specification is objected to for the following minor informality: The specification recites “https://lifescience.invitro.com.au/brands/r-and-d-systems/” on page 33, paragraph [00106]. 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:
Figure 1 is described with respect to color. Reference to specific colors in the description of the drawings should be removed.
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 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A compound represented by the formula (I): R1-Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6-Xaa7-Xaa8-R2 (I), wherein: R1 is acyl…Xaa1 is D-tyrosine, D-phenylalanine, D-N-methylphenylalanine, D-homotyrosine, D-phenylglycine, D-O-methyltyrosine or D-N-methyltyrosine; Xaa2 is glycine, sarcosine or 4-aminobutyric acid (Gaba); Xaa3 is glycine, sarcosine or 4-aminobutyric acid; Xaa4 is D-tyrosine, D-phenylalanine, D-N-methylphenylalanine, D-homotyrosine, D-phenylglycine, D-O-methyltyrosine or D-N-methyltyrosine; Xaa5 is glycine, sarcosine or a D-amino acid having a side chain with 4 or less non-hydrogen atoms; Xaa6 is…Xaa8 is absent, a D-amino acid residue, a peptide consisting of 2 to 4 D-amino acid residues…”.
17. Claim 18 is objected to for the following minor informality: Applicant is suggested to add a semicolon after each of the recited amino acid sequence. Furthermore, Applicant is suggested to amend each of the recited peptide as, for example, “tyr-Gly-Gly-phe-leu-arg-arg-NH2 (SEQ ID NO: 1)”.
18. Claim 32 is objected to for the following minor informality: Applicant is suggested to amend claim 32 as “A pharmaceutical composition comprising a compound of formula (I) or a pharmaceutically acceptable salt thereof according to claim 1 and a pharmaceutically acceptable excipient”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
19. 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.
20. Claims 1-4, 7, 9, 11, 14, 15 and 32 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.
21. Claim 1 recites the limitation of Xaa8 being “an amino substituted fatty acid or amide”. With regards to the term “an amino substituted fatty acid or amide”, the instant specification fails to define it. Therefore, it is unclear what is encompassed within the recited “an amino substituted fatty acid or amide”. Thus, the metes and bounds of instant claim 1 is vague and indefinite. Because claims 2-4, 7, 9, 11, 14, 15 and 32 depend from indefinite claim 1 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.
Claim Rejections - 35 U.S.C. § 112 paragraph (d)
22. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
23. Claim 3 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
24. Claim 3 depends on claim 1; and claim 3 recites “The compound according to claim 1, wherein R2 is hydrogen or NH2”. However, R2 in the compound recited in instant claim 1 is OH or N(R3)2. Therefore, the scope of the compound recited in instant claim 3 is broader than that of the compound recited in instant claim 1. Claim 3 does not further limit the structure of the compound recited in instant claim 1; therefore, claim 3 is improper dependent forms for failing to further limit the subject matter of claim 1.
Furthermore, in view of the disclosure in instant specification and for the purpose of compact prosecution, the Examiner is interpretating instant claim 3 as “The compound according to claim 1, wherein R2 is OH or NH2”. Such interpretation applies to all the rejections set forth below.
Claim Rejections - 35 U.S.C. § 103
25. 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.
26. 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.
27. Please note: during the search for the elected species, prior art was found for the non-elected species of compound.
Claims 1-4, 7, 9, 11, 14, 15 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Taghizadeh (US 2007/0142287 A1) in view of Carr et al (US 2006/0105947 A1).
The instant claims 1-4, 7, 9, 11, 14, 15 and 32 are drawn to a compound represented by the formula (I): R1-Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6-Xaa7-Xaa8-R2 (I), or a pharmaceutically acceptable salt thereof; and a pharmaceutical composition comprising such compound of formula (I) and a pharmaceutically acceptable excipient.
Taghizadeh, throughout the patent, teaches a pharmaceutical composition comprising a peptide ligand that binds a zeta receptor and a pharmaceutically acceptable excipient; wherein the peptide ligand that binds a zeta receptor is an enkephalin, an endorphin, a dynorphin, or a derivative thereof, such as Ph-8p (Dynorphin [1-8]) consisting of the amino acid sequence Tyr-Gly-Gly-Phe-Leu-Arg-Arg-Ile (SEQ ID NO: 11) or derivative thereof; and wherein the pharmaceutical composition can be used for treating a pathology that responds to such peptide ligand, such as cancer, for example, Abstract; page 1, paragraph [0001]; and page 4, Table 2. It meets the limitation of the pharmaceutically acceptable excipient recited in instant claim 32. Taghizadeh further teaches derivative of the peptide ligand, such as a derivative of dynorphin , wherein one or more, or even all, the residues of the dynorphin can be D-amino acids instead of naturally-occurring L-amino acids; and the peptide can be modified with an amide group at the C-terminus, for example, pages 4-5, paragraphs [0052] and [0053].
The difference between the reference and instant claims 1-4, 7, 9, 11, 14, 15 and 32 is that the reference does not explicitly teach a derivative of Ph-8p (Dynorphin [1-8]) wherein all the amino acids other than Gly is replaced with a D-amino acid and the C-terminus is modified with an amide group.
However, Carr et al, throughout the patent, teach chimeric protein comprising an opioid peptide moiety, such as Dynorphin (DYN), including DYN(1-8) consisting of the amino acid sequence Tyr-Gly-Gly-Phe-Leu-Arg-Arg-Ile (SEQ ID NO: 19), for example, Abstract; and page 6, paragraph [0050] and Table 3. Carr et al further teach replacement of one or more L-amino acids in a peptide with the corresponding D-amino acid isoforms can be used to increase the resistance of peptides to enzymatic hydrolysis, and to enhance one or more properties of biologically active peptides, i.e., receptor binding, functional potency or duration of action, for example, page 2, paragraph [0027]. Carr et al also teach replacement of the C-terminal acid with an amide can be used to enhance the solubility and clearance of a peptide, for example, pages 2-3, paragraph [0029].
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Taghizadeh and Carr et al to develop a derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2; and a pharmaceutical composition comprising such derivative and a pharmaceutically acceptable excipient for treating a pathology that responds to Dynorphin [1-8], such as cancer. The derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2 meets the limitations of compound of instant formula (I) recited in instant claims 1-4, 7, 9, 11, 14 and 15.
One of ordinary skilled in the art would have been motivated to combine the teachings of Taghizadeh and Carr et al to develop a derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2; and a pharmaceutical composition comprising such derivative and a pharmaceutically acceptable excipient for treating a pathology that responds to Dynorphin [1-8], such as cancer, because Carr et al, throughout the patent, teach chimeric protein comprising an opioid peptide moiety, such as Dynorphin (DYN), including DYN(1-8) consisting of the amino acid sequence Tyr-Gly-Gly-Phe-Leu-Arg-Arg-Ile (SEQ ID NO: 19). Carr et al further teach replacement of one or more L-amino acids in a peptide with the corresponding D-amino acid isoforms can be used to increase the resistance of peptides to enzymatic hydrolysis, and to enhance one or more properties of biologically active peptides, i.e., receptor binding, functional potency or duration of action. Carr et al also teach replacement of the C-terminal acid with an amide can be used to enhance the solubility and clearance of a peptide. And similar to Carr et al, Taghizadeh teaches derivative of the peptide ligand, such as a derivative of dynorphin , wherein one or more, or even all, the residues of the dynorphin can be D-amino acids instead of naturally-occurring L-amino acids; and the peptide can be modified with an amide group at the C-terminus.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Taghizadeh and Carr et al to develop a derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2; and a pharmaceutical composition comprising such derivative and a pharmaceutically acceptable excipient for treating a pathology that responds to Dynorphin [1-8], such as cancer.
28. Claims 1-4, 7, 9, 11, 14, 15, 17, 18 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Taghizadeh (US 2007/0142287 A1) in view of Carr et al (US 2006/0105947 A1), and further in view of Bevec et al (WO 2009/033800 A2, filed with IDS).
The instant claims 1-4, 7, 9, 11, 14, 15, 17, 18 and 32 are drawn to a compound represented by the formula (I): R1-Xaa1-Xaa2-Xaa3-Xaa4-Xaa5-Xaa6-Xaa7-Xaa8-R2 (I), or a pharmaceutically acceptable salt thereof; and a pharmaceutical composition comprising such compound of formula (I) and a pharmaceutically acceptable excipient.
The rejection to instant claimed 1-4, 7, 9, 11, 14, 15 and 32 under 35 U.S.C. 103 as being unpatentable over Taghizadeh (US 2007/0142287 A1) in view of Carr et al (US 2006/0105947 A1) has been set forth in Section 27 above.
The difference between the rejection set forth in Section 27 above and instant claims 1-4, 7, 9, 11, 14, 15, 17, 18 and 32 is that the rejection set forth in Section 27 above does not teach SEQ ID NO: 1 as the elected species of compound of formula (I); and the limitations of instant claims 17 and 18.
However, Bevec et al, throughout the patent, teach that similar to Dynorphin [1-8] taught in Taghizadeh and Carr et al, Dynorphin A (1-7) consisting of the amino acid sequence Tyr-Gly-Gly-Phe-Leu-Arg-Arg-OH as a therapeutic agent for the prophylaxis and/or treatment of cancer, autoimmune diseases, fibrotic diseases, inflammatory diseases, neurodegenerative diseases, infectious diseases, lung diseases, heart and vascular diseases and metabolic diseases, for example, Abstract; page 1, lines 6-10; and claims 1-12. Bevec et al further teach modifying Dynorphin A (1-7) by using D-amino acid and amidated amino acid, for example, page 81, lines 6-11 and 24-33.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Taghizadeh, Carr et al and Bevec et al to develop a derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2, or a derivative of Dynorphin A (1-7) consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-NH2 (identical to instant SEQ ID NO: 1); and a pharmaceutical composition comprising such derivative and a pharmaceutically acceptable excipient for treating a pathology that responds to such derivative, such as cancer. The derivative of Dynorphin A (1-7) consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-NH2 read on SEQ ID NO: 1 as the elected species of compound of formula (I).
One of ordinary skilled in the art would have been motivated to combine the teachings of Taghizadeh, Carr et al and Bevec et al to develop a derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2, or a derivative of Dynorphin A (1-7) consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-NH2 (identical to instant SEQ ID NO: 1); and a pharmaceutical composition comprising such derivative and a pharmaceutically acceptable excipient for treating a pathology that responds to such derivative, such as cancer, because Bevec et al, throughout the patent, teach that similar to Dynorphin [1-8] taught in Taghizadeh and Carr et al, Dynorphin A (1-7) consisting of the amino acid sequence Tyr-Gly-Gly-Phe-Leu-Arg-Arg-OH as a therapeutic agent for the prophylaxis and/or treatment of cancer, autoimmune diseases, fibrotic diseases, inflammatory diseases, neurodegenerative diseases, infectious diseases, lung diseases, heart and vascular diseases and metabolic diseases. Bevec et al further teach modifying Dynorphin A (1-7) by using D-amino acid and amidated amino acid.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Taghizadeh, Carr et al and Bevec et al to develop a derivative of Dynorphin [1-8] consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-ile-NH2, or a derivative of Dynorphin A (1-7) consisting of the amino acid sequence tyr-Gly-Gly-phe-leu-arg-arg-NH2 (identical to instant SEQ ID NO: 1); and a pharmaceutical composition comprising such derivative and a pharmaceutically acceptable excipient for treating a pathology that responds to such derivative, such as cancer.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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