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
Applicants’ election without traverse of claims 1, 4-7 and 43 (i.e., drawn to a cyclic peptide) in the reply filed on 02/10/2026 is acknowledged. Additionally, Applicants’ election without traverse of Species A (i.e., a single and specific peptide comprising a single and specific election for all the variables of the formula Xaa1-Xaa2-Xaa3-Xaa4-Xaa5, Applicants’ election: Xaa1 is F, Xaa2 is L, Xaa3 is S, Xaa4 is F, Xaa5 is R), in the reply filed on 02/10/2026 is acknowledged.
Upon searching the elected species (i.e., FLSFR), additional species were found, e.g., Xaa1 is 1NapA and Xaa4 is 2NapA. Accordingly, for purposes of compact prosecution, the election of species is modified only to the extent of examining these additional species. Otherwise the election of species requirement is still retained.
Priority
The present application is a CON of PCT/AU2024/050616 filed on 06/13/2024.
Claim Status
Claims 1-31 were originally filed and amended on 10/10/2025. The amendment cancelled claims 2-3, 17-20, 22-29; added new claims 32-42; and amended claims 4-16, 21, 30-31.
The amendment filed on 02/10/2026, cancelled claims 8-16, 21, 30-42; added new claim 43, and amended claims 5-7.
The amendment filed on 06/22/2026, cancelled claim 43, added new claims 44-51, and amended claims 4-5.
Sequence Interpretation
The scope of “cyclic peptide” is interpreted as open-ended requiring the sequence of the formula Xaa1- Xaa2- Xaa3- Xaa4- Xaa5. Per MPEP 2111.03(I), the transitional phrase “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Furthermore, MPEP 2111.03(IV) states that transitional phrases such as "having" must be interpreted in light of the specification to determine whether open or closed claim language is intended. In the instant case, the specification permits the inclusion of more than one variable for the formula Xaa1-Xaa2-Xaa3-Xaa4-Xaa5. As such, the Examiner is interpreting the transitional phrase “having” as open terminology.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 06/23/2026, has been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: acronym. The claim recites, “1NapA” and “2NapA”. Although, the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner respectfully requests that Applicant uses 1-naphthylalanine and 2-naphthylalanine for the first recitation, thereafter “1NapA” and “2NapA” may be utilized. Appropriate correction is required.
Claims 48-49 are objected to because of the following informalities: term abbreviation. While the instant specification recites terms "2NapA", "2-Nal" and "2-naphthyl-Ala" are as abbreviations for 2-naphthylalanine (see pg. 13, lines 29-31), consistency is required when choosing to use one of the provided abbreviations. Parent claim 1 recites 2NapA. Appropriate correction is required.
Response to Arguments
Applicants' arguments, see Response filed 06/22/2026, with respect to the Specification, have been fully considered and are persuasive. The objection to the specification (embedded hyperlinks), has been withdrawn.
Applicants' arguments, see Response filed 06/22/2026, with respect to the Specification, have been fully considered and are persuasive. The objection to the specification (Nucleotide and/or Amino Acid Sequence Disclosures), has been withdrawn.
Applicants' arguments, see Response filed 06/22/2026, with respect to the 35 U.S.C 112(b), have been fully considered and are persuasive. The 35 U.S.C 112(b) rejection to claim 43 is moot.
Applicants' arguments, see Response filed 06/22/2026, with respect to the 35 U.S.C 102(a)(1) as being by WO99/41278, have been fully considered but are not persuasive. The 35 U.S.C 102(a)(1) rejection to claims 1, 5-7 has been maintained.
Applicants' arguments, see Response filed 06/22/2026, with respect to the 35 U.S.C 102(a)(1) as being anticipated by WO 2017/060405 A1, have been fully considered but are not persuasive. The 35 U.S.C 102(a)(1) rejection to claims 1, 5-7 has been maintained.
Applicants' arguments, see Response filed 06/22/2026, with respect to the 35 U.S.C 103 as being unpatentable over WO 98/13376 International Publication Date: April 2, 1998 (herein after “Bryant et al.”), in view of WO 2017/060405 A1 International Publication Date: April 13, 2017 (cited in the IDS filed on 02/10/2026) (herein after “Tamarit et al.”); have been fully considered and are persuasive. The 35 U.S.C 103 rejection to claims 1, 4-7 and 43 has been withdrawn.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 102
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.
1. Claims 1, 44 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO99/41278 International Publication Date: August 19, 1999 (cited in the IDS filed on 02/10/2026) (herein after “278”).
For claim 1, ‘278 discloses a cyclic peptide having the following formula: A1-A2-A3-A4-A5, in which A1 is F or Y or W or 2Nap; A2 is L or I; A3 is S or T; A4 is F or Y or W or 2 Nap; A5 is R or K (see ‘278, claim 1, pg. 14, lines 4-12). Thereby, ‘278 anticipates a cyclic peptide comprising the sequence of the formula Xaa1-Xaa2-Xaa3-Xaa4-Xaa5 in which Xaa1 is F, Xaa2 is L or I, Xaa3 is S or T, Xaa4 is F or 2NapA, Xaa5 is R or K, as recited in instant claim 1.
For claim 44, ‘278 discloses a cyclic peptide having the following formula: A1-A2-A3-A4-A5, in which A1 is F or Y or W or 2Nap; A2 is L or I; A3 is S or T; A4 is F or Y or W or 2 Nap; A5 is R or K (see ‘278, claim 1, pg. 14, lines 4-12).
Per MPEP 2112.01 (I), where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. In the instant case, ‘278’s disclosed cyclic peptide would inherently possess the claimed characteristics (i.e., chemical structure and physical state) as claimed. Thereby, ‘278 anticipates the cyclic peptide of claim 1, having the following structure
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cyclo[(Phe)LS(Phe)R]); or a pharmaceutically acceptable salt, solvate or prodrug thereof, as recited in instant claim 44.
Similarly, for claims 48, ‘278 discloses a cyclic peptide having formula A1-A2-A3-A4-A5 -wherein A1 is F, A2 is L, A3 is S, A4 is F and A5 is R (see ‘278, claim 1, pg. 14, lines 4-12). Since the claimed cyclic peptide and ‘278’s cyclic peptide are identical or substantially identical, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. In the instant case, ‘278’s disclosed cyclic peptide would inherently possess the claimed characteristics (i.e., chemical structure and physical state) as claimed. As such, ‘278’s cyclic peptide having formula A1-A2-A3-A4-A5 -wherein A1 is F, A2 is L, A3 is S, A4 is 2Nap and A5 is R, anticipates the claimed chemical structure of (cyclo[(Phe)LS(S-Nal)R]); or a pharmaceutically acceptable salt, solvate or prodrug thereof, as recited in instant claim 48.
Accordingly, ‘278’s disclosure anticipates claims 1, 44 and 48.
2. Claims 1, 4, 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/060405 A1 International Publication Date: April 13, 2017 (cited in the IDS filed on 02/10/2026) (herein after “Tamarit et al.”).
For claim 1, Tamarit et al. disclose a peptide comprising the sequence AA1-Leu-AA3-AA4-AA5, wherein: AA1 designates Phe, Leu, norleucine, tryptophan, 2-naphthylalanine (2NapA), or 1-naphthylalanine (1NapA); AA3 designates Ser, Thr or Cys; AA4 designates Tyr, 2-naphthylalanine (2NapA), 1-naphthylalanine (1NapA), diphenylalanine, 7-hydroxyltetrahydroisoquinoline (7HTiq), or tetrahydroisoquinoline (Tiq); and AA5 designates Lys, Arg, or citrulline, or a salt, ester, hydrate, racemate, enantiomer, prodrug or metabolite thereof, for use to induce or stimulate an immune response in a subject in need thereof (see Tamarit et al., pg. 17, claim 1). Tamarit et al. also claim that the peptide is cyclic (see Tamarit et al., pg. 17, claim 3). Thereby, Tamarit et al. anticipate a cyclic peptide comprising the sequence of the formula Xaa1-Xaa2-Xaa3-Xaa4-Xaa5 in which Xaa1 is F or 1NapA, Xaa2 is L or I, Xaa3 is S or T, Xaa4 is F or 2NapA, and Xaa5 is R or K, as recited in instant claim 1.
For claim 4, Tamarit et al. disclose a peptide comprising the sequence AA1-Leu-AA3-AA4-AA5, wherein: AA1 designates 1-naphthylalanine (1NapA); AA3 designates Ser, Thr; AA4 designates 2-naphthylalanine (2NapA); and AA5 designates Lys, Arg (see Tamarit et al., pg. 17, claim 1).
Since the claimed cyclic peptide and Tamarit et al.’s cyclic peptide are identical or substantially identical, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. In the instant case, Tamarit et al.’s cyclic peptide would inherently possess the characteristics of the claimed cyclic peptide as recited in instant claim 4 (i.e., the chemical structure of
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(cyclo[(1NapA)LS(2NapA)R]); or a pharmaceutically acceptable salt, solvate or prodrug thereof).
For claim 48, Tamarit et al.’s disclosure anticipates the instantly claimed cyclic peptide having the following structure
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. Because Tamarit’s a peptide comprising the sequence AA1-Leu-AA3-AA4-AA5, wherein: AA1 designates Phe; AA3 designates Ser; AA4 designates 2-naphthylalanine (2NapA); and AA5 designates Lys (see Tamarit et al., pg. 17, claim 1), reads on the instantly claimed peptide.
Since the claimed cyclic peptide and Tamarit et al.’s cyclic peptide are identical or substantially identical, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not inherently possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. Therefore, Tamarit et al.’s cyclic peptide would inherently possess the characteristics of the claimed cyclic peptide as recited in instant claim 48 (i.e., the chemical structure of
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(cyclo[(Phe)LS(2Nal)R]); or a pharmaceutically acceptable salt, solvate or prodrug thereof).
Accordingly, Tamari et al.’s disclosure anticipates instant claims 1, 4 and 48.
Response to Arguments
Applicants' arguments filed 06/22/2026, with respect to the 35 U.S.C. 102 rejections have been fully considered but they are not persuasive.
Applicants assert that the examined claims are not anticipated by the prior art because the skilled person would not be able to “at once envisage” the particular combination of elements that would result in a peptide of the instant claims (see Remarks, filed 06/22/2026, pg. 8, second to last paragraph, and pg. 10, second to last paragraph). These arguments have been fully considered by are not persuasive.
Pursuant to MPEP 2131.02(III), [a] reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015).
Furthermore, [w]hen a claimed compound is not specifically named in a reference, but instead it is necessary to select portions of teachings within the reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated. One of ordinary skill in the art must be able to draw the structural formula or write the name of each of the compounds included in the generic formula before any of the compounds can be "at once envisaged." One may look to the preferred embodiments to determine which compounds can be anticipated. In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962). See MPEP 2131.02(III).
In the instant case, the cited prior art (i.e., WO 99/41278 herein after “Scott”; and WO2017/060405 herein after “Tamarit”) anticipate the instantly claimed cyclic peptide comprising the sequence of the formula Xaa1-Xaa2-Xaa3-Xaa4-Xaa5 in which Xaa1 is F or 1NapA, Xaa2 is L or I, Xaa3 is S or T, Xaa4 is F or 2NapA, and Xaa5 is R or K. As discussed in the rejections above, both Scott and Tamarit disclose a generic formula representing a cyclic pentapeptide wherein a list of alternatives for each variable in the formula is provided. Therefore, an ordinary skilled artisan would have been able to determine and/or at once envisage the structural formula or write the name of each of the peptides resulting from the generic formula by selecting various substituents from a list of alternatives given for placement at specific sites on the generic formula. Additionally, since the scope of the rejected claims is interpreted as open-ended in light of the transitional terms “comprising” and “having”, the claimed cyclic peptide encompasses unrecited elements, such as the alternative amino acids given for each variable as disclosed by Scott and Tamarit.
Accordingly, claims 1, 44 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO99/41278 International Publication Date: August 19, 1999 (cited in the IDS filed on 02/10/2026) (herein after “Scott”).
Likewise, claims 1, 4 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/060405 A1 International Publication Date: April 13, 2017 (cited in the IDS filed on 02/10/2026) (herein after “Tamarit et al.”).
Examiner’s Comment – Allowable Subject Matter
Claims 1, 4, 44 and 48 are rejected.
Claims 5-7, 45-47 and 49-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that there is no teaching or suggestion in the art for wherein the cyclic peptide is: (cyclo[(D-Phe)LS(L-Phe)R]) as recited in instant claim 5; or (cyclo[(D-1NapA)LS(L-2NapA)R]) as recited in instant claim 45; or (cyclo[(D-Phe)LS(L-2-Nal)R]) as recited in instant claim 49.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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