rtvrDETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 22, 2025 has been entered.
Claim Status
Claims 4, 7, and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Claims 1-3, 16-17 and new claims 22-23 are under consideration in this office action.
Withdrawn Rejections
Any objection or rejection of record pertaining to cancelled claims 8-11 and 13-14 is rendered moot by applicant’s cancellation of said claims.
The rejection of claims 8-11 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of cancellation of these claims.
The rejection of claims 1-3, 8-11, and 16-17 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2007/0066523 A1 is withdrawn in view of applicant’s amendment of claim 1 to limit the peptide to one wherein each amino acid of SEQ ID NO: 2 is a D-amino acid and amendment of claim 8 to remove reference to a peptide fragment.
New Objections/Rejections Necessitated by Amendment
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “an amino acid sequence selected from the group consisting of RTVRCTCI (SEQ ID NO: 2)”. As there is only one member of the group, the “group consisting of” phrase is unnecessary. Recommend amending claim to read, “A peptide comprising the amino acid sequence RTCRCTCI (SEQ ID NO: 2)”. It is noted that “the amino acid” is appropriate here, because the peptide is comprised of the entire recited sequence.
Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 16-17 and new claim 22 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066523 A1, published March 22, 2007 (“Merzouk”, IDS from 1/22/2021) in view of in view of Li et al, published June 30, 2016 (see PTO-892 from 11/20/2025).
Merzouk teaches a peptide comprised of instant SEQ ID NO: 2; the Merzouk peptide is the full amino acid sequence of IP-10 [0025]. Amino acids 5-14 are comprised of instant SEQ ID NO: 2, as in the peptide of instant claim 1 and claim 22.
It is noted that the transitional phrase “consisting essentially of” is interpreted to be equivalent to “comprising”, as there is no clear definition in the specification regarding the scope of “consisting essentially of”. See MPEP 2111.03.III: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.").
Merzouk also teaches pharmaceutical composition of peptide analogs of human IP-10 conjugate to treat a human ([0021],[0218]), as in instant claims 16-17. Merzouk does not teach the peptide wherein each amino acid of SEQ ID NO: 2 is a D-amino acid.
Li et al teaches that partial or complete replacement of L-amino acids with their D-amino acid counterpart is a method to improve performance and stability of peptide therapies (pg 2, para 1). Thus, it would have been obvious to one of ordinary skill in the art at the time the application was filed to substitute the L-amino acids of Merzouk with the D-amino acids of Li et al; such would amount to the simple substitution of one functionally equivalent element for another (i.e. D-amino acids for L-amino acids) to obtain predictable results. The motivation to do so comes from Li et al, which teaches that incorporation of D-amino acids into peptides improves serum stability and resistance to proteolytic enzymes (pg 4, para 1).
Regarding the properties of the peptide of claims 2-3, Merzouk teach that the chemokine analogs of comprising SEQ ID NO: 2 are useful for treating bacterial infection [0031]. Since the peptide taught by Li et al in view of Merzouk satisfies all structural limitations set forth in claim 1, it necessarily follows that the peptide inherently possesses bactericidal and/or bacteriostatic activity against the bacterium Klebsiella pneumoniae, absent objective evidence to the contrary. See MPEP § 2112(I); “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Response to Arguments
Applicant’s arguments filed December 22, 2025 regarding the rejection of claims 1-3 and 16-17 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant asserts that the examiner has failed to properly indicate the amino acid sequence taught by Merzouk (remarks, pg 5, pg 9-10). In the modified 103 rejection above, the amino acid residues of Merzouk are clearly indicated to be amino acids 5-14 of Merzouk SEQ ID NO: 2. Applicant also asserts that [0025] of Merzouk is related to I-309 analogues and not IL-10 (remarks, pg 5, 10). It is noted that the examiner cites [0025] on page 9 of the Merzouk specification, which includes the amino acid sequence of IP-10. This table may be [0027] on applicant’s document.
Applicant notes that the conjugate of Merzouk does not read on the peptide claimed (remarks, pg 10). The examiner admits that the term “conjugate” was inadvertently included in the rejection mailed 6/30/2025. The disclosure of Merzouk does not teach any limitation directed to a conjugate, and any reference to a conjugate has been removed from the modified 103 rejection.
Regarding examiner’s concession in the Advisory Action mailed 11/3/2025 that Merzouk does not teach a method of treating a bacterial infection, the examiner’s intention with this comment was to differentiate between the inherent antibacterial activity of the peptide and the method of treating an infection. If the peptide of claim 1 is found allowable, an additional search will be performed for the method claims.
Applicant asserts that the examiner has unsuccessfully utilized an obvious to try rationale (remarks, pg 10) because the identification of the peptide comprising SEQ ID NO: 2 is not based on a finite number of identified, predictable solutions (remarks, pg 11). Further, applicant states that claim 1 is related to a truncated N-terminal peptide only and that the office improperly ascertained the scope of the prior art and the differences between the prior art and instant claim 1 (remarks, pg 12). However, applicant must recognize that claim 1 is drawn to any peptide that comprises instant SEQ ID NO: 2; the peptide of claim 1 is not limited to an N-terminal peptide fragment. As such, the peptide of Merzouk in view of Li et al reads on the peptide of claim 1. Arguments related to the broad and general disclosure of Merzouk (pg 13) are not persuasive because claim 1 itself is broad and general. In contrast, the peptides of new claim 23 consist of SEQ ID NO: 2, where each amino acid of SEQ ID NO: 2 is a D-amino acid. This claim is not obvious over the teachings of Merzouk and Li et al.
Applicant argues that Merzouk in view of Li do not teach the peptide with the inherent property of antibacterial activity and that Merzouk shows no data whatsoever that its peptides possess these properties (remarks, pg 6). Applicant is directed to MPEP 2112.I-III, which states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USP/Q 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.").
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977).
Applicant argues that the modification of Li would modify the physical structure of the peptides and change the inherent properties of the peptide (remarks, pg 6-7). Applicant is encouraged to provide evidence that D-amino acid substituted peptides exhibit different antibacterial activity than L-amino acid peptides; this difference should not be related to the decrease in D-amino acid substituted peptide degradation (as Li et al teaches this rationale). Furthermore, absolute predictability is not a necessary prerequisite to a case of obviousness. Rather, a degree of predictability that one of ordinary skill would have found to be reasonable is sufficient. “Good science and useful contributions do not necessarily result in patentability.” PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).
The claims are directed to a peptide, which the prior art teaches. Modification of that peptide to increase stability is not sufficient rationale for nonobviousness.
The rejections under 35 U.S.C. 103 are maintained.
Conclusion
Claims 1-3, 16-17 and new claim 22 are not allowed.
New claim 23 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675