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 .
Claim Status
Claims 1, 3, 17-19, 22-24, 26-27, 37-38, 41-42, 63, 65, 81-89 are pending as amended on 6/02/2025. Following the Reply filed 6/29/2026, claims 17-19, 26-27, 37-38, 41-42, 63, 65, and 83-88 are withdrawn as directed to non-elected inventions. Claims 3 and 23 are withdrawn as directed to non-elected species. Claims 1, 22, 24, 81-82, and 89 are presently considered.
Election/Restrictions
Applicant’s election without traverse of Group I (products, namely synthetic polypeptides, as recited at claims 1, 3, 22-24, 81-82, and 89 as filed 6/02/2025) and the originally elected species of SEQ ID NO: 8 (a.k.a., ELD607) as disclosed in Example 3 in the reply filed on 6/29/2026 is acknowledged.
The originally elected species is understood to be SEQ ID NO: 8 (a.k.a., ELD607) as disclosed in Example 3 (see, e.g., Spec. filed 9/22/2023 at p. 50 at lines 15-22, Figs. 35A-D), wherein the elected species corresponds to a polypeptide consisting of the sequence VHDIVNMLIRG (see, e.g., instant SEQ ID NO: 8; corresponding to CAS No. 3081588-35-1):
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The originally elected species is understood to read upon instant claims 1, 22, 24, and 81-82 as follows: The originally elected species is understood to read upon instant claims 1, 22, 24, and 81-82; notably, regarding instant claim 24, no “dosage delivery device” was actually identified, per se, at Example 3 (see, e.g., Spec. filed 9/22/2023 at p. 50 at lines 15-22, Figs. 35A-D), but a “delivery device” capable of delivering an intravenous injection of 0.5 mg/kg ELD607 was utilized but not identified (see id.); accordingly, claim 24 is understood to define a patentably indistinct genus of such devices, which are understood to be limited to obvious variants of devices capable of delivering an intravenous injection, such as a syringe.
However, the originally elected species does not read upon instant claims 2, 23, or 89 as follows: Regarding instant claims 3 and 89, the originally elected species is not identified as having a C-terminal amidation as required by instant claim 2 (see, e.g., Spec. filed 9/22/2023 at 18 at line 25 to page 20 at line 10, noting that C-terminal amidation is recited in the description of other sequences, but not for SEQ ID NO: 8; see also instant SEQ ID NO: 8, noting that C-terminal amidation is not noted in the sequence listing; see also Spec. filed 9/22/2023 at Table 4 on p. 54, noting that SEQ ID NOs: 5 and 9 are identified as C-amidated, but SEQ ID NO: 8 is not). Regarding instant claim 23, Example 3 does not identify any additional therapeutic agent enumerated at claim 23.
Following extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species.
Accordingly, Examination was extended to the non-elected species of VHDIVNMLIRG-NH2 (C-amidated SEQ ID NO: 8, as recited at 89), and this species was subsequently deemed free of the prior art and dependent claim 89, which is limited to this species, is rejoined. Examination was then extended to the entire subgenus of non-elected species comprising SEQ ID NO: 8, which was subsequently deemed free of the prior art. Examination was then extended to the species consisting of (and subgenus of sequences comprising) instant SEQ ID NO: 82 (“HDINMLIRG”; CAS Reg No. 3081604-18-1), which were subsequently deemed free of the prior art.
Examination was then extended to the non-elected species of tetrapeptide of LIRG (CAS Reg. No. 865797-81-5), which was subsequently deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claims 17-19, 26-27, 37-38, 41-42, 53, 65, and 83-88 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. Election was made without traverse in the reply filed on 6/29/2026.
Claims 3 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/29/2026.
Accordingly, claims 1, 22, 24, 81-82, and 89 are presently considered.
Priority
The priority claim to Provisional US 63/164132 (filed 3/22/2021) is acknowledged.
Information Disclosure Statement
The IDS filed on 9/22/2023; 2/29/2024; 3/28/2024; and 2/10/2025 are each presently considered.
Drawings
The drawings filed 9/22/2023 are accepted.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope and is understood to presently define a genus of polypeptides, of unknown length, by a description of differences each member of the genus must possess relative to the unclaimed sequence of instant SEQ ID NO:1. Specifically, the claim reads upon any amino acid sequence that has at least the following changes relative to instant SEQ ID NO: 1: H14R substitution, deletion of DITL residues at positions 1-3; and deletion of L residue at position 16. As Examiner noted in the Requirement mailed 3/27/2026, claim 1 reads upon an infinitely vast genus of synthetic polypeptides, wherein the only recited and required structure that must be present is a single arginine residue (e.g., corresponding to H14R) (see, e.g., Restriction mailed 3/27/2026 at 2 at § “Examiner Notes”). Accordingly, claim 1 is satisfied by polyarginine, which, relative to instant SEQ ID NO: 1, possesses an H14R substitution and deletion of all other residues, and possesses an insertion of additional arginine residues. As another example, the tetrapeptide of LIRG satisfies the limitations of claim 1, wherein it comprises an H14R substitution, deletion of positions 16 and 1-11 relative to instant SEQ ID NO: 1. Accordingly, claim 1 is infinitely broad and vast.
Regarding instant claim 24, no “dosage delivery device” was actually identified, per se, at Example 3 (see, e.g., Spec. filed 9/22/2023 at p. 50 at lines 15-22, Figs. 35A-D), but a “delivery device” capable of delivering an intravenous injection of 0.5 mg/kg ELD607 was utilized but not identified (see id.); accordingly, claim 24 is understood to define a patentably indistinct genus of such devices, which are understood to be limited to obvious variants of devices capable of delivering an intravenous injection, such as a syringe.
Examiner notes that claim 1 excludes additional species disclosed in the originally filed disclosure. Specifically, SEQ ID NOs: 1-6, 9-81, 83-85 do not comprise an H14R mutation and/or a deletion of positions 1-4 of instant SEQ ID NO: 1. Instant SEQ ID NO: 7 lacks a deletion of positions 1-4 relative to instant SEQ ID NO: 1. Accordingly, SEQ ID NO: 8 (“VHDIVNMLIRG”) and SEQ ID NO: 82 (“HDINMLIRG”) appear to be the only species within the genus of instant claim 1 that were specifically reduced to practice on record.
Additional claim interpretations are discussed below.
Claim Rejections
Improper Markush Grouping
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations.
First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use.
Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of instant claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Instant claim 1 attempts to define an unknown genus of unknown size and infinite variability by describing how the species of the claimed genus differ from an unclaimed sequence, wherein the only required, positively recited structural features are that the claimed compounds are (i) polypeptides, and (ii) contain an arginine residue corresponding to an H14R substitution. Accordingly, the claim scope presumably encompasses polypeptides consisting of three or more amino acids (e.g., 3-700+ amino acids) (see, e.g., Spec. filed 9/22/2023 at p. 12 at lines 14-15); wherein the amino acids may include non-proteinogenic amino acids and additional modifications (see, e.g., Spec. filed 9/22/2023 at p. 10 at lines 29-32, p. 16 at lines 22-32, p. 17 at lines 1-5, p. 56 at Table 7). Accordingly, the claim scope encompasses all possible proteins and polypeptides in existence that contain at least one arginine residue. It is not credible that all possible proteins in existence having an arginine residue share a “substantial structural feature” and “a common use that flows from the substantial structural feature”. Accordingly, the Markush Grouping recited at claim 1 is improper.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1, 22, and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring protein sequences without significantly more.
The claims recite and are directed to naturally-occurring peptides (and fragments thereof), without significantly more. As non-exhaustive examples, claims 1, 22, and 24 read upon naturally occurring proteins (and fragments of naturally occurring proteins), such as WP_055259993.11 (“DIVNMLIR” is at positions 139-146), MFQ5398601.12 (“VHDIVNLIRG” disclosed at positions 159-168), and WP_068748072.13 (“DIVNMLIR” is at positions 455-462).
This judicial exception is not integrated into a practical application because the pending claims directly encompass the naturally occurring proteins and protein fragments.
Dependent claims 22 and 24 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because dependent claims 22 generically recites any pharmaceutically acceptable carrier (e.g., water, saline, etc.) and 24 generically recites any “dosage delivery device” (e.g., syringe, pipette, etc.). Such limitations are not significantly more than the judicial exception because such limitations are routine in the art and would be required to merely study, evaluate, synthesize, purify, or otherwise obtain the naturally occurring protein or protein fragments (see e.g., Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman’s art”; see also Myriad, 133 S. Ct. at 2116-19, clarifying that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility).
Regarding claims 1, 22, and 24 with respect to fragments of naturally occurring proteins as identified above, Applicant is advised that the Court has clarified that fragmentation does not constitute a feature that renders polynucleotides markedly different from what exists in nature. Even though fragmentation or truncation structurally changes a nucleic acid from its natural state, the resultant difference (e.g., “broken” bonds) is not significant enough to render the isolated polynucleotide markedly different, because the sequence of the nucleic acid has not been altered. See, e.g., Myriad, 133 S. Ct. at 2116-18. Similarly, fragmentation does not constitute a feature that renders polypeptides markedly different from what exists in nature, because the resultant difference (e.g., “broken” bonds) is not significant enough to render the isolated fragments markedly different, because the sequence of the polypeptide has not been altered.
Therefore, claims 1, 22, and 24 do not appear to recite additional elements that amount to significantly more than the judicial exception of naturally occurring peptides (and fragments thereof) as found in nature.
Summary
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. “To be patent eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception” (79 FR 74624 col I).
Accordingly, claims 1, 22, and 24 do not qualify as eligible subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by JP2005272445A (Oct. 6, 2005) as evidenced by Translation (Machine Translation of JP2005272445A to English, Translated by Patent Translate Espacenet.org on 7/15/2026, 101 pages).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1, 22, and 24, JP’445 is directed to tear secretion promoting peptides and compositions thereof (see, e.g., Translation at title, claims, ¶[0001]; see also JP’445 at Figures). JP’445 teaches and discloses the tetrapeptide of Leu-Ile-Arg-Gly-NH4 (i.e., LIRG) (see, e.g., JP’445 at Figure 1). This structure satisfies the structural requirements of instant claims 1, 22, and 24 because, relative to instant SEQ ID NO: 1 (DITLVHDIVNMLIHGL), LIRG comprises an H14R substitution, and deletion of residues in positions 1-11 and 16 (compare JP’445 at Figure 1 and LIRG with instant claim 1). Regarding instant claims 22 and 24, JP’445 identifies that such peptides have a tear promoting effect (see, e.g., Translation at claims 1, 7), and may be formulated with a pharmaceutically acceptable carrier (see, e.g., Translation at claims 1, 7, 9-10), wherein drug delivery routes are explicitly contemplated (see, e.g., Translation at claims 1, 7, 12, 15-18, 20-21). Accordingly, an artisan would at once envisage pharmaceutical formulations and suitable means of delivering such formulations to the eyes of a patient.
Accordingly, claims 1, 22, and 24 are anticipated by the prior art.
Claim 1, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 5,340,727 (Aug. 23, 1994).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claims 1, 22, and 24, US’727 discloses an 11-mer polyarginine (“(R)11”) at Table V and Example 2 (see, e.g., US’727 at col 16 at lines 5-45). The polyarginine satisfies the limitations of instant claim 1 because, relative to instant SEQ ID NO: 1, the polyarginine sequence comprises an H14R substitution, a deletion of positions 1-13 and 15-16 of SEQ ID NO: 1, and additionally comprises the addition of 10 arginine residues (compare instant claim 1 and SEQ ID NO: 1 with (Arg)11 at US’727 at col 16 at lines 5-45). In view of the in vitro testing at Example 2 (see, e.g., US’727 at col 16 at lines 5-45), an artisan would readily appreciate that the peptides were present in a pharmaceutically acceptable carrier suitable for in vitro testing, and were administered at a desired amount using a suitable delivery device (see id.).
Accordingly, claims 1, 22, and 24 are anticipated by the prior art.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WP_055259993.14
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Regarding instant claim 1, WP_055259993.1 discloses a protein that comprises “DIVNMLIR” is at positions 139-146 (see, e.g., WP_055259993.1 at 1 at positions 139-146). This satisfies the structural limitations at instant claim 1 because relative to instant SEQ ID NO: 1 (DITLVHDIVNMLIHGL), the DIVNMLIR sequence comprises an H14R substitution, and deletion of residues in positions 1-6 and 15-16, and additionally comprises an N-terminal and C-terminal trailer sequence corresponding to the remainder of the naturally occurring peptide.
Accordingly, claim 1 is anticipated by the prior art.
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 22, 24, 81-82, and 89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8-13, 17-20, 23-26 of copending Application No. 18/920,260 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner notes that the instant rejection is not inconsistent with restriction/election requirement in the instant action because the pending method claims may be subject to rejoinder prior to issuance, and the copending application was not filed as a DIV in response to the requirement of record.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
Legal analysis: The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
Regarding instant claims 1, 81-82, 89, and the instantly claimed structure of VHDIVNMLIRG, the copending claim sets are not patentably distinct because App’260 recites and claims methods utilizing the originally elected species in the instant case (compare App’260 at SEQ ID NO: 8 and claims 1, 4-5, 8-13, 17-20, 23-26 with instant SEQ ID NO: 8 and claims 1, 22, 24, 81-82, and 89, showing that both SEQ ID NO: 8 sequences are identical). Accordingly, in view of App’260, an artisan would at once envisage the product required to practice the claimed methods. Regarding pharmaceutical formulations comprising VHDIVNMLIRG as recited at instant claim 22, App’260 recites and claims methods of utilizing VHDIVNMLIRG in in vivo methods (see, e.g., App’260 at SEQ ID NO: 8 and claims 1, 4-5, 8-13, 17-20, 23-26), and therefore an artisan would readily conclude that App’260 necessarily, implicitly, and inherently required the existence and usage of the same peptide in combination with a pharmaceutically acceptable carrier suitable for usage in in vivo methods. Regarding delivery devices comprising VHDIVNMLIRG as recited at instant claim 24, App’260 recites and claims methods of utilizing VHDIVNMLIRG, wherein the compound is “delivered to”, “delivered systemically”, “delivered subcutaneously”, etc. (see, e.g., App’260 at SEQ ID NO: 8 and claims 1, 4-5, 8-13, 17-20, 23-26; see esp. id. at claims 8-13). Accordingly, an artisan would at once envisage delivery devices required to practice such steps (e.g. syringes, inhalers, etc.).
Anticipation analysis: MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the products presently claimed in view of the methods recited in the copending claim set (see, e.g., MPEP § 804(II)(B)(2)).
Accordingly, claims 1, 22, 24, 81-82, and 89 are provisionally rejected.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20190062386A1 discloses DITLVHDIVNMLIHGLQFVIKV (SEQ ID NO:2) and DITLVHDIVNMLIHG (SEQ ID NO:3), corresponding to amino acids 235-249 of human SPLUNC1 (see, e.g., US’386 at ¶[0077], claims). US’386 identifies that such sequences and “functional fragments thereof” have predictable and expected utility (see, e.g., US’386 at claims), wherein US’386 directs artisans to “functional fragments” of SEQ ID NO: 3 that may vary at three positions or less (i.e., 12/15 residues is 80% sequence identity, but 11/15 is 73.33% sequence identity) (see, e.g., US’386 at ¶[0077], explaining that “functional fragments” includes compounds sharing “at least 75%, 80%... sequence identity” with SEQ ID NO: 3).
Conclusion
No claims are allowed. Subject matter free of the prior art has been identified.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 NCBI Reference Sequence: WP_055259993.1, YitT family protein [Sarcina ventriculi], 14-MAY-2017, 1 page, also available at https://www.ncbi.nlm.nih.gov/protein/941984768?sat=54&satkey=67756972 (last visited 7/15/2026).
2 NCBI GenBank: MFQ5398601.1, MAG: S41 family peptidase [Anaerolineae bacterium], 17-JAN-2025, 2 apges, also available at https://www.ncbi.nlm.nih.gov/protein/MFQ5398601.1 (last visited 7/15/2026).
3 NCBI Reference Sequence: WP_068748072.1, UDP-N-acetylmuramoyl-tripeptide--D-alanyl-D-alanine ligase [Thermovenabulum gondwanense], 19-AUG-2016, 1 page, also available at https://www.ncbi.nlm.nih.gov/protein/1057392209?sat=54&satkey=21107580 (last visited 7/15/2026).
4 NCBI Reference Sequence: WP_055259993.1, YitT family protein [Sarcina ventriculi], 14-MAY-2017, 1 page, also available at https://www.ncbi.nlm.nih.gov/protein/941984768?sat=54&satkey=67756972 (last visited 7/15/2026).
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
Prosecution Insights