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 . 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.
Election/Restrictions
Applicants elected group I (method of treatment) using peptides to treat neuropathic pain without traverse in the reply filed on 29 Sept, 2025.
Claims Status
Claims 1, 4, 10, 64, 66, 67,70, and 71 are pending.
Claims 1, 4, 64, and 70 have been amended.
Claims 67, 70, and 71 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Objections
The objection to the drawings due to illegibility is hereby withdrawn due to amendment.
Withdrawn Rejections
The rejection of claim(s) 1, 2, 10, 64, and 66 under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (Am. J. Transl. Res. (2017) 9(3) p926-939) is hereby withdrawn due to argument.
The rejection of claim(s) 1, 2, 4, 10, 64, and 66 under 35 U.S.C. 103 as being unpatentable over Lee et al (Am. J. Transl. Res. (2017) 9(3) p926-939) is hereby withdrawn due to argument.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 10, 64, and 66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure(MPEP 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure and (d) representative number of samples.
The issue is if a person of skill in the art would know if a given ligand met the functional requirement of displacing SEQ ID 1 from LanCL1
(a and b) actual reduction to practice and disclosure of drawings or structural chemical formulas: Applicants mention a small number of peptides that appear to be variants of SEQ ID 1 (paragraph 254, for example), which applicants state are fragments of human growth hormone (paragraph 214). Applicants also describe a method of screening compounds with the required functionality (note original claim 49 and paragraph 58).
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure: Applicants are claiming a method of treating a number of diseases, comprising administering an agent that displaces SEQ ID 1 from LanCL1. This requires that whatever agent is used has the functional ability to displace this ligand from this protein. However, applicants have not defined what structural requirements are necessary to meet this functional limitation. A person of skill in the art would not know what hydrophobicity/sequence/electron density distribution is required to meet the required functional limitation. In essence, applicants have defined a critical part of their invention by function. That is not sufficient to meet the written description requirement.
As of applicant’s priority date, it was not possible to predict if a given molecule bound to a receptor. Lowe (blog “In the pipeline” entry of 7 Sept, 2022) describes an experiment where that was attempted. 39K compounds, including known antibiotics, were screened against E. coli for growth inhibition, finding 218 active compounds (1st page, 3d paragraph). These were computer docked to a set of 296 essential bacterial proteins by multiple docking procedures (1st page, 3d paragraph), along with 100 random inactive compounds (2nd page, 1st paragraph). The number of strong binders predicted were essentially the same between the active compounds and the controls, and out of 142 compound/target interactions previously known, the methodology found only 3 (2nd page, 2nd paragraph). While a given docking program may accurately predict if compound A binds to protein B, it is impossible to a priori know if the prediction is accurate. In other words, several years after applicant’s priority date, it was not possible to predict if a given compound and target bound to each other. If a compound cannot bind, it cannot displace something bound; this means that an inability to predict binding means an inability to predict displacement ability.
Nor is it possible to modify known sequences to reliably find new compounds. Guo et al (PNAS (2004) 101(25) p9205-9210) looked at the effect of random mutations (title). In a DNA repair enzyme, about one mutation in three killed the activity of the protein, consistent with studies with other proteins (abstract). Yampolsky et al (Genetics (2006) 170 p1459-1472), using a different methodology, found that even conservative substitutions were prone to problems (table 3, p1465, top of page). In other words, unless there is some information known about the binding, mutating the sequence is likely to be detrimental, making it a poor way to generate new compounds.
(d) representative number of samples: Every example that applicants give appear to be variants of SEQ ID 1, which is a fragment of human growth hormone, and are explicitly excluded. The prior art shows that it is impossible to predict a priori what compounds will bind to each other, nor is it possible to reliably modify a compound and still have it bind. With nothing but a method of screening, no embodiments that clearly meet the claim limitations, and no structural limitations, a person of skill in the art would not be able to tell from applicant’s disclosure if a given compound could be used in applicant’s method. Thus, the claims lack written description.
response to applicant’s arguments
Applicants have amended the claims to specify the portion of LANCL1 where the therapeutic binds.
Applicant's arguments filed 20 April, 2026 have been fully considered but they are not persuasive.
The basis of the rejection is that a person of skill in the art would not know if a given therapeutic met the functional limitations of the claims. Adding limitations that are inherent to the previous functional limitations does not change the analysis.
It should be noted that the fact pattern of this application is almost identical to that of University of Rochester v GD Searle (358 F.3d 916), which found the claims lack written description. Applicants will have to distinguish their application from the fact pattern of that case to overcome this rejection.
Claim Rejections - 35 USC § 112(b)
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.
Claims 10 and 64 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The rejected claims require an agent that is not a peptide “derived” from prolactin. Applicants have not defined “derived,” so the dictionary definition of derive, to obtain, actually or theoretically, from a parent substance (Merriam Webster online dictionary) will be considered how the term would be interpreted by a person of skill in the art (MPEP 2111.01(I and III)). However, essentially any sequence can be made from another polypeptide sequence by a skilled chemist; this interpretation would exclude any polypeptide agent. Given that applicants have elected peptides as the therapeutic, and they clearly consider peptides to be agents that read on the claims (note claim 10), this is not consistent with the disclosure (MPEP 2111.01(I)). This makes it unclear what is excluded by the negative limitations of the claims relating to derivatives of certain proteins.
response to applicant’s arguments
Applicants argue that they have amended to remove the term “derivative” from the claims.
Applicant's arguments filed 20 April, 2026 have been fully considered but they are not persuasive.
The rejection has been overcome for most of the claims, and has been so amended. However, the rejected claims were not amended, so the rejection is still valid for those claims.
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, 2, 10, 64, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 34, 35, and 37 of copending Application No. 18/291,004 (US 20250293435 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 describes a number of peptides that bind to LanCL1. Competing claims 34, 35, and 37 describe a number of conditions, narrowing down to neuropathic pain. Note that these peptides bind to the same protein as the agents of the examined claims, and have every structural feature that applicants have stated are required to meet the functional limitations, so they inherently will do so. Thus, the competing claims anticipate the examined claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
response to applicant’s arguments
Applicants argue that, as the later filed application, the competing claims cannot be the basis of a proper ODP rejection.
Applicant's arguments filed 20 April, 2026 have been fully considered but they are not persuasive.
It is agreed that a double patenting rejection based on a later filed application can be withdrawn under certain circumstances, but those circumstances have not been met yet – namely that the double patenting rejection be the last outstanding rejection.
New Rejections
Claim Rejections - 35 USC § 112(b)
The legal basis for rejections under this statute was given above, and will not be repeated here.
Claims 1, 4, 10, 64, and 66 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Please note that this rejection is necessitated by amendment.
Claim 1 has been amended to exclude human growth hormone peptide and homologs, and IRAK-3 peptide. Applicants have not defined “peptide,” so the dictionary definition is used (a short chain of amino acids linked by amide bond, National human genome research institute) is used. However, human growth hormone is 191 amino acids (NCBI protein, entry 1HUW_A, 2024) and human IRAK-3 is 596 amino acids (NCBI protein entry Q9Y616, 2026). While the cutoff between a peptide and a protein is not defined in the art (different groups use different cutoffs), 191 amino acids is not a “short” sequence, much less IRAK-3’s 596 amino acids. Note that, while applicants do not define the terms, they discuss peptides, polypeptides, and proteins (paragraph 59), indicating distinctions between these terms. This makes it unclear what is excluded by limitations human growth hormone peptide and IRAK-3 peptide.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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