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.
Drawings
The drawings are objected to because fig 12 is mostly illegible. Much of the text is at too low a resolution to make out. 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.
Election/Restrictions
Applicant’s election of group I (method of treatment) using peptides to treat neuropathic pain in the reply filed on 29 Sept, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants have elected treating neuropathic pain with peptides. A search was conducted for this invention, and a reference was found that anticipated it. As a result, claims 1, 2, 4, 10, 64, and 66 were examined and claims 49, 50, 52-61, 67,70, and 71 were withdrawn from consideration.
Claims Status
Claims 1, 2, 4, 10, 49, 50, 52-61, 64, 66, 67,70, and 71 are pending.
Claims 49, 50, 52-61, 67, 70, and 71 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 Sept, 2025.
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, 2, 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.
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 1, 2, 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.
The rejected claims require an agent that is not a peptide “derived” from HGH, IRAK-3, or, in a dependent claim, 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.
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.
Claim(s) 1, 2, 10, 64, and 66 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (Am. J. Transl. Res. (2017) 9(3) p926-939) with evidentiary support from Huang et al (Develop. Cell (2014) 30 p479-487).
Lee et al discuss glutathione to relieve peripheral neuropathy caused by oxaliplatin (title), which is a neuropathic pain (p926, 2nd column, 1st paragraph). Other drugs used for this purpose include pain relievers, anesthetics, and vitamin supplements (p926, 2nd column, 1st paragraph). The therapy was effective (p936, 2nd column, 4th paragraph).
Lee et al shows that glutathione, a peptide, reduces neuropathic pain. This peptide has every structural feature that applicants have disclosed as required to meet the functional limitations of the claims, and Huang et al states that LanCL1 binds glutathione (p479, 2nd column, 2nd paragraph), providing additional evidence. Thus, the sequence inherently meets the functional limitations of the claims, anticipating claims 1, 2, 10, 64, and 66.
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4, 10, 64, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (Am. J. Transl. Res. (2017) 9(3) p926-939).
Lee et al discuss glutathione to relieve peripheral neuropathy caused by oxaliplatin (title), which is a neuropathic pain (p926, 2nd column, 1st paragraph). Other drugs used for this purpose include pain relievers, anesthetics, and vitamin supplements (p926, 2nd column, 1st paragraph). The therapy was effective (p936, 2nd column, 4th paragraph). As noted above, this reference anticipates claims 1, 2, 10, 64, and 66.
The difference between this reference and the remaining claim is that this reference does not discuss a second therapeutic.
However, it discusses other therapies, which are not discussed as working through LanCL1. The MPEP states that “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . .the idea of combining them flows logically from their having been individually taught in the prior art" (MPEP 2144.06). This means that it is prima facie obvious to use the other pain relieving drugs mentioned by Lee et al with the glutathione, rendering obvious claim 4.
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.
Conclusion
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.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658