Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
2. Applicant's election without traverse of Group I, claims 1-4, 7, 9-12, 15-16, 18-19, 22, 24-25, 28 and 56-57, in the reply filed on 11 December 2025 is acknowledged. Applicant’s election of idiopathic pulmonary fibrosis as the species of disease/disorder, LIGHT and TL1A as the species of combination of targets of modulation is also acknowledged. Applicant’s election of an LTβR-IgG fusion protein and a DR3-IgG fusion protein as the species of compounds that antagonize LIGHT and TL1A, respectively, in the reply filed on 21 April 2026 is also acknowledged. Claims 9-12, 24-25 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking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. Election was made without traverse in the reply filed on 11 December 2025.
3. The restriction requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, and/or Claims
4. The Response to the Restriction Requirement filed 11 December 2025 and 21 April 2026 have been entered in full. Claims 40-41 and 53 have been canceled, claims 9-12, 24-25 and 28 have been withdrawn as discussed supra, and claims 56-57 have been added. Newly added claim 56 will be examined as it fits under the rubric of the elected invention/species. Newly added claim 57 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species. Therefore, claims 1-4, 7, 9-12, 15-16, 18-19, 22, 24-25, 28 and 56-57 are pending, and claims 1-4, 7, 15-16, 18-19, 22 and 56 the subject of this Office Action.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 30 September 2022 and 26 August 2025 have been considered by the Examiner.
Improper Markush
6. Claims 4 and 7 are 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.
7. In the instant case, the Markush grouping of various fusion proteins, peptidomimetics, small molecules, and antibodies recited in claims 4 and 7 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: the different fusion proteins, peptidomimetics, small molecules, and antibodies have different chemical structures, and thus share no structural similarity. Therefore, there is no substantial common structural feature and a common use that flows from the substantial structural feature.
8. 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 § 112
9. 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.
10. Claims 1-4, 7, 15-16, 18-19,22 and 56 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.
11. Claims 1-3 are rejected as being indefinite for reciting “the activity” of LIGHT, and “the activity” of TL1A. Since they proteins have multiple activities, without knowing if a specific activity of LIGHT, for example, is intended, or if any activity of LIGHT is intended, the metes and bounds of the claims cannot be determined. Furthermore, claims 1-2 are further indefinite for reciting “modulating”. Without knowing if the modulation is inhibitory in nature or stimulatory in nature, the metes and bounds of the claims cannot be determined.
12. Claim 3 is rejected as being indefinite for reciting “reducing, decreasing, suppressing, limiting, controlling, or inhibiting”. Since neither the art nor the specification provides an unambiguous definition of how these terms differ, either functionally or in terms of degree, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112, 1st Paragraph (Written Description)
13. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
14. Claims 1-4, 7, 15-16, 18-19, 22 and 56 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
15. The U.S. Court of Appeals for the Federal Circuit recently reaffirmed, in an en banc decision, that the written description requirement for a genus may be satisfied either by (i) the disclosure of a representative number of species falling within the scope of the genus or (ii) structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. Ariad Pharmaceuticals', Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350, 94 U.S.P.Q.2d 1161, 1171 (en banc) (Fed. Cir. 2010), citing Regents" of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568-69, 43 U.S.P.Q.2d 1398, 1406 (Fed. Cir. 1997).
16. The representative ways of satisfying the written description requirement as set out by the Federal Circuit in Ariad Pharmaceuticals comport with statements set out in the USPTO's Manual of Patent Examining Procedure (M.P.E.P.). In particular, the M.P.E.P. provides that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species of relevant identifying characteristics. M.P.E.P. § 2163, II, A, 3, (a), (ii).
17. 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: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. “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.
18. The claims are drawn very broadly to a method for one or more of: a) reducing or inhibiting a fibrotic disease in a subject in need thereof ; b) treating a skin disease or inflammation in a subject in need thereof; c) treating an autoimmune disorder in a subject in need thereof; d) treating a respiratory disease in a subject in need thereof; or e) reducing or inhibiting the activity of a LIGHT (p30 polypeptide) receptor and/or the activity of a TNF-like Ligand 1A (TL1A) receptor in a subject in need thereof; comprising modulating the activity of LIGHT (p30 polypeptide) and the activity of TNF-like Ligand 1A (TL1A) in the subject in need thereof. The claims also recite wherein modulating the activity of LIGHT and the activity of TL1A in the subject in need thereof comprises administering to the subject a sufficient amount of a first molecule that modulates the activity of LIGHT and a second molecule that modulates the activity of TL1A, or wherein modulating the activity of LIGHT and the activity of TL1A in the subject in need thereof comprises reducing, decreasing, suppressing, limiting, controlling, or inhibiting the activity of LIGHT, and reducing, decreasing, suppressing, limiting, controlling, or inhibiting the activity of TL1A. The claims also recite wherein the first molecule comprises a fusion of an immunoglobulin with a) herpesvirus entry mediator (HVEM) or b) lymphotoxin beta receptor (LTOR) polypeptide or wherein the first molecule comprises a polypeptide that binds to LIGHT, HVEM, or LTOR, a peptidomimetic that modulates LIGHT, or a small molecule that modulates LIGHT or wherein the first molecule comprises an antibody that binds to LIGHT, an antibody that binds to HVEM, or an antibody that binds to LTOR. The claims also recite wherein the second molecule comprises a fusion of death receptor 3 (DR3) with an immunoglobulin, a polypeptide that binds to DR3, a fusion of decoy receptor 3 (DcR3) with an immunoglobulin, a peptidomimetic that modulates TL1A, a small molecule that modulates TL1A, or an antibody that binds to TL1A or an antibody that binds to DR3, or wherein the method comprises administering to the subject a first molecule comprising an inhibitor of LIGHT and a second molecule comprising an inhibitor of TL1A. Thus, the claims have been broadly interpreted by the Examiner as reading upon method of treatment utilizing an extremely large genus of modulators or inhibitors of LIGHT and TL1A that are only defined by a desired function/activity.
19. While the Specification provides adequate written description for an LTβR-IgG fusion, which inhibits LIGHT via inhibiting to its cognate receptors (HVEM and LTβR), and a DR3-IgG fusion protein, which inhibits TL1A via inhibiting to its cognate receptor (DR3), in a method of treating pulmonary fibrosis (See Figure 4 and Figures 6A-6C), it does not provide adequate written description for the genus of inhibitors or modulators of LIGHT or TL1A, that have the recited functions and can be used in the claimed methods. Accordingly, the specification does not provide adequate written description of the claimed genus.
20. For genus claims, an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries. A patent must set forth either a representative number of species falling within the scope of the genus or structural features common to the members of the genus. Kubin, Exparte, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007); Ariad Pharms., Inc. v. Eli Lilly& Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010).
A “patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”), see MPEP 2163.IIAii.
21. The Federal Circuit has clarified Written Description as it applies to antibodies in the recent decision Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017). The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. 112(a) (or pre-AlA first paragraph) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called “newly characterized antigen” test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the “newly characterized antigen” test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad, 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of an antigen alone is not considered adequate written description of a claimed antibody to that antigen, even when preparation of such an antibody is routine and conventional. Id.
22. While generically the structure of antibodies is known, the structure of the presently recited antibodies to be produced and screened in the instant method can vary substantially within the above given claimed recitations. As noted in Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing at all about the structure of the antibody, wherein “instead of analogizing the antibody-antigen relationship to a ‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million keys on it.” (Internal citations omitted). Therefore, those of skill in the art would not accept that the inventor had been in possession of the full genus of inhibitors of the IL-6 signaling pathway, which are not even limited to inhibitors of IL-6/IL-6R/gp130.
23. Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
24. An adequate written description of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”). See MPEP 2163IIA3(a).
25. Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of modulators or inhibitors of LIGHT or TL1A, nor guidance as to which of the myriad of structurally undefined molecules encompassed by the claims would meet the limitations of the claims, particularly in view of the evidence cited supra.
26. It is noted that while the claims here are directed to methods of using modulators or inhibitors of LIGHT and TL1A, rather than the modulators/inhibitors themselves, the same standard applies with regard to the written description requirement. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916,926 (Fed. Cir. 2004):
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
In University of Rochester, the "claimed method depend[ed] upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment." Id. ( citation omitted). Similarly here, the claimed methods cannot be practiced without the recited activity.
27. For inventions in an unpredictable art, adequate written description of a genus, which embraces widely variant species, cannot be achieved by disclosing only one or two species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph.
28. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed structure of the encompassed genus of antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
29. With the exception of the LTβR-Fc and DR3-Fc fusion proteins, the skilled artisan cannot envision the detailed chemical structure of the encompassed modulators and inhibitors of LIGHT and TL1A, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
30. One cannot describe what one has not conceived. See Fiddles v. Baird, 30 USPQ2d 1481, 1483. In Fiddles v. Baird, claims directed to mammalian FGF’s were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
31. Therefore, only LTβR-Fc and DR3-Fc fusion proteins, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Claim Rejections - 35 USC § 112 (Enablement)
32. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
33. Claims 1-4, 7, 15-16, 18-19 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating pulmonary fibrosis in a subject in need thereof, comprising administering to said subject a LTβR-Fc fusion protein and a DR3-Fc fusion protein, does not reasonably provide enablement for the breadth of diseases/disorders/conditions recited in the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
34. Factors to be considered in determining whether a disclosure enables one skilled in the art to make and use the claimed invention in its full scope without resorting to undue experimentation include: (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the nature or complexity of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. See In re Wands, 8 USPQ2d. 1400 (Fed. Cir. 1988).
35. In the instant case, the claims are directed to a method for one or more of: a) reducing or inhibiting a fibrotic disease in a subject in need thereof ; b) treating a skin disease or inflammation in a subject in need thereof; c) treating an autoimmune disorder in a subject in need thereof; d) treating a respiratory disease in a subject in need thereof; or e) reducing or inhibiting the activity of a LIGHT (p30 polypeptide) receptor and/or the activity of a TNF-like Ligand 1A (TL1A) receptor in a subject in need thereof; comprising modulating the activity of LIGHT (p30 polypeptide) and the activity of TNF-like Ligand 1A (TL1A) in the subject in need thereof. The claims also recite wherein the fibrotic disease comprises fibrosis of a parenchymal organ or tissue, fibrosis of the lung, liver, skin, kidney, brain, heart, joints, intestine, or the bone marrow, or wherein the fibrotic disease comprises interstitial lung disease (ILD) or liver cirrhosis. Thus the claims encompass complex and unpredictable subject matter, involving the effects of complex biological molecules on diseased physiological states.
36. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology”, Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert, denied, 502 U.S. 856 (1991).
37. The specification provides detailed direction and guidance regarding the effects of an LTβR-Fc fusion, which inhibits LIGHT via inhibiting to its cognate receptors (HVEM and LTβR), and a DR3-Fc fusion protein, which inhibits TL1A via inhibiting to its cognate receptor (DR3), in a method of treating pulmonary fibrosis (See Figure 4 and Figures 6A-6C). While the level of skill in the art is high, there is insufficient guidance and a lack of working examples to support a conclusion that the recited LIGHT and TL1A modulators/inhibitors could be used to treat the breadth of diseases/disorders/conditions encompassed by the claims, including fibrotic diseases, skin disease or inflammation, autoimmune disorders, or respiratory disease.
38. For example, It is well-known in the art that the immune system is complex and the disease states associated with inflammation is broad and diverse, ranging from bacterial infection to cancer (See Ahmed, Front. Biol. 6(4):274-281, 2011). Accordingly, treatment of inflammation is extremely broad, encompassing many mechanisms, cell types, and tissue types. Likewise, the term “respiratory disease” is incredibly broad, ranging from viral and bacterial infections (e.g. pneumonia and tuberculosis), vascular diseases (e.g. pulmonary hypertension), to malignancies and cancers, In contrast to the breadth of the claims, the guidance and working examples provided in the Specification are far more limited.
39. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentech, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”, and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure”. The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art”, “[I]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement”.
40. Due to the large quantity of experimentation necessary to generate the exceedingly large genus of LIGHT and TL1A modulators and inhibitors encompassed by the claims; the lack of direction/guidance presented in the specification regarding which structural features are required in order to provide activity of the modulators/inhibitors; the breadth of the claims which fail to recite any structural limitations of inhibitors utilized in the claimed methods; the large quantity of experimentation necessary to determine how to use the LIGHT and TL1A modulators and inhibitors to treat the breadth of fibrotic diseases, skin disease or inflammation, autoimmune disorders, or respiratory disease encompassed by the claims, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to the same, the complex nature of the invention, the unpredictability of the effects of complex biological molecules on diseased physiological systems, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Summary
41. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON M LOCKARD whose telephone number is (571) 272-2717. The examiner can normally be reached M-F 9-6 EST.
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, Joanne Hama can be reached on (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JON M LOCKARD/Examiner, Art Unit 1647 June 27, 2026
Prosecution Insights