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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, the subject matter of claims 1-12, without traverse,
filed on 12/17/2025 is acknowledged. Election of species are also acknowledged: Claim 5 - Alzheimer’s disease (readable on claims 1-12), Claim 6 – alphavirus (readable on claims 1-12), Claims 10 and 11 - SEQ ID NO: 12 (readable on claims 1-9, 11, and 12); Claims 12: one galectin antigen is inserted between residues 330 and 335 of SEQ ID NO: 8. Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no generic or linking claim.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The effective filing date of 04/18/2022 from the provisional was used for examination.
Claim Status
Claims 1-13 are pending. Applicant elected SEQ ID NO: 12. Claim 12 was amended. Claims 10, 13 were withdrawn. Claims 1-9, 11, 12 were examined on their merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/30/2022, 02/24/2025, and 09/09/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements, unless lined out, are being considered by the examiner.
Claim Objections
Claims 2, 5, 6 are objected to because of the following informalities:
Claim 2: For improved language, insert “an” between “is” and “age”. Also, change “age related” to “age-related”.
Claim 5: “Neurogenerative disease should be “neurodegenerative” as this is the term used in claim 4.
Claim 6: For improved language, insert “an” between “from” and “alphavirus”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-9, 11-12 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.
Claim 1 recites a method for treating an inflammatory condition in a subject in need thereof, which comprises an effective amount of a virus like particle comprising a viral structural protein and a galectin-3 antigen. However, the claim fails to include a clear active step on how the virus like particle composition will be used with respect to a subject in need, such as administering the virus like particle to the subject (as noted in the specification).
Claims 1, 9 and 12: Claims 9 and 12 state “at least one galectin antigen”. Claim 1, which claims 9 and 12 depend on, only recites “a galectin-3 antigen”. For claim 1 to be clearer, then, it should recite “at least one galectin-3 antigen”. Similarly, claims 9 and 12 should recite “at least one galectin-3 antigen”.
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.
Claims 1, 6, 7, 8, 9, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ueno et al. (Ueno)(WO2013122262A1)(2013) in view of Constance et al. (Constance)(US2004023855-A1)(2004)(See PTO-892 Notice of References Cited).
Claims 1, 6, 7, 8, 9, and 11 as submitted 12/17/2025.
Ueno teaches a virus-like particle (VLP) comprising one or more Chikungunya virus structural polypeptides, wherein the one or more virus structural proteins are from Chikungunya virus strain 37997 or Venezuelan equine encephalitis virus strain TC-83 (p. 22, lines 1-4)(as recited in claims: 1-virus-like particle, 6 - alphavirus, 7- Chikungunya/Venezuelan equine encephalitis, 8 – Chikungunya strain 37997 or Venezuelan equine encephalitis virus strain TC-83); and where the structural polypeptides are selected from the group consisting of capsid (C) and envelope proteins E3, E2, 6K and E1 and nucleic acids encoding said proteins (p.22, line 20)(as recited in claim 9 - at least on galectin-3 antigen is inserted into the envelope protein E3). Ueno also teaches SEQ ID NO: 3 for Venezuelan equine encephalitis virus structural protein) which is a 100% match to SEQ ID NO: 8 in the instant application claim 12 (See Result 1, BAS74136, us-18-301-542a-8.align45.rag, in Supplemental Content Tab, 1/8/2026). Ueno teaches that antigens, as used herein, include but are not limited to allergens, self-antigens, haptens, cancer antigens (i.e. tumor antigens) and infectious disease antigens as well as small organic molecules such as drugs of abuse (like nicotine) and fragments and derivatives thereof. Furthermore, antigens used for the present invention can be peptides, proteins, domains, carbohydrates, alkaloids, lipids or small molecules such as, for example, steroid hormones and fragments and derivatives thereof, autoantibody and cytokine itself (p.10, lines 6-16). Ueno further teaches the composition of the present invention is useful for immunomodulation. Especially said immunomodulation is for the treatment of autoimmune disease, neural disease, inflammatory disease such as inflammatory lung disease, including the acute respiratory distress syndrome, chronic obstructive pulmonary disease and asthma, angiogenesis associated diseases including neoplasm (p. 43 lines 22-24; p. 44 lines 1-5)(as recited in claim 1).
Although Ueno mentions a self-antigen, and galectin-3 antigen is an example of a self-antigen, it does not specifically teach a galectin-3 antigen.
Constance teaches galectin-3 antigen, and in particular a recombinant N-terminally truncated galectin-3 antigen, and its use in treating cancer, inflammatory conditions, and other diseases [0160,0187]. Constance also teaches SEQ ID NO: 3 which has 75.2% similarity to the instant application’s SEQ ID NO: 12 (See Result #98, ADM48468, us-18-301-542a-12.align450.rag in Supplemental Content Tab, 1/8/2026)(as recited in claim 11). In claim 11, “a peptide of SEQ ID NO:12” is interpreted to read upon a fragment of SEQ ID NO: 12. As noted above then, Constance teaches a fragment.
Note: For claim 11, to overcome the rejection, the language of the claim should be revised from “wherein the galectin-3 antigen is a peptide of SEQ ID NO: 12” to “wherein the galectin-3 antigen is the peptide of SEQ ID NO: 12”.
One of ordinary skill would have been motivated to combine the teachings of both Ueno and Constance to arrive at the present invention. Ueno teaches use of a virus like particle with a viral structural protein, a self-antigen and treating inflammation. Constance, which also teaches treating inflammation, teaches the benefit of a galectin peptide, such as galectin-3, for treating inflammation (See MPEP 2143 Rationale G: Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention).
One of ordinary skill in the art would have had a reasonable expectation of success combine the teachings of both Ueno (alphavirus), and Constance (galectin-3 antigen) as to arrive at the present invention – a virus like particle comprising a viral structural protein and a galectin-3 antigen) to treat an inflammatory condition. There would have been a reasonable expectation of success given the underlying materials and methods are known for using alphavirus – antigen constructs, immunopathology and autoimmunity, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 2, 3, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ueno and Constance as applied to claim 1 above, and further in view of Stephenson et al. (Stephenson)(2018)(See PTO-892 Notice of References Cited).
Claims 2, 3, 4, 5 as submitted on as submitted 12/17/2025.
Ueno and Constance teach claim 1 with both teaching treatment of inflammatory conditions. Ueno and Constance did not specifically teach age related inflammatory condition (as recited in claim 2); inflammation in a central nervous system (CNS)(as recited in claim 3); inflammation in the CNS is a neurodegenerative disease (as recited in claim 4); nor the neurodegenerative disease Alzheimer’s disease (as recited in claim 5).
Stephenson teaches “[a]geing, a major risk factor in neurodegenerative diseases, has a predominantly negative effect on both innate and adaptive immune responses, reducing the efficacy of vaccinations, and increasing susceptibility to infectious, chronic, autoimmune and neurodegenerative diseases...Ageing has been associated with a low‐grade sterile inflammatory status of the immune system, frequently termed inflammaging, in which pro‐inflammatory cytokines (e.g. IL‐6, TNF, IL‐1β) are key players in unhealthy ageing…Inflammaging might be the most important aetiological factor in age‐related neurodegenerative diseases, as ‘neuro‐inflammaging’ is associated with significantly decreased numbers of neurons, neuronal arborization, spines and cortical volume…With ageing, both macrophages and microglia display impaired and prolonged activation to insults, reduced motility and impaired phagocytosis (p. 210)(as recited in claim 2). Stephenson also teaches “Neurodegenerative diseases, the leading cause of morbidity and disability, are gaining increased attention as they impose a considerable socioeconomic impact, due in part to the ageing community. Neuronal damage is a pathological hallmark of Alzheimer’s and Parkinson’s diseases, amyotrophic lateral sclerosis, Huntington’s disease, spinocerebellar ataxia and multiple sclerosis, although such damage is also observed following neurotropic viral infections, stroke, genetic white matter diseases and paraneoplastic disorders. Despite the different aetiologies, for example, infections, genetic mutations, trauma and protein aggregations, neuronal damage is frequently associated with chronic activation of an innate immune response in the CNS (as recited in claims 2, 3, 4, 5).
One of ordinary skill in the art would have been motivated to apply the method of claim 1 to a more specific inflammatory condition, e.g., one that is age-related, involves the CNS, and is a neurodegenerative disease such as Alzheimer’s disease (See MPEP 2143 Rationale G: Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention).
One of ordinary skill in the art would have had a reasonable expectation of success of using the method of claim 1 to treat a more specific inflammatory condition. There would have been a reasonable expectation of success given the underlying materials and methods are known successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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, 6, 7, 8, 9, 12 (claims submitted on 12/17/2025)(effective filing date 04/17/2023) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 6, 7, 10, 15, 16 (claims submitted on 12/15/2025)(effective filing date 04/22/2022) of copending Application No. 17726623 (reference application).
Application 17726623 teaches:
Claim 1: A virus like particle comprising an alphavirus viral structural protein and at least one galectin antigen, wherein the alphavirus viral structural protein is derived from Chikungunya virus or Venezuelan equine encephalitis virus, and wherein the at least one galectin antigen is a peptide fragment of galectin-1 or galectin-3 (as recited in the instant application claims 1, 6, 7).
Claim 4: The virus like particle according to claim 1,wherein the viral structural protein comprises capsid, El, E2 and E3 (as recited in the instant application claim 9).
Claim 5: The virus like particle according wherein the viral structural protein is derived from Chikungunya virus strain 37997 or strain OPY-1, or Venezuelan equine encephalitis virus strain TC-83 (as recited in the instant application claim 8).
Claim 6: The virus like particle according to claim 1, wherein at least one galectin antigen is inserted into the envelope protein E3 (as recited in the instant application claim 9).
Claim 7: The virus like particle according to claim 5, wherein the at least one galectin antigen is inserted between residues 321 and 326 of SEQ ID NO: 1 or SEQ ID NO: 2, or between residues corresponding to residues 321 and 326 of SEQ ID NO: 1 or SEQ ID NO: 2, or between residues 330 and 335 of SEQ ID NO: 3, or between residues corresponding to residues 330 and 335 of SEQ ID NO: 3 (as recited in the instant application claim 12 - or residues 330 and 335 of SEQ ID NO: 8; where SEQ ID NO: 8 is identical to SEQ ID NO: 3 of reference application 17726623 (see Result 1, BAS74136, us-17-726-623-3.stic.rag, in Supplemental Content Tab, 1/8/2026).
Claim 10: The virus like particle according to claim 1, wherein the at least one galectin antigen is a peptide fragment of galectin-3 (as recited in the instant application claim 1).
Claim 15: A galectin-targeting immunotherapy method, which comprises administering an effective amount of the virus like particle according to claim 1 to a subject in need thereof (as recited in the instant application claim 1).
Claim 16: The method according to claim 15, wherein the method is for treating or preventing cancer or inflammatory disease (as recited in the instant application claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other because they include similar language and scope with respect to alphavirus strains, galectin-3, E3 envelope proteins, and methods of treating inflammatory diseases. Therefore, based on the claims in the co-pending Application No. 17726623, the invention as a whole would have been prima facie obvious.
Claims 2-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15, and 16 of copending Application No. 17726623 as applied to claims 1, 6, 7, 8, 9, 12 above and further in view of Constance, and Stephenson.
Application 17726623 teaches:
Claim 1: A virus like particle comprising an alphavirus viral structural protein and at least one galectin antigen, wherein the alphavirus viral structural protein is derived from Chikungunya virus or Venezuelan equine encephalitis virus, and wherein the at least one galectin antigen is a peptide fragment of galectin-1 or galectin-3 (as recited in the instant application claim 1).
Claim 15: A galectin-targeting immunotherapy method, which comprises administering an effective amount of the virus like particle according to claim 1 to a subject in need thereof (as recited in the instant application claim 1)
Claim 16: The method according to claim 15, wherein the method is for treating or preventing cancer or inflammatory disease (as recited in the instant application claim 1).
Although the claims at issue are not identical, they are not patentably distinct from each other because they include similar language and scope with respect to virus like particles, virus structural proteins, galectin-3 antigen, and methods of treating inflammatory diseases. Application 17726623 teaches the instant application claim 1 (the instant application claims 2-5 are dependent on claim 1), however, Application 17726623 does not teach an age-related inflammatory condition, an inflammation in a central nervous system, neurodegenerative disease, or Alzheimer’s disease (as also stated in the instant application claims 2-5). As previously noted, Constance more specifically teaches the use of a galectin-3 peptide in treating inflammation and, Stephenson distinctly teaches age-related inflammatory condition; inflammation in a central nervous system; neurodegenerative disease; and Alzheimer’s disease (as recited in instant application claims 2-5).
Therefore, based on the claims in the co-pending Application No. 17726623 and the teachings of Constance and Stephenson, the invention as a whole would have been prima facie obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowable.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672