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
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, 3-13 are pending.
Previously, claims 1-13 were pending and claims 1-9, 11, 12 were examined on their merits.
Presently, claims 1, 3, 5, 6, 9, 12 are amended. Claim 2 is cancelled. Claims 10 and 13 are withdrawn.
Claims 1, 3-9, 11-12 are examined on their merits.
Claim Objections
(previous objection; objection withdrawn) Claims 2, 5, 6 were objected to because of the following informalities:
(canceled) Claim 2: For improved language, insert “an” between “is” and “age”. Also, change “age related” to “age-related”.
(amended) Claim 5: “Neurogenerative disease should be “neurodegenerative” as this is the term used in claim 4.
(amended) Claim 6: For improved language, insert “an” between “from” and “alphavirus”.
Appropriate correction is required.
Applicant contends: Appropriate corrections have been made. Claim 2 is canceled.
Office response: The objections to claims 5 and 6 are withdrawn.
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.
(previous rejection; rejection withdrawn) Claims 1-9, 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out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”.
Applicant contends: Amendments have been made to resolve the missing step and the inconsistency.
Office response: In view of applicant’s amendments to claim 1, the rejection is withdrawn.
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.
(previous rejection; rejection withdrawn as to claims 1, 6, 7, 8, 9 and 11) 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)(previously cited).
See Response to Arguments section.
(previous rejection; rejection withdrawn as to claims 2, 3, 4, 5). 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)(previously cited).
See Response to Arguments section.
(new rejection, necessitated by amendment as to claims 1, 3-5, 6-9, 11-12) Claims 1, 3-5, 6-9, 11-12 are rejected over Ueno in view of Stephenson and Constance (previously cited).
See claims 1, 3-5, 6-9, 11-12 as submitted 04/27/2026.
Ueno 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). Ueno also teaches the following two examples: (1) “when at least one antigen used for the present invention is amyloid β, the isolated nucleic acid, the vector, the composition and the method provided by the present invention can be useful for the treatment of Alzheimer's disease (an example of a neurodegenerative disease as recited in claims 4 and 5) and (2) “when at least one antigen used for the present invention is TNF alpha, the isolated nucleic acid, the vector, the composition and the method provided by the present invention can be useful for the treatment of inflammation”(p. 45-46).
Ueno also 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
While Ueno mentions a self-antigen, Ueno does not specifically teach a galectin-3 antigen.
Stephenson further teaches particulars of age-related inflammatory conditions: “[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 1). 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 1, 3, 4, and 5).
Neither Ueno nor Stephenson teach at least one galectin-3 antigen.
Constance, though, 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.
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 Ueno, Stephenson, and Constance in order to arrive at a beneficial treatment method to tackle debilitating age-related inflammatory conditions which at the time of filing were severely limited. Ueno teaches the neurodegenerative disease Alzheimer’s disease, use of a virus like particle with a viral structural protein, a self-antigen and treating inflammation. Stephenson teaches additional specifics about cytokines and age-related inflammatory conditions. Constance also teaches treating inflammation, teaches the benefit of a galectin peptide, such as the self-antigen, galectin-3, for treating inflammation (See MPEP 2143 Rationale A Combining prior art elements according to known methods to yield predictable results and 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 for combining the teachings of Ueno, Stephenson, and Constance in order to arrive at a beneficial treatment method to tackle debilitating age-related inflammatory conditions. 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.
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.
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(previous rejection; rejection withdrawn as to claims 1, 6, 7, 8, 9, 12) Claims 1, 6, 7, 8, 9, 12 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).
Applicant contends: Claim 1 has been amended to incorporate the feature recited in claim 2 and therefore, this ground for rejection became moot.
Office Response: Incorporating the features of claim 2 into claim 1 resulted in claim 16 of copending Application No. 17726623 being removed from the rejection. Additionally, copending Application No. 17726623 resulted in patent US12636341B2 which changes the rejection from “provisionally rejected” to “rejected”. See new rejection below.
(previous rejection; rejection withdrawn) 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.
Applicant contends: As discussed under the 103 rejections, Constance and Stephenson do not teach or suggest the features of the amended claims. In addition, the claims of the reference application do not cure such deficiencies.
Office response: The response provided by the applicant is not persuasive (see below in Response to Arguments). However, this rejection of claim 2 is withdrawn on account of the cancellation of claim 2. And, with the integration of the claim 2 in to claim 1, particularly the language, “an age related inflammatory condition”, claim 16 of copending Application No. 17726623 is removed from the rejection. Additionally, copending Application No. 17726623 resulted in patent US12636341B2 which changes the rejection from “provisionally rejected” to “rejected”. See new rejection below.
(new rejection, necessitated by amendment as to claims 1, 3-5, 6-9, 11-12) Claims 1, 3-5, 6-9, 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 6, 7, 10 and 15 of US Patent No. 12636341B2 (copending Application No. 17726623 status change to US Patent No. 12636341B2) in view of Constance and Stephenson.
US Patent No. 12636341B2 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 4: The virus like particle according to claim 1, wherein the viral structural protein comprises capsid, El, E2 and E3.
Claim 5: The virus like particle according to claim 1, wherein the viral structural protein is derived from Chikungunya virus strain 37997 or strain OPY-1, or Venezuelan equine encephalitis virus strain TC-83.
Claim 6: The virus like particle according to claim 1, wherein at least one galectin antigen is inserted into the envelope protein E3.
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.
Claim 10: The virus like particle according to claim 1, wherein the at least one galectin antigen is a peptide fragment of galectin-3.
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).
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. US Patent No. 12636341B2 teaches aspects of the instant application claim 1 (the instant application claims 3-5 are dependent on claim 1), however, US Patent No. 12636341B2 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 3-5). 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 3-5).
Therefore, based on the claims in US Patent No. 12636341B2 and the teachings of Constance and Stephenson, the invention as a whole would have been prima facie obvious.
RESPONSE TO ARGUMENTS
Applicant contends:
(1) Claim 1 has been amended to incorporate therein the feature of claim 2 "the method is directed to treating an age-related inflammatory condition." Since claim 2 is not rejected over Ueno and Constance, this ground for rejection is traversed.
The introduced limitation is not taught or suggested by the cited references.
Ueno broadly relates to immunomodulation and treatment of inflammatory diseases. Constance relates to galectin-3 and its therapeutic applications. However, neither reference discloses or suggests treatment of age-related inflammatory conditions, nor do they recognize or address the specific pathological context associated with aging. An age-related inflammatory condition involves distinct biological mechanisms, including chronic low-grade inflammation associated with aging (inflammaging), which is not specifically contemplated in the cited references. Accordingly, the amended claims are directed to a more specific therapeutic application that is not suggested by the prior art, and the rejection should be withdrawn.
(2) The Examiner relies on Stephenson to assert that it would have been obvious to apply the method to age-related and neurodegenerative conditions. Applicants traverse.
Stephenson merely describes:
- age-related decline in immune function, and
- chronic inflammatory status associated with aging ("inflammaging"), and its
relationship to neurodegenerative diseases.
Importantly, Stephenson does not disclose or suggest the use of galectin-3, nor does it
provide any teaching or motivation to select galectin-3 as a therapeutic agent for such conditions. Inflammation involves a large number of possible mediators and pathways.
The selection of a specific molecule such as galectin-3 from among numerous candidates requires specific technical motivation, which is absent in Stephenson. Furthermore, Ueno does not disclose galectin-3, and Stephenson does not suggest combining its teachings with a galectin-3-based immunotherapy.
Thus, there is no motivation to combine the teachings of Ueno, Constance, and Stephenson in the manner required to arrive at the claimed invention.
Accordingly, the rejection under § 103 should be withdrawn.
Office Response
Cancellation of claim 2 is acknowledged and so the rejection is moot.
The initial rejections are withdrawn for claims 1, 3-5, 6-9, 11-12 but new rejections necessitated by amendment have been formulated.
Re: Double Patenting rejections have been updated from provisionally rejected to rejected.
The applicant did not address comments for claim 11 which were as follows:
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”.
Applicant’s arguments filed 04/27/2026 have been fully considered but they are not persuasive.
A new rejection was constructed combining the teachings previously used – Ueno, Stephenson, and Constance as all three teach pertinent aspects of the invention and one of ordinary skill in the art would have been motivated to combine the teachings to yield predictable results (see above for the new rejection necessitated by the amendments, notably to claim 1)(See MPEP 2143 Rationale A. Combining prior art elements according to known methods to yield predictable results and 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 inventio). Regarding the applicant’s assertion that Ueno does not teach or suggest, itself, an age-related inflammatory condition (added to claim 1 as an amendment), it appears that Ueno, in fact, does teach the exemplary Alzheimer’s disease and treatment for it (applicant’s species election in claim 5 – Alzheimer with dependency on claims 1, 3, 4) but not with galectin-3 antigen. Stephenson’s teachings complement Ueno and Constance by addressing distinct biological mechanisms, such as “inflammaging”.
Please note that in response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references – Ueno, Stephenson, Constance, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Graham et al. (2017)(See PTO-892: Notice of References Cited) evidences that “Alzheimer's disease (AD) is the primary cause of age-related dementia. Effective strategies to prevent and treat AD remain elusive despite major efforts to understand its basic biology and clinical pathophysiology. Significant investments in therapeutic drug discovery programs over the past two decades have yielded some important insights but no blockbuster drugs to alter the course of disease” (p. 413, Abstract). Accordingly, one skilled in the art would be highly motivated to try different therapeutic approaches, known in the art, such as combining, for example Ueno’s method of treatment (where Alzheimer’s disease is provided as an example disease for treatment) in combination with different self-antigens, such as at least one galectin-3 antigen as taught by Constance.
Conclusion
No claims allowed.
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 Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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