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
This office action is a response to applicant’s communication submitted April 24, 2026, wherein claims 1, 2, and 14 are amended and claim 12 is canceled. This application is a continuation in part of PCT/RB2021/052818, filed October 29, 2021, and PCT/GB2021/052817, filed October 29, 2021, and claims priority to foreign applications GB2017251.6, filed October 30, 2020, and GB2017255.7, filed October 30, 2020.
Claims 1-11, 13, and 14 are pending in this application.
Claim 13 is withdrawn from consideration for being drawn to non-elected subject matter.
Claims 1-11 and 14 as amended are examined on the merits herein.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Great Britain on October 30, 2020. It is noted, however, that applicant has not filed a certified copy of the foreign applications as required by 37 CFR 1.55.
Withdrawn Rejections
Applicant’s amendment, submitted April 24, 2026, with respect to the rejection of claims 1-11 and 14 under 35 USC 112(a) for lacking enablement for methods of treating all possible neurodegenerative diseases, has been fully considered and found to be persuasive to remove the rejection as the claims have been amended to narrow the scope of diseases being treated to dementia. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted April 24, 2026, with respect to the rejection of claims 1-12 and 14 under 35 USC 102(a)(2) for being anticipated by Shetty et al., has been fully considered and found to be persuasive to remove the rejection as independent claim 1 has been amended to require that the polysaccharide be separated from plant tissue and cells, which is not necessarily the case with any of the herbal compositions described by Shetty et al. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted April 24, 2026, with respect to the rejection of claims 1-12 under 35 USC 102(a)(1) for being anticipated by Pujari et al., has been fully considered and found to be persuasive to remove the rejection as independent claim 1 has been amended to require that the subject be suffering from a dementia. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted April 24, 2026, with respect to the rejection of claims 1-12 for claiming the same invention as claims 11, 18, 31-33, and 39-45 of US application 18/034651, has been fully considered and found to be persuasive to remove the rejection as the claims have been amended to no longer encompass methods of treating multiple sclerosis. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
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.
Claims 1-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pujari et al. (Reference of record in previous action)
Independent claim 1 claims a method of treating, preventing, or ameliorating a neurodegenerative disorder comprising administering to a subject in need thereof an isolated polysaccharide defined by the presence of certain linked arabinofuranose residues in the backbone and side chains. Regarding the term “isolated polysaccharide” which appears in the claim, the term is defined as requiring that the polysaccharide be separated from plant tissue and cells. Dependent claims 2-11 further describe specific structural features of the polysaccharide.
Pujari et al. discloses that Kainic acid induced brain damage in rats is used as an animal model for chronic neurodegenerative diseases including Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, temporal lobe epilepsy, and amyotrophic lateral sclerosis. (p. 537 right column) Pujari et al. further describes producing an aqueous extract of S. cordifolia roots. (ARESC, abstract, p. 538 right column last paragraph, p. 543 “Abbreviations”) This aqueous extract is reasonably expected to contain at least the same components including polysaccharides present in the inventive polysaccharide, in view of the present disclosure, (see figure 20, also p. 34 line 27 – p. 35 line 17 of the present specification) which describes the polysaccharide used in the presently claimed methods as being isolated from an aqueous extract of S. cordifolia roots. The ARESC extract is furthermore administered to KA-treated rats and found to ameliorate the neurodegenerative symptoms suffered by these animals. (p. 538 right column first paragraph, p. 540 “Results” and tables 1-3)While as discussed previously the experiments described in the reference are seen to anticipate present claims 1-11, even assuming for the sake of argument that the term “dementia” appearing in the claims were interpreted in a way that would not be directly infringed by treating the animal model described by Pujari et al., it would have still been obvious to one of ordinary skill in the art at the time of the invention to administer the same ARESC extract to a subject suffering from a neurodegenerative disease such as Alzheimer’s disease. One of ordinary skill in the art would have seen this to be obvious because Pujari et al. specifically describes this extract as producing beneficial effects in an animal model of these conditions.
Therefore the invention taken as a whole is prima facie obvious.
Response to Arguments
Applicant’s arguments, submitted April 24, 2025, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. With respect to the remaining rejection under 35 USC 102(a) over Pujari, Applicant argues that the animal model described by Pujari et al. differs from a human subject suffering from Alzheimer’s disease in that it is an acute chemical brain trauma which differs from the progressive, multifaceted damage that occurs in Alzheimer’s disease. Additionally, Applicant argues that Pujari et al. describes a method of preventing acute trauma rather than reversing established disease.
However, while a rat suffering from acute treatment with kainic acid is not exactly the same as a human suffering from progressive neurodegeneration, the use of animal models of human disease is well established in the art. In particular, Pujari et al. describes kainic acid as inducing excitotoxicity by activating glutamate receptors. (p. 538 left column first paragraph) Since this is believed to be one of the mechanisms by which neurodegeneration occurs in Alzheimer’s disease, this treatment would be expected to prevent the same mechanism when it occurs chronically in a human subject.
Applicant further argues that rodent models often fail to translate into efficacy in humans, and that the disclosed experiments constitute a preliminary analysis rather than a reproducible method for treating disease in humans. However, what is necessary for a finding of obviousness is not absolute predictability but rather simply a suggestion to perform the claimed process and a reasonable expectation of success. Similarly, while Pujari describes measurements of indirect markers rather than a specific activity targeting amyloid beta, obviousness does not require that the prior art recognize a particular mode of action for the prior art process. The fact that Pujari describes the polysaccharide as having neuroprotective activity as measured by behavioral tests would suggest its use for treating Alzheimer’s disease whether or not this effect is mediated through amyloid beta.
For these reasons the rejection is deemed proper and maintained.
Conclusion
No claims are allowed in this action. 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 ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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, Scarlett Y Goon can be reached at 571-270-5241. 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.
/ANDREA OLSON/ Primary Examiner, Art Unit 1693 6/9/2026
Prosecution Insights