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 December 2, 2025, wherein claims 1 and 3-14 are amended. This application is a continuation in part of PCT/GB2021/052818, filed October 29, 2021, as well as PCT/GB2021/052817, filed October 29, 2021, which claims priority to foreign applications GB2017251.6, filed October 30, 2020, and GB2017255.7, filed October 30, 2020.
Claims 1-14 are pending in this application.
Election/Restrictions
Applicant’s provisional election without traverse of group II, claims 2-11 and 14, drawn to a method of treating a neurodegenerative disease by administering a polysaccharide to a subject, filed February 2, 2025, is acknowledged.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 12 is now included in the subject matter of group II, in view of the February 2, 2025 amendment changing the preamble to claim a method of treatment rather than a plant.
Claims 1-11 and 14 are pending in this application and 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 and 14 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 or preventing Alzheimer’s disease, does not reasonably provide enablement for methods of treating or preventing all possible neurodegenerative diseases. 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 use the invention commensurate in scope with these claims.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claimed invention is a method of treating or preventing a disease in a subject. In order to be enabled for the full scope of the claims, one skilled in the art would have to be able to reasonably treat any subject suffering from a condition that can accurately be described as a neurodegenerative disease.
The state of the prior art: The term “Neurodegenerative disease” refers to a variety of different conditions that are broadly related in that they all involve the loss of neurological function. For example as described by Fratiglioni et al. (Reference included with PTO-892) Alzheimer’s disease, Parkinson’s disease, Lewy Body dementia, Frontotemporal dementia, Amyotrophic lateral sclerosis, Huntington disease, and prion disease are all considered to be neurodegenerative diseases despite affecting different cells and having different pathogenic mechanisms. (p. 46 left column first paragraph) Most of these disorders have familial variants suggestive of genetic susceptibility, and are also believed to be caused by misfolded proteins. (p. 46 left column last paragraph – right column first paragraph) As described by Fakada et al., (Reference Included with PTO-892) while it has been proposed that multiple different neurodegenerative diseases involve oxidative stress and can be treated using antioxidants, (see abstract) these therapies are still in the investigational stage and need more research to be broadly applicable. As described by Chou et al., (Reference included with PTO-892) there exist a large number of different mechanisms underlying different neurodegenerative diseases. As described by Amor et al. (Reference included with PTO-892) immune responses are believed to be involved in neurodegeneration. (p. 153 left column first paragraph, p. 160 right column) Several immunotherapeutic agents have been tested for the treatment of certain neurodegenerative diseases. (p. 163 left column second – fourth paragraphs) In particular, nonsteroidal anti-inflammatory agents have been shown to reduce the prevalence of Alzheimer’s disease, and glucocorticoids are commonly used to treat exacerbations of multiple sclerosis.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: Multiple different factors influence the treatment of disease, and the mechanism by which an underlying cause translates into observable symptoms involves various complicated biochemical events. Even in a case when some specific feature exists in common between various diseases, such as the loss of neurons and cognitive impairment, this does not necessarily mean that there exists a therapeutic agent capable of treating all of these various unrelated conditions.
The Breadth of the claims: The claimed invention is broad, including methods of treating a wide variety of different conditions falling under the umbrella of “neurodegenerative disorders.”
The amount of direction or guidance presented: Applicant’s disclosure describes the isolation of an arabinan polysaccharide from the roots of Sida cordifolia, (p. 34 line 27 – p. 37 line 12) and indicates that these polysaccharides improve some markers of function in a mouse model of Alzheimer’s disease. (pp. 42-44) Polysaccharide treatment also reduces amyloid deposition and markers of oxidative stress and inflammation in experimental animals. (p. 45 line 6 – p. 46 line 10, pp. 47-48 examples 6-8)
The presence or absence of working examples: While the specification provides examples of the treatment of a mouse model of Alzheimer’s disease, it does not provide any basis for taking this example as representative of treatment of a wider scope of neurodegenerative diseases beyond Alzheimer’s disease.
The quantity of experimentation necessary: In order to perform the full scope of therapeutic methods beyond the specific case of Alzheimer’s disease exemplified in the present disclosure, one of ordinary skill in the art would have to explore the use of the disclosed polysaccharide in other patient populations besides those suffering from Alzheimer’s disease. The observed anti-inflammatory and antioxidant effects are suggestive of a more general effect in view of the aforementioned observations of markers of inflammation and oxidative stress in neurodegenerative disease. However, the prior art does not establish a direct correlation that would allow for one skilled in the art to reliably generalize these activities to the treatment of the broader class of neurodegenerative disease. In order to establish such a general utility. One of ordinary skill in the art would have to embark upon an extensive project of novel, unpredictable research in order to establish utility for each individual neurodegenerative disease.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent 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.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims and the unpredictability of the art, Applicants fail to provide information sufficient to practice the claimed invention for the full scope of neurodegenerative diseases.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shetty et al. (US pre-grant publication 2020/0197474, cited in PTO-892) as evidenced by Cheng et al. (Reference included with PTO-892)
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, p. 22 lines 21-24 define “isolated” as referring to a polysaccharide that is no longer in its natural environment. This is a very broad definition, which can encompass any modification of the native, living plant material form its natural state, for example if the polysaccharide is present in a whole plant that has been harvested from its native environment, in a portion of the plant such as a leaf or root that has been removed from the whole plant, in a crude extract of plant tissue with other natural products, or in pure form isolated from all other active ingredients. While the specification also states, “Thus, the term "isolated" can refer to a polysaccharide that has been separated from Malvaceae/Malvoideae/Malveae plant tissue and cells (such as Sida Cordifolia tissue and Sida Cordifolia cells),” this statement is presented in such a way as to define an example of one possible interpretation of “isolated,” but not so as to define this term in a manner narrower than the immediately preceding sentence. Dependent claims 2-11 further describe specific structural features of the polysaccharide. Dependent claim 14 exemplifies a number of specific neurodegenerative diseases to be treated.
Shetty et al. discloses a composition for treatment and management of cognitive dysfunction associated with neurodegenerative diseases. P. 1 paragraph 8) This composition is defined as a herbal composition. (p. 2 paragraph 27) One element of this composition is the plant Sida cordifolia. (p. 3 paragraph 35) Shetty et al. more specifically describes the Sida cordifolia in the composition as being the roots of the plant. Since the roots are a specific part of a plant and not the whole plant, a polysaccharide present in the roots would reasonably be considered to be “isolated” according to the broadest reasonable interpretation of the term as it appears in the present specification.
While Shetty et al. does not specifically state that the Sida cordifolia root used in the compositions described therein contains the same arabinan polysaccharide described in the present claims, Cheng et al. describes purification arabinans from an aqueous extract of s. cordifolia root powder. (p. 2 left column second and third paragraphs) These polysaccharides included an arabinan which is the same one recited in present claims 2-6 and 10. (p. 6 figure 4) Therefore it is reasonably concluded that the composition administered in the method described by Shetty et al. inherently contains the same polysaccharide recited n the present claims. Regarding the ratios recited in present claims 7-9 an the value of n recited in present claim 11, the present disclosure (see figure 20 for example) describes that the inventive material is extracted from S. cordifolia roots using the same steps of ethanol followed by aqueous extraction used by Cheng et al. Therefore it is reasonably expected that these values were the same in the whole S. cordifolia root material described Cheng et al. and Shetty et al., and that the herbal composition described by Shetty et al. therefore also inherently includes a polysaccharide having the claimed ratios and value of n.
Regarding claim 14, Shetty et al. discloses methods wherein the neurodegenerative disease being treated is Alzheimer’s disease or Parkinson’s disease, for example. (p. 15 paragraph 118)
Regarding claim 12, this independent claim simply claims a method comprising administering to a subject a plant of the Malvales order or a part thereof, without specifying the presence of any particular compound. Therefore this claim is certainly anticipated by administering any of the herbal compositions described by Shetty et al.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pujari et al. (Reference included with PTO-892)
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, p. 22 lines 21-24 define “isolated” as referring to a polysaccharide that is no longer in its natural environment. This is a very broad definition, which can encompass any modification of the native, living plant material form its natural state, for example if the polysaccharide is present in a whole plant that has been harvested from its native environment, in a portion of the plant such as a leaf or root that has been removed from the whole plant, in a crude extract of plant tissue with other natural products, or in pure form isolated from all other active ingredients. While the specification also states, “Thus, the term "isolated" can refer to a polysaccharide that has been separated from Malvaceae/Malvoideae/Malveae plant tissue and cells (such as Sida Cordifolia tissue and Sida Cordifolia cells),” this statement is presented in such a way as to define an example of one possible interpretation of “isolated,” but not so as to define this term in a manner narrower than the immediately preceding sentence. 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) Therefore Pujari et al. anticipates the present claims, since administering the extract to KA-treated rats suffering from neurodegeneration (the “ND” group in tables 1-3 of Pujari et al.) would fall within the scope of administering the claimed composition to a subject suffering from neurodegeneration.
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 1-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pujari et al. (Reference included with PTO-892)
The disclosure of Pujari et al. is discussed above. While as discussed previously the experiments described in the reference are seen to anticipate present claims 2-12, even assuming for the sake of argument that the term “neurodegenerative disease” 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 or Parkinson’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.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 18, 31-33, and 39-45 of copending Application No. 18/034651 (reference application, US pre-grant publication 2024/0000927, cited in PTO-892, herein referred to as ‘651) as evidenced by Chaudhuri. (Reference included with PTO-892) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘651 anticipate the present claims.
Specifically, pp. 11 and 18 claim a polysaccharide isolated from a part of a plant form the Sida genus, which is also a Malvales as recited in present claim 12. Claim 18 and dependent claims 39-45 further specify the structure of this polysaccharide as being the same structure recited in present claims 1-11. Claims 31-32 of ‘651 further claim a method of treating a T helper cell mediated condition comprising administering this polysaccharide to a subject. While the claims of ‘651 do not specifically refer to neurodegenerative diseases, claim 33 lists a number of TH mediated diseases including multiple sclerosis, which is reasonably considered to be a neurodegenerative disease, (See e.g. Chaudhuri, abstract and p. 1463 right column first paragraph) thereby anticipating the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 1/20/2026