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 Pursuant to the preliminary amendment dated 11/8/2023, claims 1-10, 19-30 and 36-38 are canceled, claims 11-14, 18, 31, 33-35 are amended and claims 39-48 are newly added. Claims 11-18, 31-35 and 39-48 are pen ding in the instant application and are examined on the merits herein. Priority This application is a National Stage Application of PCT/ GB2021/052818 , filed on 10/29/2021 . The instant application claims foreign priority to GB 2017255.7 filed on 10/30/2020 . Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) . The certified copy has been filed in the instant application on 4/28/2023 . Information Disclosure Statement The information disclosure statement (IDS) dated 8/16/2023 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted . Accordingly, the I DS ha s been placed in the application file and the information therein has been considered as to the merits. Claim Objections Claim 43 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only . See MPEP § 608.01(n) . Claim 43 simultaneously depends on claim 1 8 and claims 39-41. Accordingly, the claim has not been further treated on the merits. Claim Rejections - 35 USC § 112 (a) 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. Claims 31-35 and 48 are rejected under 35 U.S.C. 112(a), because the specification, while being enabling for ameliorating a condition , does not reasonably provide enablement for treating or preventing the condition . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. With respect to the claimed method , attention is directed to In re Wands , 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (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 . All of the Wands factors have been considered and those most relevant to the cited claims are discussed below. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below. Nature of the invention: The rejected invention is drawn to methods for ameliorating, treating or preventing any infection or any T-H mediated disease/condition by administering a polysaccharide composition derived from a Sida plant . Relative skill of those in the art: The relative skill of those in the art is high. Breadth of claims: The claims are broad with respect to the concepts of treatment and prevention and the nature of the condition/disease being addressed . The full scope of the claims encompasses the entire definition of treating and preventi ng, as defined in the specification at page 30 to includes “to cure or eliminating the disease, disorder or condition”. Furthermore, the full scope of the claims covers the entire scope of any infection or any T-H mediated disease . Amount of guidance/Existence of working examples: There is no guidance in the specification showing evidence that would allow one of skill in the art to conclude that the claimed method is capable of curing or eliminating any infection or any T-H mediated disease. Quantity of experimentation: One of skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed polysaccharide compositions to both healthy individuals and individuals having a representative number of infections or T-H mediated diseases/conditions, to determine if the claimed methods can be used in the fully claimed scope to treat and prevent , including cure or eliminate, such diseases/conditions . Genetech , 108 F.3d at 1366, states that “a patent is not a hunting license . It is not a reward for search, but compensation for its successful conclusion” and “[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”. Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, the state/unpredictability of the art and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success. C laim Rejections - 35 USC § 112 (b) 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. Claim s 17, 33, 34 and 44 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claim s 17 and 33 recite “such as” or “for example” . The term " such as " or “for example” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention . Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation (s) will be considered without taking into account preferences or examples. Claims 33 and 34 recite the phrase, “selected from the group comprising/consisting of…”. The phrase, “chosen from the group comprising” used when describing the Markush group of excipients renders the claim indefinite . T he recitation “chosen from the group” signifies a Markush group , which is by nature closed. Gillette Co. v. Energizer Holdings Inc ., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005) . See also MPEP § 2111.03. Thus, the claim is indefinite bec ause the recitation “chosen from the group” is followed by the use of the open transitional phrase "comprising." The term "comprising" is open language and does not allow one to determine the metes and bounds of the elements being claimed. See MPEP § 2173.05(h) . Claim 44 depicts a polysaccharide structure with star symbols representing arabinofuranose monosaccharides. It is clear in the claim 44 structure what represents the polysaccharide backbone. However, it is unclear which side chain star groups represent the (1,2) linked arabinofuranose and (1,3) linked arabinofuranose , which are both required to be present by the limitations of claim 18. The lack of clarity on the bond connectivity for the side chain monosaccharides renders the scope of the claim indefinite. 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. Claim s 31-33 and 35 are rejected under 35 U.S.C. 102(a)( 2 ) as being anticipated by Shetty et al. (US 2018/0318376 A1 , PTO-892) . Shetty et al. discloses a method for treating cancer , by orally administering an composition comprising Sida cordifolia . ( C laim 1 ; ¶0020 ) Jeong meets the claimed limitations because: 1) a cancer is a TH1 mediated disease, as per claim 33 and 2) the composition comprising Sida cordifolia fulfills the requirement of “a plant of the Sida genus or a part thereof.” Accordingly, the instant claims are anticipated by the prior art. Claim s 31-3 5 and 48 are rejected under 35 U.S.C. 102(a)( 1 ) as being anticipated by Natarajan et al. (WO 2012/131650 A1, PTO-892) . Natarajan et al. discloses a method for treating diseases/conditions by orally administering an composition comprising Coccinia indica and Sida cordifolia , where the diseases/conditions include rheumatoid arthritis, osteoarthritis, polyarthritis, gout, chronic inflammatory connective tissue diseases, lupus erythematosus, scleroderma, Sjorgen's syndrome, dermatomyositis, vasculitis, mixed connective tissue disease, tendonitis, synovitis, bacterial endocarditis, osteomyelitis and psoriasis, chronic inflammatory lung diseases, chronic respiratory disease, pneumonia, fibrosing alveolitis, chronic bronchitis, chronic obstructive pulmonary disease, bronchiectasis, emphysema, silicosis and other pneumoconiosis, tuberculosis, chronic inflammatory bowel, gastro-intestinal tract inflammatory diseases, chronic inflammatory demyelinating polyradiculoneuropathy, chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, Guillan -Barre Syndrome , myasthemia gravis , l aminitis, laryngitis, chronic cholecystitis, Hashimoto's thyroiditis . ( p. 3, Ln. 20; Claims 4, 6 ) Jeong meets the claimed limitations because: 1) the diseases/conditions disclosed are TH1 or TH2 mediated disease, as per claim 33 or 34 ; 2) bacterial endocarditis is listed, which is an infective condition meeting the limitation of an infection by a microorganism of claim 48; and 3 ) the composition comprising Sida cordifolia fulfills the requirement of “a plant of the Sida genus or a part thereof.” Accordingly, the instant claims are anticipated by the prior art. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status . 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 of this title, 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. 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. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 . Claim s 11 -18 , 39-45 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Berry et al. (US 2016/0143961 A1, PTO-892) , in view of Damm et al. (Carb. Poly., 2017, PTO-892) . Berry discloses a method of isolating polysaccharides from plant material where plants are cut, lyophilized, and ground into powder. The powder is extracted three times with 2 L of ethanol, and the concentrated extract was collected, lyophilized, and resuspended with 1 L of distilled water at 85° C. The water-soluble portion is precipitated by four volumes of ethanol at 4° C. to yield polysaccharides. (¶0773) Berry also discloses that separation of composition components may be accomplished by various techniques such as centrifugation, filtration and/or chromatography . (¶0222) Berry does not teach isolating polysaccharides from a Sida plant. Damm et al. discloses that Sida plants, such as S i da hermaphrodita , are of interest as a source of non-cellulosic polysaccharides for use as renewable intermediates for value added products or as fuel sources. (Sec. 1) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that one could employ the polysaccharide extraction process of Berry as a means to isolate Sida polysaccharides, thereby arriving at the instant invention. One would be motivated to extract polysaccharides from Sida plants based on the teaching of Damm that Sida polysaccharides are desired as intermediates or as an energy crop. One would reasonably expect the extraction process of Berry to be a functionally equivalent means to extract polysaccharides from plants because Berry teaches that the disclosed extraction process is useful for a range of plants. With respect to claims 18 and 39-45 and the structural elements related to the arabinofuranose repeat unit connectivity, it is noted that the cited art is silent with regards to the se elements . However, the instant claims describe an extraction process identical or substantially identical to that of Berry. Therefore, since the process of Berry is identical or substantially identical to the process , as described in the instant claims , one of ordinary skill in the art would necessarily expect the composition of Berry/Damm, to have the structural elements, as instantly claimed. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes , a prima facie case of either anticipation or obviousness has been established. In re Best , 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977 ).. (emphasis added, MPEP §2112.01(I)) Specifically, i t has been held in In Re Best that "Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. (See In re Ludtke , 58 CCPA 1159, 441 F.2d 660, 169 USPQ 563 (1971)) . Whether the rejection is based on "inherency" under 35 USC 102, on "prima facie obviousness" under 35 USC 103, jointly or alternatively, the burden of proof is the same , and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. (See In re Brown , 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972))…Mere recitation of newly-discovered function or property, inherently possessed by things in prior art, does not cause claim drawn to those things to distinguish over prior art; Patent Office can require applicant to prove that subject matter shown to be in prior art does not possess characteristic relied on where it has reason to believe that functional limitation asserted to be critical for establishing novelty in claimed subject matter may be inherent characteristic of prior art; this burden of proof is applicable to product and process claims reasonably considered as possessing allegedly inherent characteristics." ( In re Best, Bolton, and Shaw , 195 USPQ 430 (C.C.P.A. 1977), emphasis added) Therefore, absent evidence to the contrary, the process of Berry/Damm would necessarily produce a product with identical or substantially identical structural elements, as the composition instantly claimed. With respect to claim 47, it is noted that the combined prior art does not teach that the composition can be used in the manner instantly claimed, as an immunomodulatory agent or immunological adjuvant . However, the cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition . In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition . In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting. Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Berry et al. (US 2016/0143961 A1, PTO-892), in view of Damm et al. (Carb. Poly., 2017, PTO-892), further in view of Ahmad et al. (PNAS, 2014, PTO-892) . The disclosure of Berry/Damm is referenced as discussed above. The combined prior art does not teach the Sida species of Sida cordifolia. Ahmad et al. discloses that Sida cordifolia is a shrub found throughout the tropical and sub-tropical plains of India and a ll parts of the plant are used as anti-rheumatic, antipyretic, anti-asthmatic, laxative, diuretic, vasorelaxative , hypotensive, central nervous system depressant, antioxidant, analgesic and hypoglycemic. (p. 398, ¶1) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the Sida hermaphrodita of Damm could be substituted with Sida cordifolia, thereby arriving at the instant invention. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR , 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc. , 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co. , 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp. , 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). Moreover, one would reasonably expect Sida cordifolia to be a suitable substitute for Sida hermaphrodita because Damm teaches that Sida plant s are sought after as source materials, in part due to their large biomass. Because Ahmad teaches that Sida cordifolia is plentiful throughout India, the biomass would be comparable to that of Sida hermaphrodita , as a source material. Accordingly, the instant claims are prima facie obvious over the teachings of the prior art. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146 . The examiner can normally be reached on M-F 7:00 AM – 3:30 PM 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, Scarlett Goon can be reached on (571) 270-5341 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /DALE R MILLER/ Primary Examiner, Art Unit 1693