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 in response to Applicants’ Amendment and Remarks filed on 4/23/2026 in which claims 32-34 and 46 are cancelled and claims 11, 17, 18, 31, 35, 39-45, 47 and 48 are amended. No claims are newly added.
Claims 11-18, 31, 35, 39-45, 47 and 48 are pending 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.
Withdrawn Objection
The objection to claim 43 is hereby withdrawn. Applicant has amended the claim to remove improper multiple-dependency.
Withdrawn Rejections
All rejection(s) of record for claim(s) 32-34 and 46 is/are hereby withdrawn due to the cancellation of said claim(s) rendering said rejection(s) moot.
Applicant’s amendment, filed on 4/23/2026, with respect to the rejection of claims 31, 35 and 48 under 35 U.S.C. 112(a), has been fully considered and is persuasive. Applicant amended the claims to narrow the scope such that it is enabled by the specification. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 4/23/2026, with respect to the rejection of claims 17 and 44 under 35 U.S.C. 112(b), has been fully considered and is persuasive. Applicant amended the claims to remove the “such as “ phrase of claim 17 and clarified bond connectivity in claim 44.. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 3/25/2013, with respect to the rejection of claims 31 and 35 under 35 U.S.C. 102(a)(2) as being anticipated by Shetty et al. (US 2018/0318376 A1); and claims 31, 35 and 48 under 35 U.S.C. 102(a)(1) as being anticipated by Natarajan et al. (WO 2012/131650 A1), has been fully considered and is persuasive. Neither Shetty nor Natarajan disclose isolating a polysaccharide from Sida cordifolia. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 4/23/2026, with respect to the rejection of claims 11-18, 39-45 and 47 under 35 U.S.C. 103 as being unpatentable over Berry et al. (US 2016/0143961 A1), in view of Damm et al. (Carb. Poly., 2017), has been fully considered and is persuasive. The combined prior art does not teach isolating a polysaccharide from Sida cordifolia. The rejection is hereby withdrawn.
Objections/Rejections Necessitated by Amendment
The following are new ground(s) objections or modified rejections necessitated by Applicants' amendment, filed on 4/23/2026, wherein instant independent claim 11 is amended, wherein the remaining pending claims depend from said independent claims. Therefore, new grounds of objection have been made or rejections from the previous Office Action have been modified.
Claim Objection
Claims 31, 35 and 48 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Modified Rejection
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.
Claims 11-18 and 39-47 are rejected under 35 U.S.C. 103 as being unpatentable over Berry et al. (US 2016/0143961 A1, reference of record), in view of Damm et al. (Carb. Poly., 2017, reference of record), further in view of Ahmad et al. (PNAS, 2014, reference of record).
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 cordifolia plant.
Damm et al. discloses that Sida plants, such as Sida 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)
Ahmad et al. discloses that Sida cordifolia is a shrub found throughout the
tropical and sub-tropical plains of India and all 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 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.
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 plants 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.
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 these 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/Ahmad, 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, it 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/Ahmad 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.
Response to Arguments
Applicants’ response with respect to the rejection of Berry/Damm/Ahmad, has been fully considered but is not persuasive.
Applicant argues that the combined prior art does not teach that the isolated Sida cordifolia polysaccharide is effective for treating TH1 or TH2 mediated diseases. Applicants’ argument is not persuasive because the rejected claims do not require any therapeutic effectiveness. The rejected claims are directed to a method of preparation where a plant material is used as a source for extraction of polysaccharides. Given what is known in the art as per Berry/Damm/Ahmad, the claimed method of preparation is obvious and the polysaccharides isolated by said method of preparation would be expected to have the same or similar structural attributes, as that claimed.
The rejection is still deemed proper and is maintained.
New Grounds of Rejection
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 18, 39-45 and 47 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11, 13 and 14 of copending application 18/141286. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The method of treatment in ‘286 administers a composition identical to the composition claimed in the instant application. In order to practice the method of ‘286 one must be in possession of the necessary therapeutic composition. Since the composition claimed in the instant application and that administered in ‘286 are identical, the instant claims are an obvious variant of ‘286.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new and/or modified 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 extension fee 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.
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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.
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.
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/DALE R MILLER/ Primary Examiner, Art Unit 1693
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