DETAILED ACTION
This office action is in response to applicant’s filing dated October 6, 2025.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 6, 2025 has been entered.
Status of Claims
Claims 3, 4, 6, 8-17, 19-24, 26, 27, and 34 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed October 6, 2025. Acknowledgement is made of Applicant's amendment of claims 3, 4, 6, 8-17, 19-24, 26, and 27; and addition of new claim 34. Claims 2, 5, 7, 18, 25, and 28-33 were previously canceled.
Applicants elected without traverse a formulation species comprising (i) baicalin and (ii) catechin; (iii) Scutellaria baicalensis, (iv) Acacia catechu (Black catechu), and (v) diabetes in the reply filed on October 24, 2022. The requirement is still deemed proper.
Claims 3, 4, 6, 8-17, 19-24, 26, 27, and 34 are presently under examination as they relate to the elected species: formulation species comprising (i) baicalin and (ii) catechin; (iii) Scutellaria baicalensis, (iv) Acacia catechu (Black catechu), and (v) diabetes.
Priority
The present application claims benefit of US Provisional Application No. 63/058,698 filed on July 30, 2020. The effective filing date of the instant application is July 30, 2020.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Objections and/or Rejections
Claim Rejections - 35 USC § 112
Improper Dependent
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 4, 6, 8-17, 19-24, 26, and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 3, 4, 6, 8-17, 19-24, 26, and 27 depend from claim 34.
35 U.S.C. 112(d) states a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed.
Claim 34 is not a claim previously set forth. Thus, claims 3, 4, 6, 8-17, 19-24, 26, and 27 are rejected for improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
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, 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.
Claims 3, 8-11, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Jia (US 7,514,469 B2).
Regarding claims 3, 8-11, and 34, Jia teaches the present invention includes a novel composition of matter comprised of a mixture of Free-B-ring flavonoids and flavans (col 19, lines 29-31); in a preferred embodiment the Free-B-ring flavonoids are isolated from a plant or plants in the Scutellaria genus of plants and flavans are isolated from a plant or plants in the Acacia genus of plants (col 19, lines 43-47). Jia teaches a novel composition referred to has Univestin™ was formulated using two standardized extracts isolated from Acacia and Scutellaria, respectively, together with one or more excipients; the Acacia extract used in this example contained >60% total flavans, as catechin and epicatechin a preparation of a formulation with a standardized free-B-ring flavonoid extract from the roots of Scutellaria baicalensis, elected free-B-ring flavonoid extract plant species, and a standardized flavan extract from the bark of Acacia catechu, flavan plant species (col 38, Example 14).
Moreover, Jia teaches the Univestin™, as illustrated in Example 14, Table 11, consisted of a proprietary blend of standardized extract of Scutellaria baicalensis Georgi with a baicalin content of 82.2 % (w/w) and total Free-B-ring Flavonoids >90% (w/w) and a standardized extract of Acacia catechu with a total flavin content of 77.2% (w/w) in a ratio of 85:15 (col 24 lines 1-7). Jia teaches the concentration of Free-B-ring flavonoids in Univestin™ can be from about 1 % to 99% and the concentration of flavans in Univestin™ can be from 99% to 1 %; in a preferred embodiment of the invention, the concentration of total Free-B-ring flavonoids in Univestin™ is approximately 75% with a baicalin content of approximately 60% of total weight of the Univestin™; and the concentration of total flavans in Univestin™ is approximately 10% with a catechin content of approximately 9%. In this embodiment, the total active components (Free-B-ring flavonoids plus flavans) in Univestin™ are >80% of the total weight (col 20, lines 4-14).
Jia does not explicitly teach an embodiment wherein the catechin is present in the composition at greater than 15% of a total active component in the composition or wherein baicalin accounts for greater than 90% of the total free- B-ring flavonoids and is present in the composition at greater than 70% of the total active component in the composition.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and ratios of Free-B-ring flavonoids extract, including baicalin and flavans extract, including catechin taught by Jia as a starting point for optimizing the catechin utilized to formulate a composition baicalin and catechin to inhibit COX-1 and COX-2 since Jia teaches Free-B-ring flavonoid, baicalin, and flavans extract, catechin, is useful for inhibiting COX-1 and COX-2treating and because dosage is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the composition of claims 3, 8-11, and 34 with a reasonable expectation of success.
Regarding claims 4 and 6, Jia teaches in one embodiment the standardized Free-B-ring flavonoid extract is comprised of active compounds with a purity of between 1-99% (by weight) of total Free-B-ring flavonoids (col 19, lines 48-51); baicalin is the major active component in the extract which accounts for approximately 50-90% (by weight) of the total Free-B-ring flavonoids; in a preferred embodiment, the standardized extract contains >70% total Free-B-ring flavonoids in which >75% of the Free-B-ring flavonoids is baicalin. Moreover, Jia teaches Scutellaria baicalensis root extract having a Free-B-ring flavonoid content of 82.2% (baicalin); Acacia catechu bark extract; and excipient were combined to provide Univestin™ formulating having a blending ratio of 85:15 (col 38, lines 58-62). MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the composition of claims 4 and 6 with a reasonable expectation of success.
Regarding claim 12, Jia teaches Acacia catechu (500 mg of ground bark) was extracted with the following solvent systems. (1) 100% water, (2) 80:20 water:methanol, (3) 60:40 water:methanol, (4) 40:60 water: 55 methanol, (5) 20:80 water:methanol, (6) 100% methanol (col 36, lines 52-56).
Regarding claim 13, Jia teaches a composition comprising a mixture of Free-B-ring flavonoids and flavans synthesized together with a pharmaceutically acceptable
Carrier (col 12, lines 8-13).
Regarding claim 14, Jia teaches isolation and purification of the active free-B-ring
flavonoids from the organic extract of Scutellaria using preparative C-18 column chromatography (col 31, Example 5); and isolation and purification of active compounds from the organic extract of Acacia catechu (col 33, Example 8).
Regarding claim 15, Jia teaches Univestin™ was formulated using two standardized extracts isolated from Acacia and Scutellaria, respectively, together with one or more excipients (col 38, lines 36-38) and % content of total active ingredients was 86% (col 39, Table 11). MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claim 16, Jia teaches the composition can also include an adjuvant or a carrier; adjuvants are typically substances that generally enhance the function of the formula in preventing and treating indications and suitable adjuvants include silica, boron, histidine, copper gluconate, vitamin D, and vitamin K.
Regarding claims 17 and 19, Jia teaches unit dosage forms suitable for oral administration of an animal include powder, tablets, pills and capsules.
Regarding claim 20, Jia teaches in a preferred embodiment, doses of the mixture of Free-B-ring flavonoids and flavans and pharmaceutical compositions containing the same are an efficacious, nontoxic quantity generally selected from the range of 0.01 to 200 mg/kg of body weight (col 28, lines 16-21). MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claims 21-24, 26, and 27, the limitations of these claims are directed to an intended use of the composition, including maintains immune homeostasis by optimizing or balancing the immune response (claim 21); regulates HMGB1 (claims 22-23); supports healthy inflammatory response (claim 24); minimizes or prevents age associated chronic disease caused by AGEs and AGE-RAGE interactions (claim 26); or improves innate immunity (claim 27). Such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e. an intent to use the disclosed composition for maintaining immune homeostasis by optimizing or balancing the immune response; regulating HMGB1; supporting healthy inflammatory response; minimizing or preventing age associated chronic disease caused by AGEs and AGE-RAGE interactions; or improving innate immunity), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. In the instant case, the claims are directed to a pharmaceutical combination and, thus, would be reasonably expected to be capable of performing the intended uses as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Moreover, regarding claim 26, Jia teaches the disclosed composition is useful for treating diabetes (col 11, lines 64-67).
Taken together, all this would result in the composition of claims 12-17, 19-24, 26, and 27 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
Jia does not teach, suggest, or motivate one of ordinary skill in the art to prepare a composition comprising "at least one bioflavonoid extract enriched for at least one free-B- ring flavonoid, wherein the at least one bioflavonic extract enriched for at least one free-B-ring flavonoid comprises baicalin, which accounts for greater than 90% of the total fee-B-ring flavonoids, and wherein baicalin is present in the composition at greater than 70% of the total active component in the composition; and at least one bioflavonoid extract enriched for at least one flavan wherein the at least one bioflavonoid extract enriched for at least one flavan comprises catechin, which accounts for greater than 90% of the total free-B-ring flavans, and wherein catechin is present in the composition at greater than 15% of a total active component in the composition. The Jia reference cited portion above, the absolute highest percentage of either baicalin or catechin is 90%. There is no teaching, suggestion, or expectation that either or both of the baicalin or catechin would make up more than 90% of the flavonoids or flavins in the extract.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Jia teaches the Univestin™, as illustrated in Example 14, Table 11, consisted of a proprietary blend of standardized extract of Scutellaria baicalensis Georgi with a baicalin content of 82.2 % (w/w) and total Free-B-ring Flavonoids >90% (w/w) and a standardized extract of Acacia catechu with a total flavin content of 77.2% (w/w) in a ratio of 85:15. Moreover, Jia explicitly teaches the concentration of Free-B-ring flavonoids in Univestin™ can be from about 1 % to 99% and the concentration of flavans in Univestin™ can be from 99% to 1 %; in a preferred embodiment of the invention, the concentration of total Free-B-ring flavonoids in Univestin™ is approximately 75% with a baicalin content of approximately 60% of total weight of the Univestin™; and the concentration of total flavans in Univestin™ is approximately 10% with a catechin content of approximately 9%. In this embodiment, the total active components (Free-B-ring flavonoids plus flavans) in Univestin™ are >80% of the total weight (col 20, lines 4-14). Thus, Jia clearly suggests optimizing the amounts of baicalin and catechin and that optimizing the amounts of these components is a result effective variable. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and ratios of Free-B-ring flavonoids extract, including baicalin and flavans extract, including catechin taught by Jia as a starting point for optimizing the catechin utilized to formulate a composition baicalin and catechin to inhibit COX-1 and COX-2 since Jia teaches Free-B-ring flavonoid, baicalin, and flavans extract, catechin, is useful for inhibiting COX-1 and COX-2treating and because dosage is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Applicant argues:
The Examples in the present application show the unexpected synergy of utilizing these two formulated extracts, which could not be found in the Jia reference. The Examiner's attention is drawn to Examples 5-7, 11-12, and 40.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 716.02 states:
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992).
An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential).
In the instant case, Jia teaches the Univestin™, as illustrated in Example 14, Table 11, consisted of a proprietary blend of standardized extract of Scutellaria baicalensis Georgi with a baicalin content of 82.2 % (w/w) and total Free-B-ring Flavonoids >90% (w/w) and a standardized extract of Acacia catechu with a total flavin content of 77.2% (w/w) in a ratio of 85:15. Moreover, Jia explicitly teaches the concentration of Free-B-ring flavonoids in Univestin™ can be from about 1 % to 99% and the concentration of flavans in Univestin™ can be from 99% to 1 %; in a preferred embodiment of the invention, the concentration of total Free-B-ring flavonoids in Univestin™ is approximately 75% with a baicalin content of approximately 60% of total weight of the Univestin™; and the concentration of total flavans in Univestin™ is approximately 10% with a catechin content of approximately 9%. Thus, the prior art suggests combining an extract enriched with free-B-flavonoids, including baicalin and an extract enriched with flavans, including catechin. The closest prior art is considered to be the composition taught by Jai, which differs in amounts of baicalin and catechin. From the data provided, the Examiner is unable to ascertain if the claimed composition comprises unexpected properties from that of the prior art and that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Thus, the data is insufficient to rebut the prima facie case of obviousness set forth above.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 3, 6-11, 16, 19, 20-24, 26, 27, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 7,514,469 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a bioflavonoid composition, comprising: at least one bioflavonoid extract enriched for at least one free-B-ring flavonoid, wherein the at least one bioflavonoid extract enriched for at least one free-B-ring flavonoid comprises baicalin, which accounts for greater than 90% of the total free- B-ring flavonoids, and wherein baicalin is present in the composition at greater than 70% of the total active component in the composition; and at least one bioflavonoid extract enriched for at least one flavan wherein the at least one bioflavonoid extract enriched for at least one flavan comprises catechin, which accounts for greater than 90% of the total free-B-ring flavans, and wherein catechinis present in the composition at greater than 15% of a total active component in the composition.
The previously allowed claims are directed to a composition comprising a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin and an extract derived from Acacia enriched for flavans containing catechin, wherein said method alleviates inflammation (claim 1); wherein the composition is administered in a dosage from 0.01 to 200 mg/kg of body weight (claim 2); wherein the administration includes oral (claim 3), wherein the Free-B-ring flavonoids and said flavans are isolated from a plant part selected from the group consisting of stems, stem barks, trunks, trunk barks, twigs, tubers, roots, root barks, young shoots, seeds, rhizomes, flowers and other reproductive organs, leaves and other aerial parts (claim 5), wherein flavans are isolated from Acacia catechu (claim 6) useful for alleviating joint pain and stiffness.
Regarding the claimed amount of catechin and baicalin, the previously allowed claims are directed to wherein the composition comprises an effective amount of a composition comprised of a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin and an extract derived from Acacia enriched for flavans containing catechin or epicatechin; wherein the ratio of Free-B-ring flavanoids:flavans in the composition of matter is about 85:15. It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and ratios of Free-B-ring flavonoids and flavans extract of the copending claims Jia as a starting point for optimizing the catechin utilized to formulate a composition comprising Free-B-ring flavonoids, baicalin and flavans extract including catechin for alleviating joint pain and stiffness, since teaches Free-B-ring flavonoids and flavans extract including catechin is useful for alleviating joint pain and stiffness and because dosage is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
With regard to instant claims the limitations of instant claims 21-24, 26, and 27, these claims are directed to an intended use of the composition, including maintains immune homeostasis by optimizing or balancing the immune response (claim 21); regulates HMGB1 (claims 22-23); supports healthy inflammatory response (claim 24); minimizes or prevents age associated chronic disease caused by AGEs and AGE-RAGE interactions (claim 26); or improves innate immunity (claim 27). Such a limitation of the instant claims fails to patentably distinguish the instant claims over those of the previously allowed claims because such a limitation is an intended use of the composition (i.e. an intent to use the disclosed composition for maintaining immune homeostasis by optimizing or balancing the immune response; regulating HMGB1; supporting healthy inflammatory response; minimizing or preventing age associated chronic disease caused by AGEs and AGE-RAGE interactions; or improving innate immunity), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art.
It would have been prima facie obvious for one of ordinary skill in the art to arrive at the claimed composition from the composition of the previously allowed claims with a reasonable expectation of success.
Response to Arguments
Applicant argues:
Jia does not teach that the catechin is effective at greater than 15% of a total active component in the composition, while having a baicalin component that is greater than 70% of the total active component. This is in line with the UP894-II composition in the current application and is outside of the range of any of the compositions listed in the Jia reference.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The Examiner acknowledges that previously granted claims do not explicitly teach the catechin and baicalin are present in the claimed amounts. However, as set forth above, the previously allowed claims are directed to a composition comprising a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin and an extract derived from Acacia enriched for flavans containing catechin or epicatechin, wherein said method alleviates inflammation (claim 1); wherein the composition is administered in a dosage from 0.01 to 200 mg/kg of body weight (claim 2); wherein the administration includes oral (claim 3), wherein the Free-B-ring flavonoids and said flavans are isolated from a plant part selected from the group consisting of stems, stem barks, trunks, trunk barks, twigs, tubers, roots, root barks, young shoots, seeds, rhizomes, flowers and other reproductive organs, leaves and other aerial parts (claim 5), wherein flavans are isolated from Acacia catechu (claim 6). Thus, the composition of the previously granted claims comprises the claimed flavan species and flavonoid species.
As set forth above, the previously allowed claims are directed to wherein the composition comprises an effective amount of a composition comprised of a mixture of an extract derived from Scutellaria enriched for Free-B-ring flavonoids containing baicalin and an extract derived from Acacia enriched for flavans containing catechin or epicatechin; wherein the ratio of Free-B-ring flavanoids:flavans in the composition of matter is about 85:15. It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts and ratios of Free-B-ring flavonoids and flavans extract of the copending claims Jia as a starting point for optimizing the catechin utilized to formulate a composition comprising Free-B-ring flavonoids, baicalin and flavans extract including catechin for alleviating joint pain and stiffness, since teaches Free-B-ring flavonoids and flavans extract including catechin is useful for alleviating joint pain and stiffness and because dosage is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Conclusion
Claims 3, 4, 6, 8-17, 19-24, 26, 27, and 34 are rejected.
No claim is allowed.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628