DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/02/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 01/02/2026, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 17, 19-34 are pending of which claims 17 and 19-20 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/05/2024.
Election/Restrictions
Newly submitted claim 26 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The applicant elected the species combination in the previous election/restriction dated 09/05/2024 as the phytochemical as boswellic acid and the plant part as Curcuma longa rhizome. Therefore claim 26 is directed to compositions which do not fall under the scope of examination for the previously elected species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 26 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 21-25 and 27-34 are being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21-25, 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Gokaraju et. al. (WO2011099029A1), Justine Thiry et. al. (WO2018069057A1), Hangchang (CN105669410A) and Madhavamenon et. al. (US20140010903A1). This is a new rejection based on the amendments filed on 01/02/2026.
Gokaraju discloses a synergistic composition, wherein the composition comprises Boswellia low polar gum resin extract and one or more component(s) selected from the extract(s), fraction(s), extracts and fractions standardized to one or more Curcuminoid(s), Curcuminoid(s), phytochemical(s) and their salt(s) derived from Curcuma species (see claim 12).
Gokaraju specifically teaches including “Boswellic acids”, for instance see claims 14-15 and 18.
Gokaraju discloses that the curcuminoids, phytochemicals are from the extraction of Curcuma longa rhizome (see page 33, Preparation of Curcuma longa extract 20-99% Curcuminoids (CLE 20-99%) or Curcuma aromatica extract 20-99% Curcuminoids (CAE 20-99%)).
Gokaraju discloses “The origin of the anti-inflammatory action of Boswellia gum resin and its extracts has been attributed to a group of triterpene acids called Boswellic acids that were isolated from the gum resin of Boswellia serrata”.
Gokaraju discloses “There are numerous pharmaceutical, herbal ingredient(s) and biologically active molecules that are effective in vitro for a disease or disorder. However, several of them are not effective or not bioavailable in vivo (warm blooded animals). It is thus important to explore, identify and invent safe and effective compound(s) or composition(s) that helps increase the in vivo activity of such pharmaceutical or herbal ingredient(s) through synergism. In this process. the inventors have screened a number of extracts, fractions, phytochemical(s) and compound(s) originating from plants, animals and microorganisms; individually and in combinations” (see background of the invention). Thus, it would be understood by those skilled in the art that Gokaraju’s invention is to enhance the bioavailability of phytochemicals. Additionally, Gokaraju teaches filtering the extract carefully to remove insoluble resin material (see claim 3).
Regarding to wherein the fresh plant extract is prepared by slow extrusion of a fresh plant part to obtain a liquid extract, Gokaraju discloses extracts of Curcuma longa rhizomes as just discussed, and it is the product which is being examined. The product appears to be identical in nature to the one being claimed. Although the instant claim is directed to a product-by-process, the process itself is not what is being analyzed unless it can be shown that the process would indeed create a different product. In the instant case, there does not appear to be any difference.
Gokaraju discloses separately obtaining one or more Boswellia derived component(s) selected from extract(s), fraction(s), extracts/fractions selectively enriched in one or more boswellic acid(s) in the range of 30- 100% by titrimetric or HPLC method of analysis, phytochemicals and their salts (see claim 17), and preferably 95%-5% by the weight of at least one Curcuma derived component selected from extract(s), fraction(s), extracts/fractions standardized to one or more curcuminoids, pure curcuminoid(s), phytochemical(s) and their salts or mixtures thereof.) (see claim 30).
Gokaraju discloses wherein the Boswellic acids more preferably in the range of 50-95% by titrimetric or HPLC method of analysis (see claim 14) and “the Curcuma derived component(s) as claimed in claim 12, comprise Curcuminoid(s) in the range of 20-99% by HPLC method of analysis” (see claim 16).
Gokaraju discloses wherein the compositions are formulated as oral agents such as tablets, capsules, pills, beverages (see page 23, 2nd para., 49 claim 49).
Gokaraju does not specifically teach using a low RPM screw extruder and filtering with a 100–500-micron filter, or wherein the curcuminoid content is at less than 3% and using a solvent-free extraction of the Curcuma longa rhizome.
Thiry’s general disclosure is to devices for the continuous production of solid dosage forms (see abstract). Thiry’s invention is to remedy a low bioavailability of active ingredients in food supplement such as curcumin and berberine by increasing solubility through making uniform dispersions (see page 3, para. 3-11).
Thiry teaches use of the extruding apparatus can be used on dietary supplements such as curcumin (see claim 19).
Thiry teaches “an extruder according to the invention may be a single-screw extruder, a co-rotating screw extruder, a co-rotating or counter-rotating multiscrew extruder, possibly equipped with mixing discs. It will be appreciated by those skilled in the art that the energy to be applied to the method and apparatus according to the invention is dependent on the type of extruder or type of screw configuration that is used. Some of the energy required to melt, mix, and dissolve the components in the extruder can be provided by the heaters. However, friction and shearing of the material in the extruder may also provide a substantial amount of energy to the mixture and assist in the formation of an amorphous homogeneous melt of the component (s) with the amorphous solution polymer (s). For a twin-screw extruder, the rotational speed of the worm is preferably 50 to 300 rpm” (see page 4, para. 4-5).
Thiry teaches using a die with the extruder with a diameter of between 0.5 and 15 mm (see figures 3 and 8, and page 9, par. 3). A die is known in the art as specialized devices used in manufacturing industries to cut/and form material to specific shapes and sizes.
Hangchang’s general disclosure is used to show that curcumin can be extracted through solventless extraction.
Hangchang teaches “the extracting method of curcumin is numerous, but is summed up and mainly has: Qin Wei etc., while utilizing traditional method for extracting, employ ultrasonic technology, accelerate extraction rate, namely 0.727% is brought up to 1.011% by what conventional thermal leached. Braga Et al. co_2 supercritical fluid extraction, yield is maximum up to 2.7%” (see page 4, 4th para. background tech.).
Madhavamenon teaches curcuminoid compositions with enhanced bioavailability that have 2% curcuminoids (see abstract and claim 1 a.). Madhavamenon teaches that the extract is water-soluble (see para. 14), which would be recognizable as self-dispersing and Madhavamenon teaches that the extract can be made without solvents (see para. 3, 42-52, 56, 70, 71, and claims 1-5).
Therefore it would have been obvious to those having ordinary skill in the art before the effective filing date to use a low RPM screw extruder and to filter material that is insoluble and within the instantly claimed range for creating a composition as claimed because Thiry teaches increasing solubilities of plant extracts such as curcumin through a process of using screw extruders with die’s that would create particles in a size that would be within the filter size being claimed. One would be motivated to use low RPM in order to not generate too much heat which could degrade any phytochemicals in the extrusion process. Gokaraju already teaches filtering insoluble components from the extracts and both Gokaraju and Thiry teach that these methods would increase bioavailability of the curcumin.
Furthermore optimizing the curcuminoid content at less than 3% would be a matter of mere judicious selection and one any skilled artisan could do without any undue experimentation. Both Hangchang and Madhavamenon teach enhanced bioavailable compositions with curcuminoid extraction methods that would ultimately arrive at curcuminoids at less than 3%. It would have also been obvious to optimize both the phytochemical (boswellic acids) and the extract of fresh plant part (Curcuma longa and curcuminoids) to be within the instantly claimed amounts as the art already teaches including these active components within these ranges and optimizing them to be within the instantly claimed amounts is well within the purview of any skilled artisan.
As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Additionally, the end product is what is being examined. This is a product-by-process case. The products do not appear to be distinct from each other because the relied upon art teaches methods of using screw extruders and components needed to create the curcumin and Boswellia particles to be within the same size range. The art also recognizes that these processes help make the normally less soluble components more soluble and increases bioavailability.
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. The applicant argues that Gokaraju does not teach boswellic acids and instead teaches compositions which comprise of the boswellic acids being removed. The applicant is focusing on specific components or formulations which do not require boswellic acids however is still ignoring the entire teachings from this art as can be appreciated from the above rejections. Gokaraju indeed teaches boswellic acids being included in the compositions. For instance, Gokaraju teaches boswellic acids in claims 14-15 and 18. Although Gojkaraju may contemplate multiple synergistic formulations that may not include boswellic acids, Gokaraju indeed teaches formulations which also comprise of boswellic acids.
The applicant argues that there is not motivation to use an extraction method taught by Hangchang to arrive at a solventless curcumin extract or to use the teaching of Madhavamenon to arrive at curcuminoids at 2%. Both Hangchang and Madhavamenon teach methods for arriving at curcuminoid content at less than 3%. Madhavamenon teaches particularly of methods for obtaining enhanced bioavailable curcuminoid compositions which arrive at the same curcuminoid amounts being claimed. One could easily rely on these extraction techniques to arrive at an enhanced bioavailable composition, which is what the field of art is directed to and what the instant invention is directed to; enhancing/increasing the bioavailability of phytochemicals. Optimizing the active components of a composition is well within the purview of any skilled artisan. These active components have already been described in the art for having the same effects. The art also teaches methods for obtaining them through solventless extraction and gives reasons to use low RPM extruders as claimed. Persons would be able to arrive at the instant composition given the relied upon art.
The applicant argues that Gokaraju only teaches of Boswellia extracts without boswellic acids in them and provides table 1 of Gokaraju as evidence. Again this is merely one formulation or extraction which is contemplated by Gokaraju. Gokaraju clearly claims compositions which contain boswellic acids (see claims 14, 15 and 18).
Conclusion
No claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655