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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 03/25/2025 is acknowledged.
Claims 1-4 and 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/25/2025.
Claims 5-8 and 12-19 are being examined on the merits.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6, in line 3 recites “evaporating the organic solvent” and the recites “centrifuging the extract to remove particular matter” and it is unclear what “extract” is being centrifuged if the solvent is evaporated beforehand. Claim 7 is rejected for being dependent upon a rejected claim and for not remedying the issues of claim 6.Claim 19, recites “wherein the composition is adapted to protect cells against oxidative effect of free radicals” and it is unclear how or what limitations would meet this limitation. The metes and bounds are unclear on what needs to be done to the composition in order for this effect to take place or how a composition can be adapted for an effect.
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 (i.e., changing from AIA to pre-AIA ) 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 5-7 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Xian Li et. al. (CN102617669A).
Regarding claims 5-7 and 12-13, Li teaches “freeze-dried ‘Machesu’ mango fruit materials, including pericarp, pulp, seed coat, and seed kernel, are crushed into fine powder with a mill. Accurately weigh a certain amount of freeze-dried powder, soak it in the extract solution (methanol: ethanol: acetone 1:1:1, v/v/v) for 2 hours (solid-liquid ratio 1:20), ultrasonically extract twice, and centrifuge at 10,000 rpm after 10 min, the combined supernatants were used for HPLC analysis of mangiferin” (see page 3, embodiment 1).
Li teaches evaporating the supernatant in a rotary evaporator (see example 2, page 4).
Li does not specifically teach that the drying is done with a desiccator or wherein the starting pieces are baked to dry. However Li teaches drying in different ways and it is prima facie obvious to substitute equivalents known for the same purpose. For instance, one would want to cut and dry the mango pulp, peel and seed pieces using baking on low heat as this would be a less expensive way for drying the pieces than having to purchase a spray dryer or than freeze-drying. Also using a desiccator to dry rather than a rotary evaporator would have been obvious as these can easily be substituted by persons having ordinary skill in the art for saving on costs from the purchase of a rotary evaporator, as desiccators are relatively inexpensive.
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to create the instant method for preparing Mangifera indica as claimed. Li teaches taking the peels, pulp and seeds of Mangifera indica and drying and crushing to create a powder, extracting with an organic solvent such as acetone, removing the solvent through evaporation and centrifuging which is a process known for removing particulate matter. Using a desiccator for drying would have been an obvious substitution for those having ordinary skill in the art as discussed above.
Li does not specifically teach that the method is for treating or preventing SARS-COV-2, viral gastroenteritis, or viral pharyngitis, however this is an intended use for the product made and does not structurally change the method steps for making the product. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. (See MPEP 707.07(f) and 2141.02 |; In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and MPEP 2111.02 Il; Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Xian Li et. al. (CN102617669A) as applied to claims 5-7 and 12-13 above, and further in view of Natalia Medina Ramirez et. al. (Extraction of Mangiferia and Chemical Characterization and Sensorial Analysis of Teas from Mangifera indica L. Leaves of the Uba Variety, Beverages, 23 November 2016, 2,33, pages 1-13).
Li teaches the method for preparing Mangifera indica, however is silent on using boiling water as the extractant.
Ramirez teaches that “mangiferin is present in various parts of Mangifera indica L. and has proven biological activities, such as antioxidant capabilities. The aim of this work was to evaluate the chemical composition of teas prepared from M. indica leaves, their potential use as a source of mangiferin and their total phenolic compounds. Teas were prepared with young and mature leaves of M. indica at three (medicinal plant: solvent) ratios utilizing three different preparation techniques. The mangiferin content was analyzed via high-performance liquid chromatography (HPLC). The tea with the highest mangiferin content was characterized for its total phenolic content and antioxidant activity. The oxidative stability was also evaluated by quantifying mangiferin, total phenolics and antioxidant activity using two preservation treatments for 0, 24 and 48 h. Sensory analysis was performed to measure the acceptance of the tea. The type of leaf, preparation technique and concentration influenced the mangiferin content in the teas. The highest concentration of mangiferin was obtained through decoction at a 5% (w/v) medicinal plant concentration. This tea exhibited stability up to 48 h after preparation under both preservation treatments and provided a positive sensory acceptance for consumers with flavors added. In conclusion, teas made from M. indica leaves have great potential as sources of mangiferin and phenolic compounds” (see abstract).
Ramirez teaches washing, sanitizing and then drying M. indica plant parts in an oven at 55 +/- 2 for 38hours with air circulation, and crushing the samples then decoction was done with boiling water for 5 mins at 100 degrees Celsius (see page 3 2.2 and 2.3.1).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to substitute decoction (boiling water) as a method for extraction of the mangiferin in the method taught by Li, because as Ramirez teaches this method can also extract mangiferin from M. indica plant parts. Although Ramirez teaches those plant parts as the leaves of M. indica, persons having ordinary skill in the art would realize that mangiferin is also in the pulp, seeds and peels of the fruit as taught by Li and can use this extraction method of decocting in boiling water to bring about the active compounds from those plant parts.
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Xian Li et. al. (CN102617669A) as applied to claims 5-7 and 12-13 above, and further in view of Dr. Amanchi Bala Sudhakara Sastry et. al. (IN201941028495A).
Li teaches the method for preparing Mangifera indica, however is silent on incorporating additives to the Mangifera indica powder.
Sastry teaches “Citrus flavonoids can be divided in flavanones, flavonols, flavones, and polymethoxiflavone. Naringin is a major flavanone glycoside in Citrus fruits and it is considered a neuroprotective agent mainly because of its anti-apoptotic and antioxidant activities, together with its capability to induce neurotropic factors such as brain-derived neurotropic factor (BDNF) and vascular endothelial growth factor (VEGF)” (see page 8, para 2).
Sastry teaches “the Nigella sativa may have anti-depression, anti-inflammatory, hypoglycemic, antihypertensive, antiasthmatic, antimicrobial, antiparasitic, antioxidant and anti-Parkinson effects. N. Sativa seed and its oil are known to contain many active components that includes thymoquinone, thymohydroquinone, dithymoquinone, thymol, carvacrol, nigellimine-N-oxide, nigellicine, nigellidine and alpha-hederin” (see page 8, para. 8). Sastry also teaches adding 2-4 weight percent Nigella sativa, 2-4 weight percent citrus lemon (peel) and 2-4 percent weight Zingiber officinale (see page 3, first para.).
Regarding claims 17 and 19, pertaining to the limitations wherein the resulting composition is taken three times a day and wherein the composition is adapted to protect cells against oxidative effect of free radicals, these limitations appear to be intended uses for the composition created and do not change or limit the method steps in any structural way. Additionally, Sastry teaches that the additives would exert an effect against oxidative stress and determining a dose to be three times a day is well within the purview of any skilled artisan based on the patient’s needs and for increasing the amount of active components to be received by the individual taking the supplement,
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to add the additives citrus bioflavonoids, Zingiber officinale and Nigella sativa in the amounts claimed because Sastry teaches a synergistic blend of these ingredients at or near the instantly claimed range and for the purposes of having neuroprotective, antioxidant, antimicrobial and antihypertensive effects. Combining these ingredients as additives would have been obvious to incorporate the plants polyphenols and bioflavonoids for their beneficial properties as described above.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Haruna I. Umar et. al. (In-silico analysis of the inhibition of the SARS-Cov-1 main protease by some active compounds form selected African plants, Journal of Taibah University Medical Sciences (2012) 16(2), 162-176).
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655