DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 12/03/2025.
Claims 1-15 previously presented, claims 16-18 are currently added.
Claims 1-18 are pending.
Election/Restrictions
Claims 4, 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/15/2025.
Newly submitted claims 16 and 18 are directed to nonelected species of citrus plant material (claim 16) and nonelected species of botanical extract sterol and ecdysteroids (claim 18).
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 Accordingly, claims 16 and 18 are withdrawn from consideration as being directed to a non-elected species. 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 1-3, 5-9 and 17 read on the elected invention and species of pomegranate and flavonoids and are subject of this office action.
It is established that the examination of species will be extended to the extent necessary to determine patentability of the Markush-type claim, MPEP 803.02[R-5].
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
The following 35 USC § 112(a) rejection is necessitated by applicant’s amendment:
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 6 has been amended to recite “…wherein a weight of the ultrapure water equivalent to between 3 and 6 times the weight of the plant matter…”. Applicants do not refer to support in the originally filed specification for this amendment. However, with careful recourse to the specification, applicants disclosed in paragraph [0022] of the published application that:
“Preferably, a volume of solvent equivalent to 3 to 6 times the weight of the plant matter to be extracted is used in the extraction step”.
Therefore, applicants disclosed volume of the water and the weight of the plant matter. This does not describe what volume of water is used in the claimed method. One skilled in the art would not recognize how much water to be used in the claimed method? No disclosure of the weight or volume of the used water in order to assure one skilled in the art that applicants were in possession of the claimed subject matter. If applicant contends there is support for this limitation, then applicant is requested to specify the page and line of said support. In accordance to MPEP 714.02, applicant should specifically point out to where in the disclosure a support for any amendment made to the claims can be found.
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genetech, 108 F 3d 1361, 1365 (Fed. Cir. at 1366, 78, 1999).
The following obviousness 35 USC § 103 rejections are previously presented and are maintained:
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 1-3, 5-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Prous et al. (WO 2019/053673, IDS filed 09/26/2022) as evidenced by the article by Kalt et al. (“Recent research on the health benefits of blueberries and their anthocyanins”, previously provided), combined with either Kreuter (WO 2007/057651, IDS filed 09/26/2022) or the article by Raj et al. (“Green synthesis and characterization of ZnO nanoparticles from leafs extracts of Rosa indicia and its antibacterial activity”, previously provided).
In this rejection the species examination has been extended to non-elected species of claims 2 and 3. It is established that the examination of species will be extended to the extent necessary to determine patentability of the Markush-type claim, MPEP 803.02[R-5].
The applied reference Prous et al. has a common Assignee and inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant Claims
Claim 1 is directed to a method for preparing a botanical extract, comprising:
extracting a plant matter with ultrapure water to obtain a liquid fraction and solid plant
matter, and separating the solid plant matter from the liquid fraction;
concentrating the liquid fraction; and
purifying the liquid fraction obtained after concentrating by tangential flow filtration.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Prous teaches method of preparing botanical extract for pharmaceuticals, the method comprises the steps of a) extracting plant material using aqueous solvent, the extract comprises liquid fraction and solid fraction, and separating the liquid fraction from the solid fraction, b) concentrating the liquid fraction, and c) purifying the liquid fraction (page 4, lines 1- 10). Water can be used as the only solvent (page 5, line 14; claim 7). Extraction can be carried out at temperature between 50oC and 70oC (page 5, lines 41-42; examples 19 and 20; claim 11). Purification is carried out using tangential flow filtration using membrane with pore size of > 1000Da. The pressure of the filtration process is between 4 and 20 bar (examples 19 and 20, claims 19-21). The method can be applied to wide range of plants (page 4, lines 20-24). The extract is dried (page 6, lines 20-30; claim 29). The plant can be blueberries that comprises the active agent anthocyanins that is flavonoid as evidenced by article by Kalt (see the entire document and in particular page 225, left column, last paragraph).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Prous teaches extraction using water, the reference is silent regarding ultrapure water claimed by claim 1.
Kreuter teaches using ultrapure water for plant extraction followed by ultrafiltration to remove endotoxin from the plant (abstract; page 1, lines 32-36; page 2, lines 15-25; page 3, lines 10-17; page 4, lines 17-18).
Raj teaches ultra purified water for plant extraction (see the experimental section in page 1340).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to prepare plant extract for pharmaceuticals using water as taught by Prous, evidenced by Kalt, and use ultrapure water taught by any of Kreuter or Raj. One would have been motivated to do so because both of Kreuter or Raj teach suitability of ultrapure water for preparation of plant extract and motivated by the common sense of using pure ingredients is safer for pharmaceuticals. One would reasonably expect preparing plant extract using ultrapure water in the process taught by Prous. In any event, purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious. See MPEP 2144.01, VII. Therefore, it would have been obvious to have used the ultrapure water in the preparation method of Prous motivated by the desire to use a product that has advantageous properties, i.e. pure and toxin-free extract.
Regarding the plant matter claimed by claim 2, Prous teaches at least berries and citrus fruits.
Regarding active substances contained in the plant claimed by claims 3 and 17, Prous teaches blueberries that comprises anthocyanins that is a flavonoid as main active agent as evidenced by Kalt.
Regarding drying of plant matter as claimed by claim 5, Prous teaches drying step.
Regarding volume of solvent as claimed by claim 6, one having ordinary skill in the art would have determined the required amount of solvent based on the desired extract.
Regarding the temperature of extraction of 50oC-75oC as claimed by claim 7, Prous teaches between 50oC and 70oC that falls within the claimed temperature. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the size of the membrane in the tangential flow filtration of 100 Da to 100,000 Da as claimed by claim 8, Prous teaches size of > 1000 Da that overlaps with the claimed size. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding pressure in the tangential flow filtration between 4 and 30 bar, Prous teaches between 4 and 20 bar that falls within the claimed pressure. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 1-3, 5-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Acosta (US 2014/0343135, previously cited on PTO 892), the article by Conidi et al. (“Separation and purification of phenolic compounds from pomegranate juice by ultrafiltration and nanofiltration membranes”, IDS filed 09/26/2022) and either Kreuter (WO 2007/057651, IDS filed 09/26/2022) or the article by Raj et al. (“Green synthesis and characterization of ZnO nanoparticles from leafs extracts of Rosa indicia and its antibacterial activity”, previously provided).
Applicant Claims
Claim 1 is directed to a method for preparing a botanical extract, comprising:
extracting a plant matter with ultrapure water to obtain a liquid fraction and solid plant
matter, and separating the solid plant matter from the liquid fraction;
concentrating the liquid fraction; and
c. purifying the liquid fraction obtained after concentrating by tangential flow filtration.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Acosta teaches process of obtaining extract from plants for pharmaceutical use, the plants include pomegranate to extract polyphenols including flavonoids (abstract; ¶¶ 0017, 0101). The reference teaches process having high extraction yield for polyphenols (¶ 0032). The reference teaches effective fractionation between the polyphenolic compounds in the extract, according to their molar mass and depending on their affinity for the membranes by choosing the membrane material and regulating its filtration capacity and the transmembrane pressure applied in the process (¶ 0012). The reference teaches a process of clarification of extract by microfiltration to remove the insoluble solids, a fractionation stage by ultrafiltration or nanofiltration, that enables the separation of active compounds, a purification stage by diafiltration and finally a concentration stage (¶ 0013). The reference teaches using membranes with a filtration capacity of up to 50,000 Da during ultrafiltration (¶ 0016). The reference teaches a method comprising the steps of (i). extraction of the liquid fraction from fruit and using water; (ii). clarification of the liquid fraction obtained in stage (i) through tangential microfiltration; (iii). permeate fractionation after the tangential microfiltration through ultrafiltration and nanofiltration; (iv). purification by diafiltration of the fraction retained by the membrane in the previous filtering processes (¶¶ 0020-0026; claims). Solid are removed by filtration (¶ 0034). The reference further teaches drying the extract (¶ 0050). The temperatures of extraction is between 20oC and 50oC (¶¶ 0029, 0033). The reference teaches applying pressure to the solid residue of between 2000 and 10000 kPa, that is equal to 20-100 bar (0035). The liquid is clarified using microfiltration technology, with a membrane with a pore size between 0.05 and 1.0 µm. The operation is carried out under certain conditions such as pressure between 120 and 350 kPa, i.e. 1.2-3.5 bar and a temperature between 25oC and 50oC (¶ 0037). After the microfiltration, a permeate containing only soluble solids is obtained, which then is submitted again to a membrane separation (fractionation), specifically ultrafiltration or nanofiltration with a filtration capacity between 0.1 and 50 kDa, i.e. 100-5000 Da, and an applied transmembrane pressure between 250 and 4000 kPa, i.e. 2.5-40 bar. This operation is carried out under certain conditions, e.g. temperature between 25oC and 50oC. (¶¶ 0040-0045, 0070, 0072, 0080).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Acosta teaches extraction using water, the reference is silent regarding ultrapure water claimed by claim 1.
While Acosta suggests the elected plant pomegranate and the elected active substance flavonoids as extracted polyphenol, the reference does not exemplify pomegranate and flavonoids as claimed by claims 2 and 3, respectively, as elected species.
Conidi teaches pomegranate is recognized for its health benefits due to the presence of flavonoids, e.g. protection against cancer, diabetes, cardiovascular diseases and microbial infection. The reference teaches efficient extraction procedure using ultrafiltration and nanofiltration of pomegranate juice using membrane to clarify the juice (see the entire document, and in particular: abstract, introduction, pages 2-3, page 5, conclusion).
Kreuter teaches using ultrapure water for plant extraction followed by ultrafiltration to remove endotoxin from the plant (abstract; page 1, lines 32-36; page 2, lines 15-25; page 3, lines 10-17; page 4, lines 17-18).
Raj teaches ultra purified water for plant extraction (see the experimental section in page 1340).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to prepare plant extract for pharmaceutical using water as taught by Acosta that suggests pomegranate to extract polyphenols, and use pomegranate to extract flavonoid as taught by Conidi. One would have been motivated to do so because Conidi teaches the health benefits and properties of flavonoids from pomegranate including protection against cancer, diabetes, cardiovascular diseases and microbial infection. One would reasonably expect preparing plant extract from pomegranate using the process of Acosta to obtain extract that is rich in flavonoids that provides great health benefits.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to prepare flavonoids from pomegranate extract using water as taught by Acosta and Conidi, and use ultrapure water taught by any of Kreuter or Raj. One would have been motivated to do so because both of Kreuter or Raj teach suitability of ultrapure water for preparation of plant extract and motivated by the common sense of using pure ingredients is safer for pharmaceuticals. One would reasonably expect preparing plant extract using ultrapure water in the process taught by Acosta and Conidi. In any event, purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product unobvious. See MPEP 2144.01, VII. Therefore, it would have been obvious to have used the ultrapure water in the preparation method of Prous motivated by the desire to use a product that has advantageous properties, i.e. pure toxin-free extract.
Regarding elected pomegranate as a plant matter claimed by claim 2, Acosta and Conidi both teach pomegranate.
Regarding the elected flavonoids as active substances contained in the plant claimed by claims 3 and 17, Acosta teaches polyphenols and flavonoids, and Conidi teaches flavonoids from pomegranate.
Regarding drying of plant matter as claimed by claim 5, Acosta teaches drying step.
Regarding volume of solvent as claimed by claim 6, one having ordinary skill in the art would have determined the required amount of solvent based on the desired extract.
Regarding the temperature of extraction of 50oC-75oC as claimed by claim 7, Acosta teaches 20oC-50oC that overlaps with the claimed temperature. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the size of the membrane in the tangential flow filtration of 100 Da to 100,000 Da as claimed by claim 8, Acosta teaches 100-5000 Da that falls within the claimed size. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding pressure in the tangential flow filtration between 4 and 30 bar as claimed by claim 9, Acosta teaches 2.5-40 bar that embraces the claimed pressure. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
Applicants argue that the cited references in combination does not teach the advantageous results obtained by using ultrapure water described in currents examples 12-15. Even if a prima facie showing obviousness has been established, these unexpected results would effectively rebut any such showing. Example 12 shows the use of ultrapure water decreased sulphuric ash content in the final product from 1.7% to 0.1%. Example 13 shows ultrapure water enabled to reach a concentration between 15-20 % of dry residue through osmosis while the tap water only allowed reaching a concentration between 2.5-7.5 % of dry residue. Example 14 shows the extract obtained with ultrapure water and dried after its purification, and subjected to the conductivity test, measuring its value in a 1 % solution, the conductivity values obtained were between 2.0-2.5 mS compared to 5.0-10.0 mS of an extract made with tap water. Example 15 shows that the use of ultrapure water in the process proved to be extremely useful since it increases the effectiveness of the enzymatic complex, being able to reduce the amount used to half that used with the process carried out with tap water.
In response to this argument, it is argued that the combination of the cited references teaches the instantly claimed method including the claimed steps and the used ingredients. Ultrapure water is taught by Kreuter and Raj. Both references teach suitability of ultrapure water for preparation of plant extract. Further using purer forms of water or any material is a common sense for safety of pharmaceuticals. The plant extract obtained from the prior art combination method is expected to provide the advantages achieved by applicants, absent evidence to the contrary. Regarding the properties applicants obtained by examples 12-15 above, the resulting properties would be expected from the cited references since the combination of the references teach the claimed method steps and the claimed plant matters used in the claimed method. According to MPEP 2112.02, products of identical chemical composition (plant extracts) cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed preparation prepared by the claimed method, any properties applicants achieved are necessarily expected from the prior art method. When the prior art discloses all the limitations of a claim except a property or function and the examiner cannot determine whether or not the reference possesses properties which anticipate or render obvious the claimed invention, the examiner can shift the burden of proof to applicant. Further, examples 12-15 are using only one species: lemon rind to extract specific flavonoid: eriocitrin micelles, while the claims are very broad embracing broad plant matters and broad botanical extracts that not micelles. Applicants failed to show the broadly claimed plants matters and broadly claimed plant extracts would have the properties obtained by the applicants. This can be done by showing properties of using reasonable number of claimed plant matters and extracts, in order to assure one skilled in the art that applicants was in possession of the broadly claimed subject matter.
Conclusion
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 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, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./