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 .
Claim Status
Applicant’s remarks and amendments, filed 20 May 2026 in response to the non-final rejection mailed 20 February 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 20 May 2026 replaces all prior versions and listings of the claims.
Claims 1 and 3-18 are pending. Claims 1, 3-7, and 13-18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b). Claims 8-10, 12, 13, and 18 are amended. Claims 8-12 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s submission of replacement drawings have overcome the drawings objection in regards to overlapping text. The objection to the drawings has thus been withdrawn.
Applicant’s arguments and amendments, on page 8 of the reply filed 20 May 2026 with respect to the rejection of Claims 8-12 under 35 USC § 112(b) have been fully considered. The rejections of Claims 8-12 are withdrawn under the previous grounds of rejection due to amendment of the claims.
Applicant’s arguments and amendments, on pages 9-10 of the reply filed 20 May 2026 with respect to the rejection of Claims 8-12 under 35 USC § 103 over Zuñiga et al. in view of Azmin et al. have been fully considered. The rejections of Claims 8-12 are withdrawn due to amendment of Claim 8.
Claim Objections
Claims 8-12 are objected to because of the following informalities:
In Claim 8 at line 3, the phrase "wherein the process comprising" should instead read either the phrase --wherein the process comprises-- or --the process comprising--.
In Claim 9 at lines 2-3, the phrase “for a period from” should instead read --for a period of time from--.
In Claim 11, at line 1, the phrase “the-incubating” should instead read --the incubating--.
Appropriate correction is required.
All other claims depend directly or indirectly from objected to claims and are, therefore, also objected to for the reasons set forth above.
Claim Rejections - 35 USC § 112(b)
(grounds modified as necessitated by amendment)
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 8-12 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 8 recites the parenthetical limitations “2,4-D” and “BAP.” Parenthetical phrases are interpreted as "for example" and therefore render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the instant case, there are various types of auxin such as naphthaleneacetic acid (NAA) and 2,4-dichlorophenoxyacetic acid (2,4-D) and various types of cytokinin such as kinetin (KIN) and benzyladenine (BAP; see, e.g., Sadino, 2015, pg. 13). The parenthesis therefore makes it unclear whether auxins and cytokinins are used broadly, or only specific types of each are meant to be claimed. Clarification is necessary.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. §112(b) for the reasons set forth above.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sadino (University of Chile, 2015, Translation, 118 pages) in view of Zuñiga et al. (EP 3398607).
The instant claims are as of record, drawn to a process for producing a composition comprising an extract of maqui stem cells grown in vitro, the process comprising the steps described therein.
Sadino teaches protocols for the establishment, maintenance, and collection of cell suspension cultures (grown in vitro) from calluses derived from Aristotelia chilensis (maqui) explants, which are in turn derived from embryo, leaf, or cotyledon (adult plant leaf; Sadino, Table 2.1.1., pg. 20; as required for instant Claim 8). The cell cultures were developed by culturing the leaves in a medium supplemented with a hormone mixture comprising auxin and cytokinin (Sadino, 3.1.1., pg. 32) and then passaged (passaging a cell mass from the culturing; Sadino, 2.4.1., pg. 28-29) and assessed for growth, wherein it was concluded that exponential growth (unlimited proliferation) occurred in the various treatments used in the study (e.g., stem cells, see instant specification pg. 7; Sadino, 3.1.2., pg. 36; as required for instant Claim 8). An incubation temperature of 21°C
In order to evaluate anthocyanin content, the collected cells were lyophilized (dried) for 72 hours and then vigorously shaken (mixed) for 1 hour in the dark with 15 mL of acidified methanol (an extract; gradually added). The tube was centrifuged and the supernatant collected (liquid phase constituting the extract; Sadino, 2.4.3., pg. 30; as required for instant Claims 8 and 12). According to Annex E., 758-819 mg (0.758-0.819 g; see instant specification at pg. 8) dry weight of the biomass (Sadino, Table E.3., page 95) was used to calculate the total anthocyanin present in extracts; since the dried cells were added to 15 mL of solvent, the concentration of maqui stem cells by dry weight with respect to the solvent was therefore in the range of 0.051-0.055 w/v% (as required for instant Claim 8).
Sadino does not teach a carrier; incubating the solvent and maqui stem cell solution while stirring; solvents of ethanol or water; specific drying temperatures or times; or a higher concentration of maqui stem cells by weight with respect to the solvent.
Zuñiga et al., however, teach a natural antibacterial and antioxidant composition comprising extracts of maqui seedlings cultured in vitro. The production method comprises extraction of in vitro cultures of meristematic (stem cell) explants of maqui with 25-85% ethanol using diffusion or maceration (mixing) techniques at a temperature of 20-70°C (Zuñiga et al., [0018]-[0020]; as required for instant Claim 8). Antioxidant capacity was determined using an ethanolic extract of maqui at a concentration of 0.1 g fresh/ml ethanol, or 10 w/v% (Zuñiga et al., [0021]). The extract was additionally combined with canola oil (carrier) wherein the ethanolic extract (liquid phase) was dried in a rotary evaporator (Zuñiga et al., [0025]; as required for instant Claim 8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the method of Sadino with that of Zuñiga et al. to arrive at the instantly claimed process of producing. Sadino teaches that cell culture suspensions were incubated at 21°C in a shaker at 100 rpm (Sadino, 2.4.1., pg. 28), and while these parameters refer to the cell cultures, a skilled artisan could reasonably apply these same parameters to incubation of the cells with the solvent, particularly because Sadino references “vigorous shaking” and Zuñiga et al. use a similar method of maceration (e.g., mixing) with a temperature range of 20-70°C. A skilled artisan would be motivated to use the extraction method of Zuñiga et al. because the hydroethanolic extracts have antioxidant and antibacterial properties, which allow it to be added to food, cosmetics, pharmaceuticals, and combinations thereof (Zuñiga et al., [0001]). Additionally, a skilled artisan could do so with a reasonable expectation of success because the stem cell suspensions of Sadino have a higher production of anthocyanins in a smaller amount relative to maqui fruit (Sadino, pg. i).
If not expressly taught by the prior art, based upon the overall beneficial teaching provided by these references, the adjustments of particular conventional working conditions (e.g., determining one or more suitable incubation temperatures, stirring speeds, and incubation times (instant Claims 8 and 11); concentration of dry material in relation to solvent (instant Claim 10); and drying temperature and time (instant Claim 9) in which to perform such a method), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 20 May 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to Zuñiga et al. regarding maqui stem cells and the specific method of obtaining said stem cells have been considered but are moot because the new ground of rejection does not rely on this reference to reject the newly amended Claim 8 regarding the production method of the stem cells.
Applicant additionally argues that while meristems may comprise some remnant stem cells, the majority would be differentiated cells. It is noted that the “comprising” method of Claim 8 does not exclude the presence of additional cell types; it merely requires the presence of stem cells which are grown in vitro and then cultured.
Conclusion
No claims are presently allowed.
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.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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