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
Claims 1 and 3-18 are pending in the instant application. Applicant’s election of Group II, Claims 8-12 in the reply filed on 31 December 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1, 3-7, and 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 December 2025.
Claim 2 was canceled by Applicant’s amendment. Claims 17 and 18 are newly added. Claims 1, 3, and 5-16 are amended. Claims 8-12 are being examined on the merits.
Drawings
The drawings are objected to because all of the figures have either overlapping text in the titles and/or axis, or the axis title is covering the entire axis or the labels/numbers. This makes the figures difficult to read and interpret because the essential information is not legible.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 8-12 are objected to because of the following informalities:
In Claim 8 at line 1, the phrase “Process for” should instead read --A process for--. Appropriate correction throughout Claims 8-12 is required.
In Claim 8 at lines 2-3, the phrase “wherein the process comprising” should instead read either the phrase --wherein the process comprises-- or --the process comprising--.
In Claim 8 at line 8 (in step b), the phrase “with stirring in range” should instead read --while stirring in a range--.
In Claim 8 at line 8 (in step b), the phrase “for a period in a range” should instead read --for a period of time in a range--.
In Claim 12 at line 1, the phrase “The process to” should instead read --The process according to--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 limitations "the extract" and “the carrier.” There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “wherein the maqui stem cells are previously dried,” however it is unclear when in the method “previously” occurs.
Claim 10 recites the limitation “a concentration of the resulting mixture,” however it is unclear whether the concentration is referring to dry weight of the stem cells, the solvent, a particular component within the mixture, etc. Appropriate clarification is required.
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
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 Zuñiga et al. (EP 3,398,607 A1) in view of Azmin et al. (Sep Purif Rev, 2016, 305-320).
The instant claims are as of record, drawn to a method for obtaining a composition comprising an extract of maqui stem cells comprising mixing in vitro cultured stem cells with water, ethanol, or a mixture thereof; incubating the mixture while stirring; separating the liquid extract; and combining the extract with a carrier.
Zuñiga et al. teach a production method for a composition comprising phenol extracts of Aristotelia chilensis (maqui) wherein in vitro cultures of meristematic (stem cell) explants of maqui were extracted 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]; as required for instant Claims 8 and 10). 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).
Zuñiga et al. do not teach wherein the solvent is added gradually until the concentration of material in the solvent is relative to the dry weight of the material; stirring the mixture during incubation; or separation of the liquid phase via centrifugation or filtration.
Azmin et al., however, teach a variety of herbal processing and extraction techniques well-known to a skilled artisan. Azmin et al. teach that prior to extraction, harvested plants (e.g., meristematic extracts grown in vitro comprising stem cells) must be pre-processed, which includes drying to remove moisture for preservation, preventing bacterial activity, and restricting fungal growth (Azmin et al., Steps in Herbal Processing, page 307; as required for instant Claim 9). Azmin et al. also note that solvent system, solvent-to-herb ratio, particle sizes, temperature, duration, and agitation rate are all important parameters which can be determined via preliminary studies (Azmin et al., Steps in Herbal Processing, page 307). Separation a liquid phase comprising the extract is also discussed for various methods and can be conducted using a rotary evaporator (centrifugation; Azmin et al., Soxhlet Extraction, page 310; Marinated Extraction, page 311; Steam-distillation Extraction, page 311; Ultra High Pressure Extraction, page 312-313; as required for instant Claims 8 and 12).
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 methods of Zuñiga et al. and Azmin et al. to arrive at the instantly claimed invention. Zuñiga et al. teaches extracts of in vitro cultures of meristematic (stem cell) explants of maqui, and a skilled artisan would be motivated to utilize the various methods of Azmin et al. to arrive at an optimized method for ethanolic extraction of maqui stem cells in order to obtain a composition. A skilled artisan could do so with a reasonable expectation of success because the methods of Azmin et al. are well-known in the art of herbal extraction and would be further motivated to arrive at an optimal extraction method due to the high antioxidant content and antibacterial properties of maqui (Zuñiga et al., [0012]-[0013]). Additionally, if not expressly taught by Zuñiga et al or Azmin et al., based upon the overall beneficial teaching provided by Azmin et al. with respect to optimization of extraction techniques in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable material to solvent concentrations by dry weight (instant Claim 8); stirring speed and incubation time (instant Claims 8 and 11); and drying temperature and time (instant Claim 9)) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition made via the claimed process (regenerative, antioxidant, protective, and repairing properties of the skin) does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
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).
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655