DETAILED ACTION
Claims 1-16 are currently pending.
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 .
Priority
Acknowledgement is made of the instant application being a national stage entry under 35 USC 371 of international application PCT/EP2023/065558, filed June 9, 2023. Acknowledgment is further made of applicants' claim for foreign priority to FR application 2205547, filed June 9, 2022. A certified copy of the foreign priority document is present in the application file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/6/2024 and 1/6/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
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 Interpretation
Claims 1, 4-5, 9, 12-13 and 15-16 recite the term “Trolox”. It does not appear that the term “Trolox” is a Trademark, or mark used in commerce, since the Trademark for TROLOX, owned by Trolox Co. Ltd, directed to a natural mineral water product, was abandoned on Oct. 18, 2017 (see PTO-892). Applicant’s clamed Trolox appears to be directed to a water-soluble vitamin E derivative, i.e., 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid (page 8, Antioxidant capacity).
Further, claims 1, 5, 9 and 14 recite limitations directed to the culture medium having antioxidant capacity of a Trolox solution, e.g., greater than or equal to the antioxidant capacity of a 10 µM Trolox solution (claim 1); greater than or equal to the antioxidant capacity of a 50 µM Trolox solution (claim 5); greater than the antioxidant capacity of a 10 µM Trolox solution and lower than the antioxidant capacity of 250 µM Trolox solution (claim 9); and greater than or equal to the antioxidant capacity of a 50 µM Trolox solution (claim 14). The specification sets forth culture medium comprising ascorbic acid or Trolox at concentrations of 10 µM to 1000 µM (page 10, last 2 paragraphs to page 11, first paragraph). Thus, it is considered that ascorbic acid or Trolox at concentrations ranging from 10 µM to 1000 µM would read on antioxidant capacities of 10 µM to 1000 µM Trolox solutions.
Claim Objections
Claims 7, 13 and 15 are objected to because of the following informalities: typographical.
Regarding claim 7, it appears the phrase “…wherein the culture cells…” should read “…wherein the cultured cells…”.
Regarding claims 13 and 15, it is unclear as to what is intended by the capitalization of the terms “Trolox” and “Tocofersolan”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7, 9-12, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gao et al., (WO 2022/089606; see IDS 12/6/2024) (“Gao”).
Gao is directed to methods for producing red blood cells from a population of Lin- CD34-hemopoietic progenitor cells, wherein the method includes a first and second medium wherein the second medium comprises one or more additives including vitamins ([0007]).
Regarding claim 1, Gao’s claim 1 claims the following method:
A method for producing red blood cells, comprising the steps of:
(a) providing a population of Lin- CD34- hematopoietic progenitor cells;
(b) culturing the population of Lin -CD34 -hemopoietic progenitor cells from (a) in a first medium comprising one or more additives selected from a group consisting of an aryl hydrocarbon receptor antagonist, a HIF-1 modulator, a PPAR alpha agonist, and any combination thereof, preferably a combination of an aryl hydrocarbon receptor antagonist, a HIF-1 modulator and a PPAR alpha agonist; and
(c) culturing the population of cells obtained from (b) in a second medium comprising one or more additives selected from a group consisting of a vitamin, a methylxanthine compound, a thyroid hormone receptor agonist, and any combination thereof, preferably a combination of a vitamin, a methylxanthine compound, and a thyroid hormone receptor agonist, thereby producing red blood cells.
Gao’s claim 18 claims the second medium is a second differentiation medium and Gao’s claim 19 claims the vitamin is selected from a group of vitamin C, vitamin E, derivatives or analogues of vitamin C or E, and any combination thereof. Gao’s claim 21 claims the vitamin C and/or derivatives is present in an amount of about 1-50 μM, and Gao’s claim 22 claims the vitamin is vitamin E and/or derivatives or analogues thereof in an amount of about 1-50 μM.
Gao’s claim 44 claims the following method:
A method of producing red blood cells, comprising: culturing a population of nucleated red blood cell precursors in a medium comprising one or more additives selected from a group consisting of a vitamin, a methylxanthine compound, a thyroid hormone receptor agonist, and any combination thereof, preferably a combination of a vitamin, a methylxanthine compound, and a thyroid hormone receptor agonist, thereby producing red blood cells.
Gao’s claim 46 claims the nucleated red blood cell precursors are reticulocytes, i.e., cells requiring a supply of iron.
Gao’s claim 49 claims the vitamin is selected from a group of vitamin C (i.e., ascorbic acid), vitamin E, derivatives or analogues of vitamin C or E, and any combination thereof, and Gao’s claim 51 claims the medium comprises vitamin C (i.e. ascorbic acid) and/or derivatives or analogues thereof in an amount of about 1-50 μM.
As discussed above at Claim Interpretation, it is considered that ascorbic acid (vitamin C) at concentrations ranging from 10 µM to 1000 µM would read on antioxidant capacities of 10 µM to 1000 µM of a Trolox solution.
Thus, Gao’s claims 44, 46, 49 and 51 anticipate claim 1.
Regarding claims 2-3, Gao’s claim 49 teaches vitamin C (synonymous with ascorbic acid), thus anticipating claim 2.
Regarding claim 4, Gao’s claim 51 teaches the medium comprises vitamin C (i.e. ascorbic acid) in an amount of about 1-50 μM. It is noted the range disclosed in Gao is disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
Regarding claim 5, As discussed above at Claim Interpretation, it is considered that ascorbic acid (vitamin C) at concentrations ranging from 10 µM to 1000 µM would read on antioxidant capacities of 10 µM to 1000 µM of a Trolox solution. Gao’s claim 51 claims the medium comprises vitamin C (i.e. ascorbic acid) in an amount of about 1-50 μM. Thus, given that Gao’s teaching encompasses vitamin C in an amount including 50 µM, it is considered that Gao’s teaching reads on antioxidant capacity equal to a 50 µM Trolox solution, thus anticipating claim 5.
Regarding claims 6-7, Gao’s claim 44 claims culturing a population of nucleated red blood cell precursors to produce red blood cells, thus anticipating claims 6-7.
Regarding claims 9-12, Gao’s claims 44, 46, 49 and 51 claim a culture medium comprising the antioxidant vitamin C (ascorbic acid) at a concentration ranging from 1-50 μM, and as discussed above at Claim Interpretation, it is considered that ascorbic acid (vitamin C) at concentrations ranging from 10 µM to 50 µM would read on antioxidant capacities of 10 µM to 50 µM of a Trolox solution. It is noted the range disclosed in Gao is disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
Thus, Gao’s teaching anticipates claims 9-12.
Regarding claim 14, it is noted as discussed above, Gao’s claim 51 claims the culture medium comprises vitamin C (ascorbic acid) at a concentration ranging from 1-50 μM, and as discussed above at Claim Interpretation, it is considered that ascorbic acid (vitamin C) at concentrations ranging from 10 µM to 50 µM would read on antioxidant capacities of 10 µM to 50 µM of a Trolox solution. It is noted the range disclosed in Gao is disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
Thus, given that Gao’s teaching encompasses vitamin C in an amount including 50 µM, it is considered that Gao’s teaching reads on antioxidant capacity equal to a 50 µM Trolox solution, thus anticipating claim 14.
Regarding claim 16, Gao’s claim 51 claims the culture medium comprises vitamin C (ascorbic acid) at a concentration ranging from 1-50 μM. It is noted the range disclosed in Gao is disclosed with sufficient specificity to constitute an anticipation. See MPEP 2131.03 (II)
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.
Claim(s) 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (set forth above) as applied to claims 1-7, 9-12, 14, and 16 above.
The teaching of Gao is set forth above and anticipates claims 1-7, 9-12, 14, and 16.
Regarding claims 13 and 15, although Gao’s claims 44, 46, 49 and 51 do not further claim the water-soluble analogue or derivative of vitamin E is Trolox or Tocofersolan (claim 13), or that the water-soluble analogue or derivative of vitamin E is Trolox, Tocofersolan or MDL 73404, it is noted that Gao’s claim 52 claims the medium comprises vitamin E and/or derivatives or analogues thereof in an amount of about 1-50 μM and Gao, at [0155], further teaches the derivatives or analogues of vitamin E includes the vitamin E analogue Trolox.
Thus, Gao does render obvious the water-soluble analogue or derivative of vitamin E is Trolox, that is, Gao teaches the limitation required by the current claims and as this limitation is found in one reference it is held that employing the water-soluble derivative of vitamin E that is Trolox is within the scope of the teachings of Gao, and thus renders the invention of claims 13 and 15 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to employ Trolox as the water-soluble derivative of vitamin E. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Gao.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (set forth above) as applied to claims 1-7, 9-12, 14, and 16 above, and further in view of Lipsitz et al., (WO 2020/243006; see PTO-892) (“Lipsitz”).
The teaching of Gao is set forth above and anticipates claims 1-7, 9-12, 14, and 16.
Regarding claim 8, it is noted that Gao does not further teach the method for culturing is a perfusion culturing method. However, Lipsitz is directed to culturing methods for generating enucleated erythroid cells, i.e., red blood cells, specifically using perfusion culture that results in increased enucleated cells as compared to culturing methods that do not use perfusion culture (page 1, lines 8-9 and 16-20). Example 1 of Lipsitz shows that perfusion culture obtains 70-80% higher enucleation rate as compared to fed-batch culture.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include perfusion culturing since Lipsitz has shown perfusion culturing obtains 70-80% higher enucleation rate.
The person of ordinary skill in the art would have been motivated to modify the erythroid culture method of Gao to include perfusion culturing for the predictable result of successfully preparing mature (enucleated) red blood cells, thus meeting the limitation of claim 8.
The skilled artisan would have had a reasonable expectation of success in combining the teachings of Gao and Lipsitz because each of these teachings are directed at erythroid culture systems and methods for preparing mature red blood cells.
Conclusion
No claim is allowed. No claim is free of prior art.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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