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 .
Status of Application, Amendments and/or Claims
Claims 7-28 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 7-13 and 28, in the reply filed on 29 October 2025 is acknowledged.
At page 2 of the Response of 29 October 2025, Applicant indicates that in the Restriction requirement of 02 September 2025, claim 28 was designated as part of Group II. Applicant points out that since claim 28 depends from claim 7, it should be part of Group I.
After consideration of Applicant’s comments, the Examiner acknowledges that claim 28 was erroneously placed into Group II. Claim 28 depends from the method of claim 7 and should have been included in Group I.
Claims 14-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 29 October 2025.
Claims 7-13 and 28 are under consideration in the instant application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05 December 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
1. Claims 7, 11, 12 are objected to because of the following informalities:
1a. In claim 7, lines 3 and 5, step (a) is missing. Therefore, steps (b) and (c) should be relabeled as (a) and (b).
1b. In claim 11, line 2, the term “is/are” should be amended to recite “is”.
1c. In claim 11, line 3, the term “(LEA)” should be relocated to follow the word “abundant” (i.e., “late embryogenesis abundant (LEA) proteins,
1d. In claim 12, line 8, the acronym “G-CSFs” should recite “G-CSF”.
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.
2. Claims 7-13 and 28 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.
2a. Claims 7-13 and 28 are rejected as being indefinite because regarding claim 7, the phrase "preferably" in line 9 renders the claims indefinite. It is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
2b. Claims 8 and 28 recite the limitation "the concentration" in line 1. There is insufficient antecedent basis for this limitation in the claims. Claim 7, from which claims 8 and 28 depend, does not recite “a concentration” limitation.
2c. Claims 9 and 10 are rejected as being indefinite because claim 9 (line 2) recites that the one or more recombinant animal growth factor and one or more plant seed protein are provided as a growth factor supplement that is added to the growth medium. However, claim 7, lines 7-9 recites that the growth factor medium comprises a growth factor composition comprising the recombinant animal growth factor and plant seed protein. Therefore, it is not clear what the difference is between “a growth factor composition” as recited in claim 7 and “a growth factor supplement” as recited in claim 9. Are they the same? Or, do they comprise different ingredients besides the recombinant animal growth factor and plant seed protein? The specification does not provide a standard for ascertaining the requisite degree and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
2d. Claim 10 recites the limitation "the amount" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 7 and 9, from which claim 10 depends, do not recite “an amount”. Please note that this issue could be overcome by amending claim 10, line 1 to recite “an amount”.
Claim Rejections - 35 USC § 102(a)
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.
3. Claims 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gadellaa et al. (WO 2009/020389; cited on the IDS of 05 December 2022).
Gadellaa et al. teach a method of culturing eukaryotic cells (in particular animal cells) comprising contacting the cells with a hydrolysate of a protein-containing seed derived from a plant species of the Asteraceae family, meeting the limitations of instant claims 7 and 9 (page 3, lines 10-25; page 5, lines 37-38 through page 6, lines 1-3 and 28-31). Gadellaa et al. also disclose that the hydrolysate may be combined with other conventional constituents of culture media, such as plant or animal cytokines and/or growth factors (provided they are not of animal origin), meeting the limitations of instant claims 7 and 9 (page 5, lines 22-24).
4. Claims 7-10, 12, 13, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petit et al. (WO 2010/096588 or US 2012/0315697). It is noted that WO 2010/096588 and US 2012/0315697 have the same disclosure. Thus, for brevity, relevant portions of the WO document will be cited below.
Petit et al. teach a method for culturing cells comprising (i) supplementing cell culture media base with two or more proteins selected from the group consisting of growth factors, albumin, lactoferrin, transferrin, insulin, platelet derived growth factor, epidermal growth factors, keratinocyte growth factors, insulin-like growth factors, intestinal trefoil factors, transforming growth factors, granulocyte-stimulating factors, nerve growth factors, and fibroblast growth factors (just to name a few), and (ii) introducing cells to be cultured into the supplemented cell culture media, meeting the limitations of instant claims 7, 9, and 12 (entire page 4; page 5, 1st and 3rd paragraphs; page 11, 2nd-4th paragraphs; page 21, last paragraph through the top of page 22; page 32; page 39). Petit et al. disclose cells used in the method are eukaryotic cells, such as CHO cells, stem cells, and human embryonic stem cells (pages 57-58, 62-64).
Petit et al. indicate that proteins utilized in the cell culture media are recombinant proteins, preferably recombinant human proteins, meeting the limitations of instant claim 7 (page 4, 2nd paragraph). Petit et al. disclose that the proteins are plant-produced heterologous proteins, meeting the limitations of instant claim 7 that the growth factor is “from a non-animal source” (page 4, 2nd full paragraph; page 40, 1st paragraph; page 42, 4th full paragraph). Petit et al. teach that many suitable plant expression systems can be used for expression of the cell culture media components, such as rice, barley, wheat, rye, corn, millet, triticale, or sorghum, meeting the limitations of instant claim 13 (page 53, 4th full paragraph; page 40, 1st paragraph).
Petit et al. disclose exemplary cell culture supplements, such as a mixture of recombinant albumin and transferrin (page 5; page 40). Petit et al. disclose that the recombinant albumin also comprises a rice heat shock protein from rice seeds, meeting the limitations of instant claim 7 of “one or more plant seed protein” (page 11, last two paragraphs; page 42, last paragraph; page 55, 4th full paragraph; page 71, 3rd paragraph; Example 5, pages 73-76; Example 8, pages 83-87). Petit et al. indicate that the recombinant albumin comprises at least 0.1% wt/wt heat shock protein 70 (HSP70) (page 11, last paragraph).
Lastly, Petit et al. teach that the supplements of the invention will be added to a final concentration of about 0.1%, about 0.5%, about 1%, about 2%, about 3%, about 4%, or about 5% wt/wt or wt/volume, meeting the limitations of instants claim 8 and 10 (page 38, last paragraph through page 39, lines 1-3; page 49, 4th full paragraph). Petit et al. also state that supplements of the invention can be added to cell cultures at a concentration of about 200 mg/L to about 2g/L (0.02-0.2 w/v%), or more preferably 200 mg/L to about 1000 mg/L (0.1 w/v%), or more preferable about 250 (0.025 w/v%) to about 500 mg/L (0.05 w/v%) (page 39, 1st full paragraph). Examples 11-13 of Petit et al. indicate plant-derived recombinant lactoferrin (which is a growth factor) or plant-derived recombinant albumin in a concentration of 0.1 g/L (or 0.01 w/v%), meeting the limitations of instant claim 28 (page 90, 1st full paragraph and Table E9; pages 92-93, Tables E10, E11; page 95, Table E12).
5. Claims 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deeter et al. (WO 2007/002762 (cited on the IDS of 05 December 2022) or US 2010/0015713). It is noted that WO 2007/002762 and US 2010/0015713 have the same disclosure. Thus, for brevity, relevant portions of the WO document will be cited below.
Deeter et al. teach a method of culturing cells to achieve high growth rate and high productivity by culturing the cells with improved cell culture media, meeting the limitations of instant claims 7 and 9 (page 6, [0021]; page 1, [0003]; Examples 5, 6, 8, 9). In one example, Deeter et al. even state that, “plant derived recombinant human serum albumin can promote cell growth in serum-free media and replace animal derived albumin for use in tissue culture” (page 31, [0120]). Deeter et al. indicate that improved cell culture media comprises high-level expression of heterologous molecule components (page 17, [0077]).
Deeter et al. disclose that the cell culture media comprises at least one plant-produced heterologous protein as a cell culture media component, wherein the heterologous protein is produced by (a) transforming a plant cell with a chimeric gene comprising: (i) a promoter from the gene of a seed storage protein; (ii) a first DNA sequence, operably linked to the promoter, encoding a seed storage protein; and (iii) a second DNA sequence, operably linked to the promoter, encoding the heterologous protein, wherein the first and second DNA sequences are linked in translation frame and together encode a fusion protein comprising the storage protein and the heterologous protein; and (b) growing a plant from the transformed plant cell for a time sufficient to produce seeds containing the heterologous protein, meeting the limitations of instant claim 7 (page 5-6, [0012-0013]; page 17, [0077]; page 19, [0085]). Deeter et al. teach that the heterologous protein is harvested from the seeds (pages 19-20, [0085-0090]). Deeter et al. disclose that plant storage proteins include rice glutelins, oryzins, and prolamines; barley hordeins; wheat gliadins and glutelins; maize zeins and glutelins; oat glutelins; sorghum kafirins; millet pennisetins; and rye secalins, meeting the limitations of instant claim 11 (page 16, [0076]).
Deeter et al. state that the plant that is grown is a monocot plant, such as rice, barley, wheat, rye, corn millet, triticale, or sorghum, meeting the limitations of instant claim 13 (page 18, [0081]; page 21, [0091]).
Deeter et al. teach that the heterologous protein is a plant protein or a non-plant protein, preferably human, selected from the group consisting of growth factors, lactoferrin, transferrin, serum albumin, insulin, growth hormone, platelet derived growth factor, brain-derived neurotrophic factor, glial-derived neurotrophic factor, keratinocyte growth factors, insulin-like growth factors, intestinal trefoil factors, transforming growth factor, granulocyte colony-stimulating factors, nerve growth factors, and fibroblast growth factors (among others), meeting the “recombinant animal growth factor” limitations of instant claims 7 and 12 (page 13, [0059]; page 18, [0081]).
Lastly, Deeter et al. disclose that culturing cells with cell culture media supplemented with plant-derived recombinant human lactoferrin at a concentration of 1 mg/ml (or 0.1 wt/v%) promotes cell growth and increases cell number, meeting the limitations of instant claims 8 and 10 (page 10, [0043]; page 27, [0112]; Figure 21).
Conclusion
No claims are allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gomes et al. “Prospects for the Production of Recombinant Therapeutic Proteins and Peptides in Plants: Special Focus on Angiotensin I-Converting Enzyme Inhibitory (ACEI) Peptides” in Genetic Engineering-A Glimpse of Techniques and Applications, published 22 February 2019; www.intechopen.com/chapters/65771 (review of plant-based platforms for recombinant protein production)
Xu et al. Biotechnol Adv 30: 1171-1184, 2012 (review of plant-based platforms for recombinant protein production)
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BEB
Art Unit 1647
02 December 2025
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647