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 Claims
Claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 are pending and under exam. Claims 46-52 are new. Claims 2, 5-6, 8-9, 11-16, 18, 20-21, 23, 25-26, 28, 31, 33-34, 37, 41-45 are cancelled. Claims 35-36 and 38-40 are withdrawn.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 112
Claims 1, 4, 6-10, 12, 17-19, 22-24, and 27-30 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 1 was rejected for not clarifying that the serum protein was animal serum protein. Claim 4 was rejected for its dependency on claim 1.
The rejection is withdrawn following appropriate clarification.
Claim Rejections - 35 USC § 102
Claim(s) 1, 3, 4, 6-10 and 12 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by HK1133155B1 (Published 20-Mar-2008; hereinafter '155 patent; See PTO-892).
Claims 1 and 32 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fernández-Tomé et al (Int J Mol Sci. 2020 Jan 14; See PTO-892; hereinafter "Fernández-Tomé").
The rejections are withdrawn following claim amendments. New rejections are set forth below.
Claim Rejections - 35 USC § 103
Claim 17 was rejected under 35 U.S.C. 103 as being unpatentable over HK1133155B1 (Published 20-Mar-2008; hereinafter '155 patent; See PTO-892) as applied to claims 1, 3, 4, 6-10 and 12 above.
The rejection is withdrawn following claim amendments. New rejections are set forth below.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 112
Claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 require a plant protein homologue of a serum albumin, a serum catalase, a serum superoxide dismutase, a serum transferrin, a serum fibronectin, a serum vitronectin, a serum insulin, a serum hemoglobin, a serum aldolase, a serum lipase, a serum transaminase, a serum aminotransferase, a serum fetuin. However, it is understood by a person of ordinary skill in the art that at least fibronectin and vitronectin, insulin, and fetuin are animal proteins. It is unclear from the language of the claim as to which protein(s) in plants these terms are referring. Appropriate clarification is required. As such the metes and bound of the claims are unclear.
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.
Claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 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 1 recites: “cell culture medium supplement comprising a water-soluble fraction of a plant protein isolate, wherein the water-soluble fraction comprises a plant albumin, a plant catalase, a plant fibronectin, a plant insulin, or a combination thereof and wherein said supplement is devoid of any animal serum proteins.”
The claim requires a medium comprising a plant albumin, a plant catalase, a plant fibronectin, a plant insulin, or a combination thereof. Further claim 7 required that the medium contain a plant superoxide dismutase, a plant transferrin, a plant vitronectin, a plant leghemoglobin, a plant aldolase, a plant lipase, a plant transaminase, a plant aminotransferase, a plant cystatin, or a combination thereof.
It is recognized by a person of ordinary skill in the art that vitronectin, insulin, fibronectin are all animal proteins. The specification did not provide any examples of proteins that fall under the claimed plant homolog of vitronectin. It is further submitted that the specification did not provide any examples of such proteins. It is submitted that the Applicants did not provide adequate written description of the claimed protein.
Similar rejection applies to Fetuin (See Lynda Bourebaba et al Abstract, “Alpha 2-Heremans-Schmid glycoprotein, also known as fetuin-A (Fet-A), is a multifunctional plasma glycoprotein that has been identified in both animal and human beings”). Similarly, the specification did not provide any examples of plant homolog of transferrin, aminotransferases, superoxide dismutase. The specification taught a plant aspartate aminotransferase from wheat, and soy.
The specification gave some exemplary proteins which are homologs of fibronectin. (See instant specification [0127]). However, the exemplary proteins provided do not have homology with animal fibronectin. It is noted that the indicated proteins have fibronectin type III-like domain in analysis of their primary sequence. However, it is unclear if the exemplary proteins can themselves be categorized as plant homologs of serum fibronectin as claimed. It is submitted that the specification did not describe or provide any description or name any examples of plant homologs of fibronectin. As such the specification lacks proper written description.
Similar rejection applies to plant insulin. It is understood by a person of ordinary skill in the art that insulin is a human protein (See Butler p. 232 last para; see PTO-892). The specification exemplified glucokinin, charantin, corosolic acid as plant insulin. It is however not clear if any of the exemplified proteins are homologs of insulin in plants. It is submitted that the specification did not describe or provide any description or name any examples of plant homologs of insulin. As such the specification lacks proper written description.
It is also noted that while the specification described use of chickpea and organic pea proteins as a replacement for albumins, it is unclear if the specification adequately described use of all the claimed proteins in their cell culture medium as cell culture supplement.
The specification as filed does not provide sufficient evidence that Applicants were in possession of the full scope of the claimed invention at the time of filing. It is however clear from the specification that chickpea and organic pea proteins supports the growth of chicken fibroblasts. However, there is no support in the specification for use of each of the claimed supplements in claims 6-10. Therefore, due to the need for further experimentation to determine the exact cell supplement, and the effect of the supplement on the cells, it remains that it is the examiner’s position that the full scope of the claimed invention was not disclosed as of the filing date of the instant specification.
Claim 19 requires a catalase from various species (“ Arabidopsis catalase, a cabbage catalase, a cucumber catalase, a cotton catalase, a potato catalase, a pumpkin catalase, a spinach catalase, a sunflower catalase, a tobacco catalase, a tomato catalase, a kidney bean catalase, a mung bean catalase, or a wheat catalase”). The specification provides a general disclosure of plant catalases and describes experimental embodiments for cucumber and potato catalases with some mention of cabbage catalase., While the specification discusses molecular weights, UniProt accession numbers and routine experimentation methods for isolation of plant catalases, it does not provide experimental examples, sequence information or other direct evidence demonstrating possession of catalase from Arabidopsis, pumpkin, , spinach, cauliflower, tobacco or tomato. A person of ordinary skill in the art would not be able to ascertain from the specification that the inventors were in possession of the full scope of plant catalases recited in claim 19.
Claim 47: It is submitted that the specification fails to provide plant albumins having the function of claimed property of acting both (i) a lipid carrier and (ii) a growth factor carrier.
The specification generally discloses plant protein isolates and references plant albumins as water soluble seed proteins. It is recognized that lipid and growth factor carrier function of animal serum albumins.
“Plant albumin” encompasses a broad genus of structurally diverse seed storage proteins (e.g., 2S albumins and other water-soluble proteins), which are not universally recognized in the art as lipid or growth factor carrier proteins. The specification does not provide representative species, structural features, or functional testing sufficient to establish possession of the full scope of plant albumins having the claimed carrier functionality.
Accordingly, the specification does not reasonably convey to those skilled in the art that the inventors were in possession of plant albumins that function as lipid and growth factor carriers at the time of filing.
Therefore, claim 47 fails to satisfy the written description requirement of 35 U.S.C. §112(a).
Claim 48 and 50: The specification fails to demonstrate possession of plant fibronectin-like proteins or structural or functional homologue of a serum insulin. No experimental examples, sequences or structural/functional characterization are provided, and the disclosure only generally mentions extraction from plant cell walls or plasma membrane fractions. A skilled artisan would not recognize or be able to identify the claimed proteins from the specification.
Claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant's specification is found enabling for chickpea and organic pea proteins supporting the growth of chicken fibroblasts.
Applicant's specification is not found to be enabling for all the claimed biological molecules listed in claim 6 as cell culture supplements. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to carry out the method of the invention commensurate in scope with the current claims.
Analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention without undue or unreasonable experimentation. See Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916). The key word is 'undue,' not experimentation.' " (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
Applicants' claims are directed to a plant-derived protein supplement that is used in cell culture that is a plant albumin, catalase, superoxide dismutase, transferrin, fibronectin, vitronectin, insulin, hemoglobin, aldolase, lipase, transaminase, aminotransferase, or fetuin and is a plant analog. The breadth of the claims includes proteins that do not exist or are not yet discovered.
The specification provides support for attachment of chicken fibroblast in a serum free medium. (See [0258]). Specification provides support for purification of soluble soy or chickpea proteins and that chicken fibroblast cells can be grown with soluble soy protein as a replacement for FBS. Specification found optimal ranges for the soy or chickpea proteins to support growth of chicken fibroblasts.
At the time the invention was made it was known that there are no plant analogs for proteins such as insulin, fetuin, fibronectin, vitronectin, among others. Therefore, there was a recognized level of unpredictability with regards to finding plant homologs particularly for these proteins. Further although there were plant hemoglobin, transferrin, lipase, aminotransferase, superoxide dismutase, aldolase, catalase or transaminase in all species of plants are not known, it is understood by a person of ordinary skill in the art that the activity, stability and usefulness of the enzyme depends on its source and sequence. As the sequence of each and every claimed enzyme in all plant species are unknown, the specification is not enabling for any or all the claimed enzymes in claim 6.
Additionally, regarding claim 47, it is generally known that plant albumins are structurally diverse class of proteins including seed storage proteins and other water soluble proteins, which are not universally known to possess ligand transport or growth factor carrier capabilities. Determining which plant albumin if any, exhibit the claimed functional property would require undue screening, structural analysis and functional testing across numerous plant species and albumin subtypes.
Regarding claim 48 -50 : The specification does not enable a skilled artisan to identify, isolate or use plant fibronectin-like proteins or proteins homologous to insulin. The claims 48-49 encompass any protein “fibronectin-like” in plant cell wall or plasma membrane fractions, a broad and unpredictable group of proteins and practicing the claim would require undue experimentation. Further claim 50 encompasses any protein that is homologous to insulin. It is additionally pointed out that regarding claim 49, the specification does not provide guidance sufficient to enable a skilled artisan to make or use proteins that are within the claimed molecular weight range. No structural limitations, sequences or functional limitations are provided. As such practicing the invention would require undue experimentation.
Due to the lack of teachings in the art regarding an all the claimed enzymes, and the recognized unpredictability in identification of appropriate identity and concentration of the claimed enzymes, a large amount of guidance and teachings would be necessary in order to be enabling for methods of such.
Guidance and teachings provided by Applicants in the instant specification is limited to disclosure that soluble soy or chickpea proteins can replace FBS. None of the examples particularly show the use of each of the claimed enzymes or their appropriate concentrations for use as a cell culture supplement in the growth of chicken fibroblasts. Applicants mass spec data only showed that the albumin content was the highest in the soluble proteins. The Examiner acknowledges that the Office does not require the presence of working examples to be present in the disclosure of the invention (see MPEP §2164.02). The application fails to provide adequate operational data for the claimed invention, or results to show operability, or reduction to practice and to convincingly prove that the invention was not merely prophetic at the time of filing. In light of the state of the art, discussed above, which recognizes a high level of unpredictability in the field of genomics to find pant protein and to evaluate their use in cell culture, and limited teachings with regards to plant homologs of animal proteins, the Office would require appropriate disclosure to support the contention that all the claimed enzymes in claim 7 may be successfully employed in as cell culture supplements. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Thus, due to the high level of unpredictability in the art, the current specification would have to provide greater amounts of teachings and guidance directed to methods of carrying out the claimed invention.
Therefore, due to the sum of all the aforementioned factors, one of ordinary skill in the art, at the time the invention was made, would not expect success carrying out the claimed composition. Given that the art fails to recognize and Applicant has failed to demonstrate the claimed cell culture supplements, the skilled artisan would be faced with the impermissible burden of undue experimentation in order to practice the claimed invention using any species of stem cell. Accordingly, claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 are deemed properly rejected.
Response to Arguments:
Applicant contends that the specification provides examples sufficient written description for the recited “plant albumin”, plant catalase, “plant fibronectin”, “plant insulin”, citing representative species, isolation protocols, molecular weights, UniProt Accession numbers and working examples. Applicant’s arguments have been fully considered but are not found to be persuasive.
Fibronectin is an extracellular matrix glycoprotein in animals with defined structural domains. The specification does not identify any plant protein that possesses the structural domain architecture characteristic of fibronectin. The specification does not provide any structural criteria (e.g., conserved domains, sequence identity thresholds, binding motifs) that would delimit the scope of plant fibronectin. Instead, the specification refers to fibronectin-like proteins identified in certain plants and provides UniProt accession numbers and molecular weight ranges. However, the claims are not limited to specific disclosed sequences. Neither does the specification identify or define structural features common to the purported genus of “plant fibronectins.” No sequence alignment demonstrating homology to animal fibronectin domains are provided.
Insulin is a structurally defined peptide hormone consisting of α and β chains linked by disulfide bond. The specification does not disclose any plant-derived protein having structural characteristics of insulin. Instead, the specification identifies glukokinin, charantin and corosolic acid as an example. Charantin is described as a mixture of steroid glycosides and Corosolic acid is a pentacyclictriterpene acid. These compounds are not proteins and do not have any homology with insulin. The specification provides examples of non-protein small molecules and does not provide support for plant proteins that are structurally homologous to insulin.
Absent structural features common to the claimed genus or representative species spanning the breadth of the claim, the disclosure does not support possession of “plant insulin” or “plant fibronectins.”
Similar analyses apply to at least “plant transferrin”, “plant vitronectin”, “plant leghemoglobin”, “plant lipase”, “plant transaminase”, “plant cystatins”.
It is additionally submitted that working examples demonstrate isolation and functional testing of plant albumin-containing fractions. However, the specification does not isolate, identify, or functionally test plant catalase, plant fibronectin, plant vitronectin, plant insulin, plant transferrin, or any of the additional proteins recited in claim 7. The disclosure therefor does not support possession of these independently recited protein classes. The experimental data at most support albumin-containing plant fractions, not the broader genera recited in claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
Regarding claims 1, 3-4, 7, 10, 17, 19, 22, 24, 27, 29-30, 32 and 46-52: The claims are directed to a cell culture medium supplement devoid of any serum proteins. The claims encompass plant protein isolate, wherein the water-soluble fraction comprises a plant albumin, a plant catalase, a plant fibronectin, a plant insulin, or a combination thereof.
The claims are directed to a composition of matter, which is a statutory category of invention
(Step 1: YES).
The claims are then analyzed to determine whether they are directed to any judicial exception. The claims are directed to a water-soluble fraction of a plant protein isolate, wherein the water-soluble fraction comprises a plant albumin, a plant catalase, a plant fibronectin, a plant insulin, or a combination thereof. (Step 2A prong 1: YES).
The claims are then analyzed to determine if additional elements integrate the
judicial exception into a practical application. The claims recite no additional elements
and are limited to any and all plant proteins that are homologous to serum proteins. (Step 2A prong 2: NO). Therefore, the claims are directed to a law of nature judicial exception.
The claims are patent ineligible.
Response to Arguments: Applicants argued that the amended claims are directed to patentable subject matter as the "water-soluble fraction of a plant protein isolate" is not a naturally occurring product. Applicant’s arguments are not persuasive.
It is submitted that the broadest reasonable interpretation of a water-soluble fraction of a plant protein isolate is a crude aqueous extract containing soluble plant proteins and encompasses proteins that are structurally identical to those in plants, but merely separated from plant tissue. The claims do not require structural modification or characteristics markedly different from those in nature. As such, the same analysis as above stands for the purpose of subject matter eligibility.
Claim Rejections - 35 USC § 102
Claims 1 and 29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tjandrawinata et al (WO2010023572; published 2010/03/04; hereinafter "Tjandrawinata;" See PTO-892 of 09/30/2025).
Claims 1 and 29: Tjandrawinata disclosed the use of Cinnamomum burmannii extracts comprising glucokinin (See Tjandrawinata [43]) in a cell culture at a dose of 1-10 µg/ml. (See Tjandrawinata [62]). As indicated above, it is unclear what is meant by plant insulin. It is understood by a person of ordinary skill in the art that insulin is an animal protein. The term “plant insulin” is interpreted to recite glucokinin, charantin, or corosolic acid for the sake of compact prosecution. It is noted that Cinnamomum burmannii extracts are used as cell supplements in Tjandrawinata as required by claim 1. It is also pointed out that they are derived from plant sources and are therefore devoid of animal proteins.
Claim Rejections - 35 USC § 103
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Tjandrawinata et al (WO2010023572; published 2010/03/04; hereinafter "Tjandrawinata;" See PTO-892 of 09/30/2025), as applied to claims 1 and 29 above.
Claim 30: The teachings of Tjandrawinata are set forth above. Tjandrawinata disclosed that Cinnamomum burmannii extracts is present in the composition at a concentration of 1-10 µM in the composition. (See Tjandrawinata [63]). It is noted that Tjandrawinata doesn’t teach the concentration of glucokinin in the Cinnamomum burmannii extracts. However, it is also pointed out that one of ordinary skill would recognize that the concentration of glucokinin can be adjusted can be optimized as a matter of routine experimentation. Absent any teaching of criticality by the Applicant concerning the concentration of the claimed supplement, it would be concentration of cell culture supplements would be readily optimizable for a person of ordinary skill in the art. “[W[here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. “ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
NEW REJECTIONS NECESSITATED BY CLAIM AMENDMENTS
Claim Rejections - 35 USC § 112
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.
Claim 48 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 48 requires fibronectin-like adhesion proteins, without clear boundaries regarding the structure, sequence or function. It is submitted that the term “fibronectin-like” is vague and subjective and as such this claim is indefinite.
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, 3, 4, 7, 10, 24, 32, 46 and 51-52 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Girón-Calle et al (Cytotechnology. 2008 Jul; hereinafter "Girón-Calle;" See PTO-892), as evidenced by Liu et al ( J Food Sci. 2008 Jun; hereinafter “Liu;” See PTO-892) and Jameel et al (Front. Plant Sci., 12 April 2021; hereinafter “Jameel;” See PTO-892).
Claims 1, 3, 4, 7, 10, 24, 32, 46 and 51-52: Giron-Calle disclosed the use of two food grade proteases to produce a chickpea protein hydrolysate and tested it for supporting growth of two human cells lines: the monocytic THP-1 suspension cell line and Caco-2 adherent cell line. (See Grion-Calle Abstract). Grion-Calle found that chickpea hydrolysates produced by digesting chickpea protein isolates with alcalase and flavourzyme, resulted in 30% hydrolysis of the protein isolates (See Grion-Calle Figure 1). Giron-Calle observed long term culture of THP-1 cells in the presence of 10% (v/v) hydrolysate (22% degree of hydrolysis) and 0, 0.5 or 10% (v/v) FBS and found that supported a good rate of growth at 0% (v/v) FBS (See Giron-Calle Figure 6, lower panel; p. 268, col. 2, 3rd para). It is known generally in the art as evidenced by Liu (See Liu Abstract), that chickpea protein isolates comprise albumins and globulins. Given the partial hydrolysis of chickpea proteins, it is submitted that there was considerable albumin and globulin in the cell culture supplements taught by Giron-Calle, as required by claims 1, 4 and 10. It is submitted that teaching of growth at 0% FBS by Giron-Calle reads on supplement devoid of any animal serum component as required by claim 3. Further, it is also known as evidenced by Jameel, that chickpea comprises superoxide dismutase (See Jameel Abstract), as required by claim 7.
As indicated in 112(a) rejection it is not understood as to what is encompassed by fibronectin as required by claim 24. It is however submitted that the 10% hydrolysate with 22% hydrolysis comprises all chickpea proteins including the claimed “fibronectins”.
It is also submitted that the limitations of claims 51 and 52 constitute statements of intended use and do not impose any meaningful structural limitation of the claimed composition. The claims remain directed to the composition of claim 1, and the recited use does not meaningfully limit the structure of the supplement. Accordingly, these limitations are not afforded patentable weight in patentability analysis.
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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Girón-Calle et al (Cytotechnology. 2008 Jul; hereinafter "Girón-Calle;" See PTO-892) as evidenced by Liu et al ( J Food Sci. 2008 Jun; hereinafter “Liu;” See PTO-892) and Jameel et al (Front. Plant Sci., 12 April 2021; hereinafter “Jameel;” See PTO-892), as applied to claims 1, 3, 4, 7, 10, 24, 32, 46 and 51-52 above.
Claim 17: The teachings of Grion-Calle as evidenced by Liu and Jameel are set forth above. Grion-Calle taught the use of chickpea protein hydrolysates in 0% FBS media at various effective concentrations to support cell growth and viability. A skilled artisan would have recognized that chickpea hydrolysates contain multiple seed proteins including albumins and globulins. It would have been routine and conventional to determine an appropriate concentration of the protein supplement to achieve satisfactory cell growth in a serum-free medium. Selection of a concentration within 0.01-10% represents a predictable ordinary optimization of protein dosing in culture media, well within the purview of a skilled artisan in the art. “[W[here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. “ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
Claims 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Girón-Calle et al (Cytotechnology. 2008 Jul; hereinafter "Girón-Calle;" See PTO-892) as evidenced by Liu et al ( J Food Sci. 2008 Jun; hereinafter “Liu;” See PTO-892) and Jameel et al (Front. Plant Sci., 12 April 2021; hereinafter “Jameel;” See PTO-892) as applied to claims 1, 3, 4, 7, 10, 24, 32, 46 and 51-52 above, and further in view of Starke et al (J Biol Chem.; Published 1985; hereinafter "Starke;" See PTO-892); in view of Hisateru et al (Bulletin of the Institute for Chemical Research; Published 1954; hereinafter "Hisateru;" See PTO-892 of 09/30/2025) and Hisateru et al (Journal of the Agricultural Chemical Society of Japan; Published 1955; See PTO-892 of 09/30/2025; hereinafter "Hisateru 2").
Regarding claim 19: The teachings of Grion-Calle as evidenced by Liu and Jameel are set forth above. However, Grion-Calle did not teach or suggest use of catalases.
Starke taught the use of catalase as a cell culture supplement in rat hepatocytes was inhibited by 90% pretreatment with 20 mM aminotriazole. (See Starke Abstract). Starke taught that catalase and the GSH-GSSG cycle are active in the defense of hepatocytes against the toxicity of H2O2, and the inhibition of catalase potentiates the killing of the cells by a mechanism that is insensitive to antioxidants and unlikely, therefore, to be related to the peroxidation of cellular lipids. (See Starke Abstract). It is noted that Starke used a bovine catalase, which is not a plant homolog of serum protein as required by claim 1 (See p. 87, col. 1, last para). However, Hisateru was directed to probing activity of animal-derived catalase and plant derived catalase. (See Hisateru Fig. 1). Hisateru indicated that both beef-liver catalase and rice plant green leaf catalase have comparable activities under similar conditions at 0ºC and 20-22ºC. Given the teachings of Hisateru and in view of the teachings of Starke, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute the bovine catalase with the catalase derived from plant sources such as rice, (As required by claim 18). Further Hisateru 2 taught that the catalase activity of catalase derived from spinach leaves (as required by claim 19) is more active than rice plant green leaf catalase. One of ordinary skill in the art would have been motivated to use an equivalent substitute for the bovine catalase as taught by Starke. One of ordinary skill in the art would recognize this as simply substituting one type of catalase for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12).
Regarding claim 22: None of the references taught the claimed concentration of catalase. However, it is pointed out that one of ordinary skill would recognize that the concentration of catalase can be adjusted can be optimized as a matter of routine experimentation. Absent any teaching of criticality by the Applicant concerning the concentration of the claimed supplement, the concentration of cell culture supplements would be readily optimizable for a person of ordinary skill in the art. “[W[here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. “ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05).
Conclusion
Claims 27 and 47-50 are found to be free of art, but lack written description, enablement and are indefinite.
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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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633