Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This application is a continuation of 18,050,213, issued as US Patent No. 11,718,644, which is a continuation of PCT/US22/38074.
Status of Claims
Claims 1-30 are pending.
Claims 1-30 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 14, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 4 is objected to because claim 4 lacks a conjunction between “aminoethyl groups,” and “a resin with quaternary amine groups”.
Claim 27 is objected because claim 27 is missing “is” between “sequence that” and “at least”.
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 1 and 30 and claims 2-29 depending therefore 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.
Claims 1 and 30 recite the limitation “consumable composition”. The metes and bounds of the limitation in the context of the claim are not clear. It is unclear what compounds are “consumable”, compounds that are ingested, compounds that are bought by a consumer, compounds that are used, and etc. Clarification is requested.
Claim 1 and claims 2-30 depending therefore are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: processing step comprising an anionic resin. The recitation of “wherein the process step comprises an anionic residue” is incomplete because the steps of the processing is incomplete. Clarification is requested.
Claims 1 and 29 and claims 2-38 depending therefore 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.
The term “substantially” in claims 1 and 29 is a relative term which renders the claim indefinite. The term “substantially is not defined by the claim, 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. It is unclear as to how much attachment is considered as “substantially” attached. A perusal of the specification did not provide a clear definition for the above limitation. Without a clear definition in terms of numerical value, those skilled in the art would be unable to ascertain what levels of attachments are “substantially” attached. Clarification is requested.
Claim 3 is 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 3 recites the limitation “wherein the pH of the mixture.. is not modified to achieve a pH greater than the pI of the recombinant protein”. The metes and bounds of the limitation in the context of the claim are not clear. (1) Claim 3 depends from claim 2. It is unclear if the achieved pH of claim 3 is the same as the pH of claim 2 or a different pH. (2) It is unclear what is meant for “not modified” or what is “not modified”. Clarification is requested.
Claims 4-5 and claim 6 depending therefrom 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.
Claims 4-5 recite the limitation "the anion resin" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 4-5 depend from claim 1. Claim 1 does not recite an “anion resin”. Therefore, it is unclear if “the anion resin” recited in claims 4 and 5 refer to the “anionic resin” of claim 1 of if “the anion resin” recited in claims 4 and 5 refer to another anion resin. Clarification is requested.
Claim 4 is 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.
The term “weak anion exchange” in claim 1 is a relative term which renders the claim indefinite. The term “weak” is not defined by the claim, 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. It is unclear as to what anion exchangers are considered as a “weak anion exchanger”. A perusal of the specification did not provide a clear definition for the above limitation. Therefore, those skilled in the art would be unable to ascertain what anion exchangers are considered as a “weak anion exchanger”. Clarification is requested.
Claim 4 is 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 4 contains the trademark/trade name “Capto”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an anion exchanger and, accordingly, the identification/description is indefinite.
Claim 5 and claim 6 depending therefrom 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 5 recites the limitation (1) “a chromatography system which operates in batch mode” and (2) “various steps in a chromatography process”. The metes and bounds of the limitation in the context of the claim are not clear. (1) It is unclear if the system operates in a batch mode (in one mode) or in multiple modes. (2) It is unclear the type and number of chromatography and/or chromatographies comprised in the method. Clarification is requested.
Claim 5 and claim 6 depending therefrom 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.
Regarding claim 5, the phrase "e.g." renders 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).
Claim 6 is 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 6 recites the limitation “Ion Separator system”. The metes and bounds of the limitation in the context of the claim are not clear. It is unclear what “system” or chromatography is considered as an “Ion Separator system”. Clarification is requested.
Claims 9-10, 13, and 16 and claims 11-12 and 17 depending therefrom is 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.
Claims 9-10, 13, and 16 recite the phrase “preferred pH and/or ionic condition”. The phrase renders 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).
Claims 11, 12, and 19 and claim 13 depending therefrom 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.
The term “off-flavor” in claims 11, 12, and 19 is a relative term which renders the claim indefinite. The term “off-flavor” is not defined by the claim, 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. It is unclear as to how what component is considered as “off-flavor”. Without a clear definition in terms of numerical value, those skilled in the art would be unable to ascertain what components are “off-flavor”. Clarification is requested.
Claim 13 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “up to 80°C”, and the claim also recites “50°C to about 60°C” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 19 is 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.
The terms “virtually undetectable” and “standard consumer” in claim 19 are relative terms which renders the claim indefinite. The terms “virtually undetectable” and standard consumer” are not defined by the claim, 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. It is unclear as to what levels of protein product is considered as “virtually undetectable” to what consumer. A perusal of the specification did not provide a clear definition for the above limitation. Therefore, those skilled in the art would be unable to ascertain what levels of a protein product is considered as “virtually undetectable” to what “consumer”. Clarification is requested.
Claim 20 is 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.
The term “generally inseparable” in claim 20 is a relative term which renders the claim indefinite. The term “generally inseparable” are not defined by the claim, 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. It is unclear as to what levels of EPS is considered as “generally inseparable” from the recombinant protein when using size exclusion chromatography. A perusal of the specification did not provide a clear definition for the above limitation. Therefore, those skilled in the art would be unable to ascertain what levels of EPS is considered as “generally inseparable”. Clarification is requested.
Claim 21 is 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 21 recites the limitation “the EPS is naturally a component of a recombinant cell’s cell wall. ”. The metes and bounds of the limitation in the context of the claim are not clear. It is unclear if the EPS is endogenous to the cell wall of the recombinant cell or if the EPS occurs naturally in the cell wall due to recombinant engineered of the cell. Clarification is requested.
Claim 23 and claim 24 depending therefrom 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 23 recite the limitation "the recombinant cell that expresses the recombinant protein..” in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 23 depends from claim 1. Claim 1 does not recite “a recombinant cell that expresses the recombinant protein..”. Therefore, it is unclear if “t the recombinant cell that expresses the recombinant protein” recited in claim 23 refers to the “recombinant cell” of claim 1 of if “the recombinant cell that expresses the recombinant protein” recited in claim 23 refers to another recombinant cell. Clarification is requested.
Claim 23 and claim 24 depending therefrom 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.
Regarding claim 23, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 27 is 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 27 recites the limitation "egg-white protein has a sequence that at least 80% identical to the egg-white protein naturally produced in a bird". The metes and bounds of the limitation in the context of the claim are not clear. Since the claim does not recite the amino acid sequence identifier of the egg-white protein, it is unclear what proteins are considered as having an amino acid sequence that is at least 80% identical to a bird egg-white protein. Clarification is requested.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(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, 4-5, 7-12, 20-25, 28, and 30 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Webel (WO 203/037102 – form PTO-1449).
Regarding claims 1, 4-5, and 25, Webel discloses a method for preparing a consumable composition by obtaining a mixture comprising a recombinant phytase and cell byproducts, separating the recombinant protein from the byproducts and recombinant cells using an anion exchange chromatography such as DEAE-Sepharose and tangential flow chromatography, wherein the resin binds to the protein, collecting the separated protein, and formulating the consumable composition (abstract, pages 2-3, and pages 10-11).
Regarding claim 7, the method of Webel comprises a treatment to remove the spent recombinant cells (page 10).
Regarding claims 8-10, Webel discloses concentrating the recombinant protein to a preferred pH and further microfiltering the recombaint protein (pages 10-11).
Regarding claim 11, the microfiltration step of Webel removes some off-flavor component.
Regarding claim 12, the method of Webel includes heat and vacuum treatment step, which removes some off-flavor component.°
Regarding claims 20-22, S. cerevisiae or Pichia pastoris naturally comprises the EPS recited in claim 22 in its cell wall.
Regarding claims 23-24, Webel discloses recombinant cells expressing the phytase, such as S. cerevisiae or Pichia pastoris (page 8).
Regarding claim 28, the consumable composition of Webl is a food product (abstract).
Regarding claim 30, Webel discloses a consumable composition comprising a phytase, wherein the phytase is purified by various methods resulting in a mixture comprising phytase with reduced quantity of cell byproducts (abstract, pages 2-3, and pages 10-11).
Therefore, the reference of Webel anticipates claims 1, 6-7, 8-10, 23-26, 27-28, and 30.
Claim(s) 30 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Tripathi (Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development. Front Bioeng Biotechnol. 2019 Dec 20;7:420.- form PTO-1449).
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' The limitation “consumable composition” recited in claim 30 is indefinite, see the 112(b) rejection above. Therefore, the claim has been broadly interpreted to encompass a compound that is bought or used by a consumer, such as a pharmaceutical composition.
MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case, the structure of the claimed consumable produced implied by the steps of claim 1 is the same whether the enzyme is obtained by the recombinant techniques recited in the claims or by the method employed by Tripathi.
Regarding claim 30, Tripathi discloses a biopharmaceutical composition comprising a recombinant protein (1st paragraph under INTRODUCTION at pages 1-2). Tripathi discloses downstream processing of the recombinant protein that includes different chromatography systems, such as anion exchange chromatography (1st full paragraph at page 16). The anion exchange chromatography resulted in a high purity (up to 95%) of the recombinant protein and therefore, the composition of Tripathi has reduced quantity of cell byproducts.
Therefore, the reference of Tripathi. anticipates claim 30.
Claim(s) 30 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Anchel (102(a)(1): US 2018/0355020 - form PTO-1449. 102(a)(2): US 11,279,748 – form PTO-892, and US 11,518,797 – form PTO-1449. US 2018/0355020 is used for the specific passages of Anchel).
MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case, the structure of the claimed consumable produced implied by the steps of claim 1 is the same whether the enzyme is obtained by the recombinant techniques recited in the claims or by the method employed by Anchel.
Regarding claim 30, Anchel discloses a consumable composition comprising a recombinant egg-white protein, wherein the protein is purified of cell extract and cell, and therefore has reduced quantity of cell byproducts ([0128]-[0129]).
Therefore, the reference of Anchel anticipates claim 30.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim(s) 1, 6-10, 20-28, and 30 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mahadevan (“Clara Foods Co.”. WO 2021/034980 – form PTO-1449).
Regarding claims 1, 6-7 and 25-26, Mahadevan discloses a method for preparing a consumable composition by obtaining a mixture comprising a nutritive recombinant protein, such as recombinant ovalbumin (rOVA), and cell byproducts, separating the recombinant protein from the byproducts and recombinant cells using an anion exchange chromatography, wherein the resin binds to the protein, collecting the separated protein, and formulating the consumable composition ([0003]-[0005], [0037], [0039], and [0180]).
Regarding claims 8-10, Mahadevan discloses concentrating the recombinant protein to a preferred pH and further microfiltering the recombaint protein [0228].
Regarding claim 11, the microfiltration step of Mahadevan removes some off-flavor component.
Regarding claims 20-22, E. coli naturally comprises the EPS recited in claim 22 in its cell wall.
Regarding claims 23-24, Mahadevan discloses recombinant cells expressing the rOVA, such as Escherichia coli ([0061]).
Regarding claim 27, Mahadevan discloses a rOVA having an amino acid that is identical to a duck OVA [0013]).
Regarding claim 28, the consumable composition of Mahadevan is a food product ([0003]).
Regarding claim 30, MPEP 2113 states that “ [P]product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. [E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.”. In the instant case, the structure of the claimed consumable produced implied by the steps of claim 1 is the same whether the enzyme is obtained by the recombinant techniques recited in the claims or by the method employed by Mahadevan.
Regarding claim 30, Mahadevan discloses a consumable composition comprising a recombinant egg-white protein ovalbumin (rOVA), wherein the protein is purified by various methods resulting in a mixture comprising rOVA with reduced quantity of cell byproducts ([0003]-[0005] and [0180]).
Therefore, the reference of Mahadevan anticipates claims 1, 6-7, 8-10, 20-26, 27-28, and 30.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5, 7-13, 16, 20-28, and 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Anchel (102(a)(1): US 2018/0355020 - form PTO-1449. 102(a)(2): US 11,279,748 – form PTO-892, and US 11,518,797 – form PTO-1449. US 2018/0355020 is used for the specific passages of Anchel), Webel (“Phytex”. WO 03/037102 – form PTO-1449), and Munjal (Isolation, Purification and Characterization of Ovalbumin from Hen Egg White and to Develop and isolate antibodies against it. International Journal of Advanced Microbiology and Health Research. Volume 2, Issue 3, July-September 2018, PP. 37-46– form PTO-892).
Regarding claims 1 and 25-26, Anchel discloses a method of preparing a consumable composition by expressing a recombinant egg-white protein, such as ovalbumin, in a host cell, wherein the protein is purified of cell extract and cell, and therefore has reduced quantity of cell byproducts ([0128]-[0129]). ([0009]-[0010]).
Regarding claims 2-3, the pI of ovalbumin is 4.5 (see Munjal, abstract). Anchel discloses that the consumable composition comprising the recombinant ovalbumin has a pH ranging from 6-10, which is greater than the pI of ovalbumin.
Regarding claims 11 and 13, Anchel discloses a heat treatment of 54°C, which falls within the range recited in claim 13.
Regarding claims 23-24, the host cell of Anchel is Saccharomyces cerevisiae or Pichia pastoris ([0025]).
Regarding claims 20-22, Saccharomyces cerevisiae or Pichia pastori naturally comprises the EPS recited in claim 22 in its cell wall.
Regarding claim 27, Anchel discloses a bird ovalbumin and therefore said bird ovalbumin has an amino acid sequence identical to a bird ovalbumin ([0015]).
Regarding claim 28, the consumable composition of Mahadevan is a food product ([0032]).
Regarding claim 30, Anchel discloses a consumable composition comprising a recombinant egg-white protein, wherein the protein is purified of cell extract and cell, and therefore has reduced quantity of cell byproducts ([0128]-[0129]).
Anchel discloses using various chromatography to purify the protein from the cell but does not explicitly disclose the steps recited in claims 1, 4-5, and 7-12.
Regarding claims 1, 4-5, and 25, Webel discloses a method for preparing a consumable composition by obtaining a mixture comprising a recombinant protein and cell byproducts, separating the recombinant protein from the byproducts and recombinant cells using an anion exchange chromatography such as DEAE-Sepharose and tangential flow chromatography, wherein the resin binds to the protein, collecting the separated protein, and formulating the consumable composition (abstract, pages 2-3, and pages 10-11).
Regarding claim 7, the method of Webel comprises a treatment to remove the spent recombinant cells (page 10).
Regarding claims 8-10 and 16, Webel discloses concentrating the recombinant protein to a preferred ionic condition and further microfiltering the recombaint protein (pages 10-11).
Regarding claim 11, the microfiltration step of Webel removes some off-flavor component.
Regarding claim 12, the method of Webel includes heat and vacuum treatment step, which removes some off-flavor component.
Regarding claims 23-24, Webel discloses recombinant cells expressing the protein, such as S. cerevisiae or Pichia pastoris (page 8).
Regarding claims 20-22, S. cerevisiae or Pichia pastoris naturally comprises the EPS recited in claim 22 in its cell wall.
Regarding claim 28, the consumable composition of Webl is a food product (abstract).
Regarding claim 30, Webel discloses a consumable composition comprising a recombinant protein, wherein the protein is purified by various methods resulting in a mixture comprising the protein with reduced quantity of cell byproducts (abstract, pages 2-3, and pages 10-11).
Therefore, combining the teachings of Anchel and Webel, it would have been obvious to one having ordinary skill in the art before the claimed invention was effectively filed to improve the method of Anchel by incorporating the purification steps of Webel. One having ordinary skill in the art would have been motivated to do so in order to further improve the purity of the recombinant ovalbumin. One having ordinary skill in the art would have had a reasonable expectation of success because Anchel teaches the purification of a recombinant ovalbumin expressed from a host cell and Webel teaches purification of a recombinant protein expressed from a host cell suing various steps, such as an anion exchange chromatography such as DEAE-Sepharose and tangential flow chromatography, heat treatment, vacuum treatment, and microfiltration.
Further, the rationale supporting that the claims would have been obvious is that a method of enhancing a particular class of devices (purification of a recombinant protein expressed from a host cell) has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. One of ordinary skill in the art would have been capable of applying this known method of enhancement (purification steps of Webel) to a “base” device (recombinant ovalbumin of Webel) in the prior art and the results would have been predictable to one of ordinary skill in the art because (1) the prior art contained a “base” device (recombinant ovalbumin expressed from a host cell) upon which the claimed invention can be seen as an “improvement;” (2) the prior art contained a “comparable” device (recombinant protein expressed from a host cell) that has been improved in the same way as the claimed invention; and (3) one of ordinary skill in the art could have applied the known “improvement” technique in the same way to the “base” device and the results would have been predictable to one of ordinary skill in the art.
Therefore, the above references render claims 1-5, 7-13, 16, 20-28, and 30 prima facie obvious.
Claim(s) 6, 14-15, 18-19, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anchel (102(a)(1): US 2018/0355020 - form PTO-1449. 102(a)(2): US 11,279,748 – form PTO-892, and US 11,518,797 – form PTO-1449. US 2018/0355020 is used for the specific passages of Anchel), Webel (“Phytex”. WO 203/037102 – form PTO-1449), and Munjal (Isolation, Purification and Characterization of Ovalbumin from Hen Egg White and to Develop and isolate antibodies against it. International Journal of Advanced Microbiology and Health Research. Volume 2, Issue 3, July-September 2018, PP. 37-46– form PTO-892), as applied to claims 1-5, 7-13, 16, 20-28, and 30 above, and further in view of Tripathi (Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development. Front Bioeng Biotechnol. 2019 Dec 20;7:420.- form PTO-1449).
The combined teachings of Anchel and Webel do not disclose using continuous chromatography comprising a simulated moving bed (SMB), removing off-flavor components, and steps of removing EPS.
Regarding claim 6, Triphathi discloses using SMB in purifying recombinant proteins resulting in high purity of proteins (pages 20-21).
Regarding claim 29, Triphathi discloses various chromatography steps (pages 15-21). Therefore, one having ordinary skill in the art would have recognized to use a cation exchange to remove cell byproducts, such as exopolysaccharides.
Regarding claims 14-15 and 18-19, the chromatography, microfiltration, SMB, and heat and vacuum treatment of Anchel, Webel, and Triphathi results in a highly purified recombinant ovalbumin that is comprised in a consumable product. Therefore, one having ordinary skill in the art would recognize that the consumable composition has a reduced “off-flavor”, has an 80% reduction of the cell byproducts, and the off-flavor component is virtually undetectable to a standard consumer.
Therefore, in combining the above reference, it would have been obvious to one having ordinary skill in the art before the claimed invention was effectively filed to improve the method of Anchel and Webel by incorporating the purification steps of Triphathi. One having ordinary skill in the art would have been motivated to do so in order to further improve the purity of the recombinant ovalbumin. One having ordinary skill in the art would have had a reasonable expectation of success because Anchel teaches the purification of a recombinant ovalbumin expressed from a host cell and Webel teaches purification of a recombinant protein expressed from a host cell suing various steps, such as an anion exchange chromatography such as DEAE-Sepharose and tangential flow chromatography, heat treatment, vacuum treatment, and microfiltration.
Therefore, the above references render claims 1-16 and 18-30 prima facie obvious.
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.
Claim 30 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim interpretation
Claim 30 recites a consumable composition comprising a recombinant protein produced by separating a recombinant protein produced by a recombinant cell from by-products of the recombinant cell. The specification of the instant application and claim 26 of the instant application discloses a consumable composition comprising an egg-white proteins, such as ovalbumin, which is naturally occurring.
Therefore, claim 9 is directed to a consumable composition comprising a recombinant protein and no byproducts of the recombinant cell.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category (see MPEP 2106.03). Since the claims are directed to a composition comprising a protein, the claims are directed to a composition of matter, which is one of the statutory categories of invention. (Step 1: YES)
Step 2A Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception (see MPEP 2106.04). The claimed consumable composition comprising a recombinant protein, such ovalbumin, is not considered to have markedly different characteristics from what occurs in nature, proteins or ovalbumin from a naturally occurring egg-white, and is considered to be a law of nature exception. There is no indication in the specification that placing the recited protein in a consumable composition, such as water, or recombinantly producing the protein in a cell results in the protein or ovalbumin having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring protein or ovalbumin from an egg-white. Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed proteins and the naturally occurring proteins, the claimed consumable composition comprising a recombinant protein is directed to a judicial exception.
Step 2A Prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. There is no indication in the specification that placing the recited protein in a consumable composition, such as water, or recombinantly producing the protein in a recombinant cell result in a transformation of the protein (Step2 A: YES)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05). The claim only recites the laws of nature and do not include any additional elements that could add significantly more to the judicial exceptions (Step 2B: NO).
As such, the claims do not qualify as eligible subject matter.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,718,644 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are claiming common subject matter, as follows:
Regarding claims 1 and 14 of the instant application, claim 1 of the reference patent recites a method for preparing a consumable composition comprising a recombinant protein, wherein the recombinant protein is separated from byproducts of the recombinant cell, such as an acid, alcohol, aldehyde, aromatic, ester, or a ketone using an anionic resin. Therefore, claims 1 and 14 of the instant application are anticipated by claim 1 of the reference patent.
Regarding claims 2-3 of the instant application, claim 2 of the reference patent recites that mixture comprising the recombinant protein and byproducts has a pH greater than the pI of the recombinant protein. Therefore, claims 2-3 of the instant application are anticipated by claim 2 of the reference patent.
Regarding claim 4 of the instant application, claim 3 of the reference patent recites that the anionic resin is Capto Q resin, DEAE resin, and etc . Therefore, claim 4 of the instant application is anticipated by claim 3 of the reference patent.
Regarding claim 5 of the instant application, claim 4 of the reference patent recites that the anionic resin is a component of the two different chromographies. Therefore, claim 5 of the instant application is anticipated by claim 4 of the reference patent.
Regarding claim 6 of the instant application, claim 5 of the reference patent recites that the continuous mode comprises a SMB. Therefore, claim 6 of the instant application is anticipated by claim 5 of the reference patent.
Regarding claim 7 of the instant application, claim 6 of the reference patent recites pretreating the mixture to remove spend biomass and/or small molecules. Therefore, claim 7 of the instant application is anticipated by claim 6 of the reference patent.
Regarding claim 8 of the instant application, claim 7 of the reference patent recites a concentration step. Therefore, claim 8 of the instant application is anticipated by claim 7 of the reference patent.
Regarding claims 9-11 of the instant application, claim 21 of the reference patent recites a concentration and/or diafiltration step to produce a composition having a preferred pH and/or ionic condition, further comprising a heat treatment and diafiltration step. Therefore, claims 9-11 of the instant application are anticipated by claim 21 of the reference patent.
Regarding claim 12 of the instant application, claim 22 of the reference patent recites contemporaneous application of heat and vacuum. Therefore, claim 12 of the instant application is anticipated by claim 44 of the reference patent.
Regarding claim 13 of the instant application, claim 23 of the reference patent recites that the heat treatment is up to 80°C. Therefore, claim 13 of the instant application is anticipated by claim 23 of the reference patent.
Regarding claims 14-15 and 19 of the instant application, claim 8 of the reference patent recites byproducts identical to the off-flavor byproducts recited in claim 15 of the instant application. Therefore, claims 14-15 and 19 of the instant application is anticipated by claim 8 of the reference patent.
Regarding claim 16 of the instant application, claim 24 of the reference patent recites the method of claim 21 comprises an oxidation step. Therefore, claim 16 of the instant application is anticipated by claim 24 of the reference patent.
Regarding claim 17 of the instant application, claim 25 of the reference patent recites that the oxidation step comprises addition of hydrogen peroxide. Therefore, claim 17 of the instant application is anticipated by claim 25 of the reference patent.
Regarding claim 18 of the instant application, claim 9 of the reference patent recites that composition has at least 80% reduction in quantity of the byproducts. Therefore, claim 18 of the instant application is anticipated by claim 9 of the reference patent.
Regarding claims 20-21 of the instant application, claim 26 of the reference patent recites that the cell byproduct is an EPS. Therefore, claims 20-21 of the instant application are anticipated by claim 26 of the reference patent.
Regarding claim 22 of the instant application, claim 27 of the reference patent recites the properties of the EPS. Therefore, claim 22 of the instant application is anticipated by claim 27 of the reference patent.
Regarding claim 23 of the instant application, claim 11 of the reference patent recites that the cell is a fungal cell, bacterial cell, plant cell, insect cell, or a mammalian cell. Therefore, claim 23 of the instant application is anticipated by claim 11 of the reference patent.
Regarding claim 24 of the instant application, claim 13 of the reference patent recites cel