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 .
The preliminary amendments are received.
Claims 1-35 are canceled and New claims 36-55 are added.
Claims 36-55 are pending in this application and are being examined.
Objection(s):
Claims:
Claims 36 and 39 are objected to because of the following informalities:
In claim 36, line 6, step b), replace “Cupriavidus” with --Cupriavidus --.
In claim 39, line 2, replace “Cupriavidus necator” with --Cupriavidus necator--.
Appropriate correction is required.
Specification:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, i.e., paragraphs [0278], [0308], [0308]. [0332], and [0349]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejection - 35 USC § 112
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.
Requirement for the Deposit of Biological Material:
Claims 38 and 39 are 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.
The invention appears to employ specific strains of: Cupriavidus necator DSM 531 and Cupriavidus necator DSM 541.
It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
In addition, the deposit must meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C § 112, first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
1. Identifies declarant.
2. States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
5. States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
6. States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
7. That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
A copy of the deposit receipt(s) is required.
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 36-55 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.
In claim 36, the phrase “an environment that is suitable for culturing the Cupriavidus microorganisms” is indefinite because the suitable environment for culturing the Cupriavidus microorganisms is not defined. There is no special definition in the specification for the phrase.
Suggestion to obviate the rejection: define the suitable environment.
In claim 36, step b), the phrase “using the Cupriavidus microorganisms in the presence of the at least one source of electron donors or electron acceptors, converting the carbon source and the nitrogen source into biomass of the Cupriavidus microorganisms” is confusing which renders the claim indefinite because from the way it is written it is not exactly clear what applicant is trying to claim.
Suggestion to obviate the rejection: replace “using” with --culturing--, and replace “, converting” with –to convert--.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 47-49 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 47, the phrase “the carbon source comprises CO2, CO, CH4, or a combination thereof” fails to further limit the subject matter of the claim 36 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –are--.
In claim 48, the phrase “the nitrogen source comprises N2, ammonia, ammonium, urea, nitrate, or a combination thereof” fails to further limit the subject matter of the claim 36 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –are--.
In claim 49, the phrase “the at least one source of electron donors or electron acceptors comprises H2 and O2” fails to further limit the subject matter of the claim 36 upon which it depends. Because, comprises is open-ended.
Suggestion to obviate the rejection: replace “comprise” with –are--.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting Rejection:
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 36-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,725,290 B2. Although the claims at issue are not identical, they are not patentably distinct from each other in view of the side by side comparison (See table below) of the limitations of the claimed method of instant application and the process (product-by-process) of claims 1-18 of U.S. Patent No. 11,725,290 B2
Claims of U.S. Patent No. 11,725,290 B2:
Claims of instant application No. 18/823,534:
1. A feed, nutritional, or fertilizer product comprising biomass, protein or one or more biological nutrients produced by Cupriavidus microorganisms, wherein said biological nutrients are produced in a method that comprises the capture and conversion of inorganic or organic molecules that contain only one carbon atom into organic molecules that contain two or more carbon atoms, and into biomass by said Cupriavidus microorganisms, wherein said method comprises: a) introducing a gaseous substrate into an environment comprising Cupriavidus microorganisms, wherein said environment is suitable for culturing said Cupriavidus microorganisms, and wherein said gaseous substrate comprises a carbon source selected from the group consisting of an inorganic molecule comprising only one carbon atom, an organic molecule comprising only one carbon atom, and a combination thereof; b) introducing a nitrogen source selected from the group consisting of ammonia, ammonium, urea, nitrate, and a combination thereof, into said environment, thereby producing said biomass, protein and one or more biological nutrients; wherein said Cupriavidus microorganisms chemoautotrophically convert the carbon source via at least one chemosynthetic carbon-fixing reaction and at least one anabolic biosynthetic pathway into said organic molecules and into chemoautotrophically produced biomass of Cupriavidus microorganisms that comprises said organic molecules, and wherein said chemoautotrophically produced biomass of Cupriavidus microorganisms comprises protein in a quantity that is greater than 60% of the total cell mass, wherein the at least one chemosynthetic carbon-fixing reaction and the at least one anabolic biosynthetic pathway are at least partially driven by chemical and/or electrochemical energy provided by electron donors and electron acceptors that have been generated chemically, electrochemically, thermochemically, are introduced into the environment from at least one source external to the environment, and combinations thereof, and wherein said organic molecules and said chemoautotrophically produced biomass of Cupriavidus microorganisms comprise biological nutrients capable of feeding, providing nutrition to, or fertilizing one or more other organisms.
17. The feed, nutritional, or fertilizer product according to claim 1, wherein said Cupriavidus microorganisms are grown within a consortium of microorganisms in said environment that is suitable for culturing said Cupriavidus microorganisms.
36. A method of producing a product comprising biomass, the method comprising:(a) introducing (i) a carbon source, (ii) a nitrogen source, and (iii) at least one source of electron donors or electron acceptors into a reactor comprising Cupriavidus microorganisms, wherein the reactor comprises an environment that is suitable for culturing the Cupriavidus microorganisms; (b) using the Cupriavidus microorganisms in the presence of the at least one source of electron donors or electron acceptors, converting the carbon source and the nitrogen source into biomass of the Cupriavidus microorganisms, wherein the biomass of the Cupriavidus microorganisms comprises protein in a quantity that is greater than 60% of the total biomass.
37.method of claim 36, further comprising:(a) recovering the biomass from the reactor; and (b) processing the biomass into the product.
47. The method of claim 36, wherein the carbon source comprises CO2, CO, CH4, or a combination thereof.
Note: CO2, CO, CH4 are organic molecules comprising only one carbon atom.
48. The method of claim 36, wherein the nitrogen source comprises N2, ammonia, ammonium, urea, nitrate, or a combination thereof.
53. The method of claim 36, further comprising, wherein prior to (a), generating the carbon source through a thermochemical process comprising gasification, pyrolysis, steam reforming, or autoreforming.
2. The feed, nutritional, or fertilizer product according to claim 1, wherein said biological nutrients further comprise one or more amino acids, or other nutrients in a quantity that is equal to or greater than at least 10% of the total dry cellular mass.
42. The method of claim 36, wherein the biomass of the Cupriavidus microorganisms comprises essential amino acids.
3. The feed, nutritional, or fertilizer product according to claim 1, wherein said chemoautotrophically produced biomass of Cupriavidus microorganisms is produced by Cupriavidus necator DSM 531.
38. The method of claim 36, wherein the Cupriavidus microorganisms comprise Cupriavidus necator DSM 531.
4. The feed, nutritional, or fertilizer product according to claim 1, wherein said chemoautotrophically produced biomass of Cupriavidus microorganisms is produced by Cupriavidus necator DSM 541.
39. The method of claim 36, wherein the Cupriavidus microorganisms comprise Cupriavidus necator DSM 541.
5. The feed, nutritional, or fertilizer product according to claim 1, wherein said protein and/or said chemoautotrophically produced biomass of Cupriavidus microorganisms are not deficient in any essential amino acids.
43. The method of claim 36, wherein the biomass of the Cupriavidus microorganisms comprises lysine or methionine.
6. The feed, nutritional, or fertilizer product according to claim 1, wherein said protein and/or said chemoautotrophically produced biomass of Cupriavidus microorganisms are not deficient in lysine or methionine.
43. The method of claim 36, wherein the biomass of the Cupriavidus microorganisms comprises lysine or methionine.
Note: lysine and methionine are essential amino acids.
7. The feed, nutritional, or fertilizer product according to claim 1, wherein said biological nutrients further comprise a B vitamin selected from the group consisting of vitamin B1, B2, and B12.
44. The method of claim 36, wherein the biomass of the Cupriavidus microorganisms further comprises a B vitamin selected from the group consisting of vitamin B1, B2, and B12.
8. The feed, nutritional, or fertilizer product according to claim 1, wherein said chemoautotrophically produced biomass of Cupriavidus microorganisms comprises protein in a quantity that is greater than 70% of the total cell mass.
40. The method of claim 36, wherein the protein is at a quantity that is greater than 70% of the total biomass by weight.
9. The feed, nutritional, or fertilizer product according to claim 1, wherein said chemoautotrophically produced biomass of Cupriavidus microorganisms comprises protein in a quantity that is greater than 80% of the total cell mass.
41. The method of claim 36, wherein the protein is at a quantity that is greater 80% of the total biomass by weight.
10. The feed, nutritional, or fertilizer product according to claim 1, wherein said biological nutrients further comprise fats and carbohydrates produced by said Cupriavidus microorganisms.
45. The method of claim 36, wherein the biomass of the Cupriavidus microorganisms further comprises fats or carbohydrates.
11. The feed, nutritional, or fertilizer product according to claim 1, wherein said biological nutrients further comprise protoplasm or an extract of protoplasm produced by said Cupriavidus microorganisms, wherein said protoplasm is of nutritional value to humans, animals, and/or other heterotrophs.
46. The method of claim 36, wherein the biomass of the Cupriavidus microorganisms further comprises protoplasm or an extract of protoplasm.
13. The feed, nutritional, or fertilizer product according to claim 12, wherein said organic molecules and said chemoautotrophically produced biomass of Cupriavidus microorganisms further comprise hydrogen and carbon, wherein said hydrogen is derived entirely from H.sub.2O and said carbon is derived entirely from CO.sub.2 captured from the atmosphere and/or from greenhouse gas emissions.
49. The method of claim 36, wherein the at least one source of electron donors or electron acceptors comprises H2 and O2.
50. The method of claim 47, further comprising capturing the carbon source from the atmosphere prior to (a), wherein the carbon source comprises CO2.
14. The feed, nutritional, or fertilizer product according to claim 13, wherein said organic molecules and said biomass of Cupriavidus microorganisms further comprise nitrogen, wherein said nitrogen is derived from ammonia, ammonium, urea, and/or nitrate that is recovered from urine, agricultural waste, fish waste, aquaculture waste, and/or other animal waste.
51. The method of claim 36, further comprising, prior to (a), generating the carbon source or the nitrogen source from municipal solid waste, black liquor, agricultural waste, wood waste, stranded natural gas, biogas, sour gas, methane hydrates, tires, petcoke, sewage, manure, straw, lignocellulosic energy crops, lignin, crop residues, bagasse, saw dust, forestry residue, food waste, waste carpet, waste plastic, landfill gas, kelp, seaweed, or lignocellulosic biomass.
15. The feed, nutritional, or fertilizer product according to claim 14, wherein said organic molecules and said biomass of Cupriavidus microorganisms further comprise phosphorous, wherein said phosphorous is derived from phosphate recovered from urine, agricultural waste, fish waste, aquaculture waste, and/or other animal waste.
52. The method of claim 36, further comprising, prior to (a), recovering the nitrogen source from urine, agricultural waste, fish waste, aquaculture waste, and/or other animal waste.
55. The method of claim 36, further comprising, prior to (b), introducing phosphorous to the reactor.
Therefore, in view of the above, it would have been obvious to a person of ordinary skill in the art to apply the teachings of claims 1-18 of U.S. Patent No. 11,725,290 B2, in order to provide the claimed method of producing a product comprising biomass as disclose by claims 36-55 of instant application. It should be noted that reactor is inherently present in the process taught by claims of 1-18 of U.S. Patent No. 11,725,290 B2.
Prior art teachings:
Kunasundari et al. (which is cited in the parent application 16/086,572) teach a product comprising one or more biological nutrients (lyophilized cells of Cupriavidus necator H16, formerly known as Hydrogenomonas eutropha as a source of single cell protein or SCP for animal feed) (see for example, p. 2 left-hand column 1st and 2nd paragraphs, p. 4 right-hand column/Results 1st and 2nd paragraphs, and Abstract), and further teach the biomass comprises one or more amino acids, proteins, or other nutrients in a quantity that is equal to or greater than at least 10% of the total dry cellular mass (crude protein of the lyophilized cells was determined to be 43 ±3 wt%) (see for example, p. 4 right-hand column/Results 1st paragraph).
However, the claimed method of producing a product comprising biomass, the method comprising:(a) introducing (i) a carbon source, (ii) a nitrogen source, and (iii) at least one source of electron donors or electron acceptors into a reactor comprising Cupriavidus microorganisms, wherein the reactor comprises an environment that is suitable for culturing the Cupriavidus microorganisms; (b) using the Cupriavidus microorganisms in the presence of the at least one source of electron donors or electron acceptors, converting the carbon source and the nitrogen source into biomass of the Cupriavidus microorganisms, wherein the biomass of the Cupriavidus microorganisms comprises protein in a quantity that is greater than 60% of the total biomass, is not taught by the prior art.
Conclusion(s):
No claim(s) is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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