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 claim amendment is received.
Claims 1-35 are canceled by Applicant.
New claims 36-55 are added.
New claims 36-55 are pending and are being examined.
Objection(s):
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See paragraphs [0278], [0308], [0330], [0332], [0333], 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 Rejections - 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.
Deposit of Biological Material:
Claim 38 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The invention appears to employ a specific strains: Xanthobacter autotrophicus strains DSM 431, DSM 432, DSM 1618, DSM 2267, and Xanthobacter flavus DSM 3874.
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.
It appears that a deposit was made in this application as filed as noted in applicant’s specification (pages 12 and 18-19). However, it is not clear if the deposit 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.
Copy of deposit receipt is/are required.
Claim Rejections - 35 USC § 101
(Law of Nature or Natural Product)
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 36-48 and 52-55 are rejected under 35 U.S.C. 101 because;
The claimed invention is directed to a judicial exception, i.e., a natural product without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
According to Section I of the 2019 Revised Patent Subject Matter Eligibility Guidance, “the judicial exceptions are for subject matter that has been identified as the ‘‘basic tools of scientific and technological work,’’ which includes ‘‘abstract ideas’’ such as mathematical concepts, certain methods of organizing human activity, and mental processes; as well as laws of nature and natural phenomena”, and “the USPTO has set forth a revised procedure, rooted in Supreme Court caselaw, to determine whether a claim is ‘‘directed to’’ a judicial exception under the first step of the Alice/Mayo test (USPTO Step 2A).” (Also see “2019 Revised Patent Subject Matter Eligibility Guidance, Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019 / Notices, p. 50-57”).
Step 2A asks: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? In the context of the flowchart in MPEP § 2106, subsection III, Step 2A determines whether:
• The claim as a whole is not directed to a judicial exception (Step 2A: NO) and thus is eligible at Pathway B, thereby concluding the eligibility analysis;
or
• The claim as a whole is directed to a judicial exception (Step 2A: YES) and thus requires further analysis at Step 2B to determine if the claim as a whole amounts to significantly more than the exception itself.
Step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Claims 36-48 and 52-55 are drawn to a composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weight.
The broadest reasonable interpretation of instant claim 1 Xanthobacter microorganisms, which are naturally occurring microorganisms (Xanthobacter autotrophicus isolated from rock surface biofilms of freshwater streams, etc.) (See for example, p. 114, left-hand column 2nd paragraph of Tay et al.).
Thus, the claims as a whole are directed to a judicial exception.
In addition, there is/are no evidence of any markedly different functional characteristic(s) other than the inherent natural properties of the claimed Xanthobacter microorganisms. Therefore, claims as a whole do not amount to significantly more than the exception itself (Answer to Step 2B: No).
As indicated above, step 2A is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
In this case, there is no additional elements recited in the claims, except the natural cellular components of Xanthobacter microorganisms, and thus they are not considered ‘significantly more’ than the judicial exception.
Therefore, do not integrate the judicial exception into a practical application of that exception (Answer to Step 2A Prong Two: No).
In addition, depositing and obtaining an accession/registration number (claim 38) do not consider to improve the judicial exception or do not use the judicial exception in a particular technological environment such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
In Funk Brothers the Supreme court concluded that naturally-occurring bacteria, isolated from their natural surroundings, was not patent eligible: “[t]he qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of the knowledge of all men…manifestations of laws of nature, free to all…and reserved exclusively to none…” the qualities of the bacteria being “.. the work of nature…unaltered by the hand of man.”.
Therefore, the subject matter of claims 36-48 and 52-55 as a whole is not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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.
Claims 36, 37, 42-48 and 53-55 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Tay et al. (Syst Appl Microbiol. 1999 Feb;22(1):113-8).
Regarding claims 36, 37 and 52, Tay et al. disclose composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weight, Xanthobacter microorganisms comprise Xanthobacter autotrophicus (biomass of Xanthobacter autotrophicus strains, cells of Xanthobacter autotrophicus, and 50% of dry cell weight is protein) (See for example, p. 114 right-hand column 2nd paragraph and, p. 116 Table 3, and part “b” description).
Regarding the claimed properties as recited in claims 42-48 and 53-55, since Tay et al. disclose the claimed composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weigh, therefore the composition appears to be the same as the claimed composition as such it inherently has all the claimed properties (which are not disclosed).
Tay et al. therefore anticipate the claimed composition.
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.
A)
Claims 36-48 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 14 of U.S. Patent No. 12,320,014 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 1-9 and 14 of U.S. Patent No. 12,320,014 B2.
Claims 1-9 and 14 of U.S. Patent No. 12,320,014 B2:
Claims 36-48 and 52 of instant application:
1. A feed, nutritional, or fertilizer product comprising protein produced by Xanthobacter microorganisms, wherein said protein is produced in a method that comprises chemoautotrophic capture and conversion of a carbon source by said Xanthobacter microorganisms into biomass comprising protein, and … biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total cell mass, …
36. A composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weight.
39. The composition of claim 36, wherein the quantity is greater than 60% of the total biomass by weight.
40. The composition of claim 36, wherein the quantity is greater than 70% of the total biomass by weight.
41. The composition of claim 36, wherein the quantity is greater than 80% of the total biomass by weight.
52. The composition of claim 36, wherein the biomass comprises cells of the Xanthobacter microorganisms.
2. The feed, nutritional, or fertilizer product according to claim 1, wherein said Xanthobacter microorganisms comprise Xanthobacter autotrophicus or Xanthobacter flavus.
37. The composition of claim 36, wherein the Xanthobacter microorganisms comprise Xanthobacter autotrophicus or Xanthobacter flavus.
3. The feed, nutritional, or fertilizer product according to claim 2, wherein said Xanthobacter microorganisms are Xanthobacter autotrophicus strain DSM 431, DSM 432, DSM 1618, DSM 2267, or DSM 3874.
38. The composition of claim 37, wherein the Xanthobacter microorganisms comprise Xanthobacter autotrophicus strain DSM 431, DSM 432, DSM 1618, DSM 2267, or Xanthobacter flavus strain DSM 3874.
4. The feed, nutritional, or fertilizer product according to claim 1, wherein said protein and/or said chemoautotrophically produced biomass of Xanthobacter microorganisms are not deficient in any essential amino acids.
42. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises essential amino acids.
5. The feed, nutritional, or fertilizer product according to claim 1, wherein said protein and/or said chemoautotrophically produced biomass of Xanthobacter microorganisms are not deficient in lysine or methionine.
43. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises lysine or methionine.
6. The feed, nutritional, or fertilizer product according to claim 1, wherein said product further comprises a B vitamin selected from the group consisting of vitamin B1, B2, and B12.
44. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms further comprises a B vitamin selected from the group consisting of vitamin B 1, B2, and B12.
53. The composition of claim 36, wherein the biomass comprises one or more vitamins.
7. The feed, nutritional, or fertilizer product according to claim 1, wherein said product further comprises carbohydrates produced by said Xanthobacter microorganisms.
45. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises fats or carbohydrates.
8. The feed, nutritional, or fertilizer product according to claim 1, wherein said product further comprises protoplasm or an extract of protoplasm produced by said Xanthobacter microorganisms, wherein said protoplasm is of nutritional value to humans, animals, and/or other heterotrophs.
46. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises protoplasm or an extract of protoplasm.
9. The feed, nutritional, or fertilizer product according to claim 1, wherein said product does not comprise cell mass or biomass or organic molecules derived from a photosynthetic organism.
47. The composition of claim 36, wherein the composition does not comprise cell mass, biomass, or organic molecules of a photosynthetic organism.
14. The feed, nutritional, or fertilizer product according to claim 1, wherein said product does not comprise gossypol, glucosinolates, saponins, or trypsin inhibitors.
48. The composition of claim 36, wherein the composition does not comprise gossypol, glucosinolates, saponins, or trypsin inhibitors.
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 1-9 and 14 of U.S. Patent No. 12,320,014 B2, in order to provide the claimed composition as disclose by claims 36-48 and 55 of instant application. It should be noted that since claims 1-9 and 14 of U.S. Patent No. 12,320,014 B2, disclose the claimed composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weigh, therefore the claimed density (recited in claims 54 and 55) (which are not disclosed) are inherent.
B)
Claims 36, 39-41, 49 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,203,738 B2 Although the claims at issue are not identical, they are not patentably distinct from each other because;
Claim 1 of U.S. Patent No. 11,203,738 B2 teach a meat substitute composition comprising protein… of microorganism cells comprise bacterial cells selected from … Xanthobacter, and processing the microorganism cells into a high-protein protein hydrolysate, protein isolate, and/or protein concentrate ingredient that exhibits one or more of the following characteristics: bland flavor, light cream color, easy dispersibility, high water absorption, and high fat adsorption, wherein said high-protein … protein isolate (single cell protein) … ingredient comprises 65% to 85% or higher protein by weight.
Therefore, it would have to apply the teaching of claim 1 of U.S. Patent No.11,203,738 B2 in order to provide the claimed composition of at least claims 36, 39-41, 49 and 52 of instant application.
C)
Claims 36, 39-41 and 49-52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,203,738 B2 in view of Labuza et al. (Biotechnol. Bioeng., 1970, 12: 135-140).
The teachings of claim 1 of U.S. Patent No.11,203,738 B2 were discussed above. Regarding claims 50 and 51, before the effective filing dated of the invention Labuza et al. teach technique of spray drying to dry and prepare dry cultures of microorganisms (See for example, p, 135, Introduction). Therefore, a person of ordinary skill in the art before the effective filing dated of the invention would have been capable of applying this known technique of drying taught by the prior art to dry and provide the claimed subject matter/composition of claims 50 and 51 of instant application.
D)
Claims 36-46 and 52-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36 and 38-47 of U.S. Co-pending application No.18/823526 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of producing a product comprising biomass of the Xanthobacter microorganisms, wherein the biomass of the Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass, make obvious the composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weight, as disclosed by claims 36-46 and 52-53 of instant application (see side-by-side comparison of claims below).
Claims 36 and 38-47 of U.S. Co-pending application No.18/823526:
Claims 36-46 and 52-53 of instant application:
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 Xanthobacter microorganisms, wherein the reactor comprises an environment that is suitable for culturing the Xanthobacter microorganisms;(b) using the Xanthobacter 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 Xanthobacter microorganisms, wherein the biomass of the Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass.
36. A composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weight.
52. The composition of claim 36, wherein the biomass comprises cells of the Xanthobacter microorganisms.
38. The method of claim 36, wherein the Xanthobacter microorganisms comprise Xanthobacter autotrophicus or Xanthobacter flavus.
37. The composition of claim 36, wherein the Xanthobacter microorganisms comprise Xanthobacter autotrophicus or Xanthobacter flavus.
39. The method of claim 38, wherein the Xanthobacter microorganisms comprise Xanthobacter autotrophicus strain DSM 431, DSM 432, DSM 1618, or DSM 2267, or Xanthobacter flavus strain DSM 3874.
38. The composition of claim 37, wherein the Xanthobacter microorganisms comprise Xanthobacter autotrophicus strain DSM 431, DSM 432, DSM 1618, DSM 2267, or Xanthobacter flavus strain DSM 3874.
40. The method of claim 36, wherein the protein is at a quantity that is greater than 60% of the total biomass by weight
39. The composition of claim 36, wherein the quantity is greater than 60% of the total biomass by weight.
41. The method of claim 36, wherein the protein is at a quantity that is greater than 70% of the total biomass by weight.
40. The composition of claim 36, wherein the quantity is greater than 70% of the total biomass by weight.
42. The method of claim 36, wherein the protein is at a quantity that is greater than 80% of the total biomass by weight.
41. The composition of claim 36, wherein the quantity is greater than 80% of the total biomass by weight.
43. The method of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises essential amino acids
42. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises essential amino acids.
44. The method of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises lysine or methionine.
43. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises lysine or methionine.
45. The method of claim 36, wherein the biomass of the Xanthobacter microorganisms further comprises a B vitamin selected from the group consisting of vitamin B1, B2, and B12.
44. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms further comprises a B vitamin selected from the group consisting of vitamin B 1, B2, and B12.
53. The composition of claim 36, wherein the biomass comprises one or more vitamins.
46. The method of claim 36, wherein the biomass of the Xanthobacter microorganisms further comprises fats or carbohydrates.
45. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises fats or carbohydrates.
47. The method of claim 36, wherein the biomass of the Xanthobacter microorganisms further comprises protoplasm or an extract of protoplasm.
46. The composition of claim 36, wherein the biomass of the Xanthobacter microorganisms comprises protoplasm or an extract of protoplasm.
Therefore, the method of producing a product comprising biomass of the Xanthobacter microorganisms, wherein the biomass of the Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass, make obvious the composition comprising biomass of Xanthobacter microorganisms, wherein the biomass of Xanthobacter microorganisms comprises protein in a quantity that is greater than 10% of the total biomass by weight, as disclosed by claims 36-46 and 52-53 of instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion(s):
No claim(s) is allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651
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