DETIALED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
1. Claims 1-9 and 11-21 are pending and subject to examination on the merits. Claims 12-20 are withdrawn from consideration as being drawn to non-elected subject matter. Claims 1-9, 11, and 21 are currently under examination.
Priority
2. Acknowledgment is made for the Applicant’s claim for domestic priority based on the US provisional application PRO 63/608,793 filed 11 December 2023.
Modified and Maintained Rejections—necessitated due to claim amendments
Claim Rejections - 35 USC § 102
3. 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.
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 1-9 and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Pearlman et al (Pearlman et al., 2019, US 2019/0124947 A1—cited herein). Regarding claims 1-2 and 4-6, drawn to a non-naturally occurring C1-fixing strain of Cupriavidus necator (claim 2) capable of growing autotrophically at a temperature from above 30oC up to about 40oC to produce single-cell protein (claim 4) from a gaseous substrate comprising H2 and CO2 (claims 5-6), Pearlman et al teaches a Cupriavidus necator H16 growing chemoautolithotrophically continuous in the presence of H2 and CO2 for the production of single-cell protein (p. 12, “Example 9: Single Cell Protein Production from Gas Fermentation,” paragraphs 0096, 0101). Pearlman et al. specifically teaches the incubation of a 1L flask at 37oC and 200rpm for 24hrs (p. 7, “Example 3: Generation of H16 delta-phaCAB Cupriavidus necator,” paragraph 0065, Table 7). Pearlman et al. continues to teach that the single cell protein was produced from the gaseous composition, where 100% of the cells were retained (p. 12, paragraph 0102), and the subsequent percent weight amino acids on a dry weight basis was calculated (p. 13, Table 19). Regarding claim 3, drawn to a non-naturally occurring strain that does not natively produce polyhydroxyalkanoates (PHAs), Pearlman et al. teaches a Cupriavidus necator strain with attenuated or eliminated PHB production by modifying one or more of the phaCAB operon enyzmes which enable the strain to produce PHB; specifically a C. necator H16 strain with a deletion ΔphaCAB or a G320A point mutation in phaC (p. 2, paragraph 0029), where Pearlman et al. teaches that the most common PHA is PHB (p. 1, paragraph 0006). Regarding claim 7, where the SCP is converted to a nutritive compound, Pearlman et al. teaches a method of producing a SCP for use in nutritive compositions (p. 3, paragraph 0040). Regarding claim 8, drawn to the enhancement of nutritive products by genetic engineering, Pearlman et al. teaches that the C. necator H16 ΔphaCAB SCP prepared as feedstock for salmon showed higher growth among the salmon than the reference diet and excellent amino acid digestion (p. 8, paragraph 0079). Regarding claim 9, drawn to a freeze-dried food, Pearlman et al. teach the utilization of pasteurized freeze-dried C. necator H16 ΔphaCAB SCP to feed salmon (p 8, paragraphs 0077-0078).
6. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
7. Claim 11 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Pearlman et al (Pearlman et al., 2019, US 2019/0124947 A1—cited herein).
The teachings of Pearlman et al. are discussed above and incorporated into the instant rejection.
Regarding claims 11 and 21, drawn to a non-naturally occurring C1-fixing strain with 95% identity to SEQ ID NO: 1, Pearlman et al. teaches the utilization C. necator H16 strain. It appears that the strain of Pearlman et al. is the same strain as the C. necator H16 strain sequenced as SEQ ID NO: 1. While Pearlman et al. are silent as to the sequence of C. necator H16, it inherently possesses the same genome sequence, and thus, Pearlman et al. anticipate the instant claim - See MPEP 2112.01: “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d”
On the other hand, it would be obvious that the strain of Pearlman et al. is the same strain as the sequence genome of H16 of instant SEQ ID NO: 1, or that having 95% identity thereto, because strains and their genomes are inseparable. Just because Pearlman et al. did not sequence the genome does not render the currently sequenced genome new.
Double Patenting
7. 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.
8. Claims 1-3 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18977534 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘534 claims would necessarily anticipate the instant claims.
The instant claims in the broadest are drawn to a non-naturally occurring C1-fixing strain (claim 1), selected from Cupriavidus necator and Ralstonia eutropha (claim 2), that does not natively produce PHAs (claim 3), where said strain is Cupriavidus necator DSM34774 (claim 11) or 95% sequence identity to SEQ ID NOs: 1 or 3 (clam 11).
The ‘534 claims in the broadest are drawn to a recombinant C1-fixing microorganism, Cupriavidus necator or Ralstonia eutropha (claim 4), comprising a mutation at a membrane bound hydrogenase gene locus, wherein said mutation is a deletion (claim 2), wherein the membrane hydrogenase gene is hoxKGZ (claim 3), and the microorganism does not natively produce PHAs (claim 5). Dependent claims 6 and 7 are drawn to a Cupriavidus necator DSM 34774, and dependent claim 8 is drawn to a microorganism with 95% sequence identity to SEQ ID NOs: 1 or 3.
It is notable that SEQ ID NOs: 1 and 3 of the ‘534 claims and the instant claims are identical (See Supplemental Files: 20250818_120638_us-18-977-534-1_copy_1_100000.oligo.rnpm, result 1 and 20250818_120845_us-18-977-534-3_copy_1_100000.oligo.rnpm, result 1 found in 18977534).
The difference between the two sets of claims is that the ‘534 claims comprise a mutation in the membrane bound hydrolase, and the instant claims specifically claim that the C1-fixing non-natural engineered microorganism is capable of growing autotrophically up to 40oC. However, the ‘534 claims would still anticipate the instant claims because the ‘534 specification specifies that the C1-fixing strain is capable of continuous growth autotrophically at up to about 40oC (paragraph 0038). Additionally, the mutation in the membrane bound hydrolase could be comprised in the mutant C1-fixing strain of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments and Examiner’s Rebuttal
The applicant traverses the previous 35 U.S.C. 102(a)(1) and 102(a)(2) rejections of record of claims 1-9 over Pealman et al. and the previous rejection of record of claim 11 under 35 U.S.C. 102(a)(1) and 102(a)(2) or in the alternative of 35 U.S.C. 103 over Pealman et al, contending that claim 1 was amended to recite at a temperature from above 30oC up to about 40oC. Additionally, claim 10 was cancelled, and its’ claim limitations were added to claim 11. Claim 21 was newly added and included in the above modified rejection of record.
First, the applicant argues that Pearlman does not teach a strain capable of continuously growing autotrophically at a temperature from above 30oC up to about 40oC by reciting paragraph 0113 of Pearlman et al., where the organism was grown at 30oC. However, as demonstrated in the rejection above, Pearlman et al. also teaches a specific example, where the organism is grown at 37oC for 24hrs.
Second, the applicant argues that claim 11 is dependent on claim 1, and therefore, argues that the same growth temperature is not met by Pearlman et al. Again, as addressed above and in the modified rejection of record, Pearlman does teach a specific example of growing the organism at 37oC.
Third, the applicant argues that it is non-obvious to grow the organism at the recited temperature; however, the rejections of record do not claim obviousness for growth at a temperature from above 30oC up to about 40oC. The argument of obviousness, however, was directed to the genome and strain, where specifically, the argument states, “On the other hand, it would be obvious that the strain of Pearlman et al. is the same strain as the sequence genome of H16 of instant SEQ ID NO: 1, or that having 95% identity thereto, because strains and their genomes are inseparable. Just because Pearlman et al. did not sequence the genome does not render the currently sequenced genome new.”
Fourth, the applicant argues that the claims are not in final form and therefore cannot file a terminal disclaimer; as such, the non-statutory double patenting rejection of claims 1-3 and 11 still stands, as maintained above. This is understood and the rejection of record is maintained.
The examiner does not find the arguments presented by the applicant persuasive, and for these reasons, the rejections of record above apply.
Conclusion
9. All claims are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CIARA A MCKNIGHT whose telephone number is (703)756-4791. The examiner can normally be reached M-F 8:00am-4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CIARA A MCKNIGHT/Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
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