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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 11/10/25. Claims 80-89 are considered on the merits.
Election/Restriction Requirement
Applicant’s election without traverse of Group I, claims 80-89 in the reply filed on 11/10/25 is acknowledged. Claims 90-99 are withdrawn
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 80-89 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 80 is indefinite because the method steps are inconsistent. Step a) cultivates the Xanthobacter bacteria cells to produce a biomass. However Steps b) and c) only limit the homogenization and protease treatment is to the bacteria cells, not the biomass. It is unclear what is the sequence of these method steps since the homogenization and protease treatment could occur prior to cultivation since they are only applied to the bacterial cells and not the biomass. Applicant may wish to amend claim 80 as follows to remove this portion of the rejection:
b. rupturing the Xanthobacter bacterial cells of the biomass by homogenization; and
c. treating the homogenized biomass of Xanthobacter bacterial cells with one or more proteases at a temperature between 10°c and 80°C.
Claim 80 has the limitation “cultivating…cells by gas bioprocessing to produce a biomass”. The Specification does not define the term “gas bioprocessing”. The Specification does have a single use of “syngas bioprocessing” [49]. However it is unclear what limitations are imparted with “bioprocessing”. For example, this could mean the cells are producing syngas or are consuming syngas. These are two mutually exclusive scenarios that blur the metes and bounds of the claim.
Claim 81 it separate the biomass of claim 80 from a culture medium. However no culture medium is mentioned in claim 80 so it is unclear what step this separation occurs.
Claim 83 is indefinite because it depends from claim 80 which has a narrow temperature range 10-80 °C, but claim 83 has a broader temperature range of “at least 30 °C”. At least 30°C can read on a temperature larger than 80°C. This scenario shows that claim 83 fails to further limit claim 80 and the metes and bounds of the temperature range are not clearly defined.
Also claim 83 has the phrase “heating the biomass”. This phrase is absent in claim 80. The protease treatment at elevated temperatures in claim 80 step c) are not clearly direct to the biomass. So it is unclear if this heating is an independent step or is a modification of step c).
The term “dry protein product” in claim 89 is not found in the Specification. It is unclear what are the metes and bounds of this claim.
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.
Claim 83 is 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. Claim 83 has a broader temperature range of “at least 30 °C” than claim 80 which limits the temperature range between 10-80°C. 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.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 80-89 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In the instant case, the Specification does not disclose the method in a cohesive manner to indicate they had possession of the invention for the following reasons:
Claims 80-99 were new claims submitted as a preliminary amendment on 3/25/25 and do not appear in the parent applications.
Steps a)-c) are not found together in the Specification attached to any method. The Specification does not disclose any embodiment nor any alternative embodiments where the sequences of steps a)-c) are executed.
There are no expressed teachings where steps a)-c) are executed to produce a growth medium. The closes found was [54] which recites a natural or engineered organism can use a gaseous substrate as an energy source but, steps b)-c) are absent.
The concept of “cultivating Xanthobacter bacterial cells by gas bioprocessing to produce a biomass” is not disclosed in the Specification. This phrase is not found in the Specification. Also the terms “bioprocessing” and “Xanthobacter” are not found in the same vicinity of the Specification. The only instance of bioprocessing is for syngas, a much narrower term, than simply gas.
The range heating “at least 30°C” is not associated with protease hydrolysis but only found as a condition for alkali hydrolysis [395]. Applying this to the protease treatment appears to be a new concept.
In summary, while the Specification discloses some of the steps of the claims, these are not collected into a single embodiment, or listed as alternative embodiments. The Specification does not appear to link these steps to a common goal of producing a growth medium from Xanthobacter cultured from gas bioprocessing. One of ordinary skill in the art would not immediately envision the method of claim 80 from the totality of the Specification, but would require some inspiration to assemble the disembodied steps into an invention resembling claim 80.
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.
Claim 80-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 80-89 of copending Application No. 18/927305. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same steps of producing a growth medium. The common steps are:
a. cultivating bacterial cells by gas bioprocessing to produce a
biomass;
b. rupturing the bacterial cells by homogenization; and
c. treating the bacterial cells with one or more proteases at a
temperature between 10°c and 80°C.
Claims 81-86, and 88-89 are identical after claim 80. The only difference between the two methods is the current claims are narrower by limiting the bacterial cells to Xanthobacter, which are considered a knallgas bacterial cell since it can utilize H2 as an electron donor and O2 as an electron acceptor [182 and 246]. Therefore claims 80 and 87 overlap in scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Free of the Art
The closest prior art is WO 2017/165244 with priority to March 19th, 2016. However this prior art cannot be applied since it falls under a 102(b)(2)(A) exception because John Reed, Jil Geller, and Sonali Hande are common inventors. Other close prior art is WO 03089625 which produces a single cell bacteria protein by fermenting Methylococcus capsulatus, Ralstonia sp. DB3, and Brevibacillus agri DB5 with natural gas (WO’625 pg 22, and Abstract). However they only disclose using methanotrophic bacteria, which does not include Xanthobacter.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699