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 .
Applicant’s arguments filed 1/16/2026 has been entered. Claims 6-10 are pending.
Response to Amendment
The declaration under 37 CFR 1.132 filed 1/16/2026 is insufficient to overcome the rejection of claims 6-10 based upon Ye et al. (US 11,192,155; patented December 7, 2021) in view of Streicher et al. (Transduction of the Nitrogen-Fixation Genes in Klebsiella pneumoniae, Proc. Nat. Acad. Sci. USA, Vol. 68, No. 6, pp 1174-1177, June 1971) as set forth in the last Office action because: The data while showing a significant increase for ammonium nitrogen content and nitrogenase activity after 1-3 week for phage YSZKA does not provide a significant increase for nitrate nitrogen. Therefore, the showing is not commensurate in scope with the claimed method which is drawn to a method for compensating soil nitrogen fixation efficiency.
Maintained 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.
Claims 6-10 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. It is apparent that φYSZKA is required to practice the invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. The deposit is a Budapest Treaty depository collected in the China Center for Type Culture Collection (CCTCC) on August 2, 2018 and assigned a CCTCC NOL M 2018513. The following is a quotation of the first paragraph of 35 U.S.C. 112:
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the nature of the invention
2) the state of the prior art
3) the relative skill of those in the art
4) the predictability of the art
5) the breadth of the claims
6) the amount of direction or guidance provided
7) the presence or absence of working examples
8) the quantity of experimentation necessary
The instant specification fails to provide guidance that would allow the skilled artisan to practice the instant invention without resorting to undue experimentation, as discussed in the subsections set forth herein below.
The nature of the invention.
The claimed invention is drawn to adding Klebsiella pneumoniae phage φ YSZKA to soil.
The state of the prior art & predictability of the art
It is generally accepted that biological deposits require accession number to distinguish between different strains. Ye et al. teach a method of remediating contaminated soil by inoculating the soil with phage φ YSZPK Accession no. CCTCC M 2018516 (US 11,192,155; abstract). Since the claims do not include an identifying accession number it would not be predictable how to identify and use the claimed phage φ YSZPK.
The breadth of the claims
The recitation φ YSZPK reads any phage of similar name including those with an additional taxonomic designation other than Klebsiella pneumoniae.
The presence or absence of working examples
The specification only provided a detailed evaluation of 100 mL of phage φ YSZPK Accession no. CCTCC M 2018513 in a concentration of 106 PFU.mL-1 to promote soil nitrogen fixation.
The quantity of experimentation necessary & relative skill in the art
To determine how to prepare all Klebsiella pneumoniae phage φ YSZKA which can be applied to soil would require undue experimentation for one skilled in the art.
Response to Arguments
Applicant's arguments filed 1/16/2026 have been fully considered but they are not persuasive.
Applicant argues that a proper deposit has been made in the specification on page 3, line 29 through page 4, lines 1 and on page 5, line 29 through page 6, line 1. The Examiner agrees, however the enablement rejection has not been completed address. The specification only provides enablement for phage φ YSZPK Accession no. CCTCC M 2018513 whereas the claims are drawn to any phage YSZPK including those not currently known or classified. Therefore the rejection has been maintained.
Maintained Claim Rejections - 35 USC § 103
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 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 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.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al. (US 11,192,155; patented December 7, 2021) in view of Streicher et al. (Transduction of the Nitrogen-Fixation Genes in Klebsiella pneumoniae, Proc. Nat. Acad. Sci. USA, Vol. 68, No. 6, pp 1174-1177, June 1971).
Applicant’s Invention
Applicant claims a method of compensating soil nitrogen fixation efficiency comprising adding Klebsiella pneumoniae phage φ YSZKA to soil.
Determination of the scope and the content of the prior art
(MPEP 2141.01)
With respect to claims 6-10, Ye et al. teach a method of remediating contaminated soil of multiple antibiotic resistance pathogenic bacteria by inoculating the soil with a phage Pseudomonas aeruginosa and Klebsiella pneumonia phage φ YSZPK to control and inactivate the bacteria in a soil-vegetable system (abstract; column 4, lines 8-34). Biochar is known to synergistically control the transmission of antibiotic resistant bacteria and genes in soil-plant systems and is useful in preserving fertility of soil, improve crop quality and yield (column 1, lines 43-60). Bacteriophages (phages) are added to contaminated soil-plant systems to infect and inactivate pathogenic bacteria (column 1, line 61 through column 2, line 5). Ye et al. teach adding biochar and phage to contaminated soil results in restoring soil ecology (column 3, line 60 through column 4, line 5; limitation of claim 9). The soils were then used for planting vegetables selected from carrots, pod peppers and lettuces (Examples 2-4).
Claim 7 is drawn to the intended use of the soil and claim 8 is drawn to inherent properties of the soil. Claim 10 requires adjusting the amount of Klebsiella pneumonia phage added to the soil to change nitrogen content which would have been a routine optimization depending on the properties of the soil that is treated.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Although Ye et al. teach methods of applying Klebsiella pneumonia phage φ YSZPK to soil to aid in remediating soil and improve soil ecology. Ye et al. does not specify compensating soil nitrogen fixation efficiency by applying Klebsiella pneumonia phage φ YSZKA to soil. It is for this reason that Streicher et al. is joined.
Streicher et al. teach the bacteriophage Klebsiella pneumonia has strains which are known to be nitrogen fixing (page 1175, Results).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Ye et al. and Streicher et al. are both drawn to properties of Klebsiella pneumonia. Therefore, it would have been prima facie obvious to one of ordinary skill to combine the teachings of Ye et al. Streicher et al. to apply Klebsiella pneumonia phage to soil to compensate soil nitrogen fixation efficiency with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Ye et al. and Streicher et al. to further include injecting soil with Klebsiella pneumonia phage because Streicher teach Klebsiella pneumonia strains are known to be nitrogen fixing.
Response to Arguments
Applicant's arguments filed 1/16/2026 have been fully considered but they are not persuasive.
Applicant argues the phage disclosed by Ye has clear and substantial differences φ YSZKA targets only Klebsiella pneumoniae whereas φ YSZPA has dual host specificity and therefore functions differently. The Examiner is not convinced by this argument because Ye et al. teach a method of remediating contaminated soil of by inoculating the soil with a phage phage φ YSZPK (abstract). Therefore, adding phage φ YSZPK to soil would have been prima facie obvious to one of ordinary skill in the art. Furthermore, the claims are not commensurate in scope the species argued and the accession number of the phage is not specified.
Applicant argues that the claimed phage φ YSZKA demonstrates unexpected results. The Examiner is not persuaded by this argument because while showing a significant increase for ammonium nitrogen content and nitrogenase activity after 1-3 week phage YSZKA does not provide a significant increase for nitrate nitrogen. Therefore, the showing is not commensurate in scope with the claimed method. Therefore the rejection has been maintained.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE D JOHNSON whose telephone number is (571)270-3285. The examiner can normally be reached Monday-Friday 9:00 am-5:30 pm.
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, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
DANIELLE D. JOHNSON
Examiner
Art Unit 1617