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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/31/25 has been entered.
Claims 1-7, 12-14 have been canceled. Claims 8-9, 15-17 are still at issue and are present for examination.
Claims 10-11 remain withdrawn as drawn to non-elected invention.
Applicants' arguments filed on 10/31/25, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
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 8-9, 15-17 remain 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 according to previous office actions.
In response to this rejection, applicant has amended claim 8 such that now, AXE and LPMO are “ recombinant” and firstly cites a series of applications or patents in which it has been disclosed that for example, beta-xylosidase and endoxylanase and lytic monooxygenase (LPMO) are from Talaromyces emersonii. Secondly applicant mentions that in certain world patents it has been explained that LPMO and AXE may be recombinant and hence, no new matter has been introduced into the elected claims.
These arguments were fully considered but were found unpersuasive.
Regarding applicant’s first and second arguments above, applicant keeps referring to patents and applications, which are neither incorporated by reference nor have been provided (see also interview summary). Therefore, the examiner cannot verify if new matter has been introduced or not.
With respect to applicant’s second argument alone, it should be noted that the term “recombinant” as recited in claim 8, refers to an AXE and an LMPO which have been produced in any generic host but applicant merely cites and refers to recombinant AXE and LPMO enzymes expressed in A, niger, which is a single species. Applicant is fully aware that a recombinant enzyme depending on the host expressed therein, can have different levels of activity due to the host machinery and levels of post translation modifications etc. and hence, providing the activity or performance of a recombinant enzyme expression in a single species is hardly adequate to support the scope of the term “recombinant” instantly used in the amended claims. Therefore, the examiner maintains that instantly elected claims as amended still recite New Matter.
In addition to the above rejection, the examiner could not find explicit support for the phrase added at the end of claim 8 either. More specifically, the phrase “the enzyme composition yields higher hydrolysis performance ….” cannot be found in the text of the disclosure. Applicant is advised to refer the examiner where the amendment made to the end of claim 8 is found in the specification.
Therefore, this rejection remains for applicant to consider.
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 8-9, and 15-17 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 8 (and its dependent claim 9) and claims 15-17, it is unclear if the enzyme composition recited in part (a), is a single cocktail or some of if the constituent enzymes were introduced one or two at the time in a step wise (sequential) manner into the claimed composition. Further, in page 10 of response, applicant cites example 3 of WO/2011/000949 as the source based on which, instant cellulase compositions are produced and said example refers to specific mutant strains from which cellulase compositions are prepared. Based on that response, it is currently unknown if AXE, LPMO, BX, etc. are all full-length wild type enzymes or whether they have been optimized (mutated by insertion, substitution, deletion etc.) for higher activities before being added to the enzyme composition. If said cellulase enzymes have been optimized, applicant must provide some information as to their structure(s) and conditions under which their activities were assessed. Appropriate clarification is required. Claim 9 is merely rejected for depending from claim 8.
Claims 8-9, and 15-17 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. The term “total” in part (c) of claim 8 (and its dependent claims 9, 15-17) is unclear. Said term implies that AXE, LPMO, HC etc. are originating from different preparations (such as solubilized cellulases (non-recombinant), recombinant and mutant AXE, LPMO , HC etc.) and are pooled together to make a “total” (see also Table 2 in the specification referring to enzyme blends comprising a cellulase composition and a single LPMO expressed in A, niger). However, claim 8 part (a) does not mention any different preparations or structures for its enzymes that were pooled together to make a “total”.
Appropriate clarification is required. Claims 9 and 15-17 are merely rejected for depending from claim 8.
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 (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.
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.
Claim(s) 8-9, 15-17 remain rejected under 35 U.S.C. 103 as being unpatentable over Liu (cited previously) according to previous office action. In traversal of this argument, applicant argues that (1) he/she has amended claim 1, see the amendments added at the end of claim 8, and in view of applicant, a person of ordinary skill would not conclude that Liu’s success at producing alcohol with its enzyme compositions implies that the “optimal” ratios of AXE, LPMO and hemicellulases were utilized. In applicant’s view, mere success at producing alcohol with a composition of identified enzymes by Liu does not inform the skilled artisan about the relative ratios of enzymes in that composition.
(2) The Office assertion that “depending on the cell’s physiological conditions, AXE, LPMO and HE ratios in said whole cells may inherently arrive at enzyme ratios instantly claimed is not sufficient to establish inherency because it shows that the limitations at issue are not necessarily present or the natural result of the combination elements explicitly disclosed by Liu. Applicant adds that there is nothing in said reference that teaches or suggests a process using enzyme ratios instantly claimed and Liu fails to teach or suggest any motivation to modify Liu to achieve ratios instantly claimed.
(3) Table 3 of the specification (which is based on enzyme blends using T. emersonii or apparently mutants thereof ), show that AXE and LPMO combined with BX and EX in the ratios as claimed, exhibited superior lignocellulose hydrolysis performance as compared to blends having enzyme ratios outside those defined in claim 1 (wherein claim 1 is currently canceled and is assumed that applicant is referring to claim 8). Applicant then continues stating that applicant’s superior hydrolysis results must be compared to the average hydrolysis performance of blends that fall outside the claimed ratios and based on that comparison the average improvement by instant method is 5.38% and not 3.15%, mentioned by the examiner previously.
Further even one agrees that the hydrolysis performance has improved by 3.15%, assuming that a Biotechnol plant has an annual output of 50 million gallons per year, with a yield of 80% efficiency, an increase of 3.15% of original yield may result in additional revenue of 3.5 million dollars, which is significant.
These arguments were fully considered but were found unpersuasive.
With regards to applicant’s first and second arguments, it should be noted that said claim 8 is totally confusing (see 112 second rejections above) and based on ambiguities of said claim 8, there is no reason to think that the relative ratios of enzymes in a broth (blend) of lysed T. emersonii and/or even those in intact version of said cell in Liu are not as “optimal” (whatever that terms means) as those instantly claimed for producing higher hydrolysis performance as compared to control.
The point is well taken that the use of the term “inherently” by the examiner in the last office action, may have implied that the “optimal” ratios were not present in the blends used by Liu. The examiner agrees that it is possible that at times, said term may have been used inappropriately and said term should have been best replaced with “inevitably”, but this does not remove the position of Liu as an art that renders this invention obvious for the reasons of record.
Regarding applicant’s third argument, once again as mentioned numerous times before, applicant is reminded that in the absence of reliable statistical data showing the number of times each experiment shown in Table 3, is repeated and how much standard deviation is in each experiment etc., it is hard to assess how surprising and unexpected instant yields are. Further, the enzyme blends displayed in Table 2 appear to be a mixture (blend) of cellulases and recombinant enzymes, wherein some or all of said enzymes are mutated and currently it is unclear what said mutants structurally are and how their activities were determined. Furthermore, it is noted that Table 3 is incomplete as it lacks any data showing for example, the following : 1) an enzyme blend performance wherein the ratio of RAXE and R LPMO are within the ranges instantly claimed but the ratio of RHC alone is out of range or (2) a blend performance, wherein the ratio of RHC and RAXE are within the instantly claimed ranges but the ratio of RLPMO alone falls outside the range. In examiner’s view, in the absence of blend performances corresponding to situations such as 1-2, what applicant has presented as “superior” hydrolysis performance can possibly be biased.
Therefore, in view of explanations provided above in addition to those elaborated previously, instant rejection remains.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARYAM MONSHIPOURI whose telephone number is (571)272-0932. The examiner can normally be reached full-flex.
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, Melenie L Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARYAM MONSHIPOURI/Primary Examiner, Art Unit 1651