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
1. Applicant’s election of Group II (claims 9 & 11-14) with traverse in the reply filed on 3/13/26 is acknowledged. The traversal is on the grounds that there is no serious search burden in examining currently pending claims 9-15.
Applicants’ arguments are found to be persuasive in order to rejoin Group II claims 10 & 15 with elected claims of Group I. Hence, all pending claims 9-15 (Group I & II) will be examined in this Office Action.
In view of the withdrawal of the restriction requirement between Group I & II, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim may be allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
2. Priority
Receipt is acknowledged of papers (foreign priority filed 4/6/21) submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
3. IDS(s) filed 10/3/23 & 10/4/23 are acknowledged. Signed copies of the IDS(s) are provided with this Office Action.
4. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
5. Claim Rejections - 35 USC § 112 (second paragraph)
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 9-15 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 pre-AIA the applicant regards as the invention.
Claims 9 & 10 recite the expression “optionally” which attempts to give both broad and narrow meaning to the scope of the above claims. These claims are unclear.
Claims 11-15 are included in the rejection for failing to correct the defect present in the base claim(s).
6. 35 U.S.C. § 112, first paragraph (Written Description)
Claims 9-15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to the following genus claims.
Instant claims 9-15 are drawn to as follows:
9. (Previously Presented) A process for the preparation of a sugar from cellulosic material comprising: a) hydrolyzing the cellulosic material with an enzyme composition to obtain the sugar, and b) optionally, recovering the sugar, wherein the enzyme composition comprises glucoamylase and cellobiohydrolase I and the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHIis from 0.60 to 0.98.
10. (Previously Presented) A process for producing a fermentation product from a cellulosic material, which process comprises: a) hydrolyzing the cellulosic material with an enzyme composition to obtain a sugar, b) fermenting the obtained sugar by contacting the obtained sugar with a fermenting microorganism to produce the fermentation product, and c) optionally, recovering the fermentation product, wherein the enzyme composition comprises glucoamylase and cellobiohydrolase I and the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHIis from 0.60 to 0.98.
11. (Previously Presented) The process according to claim 9, wherein an enzyme composition comprising glucoamylase (GA) and cellobiohydrolase I (CBHI), wherein the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHI is from 0.60 to 0.98 is used.
12. (Previously Presented) The process according to claim 9, wherein the enzyme composition is used in an amount of 2 mg to 20 mg protein/gram dry matter weight of glucans in the cellulosic material.
13. (Previously Presented) The process according to claim 9, wherein the cellulosic material is subjected to pretreatment before the enzymatic hydrolysis.
14. (Previously Presented) The process according to claim 13, wherein the pretreatment is steam treatment, dilute acid treatment, organosolv treatment, lime treatment, ARP treatment or AFEX treatment.
15. (Previously Presented) The process according to claim 10, wherein the fermentation product is alcohol and the fermenting microorganism is an alcohol producing microorganism that is able to ferment at least one C5 sugar.
The claims are described by functional limitations only and are devoid of a reference structure for the claimed glucoamylase and cellobiohydrolase I, used in the method. The claimed invention encompasses a genus of glucoamylase and cellobiohydrolase I from any source not adequately described.
Instant specification describe - A process for the preparation of a sugar from cellulosic material comprising: a) hydrolyzing the cellulosic material with an enzyme composition to obtain the sugar, and b) SEQ ID NO: 2 and cellobiohydrolase I of SEQ ID NO: 4 and the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHIis from 0.60 to 0.98.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe aninvention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what isclaimed."). Thus, an applicant complies with the written description requirement "bydescribing the invention, with all its claimed limitations, not that which makes it obvious,"and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966."Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents" of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case is discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
Moreover, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
7. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 9-15 are provisionally rejected under the judicially created doctrine of double patenting over claims 10 & 12-17 of co-pending Application No. 18/553,817 (PG Pub. 20240182936 A1) This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
The subject matter claimed in the instant application is fully disclosed in the referenced co-pending application and would be covered by any patent granted on that co-pending application since the referenced co-pending application and the instant application are claiming common subject matter, as follows:
Instant claims 9-15 are drawn to as follows:
9. (Previously Presented) A process for the preparation of a sugar from cellulosic material comprising: a) hydrolyzing the cellulosic material with an enzyme composition to obtain the sugar, and b) optionally, recovering the sugar, wherein the enzyme composition comprises glucoamylase and cellobiohydrolase I and the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHIis from 0.60 to 0.98.
10. (Previously Presented) A process for producing a fermentation product from a cellulosic material, which process comprises: a) hydrolyzing the cellulosic material with an enzyme composition to obtain a sugar, b) fermenting the obtained sugar by contacting the obtained sugar with a fermenting microorganism to produce the fermentation product, and c) optionally, recovering the fermentation product, wherein the enzyme composition comprises glucoamylase and cellobiohydrolase I and the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHIis from 0.60 to 0.98.
11. (Previously Presented) The process according to claim 9, wherein an enzyme composition comprising glucoamylase (GA) and cellobiohydrolase I (CBHI), wherein the glucoamylase is present at a fraction relative to the glucoamylase and the cellobiohydrolase I as defined by RGA, and wherein the cellobiohydrolase I is present at a fraction relative to the cellobiohydrolase I and the glucoamylase as defined by RCBHI, wherein RGA is from 0.02 to 0.40 and RCBHI is from 0.60 to 0.98 is used.
12. (Previously Presented) The process according to claim 9, wherein the enzyme composition is used in an amount of 2 mg to 20 mg protein/gram dry matter weight of glucans in the cellulosic material.
13. (Previously Presented) The process according to claim 9, wherein the cellulosic material is subjected to pretreatment before the enzymatic hydrolysis.
14. (Previously Presented) The process according to claim 13, wherein the pretreatment is steam treatment, dilute acid treatment, organosolv treatment, lime treatment, ARP treatment or AFEX treatment.
15. (Previously Presented) The process according to claim 10, wherein the fermentation product is alcohol and the fermenting microorganism is an alcohol producing microorganism that is able to ferment at least one C5 sugar.
Claims 10 & 12-17 of the co-pending application 18/553,817 are drawn to as follows:
10. (Previously Presented) A process for producing a fermentation product from a cellulosic material, which process comprises: a. hydrolyzing the cellulosic material with an enzyme composition to obtain a sugar, b. fermenting the obtained sugar by contacting the obtained sugar with a fermenting microorganism to produce the fermentation product, and c. optionally, recovering the fermentation product, wherein the enzyme composition comprises: glucoamylase and in an amount of 0.1% to 13% (w/w) of the total amount of protein in the enzyme composition, said glucoamylase comprising the amino acid sequence of the mature polypeptide of SEQ ID NO:2, cellobiohydrolase I in an amount of 20% to 45% (w/w) of the total amount of protein in the enzyme composition, said cellobiohydrolase I comprising the amino acid sequence of the mature polypeptide of SEQ ID NO:4: and a beta-glucosidase: wherein glucoamylase activity is present at a fraction relative to glucoamylase activity and cellobiohydrolase I activity as defined by RGA, and wherein cellobiohydrolase I activity is present at a fraction relative to cellobiohydrolase I activity and glucoamylase activity as defined by RCBHI, wherein RCBHI is from 0.42 to 0.97 and RGA is from 0.03 to 0.58.
11. (Cancelled)
12. (Currently Amended) The process according to claim[[ 9]]10, wherein the enzyme composition is used in an amount of 2 mg to 20 mg protein/gram dry matter weight of glucans in the cellulosic material.
13. (Currently Amended) The process according to claim[[ 9]]10, wherein the cellulosic material is subjected to pretreatment before the enzymatic hydrolysis.
14. (Previously Presented) The process according to claim 13, wherein the pretreatment is steam treatment, dilute acid treatment, organosolv treatment, lime treatment, ARP treatment or AFEX treatment.
15. (Previously Presented) The process according to claim 10, wherein the fermentation product is alcohol and the fermenting microorganism is an alcohol producing microorganism that is able to ferment at least one C5 sugar.
16. (New) The process according to claim 10, wherein the enzyme composition comprises beta-glucosidase in an amount of 1% to 20% (w/w) of the total amount of protein in the enzyme composition.
17. (New) The process according to claim 10, wherein the enzyme composition is a whole fermentation broth.
Given the fact pattern of the instant case as well as the co-pending application, the species claims of the co-pending application wherein the glucoamylase & cellobiohydrolase I are drawn to specific sequences of SEQ ID NO: 2 & SEQ ID NO: 4 respectively, anticipates the instant genus claims wherein the glucoamylase & cellobiohydrolase I are from any source; all other limitations being similar in scope.
8. 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 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.
Claim(s) 9-11 & 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/057517.
WO 2015/057517 A1 (DANISCO US INC [US]) 23 April 2015 (2015-04-23) teaches enzyme compositions and method for the preparation of a sugar from cellulosic material comprising: a) hydrolyzing the cellulosic material with an enzyme composition to obtain the sugar comprising a glucoamylase, a 1.1 cellobiohydrolase and a beta-glucosidase for saccharification of grain-based plant materials. The indicated amounts of enzymes used in the
composition include 0.1 mg glucoamylase/g dry solids and 2.5 mg cellobiohydrolase/g dry solids which amounts to a RGA of 0.038 (0.1/(0.1 + 2.5)) and a RCBHI of 0.96 (2.5/(2.5 + 0.1)). The glucoamylase may be glucoamylase EC 3.2.1.3 which corresponds to GH15 and cellobiohydrolase EC 3.2.1.91 corresponds to GH7. Beta-glucosidase can make up between 5 to 50% of the total weight of enzymes. The enzyme compositions are used to prepare a sugar which is converted into a fermentation product such as ethanol. An optional pretreatment step is also disclosed. See abstract, full patent and paragraphs ([21]-[27],[37],[42],[89],[95][187],[211]), which anticipates claim 1-3, 6-11 & 13.
9. No claim is allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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, Robert B Mondesi can be reached on 408 918 7584. 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.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940