DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on November 13, 2025, has been received and entered.
Claim Disposition
3. Claim 4 has been cancelled. Claims 1-3 and 5-8 are pending and are under examination.
Claim objection
4. Claims 1-3 and 5-8 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “…….wherein the enzyme-immobilization carrier comprises the plant protein…..”, in lieu of “included”. See also claims 5-7 with similar language. The dependent claims hereto are also included.
For clarity it is suggested that claim 2 is amended to recite “further comprising for the limitations in E and F. The dependent claims hereto are also included.
Claim 7 is objected to for the recitation of multiple ‘wherein’ clause with no linkage, as the transitional phrase ‘and’, “or” OR ‘and/or” is missing.
Appropriate correction is required.
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.
5. Claims 1-3 and 5-8 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) contain 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.
The claimed invention is directed to an enzyme-immobilization carrier with the following characteristics: enzyme immobilization carrier is a porous body comprising a plant protein obtained from soybeans, wherein an enzyme that is to be immobilized on the enzyme immobilization carrier acts as a substrate for fats and oils…..” (see claim 1 in its entirety). The claimed invention broadly recites “an enzyme” and the specification and dependent claim 8 only mentions lipases and phospholipases (see paragraph [0002 for example, in the specification). The enzyme-immobilization carrier of the present invention is distinguished in shape from a porous body produced by a twin-screw extruder. Furthermore, at paragraph [0009] of the specification it is disclosed that “an enzyme immobilization carrier of the present invention is a carrier in a case where an enzyme is immobilized to be used in an enzymatic reaction”, which implies a kit. The claimed invention is not adequately described because the carrier could be construed a device/apparatus, a kit. Additionally, the claimed invention is directed to a plant protein that the specification at paragraph [0005] is known. The art recognizes that soybean based plant proteins include whole foods like edamame, tofu, tempeh and soy milk, with more concentration in protein isolates, soy flour and textured vegetable protein, thus although this is known in the art, the claimed invention needs to be adequately described with respect to the enzyme and plant protein (especially with the recitation that the enzyme acts as a substrate which means specificity is needed). Note that the dependent claims and other independent claims (such as claims 5-7) recites similar language as claim 1 thus included.
The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. The claimed invention encompasses a large variable genus of components and products. The claimed invention is overly broad and encompasses large variable genus of carriers and enzymes. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, 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 structures, 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).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the fusion protein that encompasses mutants and fragments with no asserted activity.
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.
6. Claims 1-3 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.
Claims 1 and dependent claims hereto are indefinite for the recitation of “…..wherein the enzyme immobilization carrier has a porous body comprising a plant protein …… and wherein the plant protein is included in the enzyme immobilization carrier with a protein content of 80%….” because it is unclear what plant protein and enzymes are needed for the enzyme to act as a catalyst and be immobilized on the carrier and what role the plant protein. Therefore, clarification is needed.
Claim 3 lacks clear antecedent basis for the recitation of an oil system because claim 1 only mentions “oils and fats”.
Claim 2 is indefinite for the recitation of limitations that should be preceded with ‘further comprising” because these limitations were not mentioned in the independent claim nor is there a nexus mentioned for these new limitations to the objective of the invention.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that new rejections and objections have been instituted for the reasons stated above based on amendments made to the claims. Applicant traversed the 112 first paragraph rejection by stating that amendments were made, however, the amendments reduced some issues like objections and resolved some of the 112 first and second paragraph issues, but it also raised new issues which are addressed herein. Therefore, the rejection is made final.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652