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 February 9, 2026, has been entered.
Claim Disposition
3. Claims 2, 4, 7-9 and 18-20 have been cancelled. Claims 1, 3, 5-6, 10-17 and 21-24 are pending. Claims 1, 3, 5-6, 10-15 and 21-24 are under examination. Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claim Objection
4. Claim 5 is objected to for the flowing informalities:
For clarity and precision of claim language it is suggested that claim 5 is amended to read, “…..claim 1, wherein the catalytic triad is……”.
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, 5-6, 10-15 and 21-24 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. The claimed invention as amended is directed to a solution stable enzyme composition comprising a thermophilic fungal sterol esterase comprising an amino acid sequence WGESAG (SEQ ID NO:33) and a catalytic triad composed of S,H and E/D… wherein said thermophilic fungal sterol esterase has at least 70% sequence identity with a sterol esterase from SEQ ID NO:1” and other components set forth in items (b-d). The claimed invention is not adequately described and encompasses a broad genus of fragments, derivatives, analogs, homologues, variants for the enzyme with recitation of ‘an amino acid sequence’ which reads on a 3-mer and the percentage language that is also very broad. In addition, some of the other components in the composition are not adequately described and does not clearly establish the function of the solution stable enzyme as retaining a sterol esterase activity. The invention also encompasses any gene that could encode a sterol esterase from the genome of a thermophilic fungus from any of the organisms provided, which encompasses a large variable genus. It is generally established in the art that several different genes can encode the same protein, thus no correlation is made between structure and function for the recited gene. The claimed invention is directed to a product, a composition, however, the components are not clearly defined. It is noted that dependent claims such as claims 9-13 provides some of the missing information, however, independent claim 1 needs to stand on its own. The claimed invention comprises an enzyme component comprising a sterol esterase enzyme having “an” amino acid sequence WGESAG and a catalytic triad, and there are no indicia in the claimed embodiment to indicate that is the only enzyme in the ‘component’ therefore, claim 1 still encompasses a large genus of enzymes, especially with the varied structure.
The invention as claimed in claim 1 also encompasses a large genus of organic sugar alcohol, hydroxyl groups and antimicrobial preservative (albeit, optional). The claimed invention also has a genus of for example, sterol esterase (1), fragments with the recitation of at least 60% sequence identity (see claim 7), salts and esters thereof (see claim 12), serine protease inhibitors (see claim 15) and surfactants and inhibitors (claims 22-24). The claims are overly broad and not adequately described. The invention as claimed is not commensurate in scope with the disclosure in the specification.
The specification fails to provide any additional representative species of the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species which are adequately described are representative of the entire genus. The written description requirement
for a claimed genus may be satisfied through sufficient description of a
representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of
the claimed genus.
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. 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 enzymes, genus of microorganisms; 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). Thus, for all these reasons the claimed invention is not adequately described.
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. Claim 3 is 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 3 lacks clear antecedent basis for the recitation of “ the thermophilic fungal esterase is thermostable and retains at least 50% enzyme activity……because no activity is recited in the independent claim to be retained after alterations.
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 some rejections remain or have been instituted based on amendments made to the claims for the reasons set forth above and herein.
Applicant opines that the invention in claim 1 is directed to a solution stable enzyme composition comprising a thermophilic fungal sterol esterase which is defined by its structural features as specified in (a); and with combination of (b and c), enable the claimed extended solution stability for at least 4 weeks…. Therefore, the claimed invention does not encompass a broad genus of fragments… variants for the enzyme, neither does the invention claim a 3-mer. This argument is not persuasive especially with the newly submitted language of ‘at least 70% sequence identity to SEQ ID NO:1”. This is in no way specific or is claiming a specific structure. There are no indicia of an activity or retention of an activity in claim 1. Furthermore, as set forth in the rejection, the recitation of “an amino acid” reads on a lot of variability just in the recited WGESAG of SEQ ID NO:33 so indeed the language reads on a 3-mer or less. There is no guarantee with the instant claim language that the catalytic triad remains intact. The invention as claimed is overly broad and lacks adequate written description. The claims are not commensurate in scope with the disclosure in the specification, thus applicant’s arguments of what the specification discloses at page 11 is not persuasive is the claims are not limited to said embodiments.
Applicant’s arguments that the recited at least 70% sequence identity provides more structural limitations is not persuasive, because it created more issues that needs to be addressed. Applicant also opine that adequate representative number of species is provided, however, that is simply not correct based on the large genus of genes, expression products and microorganisms encompassed in the claims.
This argument is not persuasive because the invention as amended is directed to any structure in SEQ ID NO:33, any gene of the genome of the list of organisms and any esterase that is at least 70% identical to either SEQ ID NO:1. The claimed invention remains directed to large variable genus, see claim 1, for example. Applicant’s amendments and statements does not obviate this ground of rejection because demonstration of possession of the entire genus is lacking, a representative amount was not adequately described. The limitations of the specification cannot be read into the claims and the claimed invention is a composition with a fungal sterol esterase with variants and optionally any antimicrobial preservative and water with the open language of comprising which means additional components could be present. The claimed invention is also directed to any gene that could encode the sterol esterase from the laundry list of organism in claim 6 and the enzyme is also claimed as being at least 70% identical to SEQ ID NO:1. Thus applicant’s statements that the invention is narrowly defined is not accurate. Therefore, the written description rejection remains.
Applicant is reminded that 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 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).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5 on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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