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 Preliminary Amendments filed on September 4, 2023 and September 7, 2023 and March 16, 2026, have been received and entered.
3. Applicant's election without traverse of Group I (claims 1-11) on March 16, 2026, is acknowledged.
Claim Disposition
4. Claims 1-15 are pending. Claims 1-11 are under examination. Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. The claims are only being considered to the extent that they pertain to the elected subject matter.
Drawings
5. The Drawings filed on September 4, 2023 are accepted by the examiner.
Information Disclosure Statement
6. The Information Disclosure Statement filed on September 4, 2023, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Specification objection
7. The specification is objected to for the following informalities:
The specification is objected to because the priority information is not on page 1 of the specification.
Appropriate correction is required.
Claim objection
8. Claims 1-11 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to delete “providing an enzyme”. For example:
“ A method for improving the stability of an enzyme, comprising: [[the steps of:]]
[[providing an enzyme;]]
contacting an [[the]] enzyme with a storage solution…..”.
For clarity it is suggested that claims 2-11 are amended to delete ‘according to’ and instead insert “of” ( for example, “The method of claim 1….”).
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.
9. Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 is directed to a method for improving the stability of an enzyme, comprising the steps of providing any enzyme, contacting said enzyme with a storage solution comprising any oligosaccharide to obtain a storage composition, and optionally drying the storage composition. The claimed invention is not adequately described and encompasses a large variable genus of enzymes and oligosaccharide that are not defined by a structure. No correlation is made between structure and function and there are no indicia of what else the composition comprises to be considered as an improvement. There is no comparison made or quantifiable way to decipher that said enzyme is more stable than one that was not contacted with the undefined oligosaccharide or storage composition. The claims are overly broad and not commensurate in scope with the disclosure in the specification. It is noted that dependent claim 2 recites that the enzyme is a hydrolase, however hydrolases are a major class of enzymes that encompasses over 200 individual hydrolases enzymes such as esterases, glycosidases, peptidases and nucleases to name a few. Applicant has not demonstrated possession of the entire genus of hydrolases. The claimed invention is also not adequately described with respect to the storage solution, because the oligosaccharide is not described or how much of it is needed in the solution and what else is contained in the composition to obtain the desired result of improved stability. The art generally recognizes that high concentrations sugars in some cases can lead to inactivation via the Maillard reaction at high temperatures, thus the conditions of which the storage solution is used will impact the outcome of improvement and the claimed invention is generic and broad. The invention discloses that oligohexose is the oligosaccharide (see claim 8) which does not limit claim 1 that would encompass for example oligosaccharides like FOS, GOS, XOS to name a few.
The claimed invention is not adequately described, encompasses a large variable genus of products to be utilized in the method with few method steps, and not commensurate in scope with the disclosure in the specification. The specification fails to provide a representative number of species for 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. 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 products or diseases or conditions, 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.
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.
10. Claims 1-11 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.
Claim 1 is indefinite for the recitation of “improving stability of an enzyme” because it is not clear how to determine how much improvement, what baseline and end point. Is it thermal stability or something like folding. The dependent claims hereto are also included.
Claim 5 is indefinite for the recitation of a pharmaceutically acceptable solution, because there is no pharmaceutically acceptable carrier provided.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
11. Claim(s) 1 and 4-11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by JP 2005 052044 A.
The primary reference discloses a method to stabilize protocatechuic-acid dioxygenase and a manufacturing method of the stabilized lyophilized product. The stabilization of the enzyme is done by adding a stabilizer to the enzyme, the stabilizer is an aldohexose, a ketohexose, an hexose or an oligosaccharide. The amount of stabilizer is 30% (see claims 1-4, 10-17 of the reference). The claimed invention recites “about” thus the stabilizer weight is anticipated. The primary reference discloses that the type of buffer solution is not particularly limited, but those having a buffering ability in the stable pH range of the enzyme are preferred. For example, various phosphate buffers such as potassium phosphate (K-phosphate), sodium phosphate, tris salt, organic acid salts such as acetic acid, malic acid, and maleic acid, PIPES, TES, MOPS, HEPES, BisTris, Bicine, etc. Can be used. The stable pH region, for example, in the case of protocatechuate dioxygenase derived from the genus Pseudomonas, the lower limit at the time of commercialization from the pH stable range of this enzyme is preferably 6.0, more preferably 6.5, and most preferably 7.0, which falls within the claimed range. The invention of claim 1 with no specific enzyme or oligosaccharide is recited as having degree of polymerization of 2-75, therefore the art enzyme and oligosaccharide would meet this limitation and it is construed as an inherent property, thus anticipated. The primary reference obtained good storage and high activity (see for example Table 2 and the entire document). Therefore the limitations of the claims are met by the reference.
Conclusion
12. No claims are presently allowable.
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 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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