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 Amendment filed on December 3, 2024, has been received and entered.
Claim Disposition
3. Claims 1-13 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on December 3, 2024, 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
5. The specification is objected to for the following informalities:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "Fish feed or additive and methods of using the same".
The specification is also objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See pages 3 and 10, for example. It is suggested that http:// is deleted.
Appropriate correction is required.
Claim objection
6. Claims 1-13 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to delete all reference to “i.e. or e.g.” , ‘preferably’, EC numbers and Example 1”. For clarity claim 1 should be amended to delete the extraneous ‘and/or’ between the EC numbers. For clarity claim 1 should be amended to read, “…wherein the phytase activity,……wherein the phytase activity is dosed……,wherein the phytase activity is dosed at a level about 500……and wherein the phytase activity is dosed at a level about…..”. The dependent claims hereto are also included.
For clarity it is suggested that claims 1-13 are amended to recite, “the” in lieu of ‘said’, for example, “wherein the phytase..”.
For clarity it is suggested that claims 3 is amended to delete, “such as”.
For clarity it is suggested that claim 4 is amended to extraneous ‘and/or’ in list. The dependent claims hereto are also included.
For clarity it is suggested that claim 7 is amended to delete ‘according to’ and instead recite ‘of’.
For clarity it is suggested that claim 10 is amended to delete “Example 1 and/or Figure1”.
For clarity claims 11-13 should be amended to delete mention of “use” (i.e., A method of…”).
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.
7. Claims 1-13 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 fish feed or fish feed additive comprising one or more polypeptide having phytase activity”. The claimed invention encompasses a large variable genus of polypeptides that are described by EC numbers, thus not adequately described. No correlation is made between structure and function for the polypeptide. Thus the claimed invention is overly broad and not commensurate in scope with the disclosure in the specification, and does not demonstrate possession of the large genus. 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, 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.
8. Claims 1-13 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 1-13 are indefinite for the recitation of "preferably” , ‘further preferably, ‘most preferably’, ‘ie’, ‘’e.g.’ and ‘such as’ with limitations in the claims, as the phrase preferably (for example and such as) renders the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP 2173.05(d).
Claims 1-13 are indefinite for the recitation of “shown in Example 1’ and ‘shown in Example 1 and/or Figure 1’, because this renders the claim as incomplete because disclosure in the specification is being relied on to complete the claim limitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
9. Claims 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a non-statutory subject matter. Note that claims 11-13 are directed to a ‘use’ of a fish feed or fish feed additive, instead of a proper method/process with method steps. The claimed invention in claims 11-13 has no positive method steps, which does not set forth what method/process is encompassed. Without setting forth any steps involved in the process/method, results in an improper definition of a process and is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
10. Claim(s) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2022049230 (of record in the application).
The reference discloses using a bacterial EC3.1.3.8 phytase (or EC 3.1.3.26
or EC 3.1.3.72) to improve phosphorus digestibility and hence reduce P- secretion/excretion by fish (tilapia, seabream). The phytase is added in an
amount of e.g. 500 or 1000 phytase activity units/kg fish feed. The phytase diets
in Table 23 do not comprise any dicalcium phosphate. Implicitly, the reduced
phosphorus secretion/excretion includes post-prandial soluble phosphorus
secretion/excretion (page 8, paragraph [0221] - paragraph [0222]; page 24, paragraph [0536]; examples 12, 13). Therefore, the limitations of the claims are met by the reference.
11. Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2013102430 (of record in the application).
The reference discloses a bacterial-derived BP17 phytase (EC
3.1.3.26), used at 500, 750, 1000 or 2000 units/kg fish feed. Digestibility is improved and secretion/excretion reduced (page 2, paragraph [0010]; example 23; page 10, paragraph [0087] - page 12, paragraph [0094]). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert 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.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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