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 January 7, 2025, has been received and entered.
Claim Disposition
3. Claims 16, 19-21 and 25-167 were canceled. Claims 1-15, 17-18 and 22-24 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on July 7, 2025, 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. Note that a few references have been lined through based on a missing date or improper citation of the date.
Abstract Objection
5. The abstract is objected to for the following informalities:
The abstract is objected to because the organism name is not italicized (see Bacillus subtilis).
The abstract is objected to for being very verbose. Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Appropriate correction is required.
Specification Objection
6. The specification is objected to for the following informalities:
The specification is objected to because the priority information does not state that this application is the national stage of PCT/EP2023/069902.
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: "Peroxidase based biocontrol agents and methods of using the same".
The specification is objected to because not all the organism names are italicized, see Botrytis cinerea on page 163, for example.
The specification is objected to because trademarks are disclosed and they are not all capitalized and don’t all have generic terminology. The use of the trademark such as TECAN, Microtiter, for example, has been noted in this application (see page 162, for example). It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner, which might adversely affect their validity as trademarks.
Appropriate correction is required.
Claim objection
7. Claims 1-15, 17-18 and 22-24 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “A method for [[preventing and/or]] controlling the growth and/or the spreading of a pathogen, [[said method]] comprising:
contacting the pathogen with a bacterial heme peroxidase”. The dependent claims hereto are also included.
For clarity and consistency it is suggested that claim 2 is amended to recite ‘the’ in lieu of ‘said’, for example, “……wherein [[said]] the bacterial heme peroxidase….….”. See also claims 3-15, 17, 22-24.
For clarity it is suggested that claim 6 is amended to read, “….a reducing agent, [[and/or (i)]] hydrogen peroxide and/or [[(ii)]] a hydrogen peroxide donor system[[;]] in an aqueous solution.
For clarity it is suggested that claim 7 is amended to read, “…sugar substrate, that is glucose….”.
For clarity it is suggested that claim 8 is amended to read, “…..at least one [[further]] additional agent.” See also claim 9 with similar language.
For clarity it is suggested that claim 11 is amended to read, “…a mammal, [[or]] or a crop [[, wherein the method is non-therapeutic and/or is not a method for treatment of the human or animal body by therapy]]”.
For clarity it is suggested that claim 12 is amended to recite, “……fungi, [[moulds]] molds [[and]] yeasts [[,]] and bacteria [[, pathogenic bacteria]]”.
For clarity it is suggested that claim 13 is amended to read, “[[A]] The bacterial heme peroxidase [[as defined in]] of claim 2, [[for use in the prevention and/or controlling of]] wherein the bacterial heme peroxidase controls a pathogen….an animal body”.
For clarity it is suggested that claim 14 is amended to read, “The bacterial heme peroxidase [[for use]] of claim 13…..is [[to be brought into contact]] contacted with [[biological ]] tissue or skin of the [[said]] human or animal [[,in particular with]] , and wherein the tissue is mucosae [[or with skin, in particular epidermal skin like]] and the skin is scalp or facial [[skin]]”.
For clarity it is suggested that claim 15 is amended to read, “A method for [[preventing and/or]] controlling…..,[[said method]] comprising:
applying [[a sufficient amount of a]] the bacterial heme peroxidase [[as defined in]] of claim 1……”.
For clarity it is suggested that claim 17 is amended to recite, “wherein” in lieu of “whereby”. In addition, claim 17 should be amended to spell out the acronym (ABTS).
For clarity and precision of claim language it is suggested that claim 18 is amended to read, “A bacterial heme peroxidase, wherein [[for use in preventing and/or controlling]] the bacterial heme controls growth and/spreading of a pathogen in or on [[the]] a human or an animal body [[and /or for use]] as a medicament”.
For clarity it is suggested that claim 22 is amended to read, “The bacterial heme peroxidase [[for use]] of claim 18….”.
For clarity it is suggested that claim 23 is amended to read, “The bacterial heme peroxidase [[for use]] of claim 18, wherein [[said]] the bacterial heme..……[[as defined]] and is set forth in SEQ ID NO: 1……[[ or a functional fragment thereof]]”. See also claim 4 with similar language.
For clarity it is suggested that claim 24 is amended to read, “The bacterial heme peroxidase [[for use]] of claim 18…….wherein the [[amino acid sequence of said]] bacterial heme peroxidase has an amino acid sequence that is at least [[about 40%, 50%60%, at least about 70%, at least about 80%, 82%, 85%, at least about 90%, 91%, 92%, 93%, 94%,]] identical to SEQ ID NO: 1…..SEQ ID NO:11, and SEQ ID NOs: 25-27 [[,wherein the amin acid sequence of said bacterial heme peroxidase is at least about 82%, 85%, 90%, 91% or 92% identical to SEQ ID NO: 1, SEQ ID NO: 18, SEQ ID NO: 11 and SEQ ID NO-25-27]]”. See also claims 4-5 with similar language.
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.
8. Claims 1-15, 17-18 and 22-24 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 preventing and/or controlling the growth and/or the spreading of a pathogen, comprising contacting the pathogen with a bacterial heme peroxidase”. The invention is also directed to an amino acid sequence at least about 40, 50, 60, 70% etc. identical to 6 different structures or a functional fragment thereof, and the claimed invention is devoid of any specific structural limitations with functional language. The claimed invention encompasses a large variable genus of fragments thereof that may not retain function and is not adequately described structurally. The invention is directed to preventing growth and spreading of a pathogen and there is no specific pathogen recited in the claim. The claimed invention is broad and not in scope with the disclosure in the specification because it has not demonstrated the ability to prevent any and all pathogens from growing and spreading with a bacterial heme peroxidase from any origin and with any structure. The claimed invention also encompasses a large genus of fragments, reducing agents, further agents (including also any peptides, proteins etc.), any living organisms and any route of administration of any medicament/therapy. The claimed invention is overly broad 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, 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.
9. Claims 1-15, 17-18 and 22-24 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, 18 and the dependent claims hereto are indefinite for the recitation of preventing because its functional scope creates a zone of uncertainty for a person of ordinary skill because the word prevention connotes absolute 100% whereas it can also be construed as substantial reduction. Is the method achieving total prevention, absolute prevention or substantial reduction.
Claim 5 lacks clear antecedent basis for the recitation of “the amino acid sequence’’. See also claim 24 with similar language.
Claim 11 lacks clear antecedent basis for the recitation of “the human or animal body’’.
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) 1-5, 13, 18 and 22-24 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by DATABASE UniParc (of record in the application, Aug. 2017).
The reference discloses a 659 amino acid protein from Hydrocoleum sp. CS-953. The sequence is a 100% identical to SEQ ID NO: 1 of the instant application and 91.8% identical with SEQ ID NO:11 of the application (see the entire document). Peroxidases are an enzyme group that inherently break down toxic hydrogen peroxide and other peroxides in living cells (thus defend against diseases). Therefore the limitations of the claims are met by the reference.
11. Claim(s) 1-5, 13, 18 and 22-24 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by DATABASE UniParc (of record in the application, June 2020).
The reference discloses a 659 amino acid protein from Okeania sp. SIOF9 with a sequence that is 91.8% identical to SEQ ID NO:1 and 99.7% identical with SEQ ID NO:11 of the application (see the entire document). Peroxidases are an enzyme group that inherently break down toxic hydrogen peroxide and other peroxides in living cells (thus defend against diseases). 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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