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 13, 2023, August 12, 2024 and May 4, 2026, have been received and entered.
Restriction Requirement
3. Applicant’s election of Group III without traverse, on May 4, 2026, is acknowledged.
Claim Disposition
4. Claims 1-19 have been cancelled. Claims 29-42 have been added. Claims 20-42 are pending and are under examination.
Specification
5. The specification is objected to because of the following informalities:
The specification is objected to because trademarks are disclosed and they are not capitalized. The use of the trademark such as TRILON M, has been noted in this application (see page 66, 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.
The specification is objected to because the organism names are not consistently italicized, see “Bordetella” Table 19, page 64 for example.
Appropriate correction of the above is required.
Information Disclosure Statement
6. The Information Disclosure Statements filed on May 26, 2026, March 10, 2026, January 22, 2026, December 5, 2025, October 15, 2025 and December 6, 2023, have 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 some references have been lined through based on improper date citation or missing dates.
Claim Objection
7. Claims 20-42 are objected to because of the following informalities:
For clarity and precision of claim language, it is suggested that claim 20 is amended to read, “A method of processing….a target nucleic acid, [[the method]] comprising:
contacting the biological sample with a composition……..”. See also claim 21 with similar language. The dependent claims hereto are also included.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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 20-42 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention.
The claimed invention is also directed to a method of processing a biological sample comprising a target nucleic acid, comprising contacting a biological sample with at least one protease….(see claim 20 in its entirety). The specification discloses that the nucleic acid can be RNA or DNA, however, this does not represent adequate written description. The claimed method encompasses a large genus of nucleic acids that could be contained in a pulmonary sample.
The claimed invention is also directed to a method of inactivating infectious pathogens in a biological sample, comprising a target nucleic acid, comprising contacting the biological sample with a composition comprising at least one protease and an anionic detergent (see claim 21 in its entirety). The claimed invention is overly broad and not adequately described because it comprises a large genus of infectious pathogens, biological sample and target nucleic acids that are not defined.
The claimed invention encompasses a large variable genus that is not adequately described nor did applicant demonstrate possession of the entire genus. The claims are 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.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Moreover, 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 21 and 36-42 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 21 and the dependent claims hereto are indefinite for the recitation of a method to inactivate infectious pathogens in a biological sample and the sample is not identified, the pathogen that is infectious is not identified and the target is an unidentified nucleic acid in the unknow biological sample. The specification broadly construes biological sample". It would appear that the applicants understand a very large variety of materials as biological materials such as bodily fluids, viruses, bacteria, polymers including
polysaccharides, polypeptides. The metes and bounds of the claim language is vague rendering the claims as indefinite.
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) 21 and 36-42 is/are rejected under 35 U.S.C. 102(a)(1) and (a) (2) as being anticipated by WO 00/27082 (6/3/99, of record in the application).
The claimed invention is directed to a method of processing a biological sample and a method of inactivating infectious pathogens. The primary reference discloses detergent compositions (p.29, I.19). The surfactant is present at a level from 0.1% to 60% by weight (p.10, Iines 9-10). The enzymes are selected from proteases (i.e. protease subtilase), lipases, cutinases, amylases (p. 43, par.2). The reference discloses under the ‘Summary of Invention’ that,
In a third aspect the invention relates to an expression vector comprising an isolated DNA sequence encoding a subtilase variant of the invention. In a fourth aspect the invention relates to a microbial host cell transformed with an expression vector according to the fourth aspect . In a further aspect the invention relates to the production of the subtilisin enzymes of the invention by inserting an expression vector according to the fourth aspect into a suitable microbial host, cultivating the host to express the desired subtilase enzyme, and recovering the enzyme product .
Further the invention relates to a composition comprising a subtilase variant of the invention. Even further the invention relates to the use of the mutant enzymes for a number of industrial relevant uses, in particular for use in cleaning compositions and cleaning compositions comprising the mutant enzymes, especially detergent compositions comprising the mutant subtilisin enzymes such as Carlsberg (see pages 4 and 10, for example).
In addition, surfactants are disclosed such as alkyl sulfate (page 30, lines 10-37), buffer solution (detergent builder, page 42, lines 6-30) and several purification steps (including ultrafiltration), chelator and or/calcium chelator comprising Trilon M, trisodium citrate, EDT or EGTA (see page 42, Iines 6-10). The reference also teaches use of microbicide, bactericide, biocide, fungicide and/or benzisothiazolinone (BIT) (see page 50, lines 5-10). Stabilizing agents such as propylene glycol (see page 51, lines 14-34). Therefore, the limitations of the claims are met by the reference.
Conclusion
11. 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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