DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The amended claim set filed on 8 May 2026 is acknowledged. Claims 17, 19-21, 23, 29, 32-33, 35-39, 41-45, and 47-51 are currently pending. Of those, claims 17, 19-21, 23, 29, 32-33, 35-39, 41-45, and 49 are amended. Claims 50-51 are new, and no claims are withdrawn. Claims 1-16, 18, 22, 24-28, 30-31, 34, 40, and 46 are cancelled. Claims 17, 19-21, 23, 29, 32-33, 35-39, 41-45, and 47-51 will be examined on the merits herein.
Response to Amendment
Applicants’ arguments filed 8 May 2026 is acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks”, and the Non-Final Office Action mailed 9 January 2026 will be referred to as “NFOA”.
Priority
The instant application is a 371 of application PCT/AU2021/051121 (filed 24 September 2021) and claims priority to Australian Provisional Application No. 2020903460 (filed 25 September 2020). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, there does not appear to be support in either the PCT application or the foreign priority document for the limitations “the landing zones… do not comprise a nuclease recognition site or nuclease target sequence” in claim 17 or “wherein the landing zones do not comprise a recognition site for a site-specific nuclease and the recombination does not involve cleavage at a recognition site for a site-specific nuclease” in claims 17 and 19-21. Therefore, for the purposes of searching the prior art, the effective filing date of instant claims 17, 19-21, 23, 29, 32-33, 35-39, 41-45, and 47-51 is 24 March 2023.
Objection(s) and Rejection(s) Withdrawn
The objections to the disclosure are withdrawn in view of the amendments to the specification.
The objections to claims 19-20 and 29 are withdrawn in view of the amendments to the claims.
The objections to claims 30-31 are moot because the claims are cancelled.
The rejection of claims 17, 19-21, 23, 29, 32-33, 35-39 and 41-43 under 35 U.S.C. 112(b) is withdrawn in view of the amendments to the claims.
The rejection of claims 17, 19-21, 23, 29, 32-33, 35-39, 41-45, and 47-49 under 35 U.S.C. 112(a) is withdrawn in view of the amendments to the claims.
The rejection of claims 17, 19-21, 23 and 47-49 under 35 U.S.C. 102 is withdrawn in view of the amendments to the claims.
The rejection of claims 17, 19-21, 23, 29, 32-33, 35-39, 41-43, and 47-49 under 35 U.S.C. 103 is withdrawn in view of the amendments to the claims.
The rejection(s) of 18, 22, 26-28, 30-31, 34, 40, and/or 46 under 35 U.S.C. 112(b), 112(a), 102, and/or 103 are moot because those claims are cancelled.
Claim Objections
Claims 47-49 remain objected to and claim 17 is newly objected to because of the following informalities:
In claim 17, line 22, “thenucleic acid cassette” should read “the nucleic acid cassette”, and
In claims 47-49, bacterial genera and species names (e.g., Synechocystis sp., Synechococcus sp., Synechococcus elongatus, Anabaena variabilis, and Leptolyngbya sp.) should be italicized.
Appropriate correction is required.
New Rejection(s)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112(b)
Claims 17-19 are newly 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.
The term “substantially homologous” in claims 17 and 19 is a relative term which renders the claim indefinite. The term “substantially homologous” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As written, one cannot determine the threshold of homology necessary to determine if a given sequence is “substantially” homologous with another. In the interest of compact prosecution two homologous sequences are assumed to be substantially homologous unless the art teaches otherwise.
Clarification is requested.
Claim Rejections - 35 USC § 112(a)
Claims 17, 19-21, 23, 29, 32-33, 35-39, 41-45, and 47-51 are newly 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. This is a new matter rejection.
Claim 17 has been amended to recite “the landing zones… do not comprise a nuclease recognition site or nuclease target sequence” and claims 17 and 19-21 have been amended to recite “wherein the landing zones do not comprise a recognition site for a site-specific nuclease and the recombination does not involve cleavage at a recognition site for a site-specific nuclease.” However, there does not appear to be a written description of the claim limitations in the application as filed.
Applicant has pointed out para. 40-44, 54-55, and 84-93 of the instant specification (Remarks pg. 12). However, there is no description of a nuclease recognition site, nuclease targeting sequence, site-specific nuclease, or cleavage at a recognition site for a site-specific nuclease in any of these paragraphs. From MPEP 2173.05(i): “Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977)” Because the specification does not teach the new limitations, either by positively reciting them or by specifically teaching their exclusion, there is not sufficient support for these new limitations in the disclosure.
Accordingly, the newly added limitations constitute new matter.
Claims 23, 29, 32-33, 35-39, 41-45, and 47-51 are dependent upon claims 17 and 19-21 and thus require the elements recited in the newly added limitations; thus, these claims are also rejected.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAMIRA JEAN-LOUIS can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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