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 .
Continued Examination Under 37 CFR 1.114
`A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/20/2025 has been entered.
Status of claims
Claims 17, 21-25 and 28-33 as amended on 7/23/2025 are currently pending.
Claims 21-23, 30 and 32 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions.
Claims 17, 24, 25, 28, 29 and 33 as amended on 7/23/2025 are under examination in the instant office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17, 24, 25, 28, 29 and 33 as amended are rejected under 35 U.S.C. 103 as being unpatentable over Kassmannhuber et al (“Functional display of ice nucleation protein InaZ on the surface of bacterial ghosts”. BIOENGINEERED, 2017, Vol. 8, No. 5, pages 488-500), EP 1 829 890 (Yasuhiro)(IDS reference), and WO 2018/201161 (Shakeel et al).
The cited reference by Kassmannhuber (2017) discloses a bacterial preparation comprising inactivated bacterial ghosts (BGs) or fragments derived from recombinant E.coli that are carrying or comprising heterologous ice nucleation protein (INP) from Pseudomonas syringae, wherein INP is anchored or displayed on the outer membrane (see abstract).
The cited reference by Kassmannhuber does not teach that the bacterial ghosts and/or fragments carrying INPs are fixed with a fixation agent.
However, the prior art teaches, for example: EP 1 829 890 (Yasuhiro), teaches that polypeptides INP including INP derived from Pseudomonas syringae are difficult to be used in a pure form as materials for promoting freezing of water (par. 0006, 0008) and that these polypeptides are treated with cross-linking agents such as glutaraldehyde (0073).
The cited document WO 2018/201161 (Shakeel et al) clearly acknowledges that fixative agents including glutaraldehyde provide stability for cell-based preparations (0014), wherein the cell-based preparations comprise anucleated cells produced from bacteria including E.coli (par. 0009, pages 2-3) carrying heterologous polypeptide (page 4, last line) such as ice nucleation protein (page 5, line 7).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was made to modify the bacterial preparations carrying INPs disclosed by Kassmannhuber by treatment with a fixation agent or glutaraldehyde with a reasonable expectation of success in providing stable and beneficial preparations because prior art teaches and suggests that polypeptides INP including INP derived from Pseudomonas syringae are difficult to be used in a pure form as materials for promoting freezing of water and they should be treated with cross-linking agent or glutaraldehyde (EP 1 829 890) and that fixative agents including glutaraldehyde provide stability for cell-based preparations comprising cellular material including E.coli carrying heterologous polypeptide including INPs (WO 2018/201161).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 7/23/2025 have been fully considered but they are not all found persuasive.
Claim rejection under 35 U.S.C. 102 (a) (1) as being anticipated by WO 2018/201161 (Shakeel et al) has been withdrawn in view of applicants arguments (response page 6) and the as-filed specification definitions about “bacterial ghost” being an empty cell envelope from which cell content is ejected (par. 0029 of published application US 2022/0348614) while the cited anucleated minicells carrying INP comprise cytoplasm, RNA, etc (par. 00140 of Shakeel).
Claim rejection under 35 U.S.C. 101 was withdrawn in the prior office action in view of claim amendment drawn the use and/or incorporation of non-natural compound glutaraldehyde as a fixation agent.
With regard to claim rejection under 35 U.S.C. 103 Applicants’ main argument is that glutaraldehyde treatment of cells carrying ice nucleation protein leads to formation of ice crystals at relatively high temperatures as shown at example 7 and figure 5 of specification.
This argument is not found persussve because demonstrate formation of ice crystals at relatively high temperatures for E.coli cells carrying ice nucleation protein (InaZ-cyto and InaZ-OM) versus empty E.coli cells without INP (see par. 0126 of published application US 2022/0348614). Thus, it appears that formation of ice crystals at relatively high temperatures occurs as a result of incorporation of ice nucleation protein (InaZ-cyto and InaZ-OM) into cells E.coli rather than treatment with glutaraldehyde as argued.
Furthermore, the evidence necessary to overcome a prima facie case of obviousness must not only be clear and convincing, but must also be commensurate in scope with the claimed subject matter. It is well recognized that unexpected effects are highly unpredictable results that are very dependent on the ingredients used and the amounts of each. Thus, any combination for which unexpected effect is not clearly established would be properly rejected because non-obviousness would not have been established.
No claims are allowed.
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Vera Afremova
February 17, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653