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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4) in the reply filed on 10/27/2025 is acknowledged.
Claims 5-20 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-4 have been considered on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because of the following informalities: the instant specification discloses the following paragraph at p.5.
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It appears that the phrase of “temperature of 0°C to 80°C” should be “temperature of 0°C to -80°C” instead.
Appropriate correction is required.
Claim Interpretation
Claims 1-2 are interpreted as a composition comprising plurality of cryo-silicified cells comprising accessible biological information including nucleic acids and/or proteins. The term “library” is not particularly defined in the instant specification, and thus, it is interpreted as any mixture of cryo-silicified cells or a population of any cryo-silicified cells.
Claim 3 is interpreted as the cryo-silicified cells being any mammalian cell under the broadest reasonable interpretation. The limitation directed to “prepared from cells isolated from a patient infected with a virus, diagnosed as having a disease, or both” does not particularly limit the cells in their properties rather the limitation is directed to the patient. Thus, the scope of the claimed cells “prepared from cells isolated from a patient infected with a virus, diagnosed as having a disease, or both” encompass those normal cells as well as infected or diseased cells.
Claim 4 is interpreted that the claimed cells of claim 1 is tumor cells, B cells or tissue cells (i.e. any mammalian cells).
Claim Rejections - 35 USC § 112
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.
Claims 1-4 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.
The term “library” in claim 1 and its dependent claims is not clear what subject matter this term intends to point out. Is this meant to be intended purpose/use of the claimed cell being a part of a cell library? Does the term have any particular structure given to the composition other than “plurality” as disclosed in the claims? Clarification is required.
The term “cryo-silicified” is not clear what this term intends to point out. According to the definition given in the instant specification, the term “cryo-silicification” refer to the process of silicification of sample where the silicification process occurs at room temperature for a period of time followed by subsequent incubation of the sample in an environment with a temperature of 0°C to 80°C for a period of time. The definition given in the specification does not disclose how this term or the process reflects “cryo-” of the term. The definition refers to the subsequent incubation of the silicified sample in an environment with a temperature that does not belong to any “cryopreservation”. Clarification is required. For search purpose, this term is interpreted as the silicified cells being cryopreserved.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2014, Angew. Chem. Int. Ed.) in view of Lei et al. (2021, JACS; published 4/7/2021) as evidenced by HeLa (2023, Product Sheet; ATCC)
Lee et al. teach a cytoprotective silica coating for individual mammalian cells using bioinspired silicification (see entire document). Lee et al. teach that HeLa cells were silicified (HeLa@SiO2 cells) after culturing and detaching the cells from culture flask, and thus, the HeLa@SiO2 cells are plurality of individually silicified HeLa cells. The term “library” is interpreted as an intended purpose of the composition being used as a part of a cell library, and thus, the teaching of Lee et al. would meet the “library composition” as the term is broadly interpreted as any population of cryo-silicified cells or a population of any cryo-silicified cells.
Regarding the “cryo-silicified cells”, Lee et al. do not teach that the silicified cells are cryopreserved.
Lei et al. teach that cryo-silicification promises to provide for long-term genome and proteome preservation needed for personal bioinformation identification (p.14, 2nd col.). Lei et al. also teach that the technique of cryo-silicification conducted at -80°C without fixation to silicify cancer cells (p.13, 2nd col.).
It would have been obvious to a person skilled in the art to cryopreserve the silicified HeLa cells of Lee et al. with a reasonable expectation of success because Lei et al. teach the cryopreservation of silicified tumor cells for long-term genome and proteome preservation.
Furthermore, a person of ordinary skilled in the art would have been motivated to combine cryopreservation and silicification because it is known in the art that silicification is an alternative to cryopreservation according to Lei et al. (see Abstract)
As the silicification is an alternative storage method to the cryopreservation, one skilled in the art would utilize both means known in the art for the same purpose of storing mammalian cells (see MPEP2144.06).
Regarding the wherein clause of claim 1 directed to at least a portion of the cryo-silicified cells comprises accessible biological information, and the biological information being genetic information, proteomic information or transcriptomic information (claim 2), the silicified cells of Lee et al. would inherently contain these information as the HeLa cells coated with silica by silicification would have intact cellular materials including nucleic acids and proteins present in the cells as the silicification is a means known in the art for biological preservation.
Regarding claim 3, the HeLa cells of Lee et al. are considered as cells from a patient diagnosed as having a disease because HeLa cells are known as cervical carcinoma cells taken from a patient having cervical carcinoma (see HeLa Product Sheet from ATCC).
Regarding claim 4, the HeLa cells of Lee et al. are tumor/cancer cells according to HeLa Product Sheet.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,896,653 in view of Lei et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘653 patent disclose a composition comprising a silicified cell which is a tumor cell, and the cell is part of a spheroid or organoid, and the tumor cell is from a subject having or at risk of having the tumor. While the claims of the ‘653 patent do not particularly teach the composition comprising a silicified tumor cell being cryopreserved, however, it would have been obvious to a person skilled in the art to cryopreserve the silicified tumor cells of the ‘653 patent as Lei et al. teach that cryo-silicification promises to provide for long-term genome and proteome preservation needed for personal bioinformation identification (p.14, 2nd col.). Furthermore, Lei et al. teach that silicification is an alternative method to cryopreservation to store cells, and one skilled in the art would combine the equivalent methods for the same purpose. While the claims disclose “a silicified cell” or “a tumor cell”, these terms are interpreted as one or more rather than a single cell based on the definition given in the specification of the ‘653 patent with regard to the term “a” and “an” (col. 15, lines 37-40).
Thus, the claims of the ‘653 patent in view of Lei et al. render the claims of the instant application obvious.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631