DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of the species of peptide/protein in claim 15, and first antibody/fragment and second antibody/fragment in claim 23, in the reply filed on 20 January 2026 is acknowledged. However, upon further search and consideration, all of the species of claims 15 and 23 are rejoined, and hereafter examined on the merits.
Claims 1-16, 18, 21, 23, and 37 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2021/060164, filed November 19, 2021, which claims priority to U.S. Provisional Application No. 63/115936, filed November 19, 2020.
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 1-16, 18, 21, 23, and 37 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 1 recites the limitation "the surface" in step (c). There is insufficient antecedent basis for this limitation in the claim. No surface is previously recited in the claim.
Claims 2-16, 18, 21, 23, and 37 are included in this rejection, as these claims depend from above rejected claims and fails to remedy the noted deficiencies.
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.
Claims 1-15, 18, 21, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mohanty et al. (US 2017/0135336; Published 2017).
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With regard to claim 1, Mohanty et al. teach a method for vitrification of biological materials above cryogenic temperature (Abs.; claim 1). Referring to Fig. 5, reproduced here, the method comprising: (a) overlaying a vitrification mixture (52) comprising a biological sample and a vitrification medium on a substrate comprising a capillary network (53), where the substrate is in an enclosure (55), which is a desiccation chamber (Para. 67); (b) a reduced pressure is maintained inside the enclosure (55) (Para. 68), which is lowering the atmospheric pressure within the desiccation chamber; (c) performing the capillary assisted vitrification method at a temperature of 25°C (Para. 81), which is providing a heat energy from the surface to the vitrification mixture, wherein the heat energy is sufficient to prevent the vitrification mixture from experiencing a freezing condition; and (d) desiccating the vitrification mixture by capillary action until the vitrification mixture enters a glassy state (Para. 67).
With regard to claim 2, Mohanty et al. teach that the capillary network is provided by contours along the surface of the substrate (see Fig. 5, 6A).
With regard to claim 3, as Mohanty et al. teach the desiccation chamber with the substrate therein (Fig. 5; Para. 67), the substrate is associated with a wall of the desiccation chamber.
With regard to claim 4, Mohanty et al. teach that the capillary network within the desiccation chamber is contacted by an underlying solid support substrate (Fig. 6A, Para. 69).
With regard to claims 5 and 6, Mohanty et al. teach the method as claimed, including the components as claimed. As such, the results that vitrification of the vitrification mixture occurs in less than 30 minutes, or less than 10 minutes, would naturally flow from performance of the method as taught by Mohanty et al.
With regard to claim 7, Mohanty et al. teach that the capillary assisted vitrification may be performed at a temperature up to 60°C, including 25°C (Para. 81). Thus, the heat energy is provided by heating the vitrification mixture to provide for vitrification.
With regard to claim 8, Mohanty et al. teach that the atmospheric pressure is lowered to less than 1 atm, including to 100 mmHG (0.1 atm) or 10 mmHg (0.01 atm) (Para. 83), which are fully encompassed withing about 0.9 atm to about 0.005 atm, and with are deemed to be “about” 0.004 atm, as a specific definition for “about” is not provided by in the instant specification.
With regard to claims 10 and 11, Mohanty et al. teach that the method is performed at a vitrification temperature of from 0.1°C to 40°C (Para. 81), which is providing heat energy sufficient to keep the biological sample at a temperature of from about 0 °C to about 40 °C during vitrifying; and providing heat energy sufficient to prevent crystallization within the vitrification mixture during vitrification.
With regard to claim 12, Mohanty et al. teach that the vitrification medium comprises trehalose, glycerol and betine and/or choline (Para. 78, 80).
With regard to claim 13, Mohanty et al. teach that the capillary network is hydrophilic (Para. 64-65; Fig. 4).
With regard to claim 14, Mohanty et al. teach that the capillary network comprises contiguous capillary channels (see Fig. 5, 6A, 7B; claim 1a).
With regard to claim 15, Mohanty et al. teach that the biological sample includes proteins, and also includes cells, tissues, organs, and cell-based constructs (Para. 50), which inherently comprise nucleic acids, amino acids, polynucleotide chains, peptides, proteins, and/or antibodies.
With regard to claim 18, Mohanty et al. teach that the biological sample is Chinese Hamster Ovary (CHO) cells, where a 20µL sample of the CHO cells having a concentration of 1x105 cells/mL is placed on top of the capillary substrate as part of the vitrification mixture (Ex. 1, Para. 95-96). CHO cells range in mass from about 199-293 pg per cell (see Art of Record: Szeliova et al.), which provides for a biological sample having a mass of about 0.002µg to about 0.003µg present in the vitrification mixture, which is fully encompassed within 1 µg or less.
With regard to claim 21, Mohanty et al. teach that the vitrification mixture further comprises trehalose (Para. 12), which is a second material.
With regard to claim 23, Mohanty et al. teach that the vitrification mixture comprises an enzyme as the biological material (Para. 50), which is a first reagent material that is a first enzyme. Additionally, Mohanty et al. teach that the vitrification mixture further comprises trehalose (Para. 12), which is a second reagent material.
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 1, 16, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Mohanty et al.
The teachings of Mohanty et al. as applied to claim 1 have been set forth above.
With regard to claim 16, Mohanty et al. teach that the substrate is a PDMS cast with a dimension of 0.25 inch x 0.38 inch, which is an area of 61.3 mm2, having a polypropylene membrane on the substrate to provide the capillary action to desiccate the cells (Ex. 1, Para. 95), where a 20µL sample of cells is then placed on the substrate for vitrification (Para. 96). Which is overlaying the vitrification mixture on the substrate at a volume of 0.3 µl/mm2. It would have been routine for one of ordinary still in the art to adjust the volume of the vitrification mixture overlayed on the substrate depending on factors including the type of biological sample to be vitrified, the pore width and depth, the vitrification temperature utilized, the pressure applied, and the additional components present in the vitrification mixture. Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the volume of the vitrification mixture overlayed on the substrate, including to a volume of 0.1 to 0.25 µL/mm2, to result in an overlay of appropriate thickness given factors including the type of biological sample to be vitrified, the pore width and depth, the vitrification temperature utilized, the pressure applied, and the additional components present in the vitrification mixture, to result in a method that provides a biological sample that has been vitrified as desired when practicing the taught method.
With regard to claim 37, Mohanty et al. teach the method of claim 1, including the steps of (a)-(d) as set forth in the anticipation rejection above. While it is not specifically taught that the steps of the process are repeated a second time with a second vitrification mixture, it would have been obvious to one of ordinary skill in the art to repeat the method as desired to provide for additional vitrified biological materials. Further, Mohanty et al. teach that the vitrification mixture can include trehalose, glycerol, choline, and/or betine (Para. 12), which are a second reagent material. As such, it would have been obvious to include a second reagent material in the second reagent mixture.
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 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 9, and 10 of U.S. Patent No. 10,568,318. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a process for vitrification of one or more biological materials above cryogenic temperature, the process comprising: overlaying a vitrification mixture comprising a biological sample and a vitrification medium on a substrate comprising a capillary network in a desiccation chamber; lowering the atmospheric pressure within the desiccation chamber; providing a heat energy from the surface to the vitrification mixture, wherein the heat energy is sufficient to prevent the vitrification mixture from experiencing a freezing condition; and desiccating the vitrification mixture by capillary action until the vitrification mixture enters a glassy state; and the vitrification medium comprising trehalose, glycerol, and betine and/or choline. (Instant claims 1, 12; Cited patent claims 1, 5, 6, 9, 10).
Claims 1 and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 7, 10, and 11 of U.S. Patent No. 11,576,374. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a process for vitrification of one or more biological materials above cryogenic temperature, the process comprising: overlaying a vitrification mixture comprising a biological sample and a vitrification medium on a substrate comprising a capillary network in a desiccation chamber; lowering the atmospheric pressure within the desiccation chamber; providing a heat energy from the surface to the vitrification mixture, wherein the heat energy is sufficient to prevent the vitrification mixture from experiencing a freezing condition; and desiccating the vitrification mixture by capillary action until the vitrification mixture enters a glassy state; the vitrification medium comprising trehalose, glycerol, and betine and/or choline; and the capillary network is hydrophilic and comprises contiguous capillary channels (Instant claims 1, 12-14; Cited patent claims 1, 2, 6, 7, 10, 11).
Claims 1, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 7, 10, and 11 of U.S. Patent No. 12,075,773. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a process for vitrification of one or more biological materials above cryogenic temperature, the process comprising: overlaying a vitrification mixture comprising a biological sample and a vitrification medium on a substrate comprising a capillary network in a desiccation chamber; lowering the atmospheric pressure within the desiccation chamber; providing a heat energy from the surface to the vitrification mixture, wherein the heat energy is sufficient to prevent the vitrification mixture from experiencing a freezing condition; and desiccating the vitrification mixture by capillary action until the vitrification mixture enters a glassy state; the vitrification medium comprising trehalose, glycerol, and betine and/or choline; and the capillary network is hydrophilic and comprises contiguous capillary channels (Instant claims 1, 12, 13; Cited patent claims 1, 2, 6, 7, 10, 11).
Claims 1, 2, 5, 6, 8-11, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 12, 14, 17, 19, 21, 23, and 24 of copending Application No. 18/571569 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a process for vitrification of one or more biological materials above cryogenic temperature, the process comprising: overlaying a vitrification mixture comprising a biological sample and a vitrification medium on a substrate comprising a capillary network in a desiccation chamber; lowering the atmospheric pressure within the desiccation chamber; providing a heat energy from the surface to the vitrification mixture, wherein the heat energy is sufficient to prevent the vitrification mixture from experiencing a freezing condition; and desiccating the vitrification mixture by capillary action until the vitrification mixture enters a glassy state (Instant claims 1; Cited patent claims 1, 14).
The capillary network is provided by contours along the surface of the substrate (Instant claims 2; Cited patent claims 17). Vitrification of the vitrification mixture occurs in less than 30 minutes (Instant claims 5, 6; Cited patent claims 19). The atmospheric pressure is lowered to a value of from about 0.9 atm to about 0.005 atm, and about 0.004 atm (Instant claims 8, 9; Cited patent claims 21). The heat energy provided is sufficient to prevent crystallization of the bioactive agent within the vitrification mixture during vitrification, and is sufficient to keep the bioactive agent at a temperature of from about 0°C to about 40°C during said vitrifying (Instant claims 10, 11; Cited patent claims 23, 24). The biological sample is selected from the group consisting of a nucleic acid, an amino acid, a polynucleotide chain, a peptide, a protein, and an antibody (Instant claims 15; Cited patent claims 9, 10, 12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 and 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 8-11, 13, 14, 16, 17, and 23 of copending Application No. 18/253077 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a process for vitrification of one or more biological materials above cryogenic temperature, the process comprising: overlaying a vitrification mixture comprising a biological sample and a vitrification medium on a substrate comprising a capillary network in a desiccation chamber; lowering the atmospheric pressure within the desiccation chamber; providing a heat energy from the surface to the vitrification mixture, wherein the heat energy is sufficient to prevent the vitrification mixture from experiencing a freezing condition; and desiccating the vitrification mixture by capillary action until the vitrification mixture enters a glassy state; and the vitrification medium comprises trehalose and glycerol (Instant claims 1, 12; Cited patent claims 1, 23).
The capillary network is provided by contours along the surface of the substrate (Instant claims 2; Cited patent claims 8). The substrate is a wall of the desiccation chamber or is associated with a wall of the desiccation chamber; and the capillary network within the desiccation chamber is contacted by an underlying solid support substrate (Instant claims 3, 4; Cited patent claims 9, 10). Vitrification of the vitrification mixture occurs in less than 30 minutes (Instant claims 5, 6; Cited patent claims 11). The atmospheric pressure is lowered to a value of from about 0.9 atm to about 0.005 atm, and about 0.004 atm (Instant claims 8, 9; Cited patent claims 14). The heat energy is provided by heating the vitrification mixture; the heat energy provided is sufficient to prevent crystallization of the bioactive agent within the vitrification mixture during vitrification, and is sufficient to keep the bioactive agent at a temperature of from about 0°C to about 40°C during said vitrifying (Instant claims 7, 10, 11; Cited patent claims 13, 16, 17). The biological sample is selected from the group consisting of a nucleic acid, an amino acid, a polynucleotide chain, a peptide, a protein, and an antibody (Instant claims 15; Cited patent claims 2, 6).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Art of Record:
Szeliova et al., What CHO is made of: Variations in the biomass composition of Chinese hamster ovary cell lines, Metabolic Engineering, Vol. 61, (2020), pp. 288-300 (CHO cells range in mass from about 199-293 pg per cell).
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653