DETAILED ACTION
Applicant’s reply, filed 26 May 2026 in response to the restriction requirement mailed 24 February 2026, has been fully considered. As per Applicant’s election of Group I, claims 1-18, are pending under examination in the forms originally filed, and claims 19-20 are withdrawn (see below).
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 26 May 2026 is acknowledged.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 May 2026.
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 1-2, 4, 7, 9-10 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schryver et al (US 10,295,268).
Regarding claim 1, Schryver teaches phase change thermal-sink apparatuses (instant device) which comprise a cartridge for maintaining a desired temperature constructed by sealing a thermoconductive cover on a flexible base container that is filled with phase change material medium (abstract; Figs 1-3). Schryver teaches the device may be used to cool, maintain, and regulate temperatures of an external object (col 2 ln 50-54; col 6 ln 60-65) or may be used to warm or as a passive thermal buffer (col 15 ln 32-37). Schryver teaches external objects include biological samples, sample trays, sample tubes, etc. (col 4 ln 35-43) and various sample vessels (col 12 ln 34-50), as well as external objects not in direct contact (col 13 ln 412).
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Schryver teaches the flexible and expandible base container (Fig. 1, 110) is a non-porous flexible polymer material (col 2 ln 58-65; col 8, ln 15-24) which is moldable or may be a flexible bag (col 13 ln 63-67) (instant film material arranged to form a pouch). Schryver further teaches the thermoconductive cover (Fig. 1, 105) is a made of a thermoconductive material (col 3 ln 52-60) sealed to the base container (col 4 ln 11-23; col 5 ln 26-35; Fig. 1, 115), the underside of which may be laminated with a thin layer of plastic (col 8 ln 51-54). Schryver additionally teaches that a compressible element, in the form of closed cell foam, may be included in the cartridge which in contact with the phase change medium (col 5 ln 37-44)(instant solid carrier disposed within an inner cavity of the pouch).
Schryver further teaches the phase change medium is an aqueous or liquid medium, preferably water admixed with another substance such as alcohol (col 4 ln 63 to col 5 ln 5)(instant phase change material capable of liquid to gas phase transition), or may be a non-aqueous medium (col 9 ln 41-52).
The device as taught by Schryver includes thermoregulation of biological samples, organic materials, inorganic materials, chips, sample tubes, etc. in order to cool, warm or buffer transient temperature changes (see above), which can be considered temperature regulation devices for regulating temperature (see also In re Tuominen, 671 F.2d 1359, 213 USPQ 89 (CCPA 1982); In re Schreiber, 44 USPQ 2d 1429, (Fed. Cir. 1997)).
Regarding claim 2, Schryver teaches the device as set forth in claim 1 above and further teaches the base container is a non-porous flexible polymer material (col 2 ln 58-65; col 8, ln 15-24) which is moldable or may be a flexible bag (col 13 ln 63-67). Schryver teaches polymers include TitanTM polymers, PETG polymers, and other weatherable polymer materials (instant polyester).
Regarding claims 4 and 7, Schryver teaches the device as set forth in claim 1 above and, as noted, teaches an aqueous medium comprising water in combination with a further component including alcohol (col 4 ln 63 to col 5 ln 4)(instant solvent (claim 4); instant solvent mixture (claim 7)).
Regarding claim 10, Schryver teaches the device as set forth in claim 1 above and further teaches the sealing of the cover to the base contain may occur via adhesive, compression bands, and fusion welding, etc. (col 7 ln 58 to col 8 ln 3)(instant heat sealed).
Regarding claims 9 and 12-13, Schryver teaches the devices as set forth in claim 1 above and further teaches the internal volume of the cartridge can be altered/selected as needed, where illustrative volume ranges include microliters to milliliters (col 15 ln 8-13), where the cartridge is filled completely (col 14 ln 1-2) (substantially overlaps with and renders taught instant 0.25 mL to 2.0 mL (claim 9)).
Schryver further teaches the cartridge can be of any size usable in any application desired, where one can select the size that is appropriate (col 5 ln 45-49). Further, Schryver teaches any size and shape, where the size, thickness, and overall dimensions are selectable and adjustable to provide the optimal, most functional cartridge for the desired application (col 15 ln 4-12). As an example (see Fig. 1)(instant planar shape), Schryver describes a cartridge having dimensions of about 9” in length, 7.5” in width, and 2.5” in height (col 7 ln 42-43)(substantially overlaps with and renders taught instant about 10 to about 100 cm2 (claim 12); in combination, the above substantially overlaps with and renders taught instant ratio of about 2.5 to about 250 µm/cm2 (claim 13)).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schryver et al (US 10,295,268) in view of Moorman et al. (US 9,995,411).
Schryver teaches the devices as set forth in claim 1 above and teaches cartridges (see above). Schryver further teaches the flexible materials of the base container are selected from polymer materials including polyethylene, polypropylene, TitanTM, PETG, etc. and other weatherable polymer materials (col 2 ln 59-65). Schryver does not specifically teach biaxially oriented polyethylene terephthalate (BoPET)(claim 3). However, Moorman teaches cartridge devices wherein suitable/useful materials in the formation thereof include PET, in the form of bo-PET, and PETG polymers as equivalent materials (col 11 ln 5-15). Moorman and Schryver are analogous art and are combinable because they are concerned with the same field of endeavor, namely cartridge devices used in proximity with biological materials. In view of the recognition by Moorman that PETG and bo-PET are equivalent and interchangeable, it would have been obvious to one of ordinary skill in the art to substitute the PETG of Schryver with the Bo-PET of Moorman and thereby arrive at the present invention. Case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable (See In re Ruff 118 USPQ 343 (CCPA 1958; MPEP 2144.06).
Claims 5-6, 9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Schryver et al (US 10,295,268).
Regarding claims 5-6, Schryver teaches the device as set forth in claim 1 above and further teaches, as noted, that the phase change medium may include alcohols, as well as glycerol, polyethylene glycol, etc. (col 5 ln 1-4). Schryver does not specifically teach methanol, ethanol, or isopropanol (claim 5) or a boiling point of between about 20 and about 80 ºC (claim 6). However, as Schryver teaches use of alcohols it would have been obvious to one of ordinary skill in the art to select from the known and commonly available alcohols (wherein methanol and ethanol are the simplest and most readily, commercially available alcohols) having such boiling points and arrive at the instant invention with a reasonable expectation of success.
Regarding claim 11, Schryver teaches the device as set forth in claim 1 and teaches, as-noted above, a compressible element in the form of closed cell foam may be included in the cartridge which in contact with the phase change medium (col 5 ln 37-44). Further, Schryver teaches that all dimensions, thicknesses, and size aspects of the devices are selectable and adjustable to provide the optimal, most functional cartridge for the desired application (col 15 ln 4-13). As such, it would have been obvious to one of ordinary skill in the art at the time of filing to ‘substantially’ match the size of the compressible element included within the base container to ‘a planar’ surface thereof and arrive at the instant invention thereof. Motivation stemming from the teaching of Schryver that the compressible element is present to provide a reducible volume in response to external pressures (col 5 ln 39-44) and further that all dimensions, thicknesses, and sizes can be adjustable for optimal performance and functionality.
Regarding claims 9, 12 and 13, as an alternative to the above anticipation rejection, Schryver teaches the devices as set forth in claim 1 above and further teaches that the cartridge can be of any size usable in any application desired, where one can select the size that is appropriate (col 5 ln 45-49). Further, Schryver teaches any size and shape, where the size, thickness, and overall dimensions are selectable and adjustable to provide the optimal, most functional cartridge for the desired application (col 15 ln 4-12), and teaches the internal volume of the cartridge can be altered/selected as needed, where illustrative volume ranges include microliters to milliliters (col 15 ln 8-13), where the cartridge is filled completely (col 14 ln 1-2).
Schryver does not explicitly teach 0.25 mL to 2.0 mL volume of phase change medium, or a surface area of about 10 to about 100 cm2, or a volume to surface area ratio of about 2.5 to about 250 µm/cm2. However, the experimental modification of this prior art in order to ascertain optimum operating conditions fails to render applicant’s claims patentable in the absence of unexpected results (see: In re Aller, 105 USPQ 233; and MPEP 2144.05). At the time of the invention a person having ordinary skill in the art would have found it obvious to optimize the dimensions and internal volume of the cartridge and would have been motivated to do so as Schryver explicitly states any size and volume may be readily selected and adjusted to provide the optimal, most functional cartridge for the desired application. A prima facie case of obviousness may be rebutted, however, where the results of the optimizing variable, which is known to be result-effective, are unexpectedly good (see In re Boesch and Slaney, 205 USPQ 215).
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/970,704 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant and copending claims are directed to substantially similar temperature regulation systems comprising devices thermally regulating a biochemical reaction, comprising substantially similar pouch materials, phase change materials, and solid carrier materials, arranged in a substantially similar manner and having substantially similar materials, amounts, dimensions, etc.
While the claims of the copending application claim a solid carrier and claim nucleic acid amplification reactions, they are silent as to a fabric solid carrier and LAMP or RT-LAMP reactions, respectively. However, case law holds that those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in an application defines an obvious variation of an invention claimed in the patent (see In re Vogel, 422 F.2d 438, 164 USPQ 619,622 (CCPA 1970)). Therefore, it would have been obvious to one of ordinary skill in the art to select a fabric like presently claimed in the instant claims as the solid carrier as claimed by the copending application (as described by the specification of the copending application [0049]); and it would have been obvious to one of ordinary skill in the art to select LAMP or RT-LAMP reaction devices like presently claimed in the instant claims as the nucleic acid amplification reactions claimed by the copending application (as described by the specification of the copending application [0006]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANE L STANLEY whose telephone number is (571)270-3870. The examiner can normally be reached M-F 7:30 AM to 3:30 PM.
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/JANE L STANLEY/ Primary Examiner, Art Unit 1767
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