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 1-5 and 8-9, in the reply filed on December 22, 2025 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 30 March 2023, 23 October 2023, and 23 December 2024 have been considered and made of record.
It should be noted that the document numbers of the cited U.S. Patent Publications US 2018/211295 (Cite No. US3) and US 2020/071655 (Cite No. US4) appear to be incomplete/incorrect document number.
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.
Claim 3 is 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” in claim 3 is a relative term which renders the claim indefinite. The term “substantially” 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.
Appropriate correction is required.
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.
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) 1-3 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al. (US 2019/0169572; hereinafter “Shi”) in view of Thompson et al. (US 6,673,008; hereinafter “Thompson”) and Loderer et al (US 2018/0110913; hereinafter “Loderer”).
Regarding claims 1 and 8, Shi discloses a calibration cassette for use in an automated biological material engineering system, comprising: a low temperature chamber including a media storage vessel (see, e.g., FIGS. 6A-6B: chamber (604) including a media bag; [0012], [0159]-[0160]); a high temperature chamber separated from the low temperature chamber by a thermal barrier, the high temperature chamber including a cell culture chamber (see, e.g., FIGS. 6A-6B: chamber (606) including cell culture chamber (610), and is separated from chamber (604) by a thermal barrier; [0012], [0159]-[0160]); and one or more fluidics pathways connected to the cell culture chamber and the media
storage vessel (FIG. 6G; [0162], [0169]). Shi does not explicitly disclose a first array of sealed temperature probes in the media storage vessel, and a second array of sealed temperature probes in the cell culture chamber, a third array of sealed temperature probes in the one or more fluidics pathway and electrical connection elements that are electrically connected to each of the first, second, and third arrays of sealed temperature probes. However, Shi does disclose wherein the low temperature chamber and high temperature chamber are each maintained at a desired temperature (see, e.g., [0159]). Shi further discloses wherein a temperature sensor can be employed within the cassette to optimize the cell culture process ([0083]-[0084]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated at least one sensor into each of the low temperature chamber, high temperature chamber and one or more fluidics pathways in order to ascertain that the desired temperature had been achieved. Thompson discloses a system comprising a cartridge comprising a cell culture chamber having a first temperature sensor (FIG. 7: a cartridge comprising a sensor 192a; col. 25, ll. 22-33 and 44-48), a medium vessel having a second temperature sensor (FIG. 7: media reservoirs (142a), sensor (143a); col. 24, ll. 30-47), and electrical connection elements that are electrically connected to each of the first and second temperature probes (col. 24, ll. 35-40; col. 25, ll. 25-28). Loderer discloses a system comprising at least one cell culture medium fluidic pathway having a third temperature sensor connected to electrical connection elements that are electrically connected to a processor ([0029], [0031], [0068],[0072]). In view of Thompson and Loderer, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed the sensors of Thompson and Loderer with the cassette of Shi as claimed. One of ordinary skill in the art would have made said modification for the purpose of optimizing the cell culture process as disclosed by Shi ([0083]-[0084]) and Thompson (col. 24, ll. 30-47; col. 25, ll. 22-33 and 44-48). Modified Shi discloses the claimed invention except for the duplication of the first, second and third temperature probes. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the first, second and third temperature probes to comprise a first array of sealed temperature probes in the media storage vessel, and a second array of sealed temperature probes in the cell culture chamber, a third array of sealed temperature probes in the one or more fluidics pathway, wherein the first, second, and third arrays of sealed temperature probes in total include up to 12 sealed temperature probes, since it has been held that a mere duplication of working parts of a device involves only routine skill in the art (see also MPEP § 2144.04 VI. B. ). One would have been motivated to duplicate the first, second and third temperature probes of modified Shi for the purpose of enhancing the reliability of temperature measurement within the cassette. The first, second, and third arrays of temperature probes of modified Shi are considered to be sealed since the temperature probes are not directly exposed to the elements within the cassette.
Regarding claim 2, modified Shi further disclose wherein the media storage vessel is a bag (media bag; see [0159]), and wherein the first array of sealed temperature probes are attached to an internal surface of the bag (see Thompson, FIG. 7: sensor 192a; col. 25, ll. 22-33).
Regarding claim 3, modified Shi further disclose wherein the cell culture chamber is flat and substantially non-flexible (see Shi at [0163]; FIGS. 6D-6E), and wherein the second array of sealed temperature probes are attached to a bottom and/or a side of the cell culture chamber (see Thompson at FIG. 7: sensor 192a attached to a side portion of the cartridge (112); col. 25, ll. 22-33 and 44-48).
Regarding claim 9, modified Shi further disclose wherein the electric connection elements are electrically connected to a control circuit associated with the calibration cassette or to the automated biological material engineering system (computer control system; see Shi at [0084]-[0085], [0377]). Furthermore, it is noted that the automated biological material engineering system is not positively recited in the claims.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Thompson and Loderer as applied to claim 1 above, and further in view of Pethe (US 2014/0230929).
Regarding claim 4, modified Shi discloses the calibration cassette according to claim 1. Modified Shi further disclose wherein the one or more fluidics pathways include tubing and connectors (Shi at FIG. 6G: tubing component and connecting the component; [0013],[0162], [0169]; thus, the tubing component intrinsically includes connectors for connecting the tubing components), but does not explicitly disclose wherein the third array of sealed temperature probes are located within the tubing. Pethe discloses a system comprising a culture chamber (FIG. 3: bioreactor (14); [0040]), a media vessel having a temperature sensor (FIG. 3: vessel 12), and a fluidic pathway having a temperature sensor within the fluidic pathway (pathway between the media vessel (12) and bioreactor (14); [0040]-[0041]). In view of Pethe, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more fluidic pathways of modified Shi such that the temperature probe is located within the fluidic pathway as disclosed by Pethe. One of ordinary skill in the art would have made said modification because said modification would have been a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see also MPEP § 2144.04 VI. C.).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Thompson and Loderer as applied to claim 1 above, and further in view of Kjar et al (US 2015/0198549; hereinafter “Kjar”), Nakagawa et al (JP 2006-308401; with English machine translation; hereinafter “Nakagawa”) and Bi et al. (CN 208157400-U; with English machine translation; hereinafter “Bi”).
Regarding claim 5, modified Shi discloses the calibration cassette according to claim 1. Modified Shi discloses the claimed the first, second, and third arrays of sealed temperature probes, but does not explicitly disclose wherein the first, second, and third arrays of sealed temperature probes include resistance temperature detectors (RTD) hermetically sealed by a polymeric cover. Kjar discloses a system comprising a bioreactor and a temperature sensor probe such as resistance temperature detectors (RTD) (see [0071]). Nakagawa discloses that resistance temperature detector can be hermetically sealed with glass (see page 3 of the English machine translation document). Bi discloses wherein resistance temperature sensing unit can be covered with polymeric material so as to prevent corrosion of the resistance temperature sensing unit (see [0012] of the English machine translation document). In view of Kjar, Nakagawa and Bi, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the first, second, and third arrays of sealed temperature probes of modified Shi with the resistance temperature detectors (RTD) of Kjar ([0071]), that is hermetically sealed by a polymeric cover, as disclosed by Nakagawa and Bi to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known temperature probe for another for the predictable result of sensing temperature. Further, one of ordinary skill in the art would have made said modification in order to hermetically seal the temperature probes (see Nakagawa a t page 3) and thereby prevent corrosion of the temperature probes as disclosed by Bi (see [0012]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Smith et al. (US 2017-0096627) discloses a cassette system comprising a high temperature chamber including a cell culture chamber, and a low temperature chamber having a media vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799