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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 25, 2026 has been entered.
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
Claim Objections
Claims 2-3, 5, 8-11 and 16-17 are objected to because of the following informalities: In claims 2-3, 5, 8-11 and 16-17, “the disposable component” should read “the component” for consistency. Appropriate correction is required.
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.
Claim 1, 13-14 and 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schick et al. (already of record, US 2012/0242993; hereinafter “Schick”).
Regarding claim 1, Schick discloses an in situ probe, comprising: a component that is attached to and disposable with a single-use disposable bioreactor bag (FIG. 6: sensor assembly (606) releasably attached to a disposable bioreactor bag; see abstract, [0042], [0014], [0102], [0104]), wherein the component includes a radiation source (FIG. 6: LED 624; [0105]) and a detector (FIG. 6: detector (630); [0105]).
Regarding claim 13, Schick discloses a rocking bioreactor, comprising: a disposable single-use bioreactor bag (FIG. 6A: bioreactor 604; [0036], [0102]-[0104]); and an in situ probe integrally attached to the disposable bioreactor bag (FIG. 6: sensor assembly (606) integrally coupled to the disposable bioreactor bag 604; see Abstract; [0102], [0104]), wherein the in situ probe includes a disposable radiation source and/or a disposable detector for detecting radiation generated by the radiation source (FIG. 6: LED 624 and detector 630; see [0105]).
Regarding claim 14, Schick discloses the rocking bioreactor of claim 13. Schick further discloses the process of analyzing spectroscopically analytes in the bioreactor bag ([0105], [0110]-[0111]).
Regarding claim 16, Schick further discloses wherein the bioreactor bag and the disposable component are pre-sterilized (a pre-sterilized sensor is coupled to a pre-sterilized system including bioreactor bag; abstract, [0012], [0016]).
Regarding claim 17, Schick further discloses wherein a reusable component is configured to fit or slide into the disposable component (FIG. 6: a reusable sensor assembly 606 is matted with the optical inset 602 coupled to the bioreactor; [0014], [0016], [0036] and [0102]).
Regarding claim 18, Schick discloses the rocking bioreactor according to claim 13 as set forth above. Schick further discloses a process for monitoring the rocking bioreactor as described in claim 13, the process comprises measuring viability of cells in the bioreactor bag, wherein a front of light is distorted by a turbidity caused by live cells (turbidity of living cells is measured by said in situ probe; [0012], [0016], [0020]).
Regarding claim 19, Schick discloses an in situ probe, comprising: a reusable component and a disposable component, the disposable component being attached to a bioreactor bag, wherein, the reusable component includes a radiation source and the disposable component includes a detector for detecting radiation generated by the radiation source (FIG. 6: sensor assembly (606) releasably attached to a disposable bioreactor bag; the sensor assembly (606) includes LED (624) that can be reused, and a detector that can be disposed; see abstract, [0042], [0014], [0102], [0105]); or wherein, the reusable component includes the detector for detecting radiation generated by the radiation source, and the disposable component includes the radiation source (FIG. 6: sensor assembly (606) releasably attached to a disposable bioreactor bag; the sensor assembly (606) includes LED (624) that can be disposed, and a detector that can be reused; see abstract, [0042], [0014], [0102], [0105]). Furthermore, it is noted that the components of the in situ probe of Schick meet all of the structural features of the claimed components and thus considered to meet the limitation “a reusable component and a disposable component.”
Regarding claim 20, Schick discloses a single use flexible bag, comprising: a disposable component of an in situ probe (FIG. 6: sensor assembly (606) that is disposable releasably attached to a disposable bioreactor bag; see abstract, [0042], [0014], [0102], [0104]), wherein, the disposable component includes a radiation source, a detector for detecting radiation generated by the radiation source, or both the radiation source and the detector (FIG. 6: LED 624 and detector 630; see [0105]).
Regarding claim 21, Schick further discloses wherein the in situ probe is located at a bottom of the flexible bag (FIG. 6: optical inset component (602) integrated into a bottom portion of the disposable bioreactor bag (604) and removable attached to the reusable sensor assembly (606; corresponds to the instant in situ probe); see abstract; [0102], [0104]).
Regarding claim 22, Schick further discloses wherein the in situ probe is located at a bottom of the disposable bioreactor bag (FIG. 6: optical inset component (602) integrated into a bottom portion of the disposable bioreactor bag (604) and removable attached to the reusable sensor assembly (606; corresponds to the instant in situ probe); see abstract; [0102], [0104]).
Therefore, Schick meets and anticipates the limitations set forth in claim(s) 1, 13-14 and 16-22.
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 1, 3-6, 8-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (already of record; US 10,018,568; hereinafter “Seo”) in view of Koerperick et al. (already of record, US 2015/0330903; hereinafter “Koerperick”) and Niazi (US 2014/0024105).
Regarding claim 1, Seo discloses an in situ probe, comprising: a component that is attached to and disposable with a bioreactor (FIG. 2: replaceable sensor unit (240) coupled to water tank (220; corresponds to the instant bioreactor); col. 4, ll. 55-58; col. 5, ll. 10-16), wherein the component includes a radiation source (FIG. 2: light-emitting module 210; col. 5, ll. 4-9 and 17-21), a detector for detecting radiation generated by the radiation source (FIG. 2: sensor unit (240); col. 4, ll. 3-17 and 59-64; col. 5, ll. 4-9 and 17-21), or both. Seo differs from the claimed invention in that the bioreactor is not a disposable bioreactor bag. However, the use of flexible bioreactor is well-known in the art (see Koerperick at [0003]). Further, Niazi discloses that disposable bioreactor bags prevent cross contamination between processes and reduces manufacturing cost ([0004]). It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the bioreactor tank of Seo with a bioreactor bag since Koerperick discloses that the use of flexible and rigid bioreactors is well-known in the art (see Koerperick at [0003]). Further, one of ordinary skill in the art would have made said modification for the purpose of preventing cross contamination between processes and to reduce manufacturing cost as suggested by Niazi ([0004]).
Regarding claims 3-4, modified Seo further discloses wherein the disposable component includes an annular flange (FIG. 2: sealing members (245) laterally formed at a lower portion unit of the disposable component (sensor unit 240); col. 4, line 65 to col. 5, line 3).
Regarding claim 5, modified Seo further discloses a bottom piece that mates with the disposable component (FIG. 2: housing (243) coupled to sensor unit (240); col. 5, ll. 4-9).
Regarding claim 6, modified Seo further discloses wherein the bottom piece is also disposable (the entire structure of the probe of Seo is considered disposable; see also col. 5, ll. 4-16).
Regarding claim 8, modified Seo further discloses wherein the radiation source is contained in a bottom piece that mates with the disposable component (FIG. 2: housing (243) including light-emitting (210) module is coupled to the sensor unit (240); col. 5, ll. 4-9).
Regarding claim 9, modified Seo further discloses wherein the detector is contained in a disposable component (FIG. 2: sensor unit (240) including an enclosure enclosing the sensing means).
Regarding claim 12, modified Seo further discloses wherein a controller for controlling the probe to resolve the spectral response of contents of the bioreactor bag (FIG. 2: analysis module (250); col. 4, ll. 55-64; col. 6, ll. 45-47).
Furthermore, the limitation “for controlling the probe to resolve the spectral response of contents of the bioreactor bag” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed controller and thus since the structure is the same, the claimed functions are apparent.
Claim(s) 1, 5-6 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (already of record, US 10,018,568; hereinafter “Seo”) in view of Koerperick et al. (already of record, US 2015/0330903; hereinafter “Koerperick”) and Niazi (US 2014/0024105). This is an alternative rejection to the rejection of claim 1 in view of different interpretation of Seo et al. reference.
Regarding claim 1, Seo discloses an in situ probe, comprising: a component that is attached to and disposable with a bioreactor (FIG. 2: housing (243) including light-emitting module (210) coupled to water tank (220; corresponds to the instant bioreactor); col. 4, ll. 55-58; col. 5, ll. 4-21), wherein the component includes a radiation source (FIG. 2: housing (243) includes a light-emitting module (210); col. 5, ll. 4-9 and 17-21), a detector for detecting radiation generated by the radiation source (FIG. 2: sensor unit (240); col. 4, ll. 3-17 and 59-64; col. 5, ll. 4-9 and 17-21), or both. Seo differs from the claimed invention in that the bioreactor is not a disposable bioreactor bag. However, the use of flexible bioreactor is well-known in the art (see Koerperick at [0003]). Further, Niazi discloses that disposable bioreactor bags prevent cross contamination between processes and reduces manufacturing cost ([0004]). It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the bioreactor tank of Seo with a bioreactor bag since Koerperick discloses that the use of flexible and rigid bioreactors is well-known in the art (see Koerperick at [0003]). Further, one of ordinary skill in the art would have made said modification for the purpose of preventing cross contamination between processes and to reduce manufacturing cost as suggested by Niazi ([0004]).
Regarding claim 5, modified Seo further discloses a bottom piece that mates with the disposable component (FIG. 2: housing (243) is coupled to a bottom piece (sensor unit 240); col. 5, ll. 4-9).
Regarding claim 6, modified Seo further discloses wherein the bottom piece is also disposable (the entire structure of the probe of Seo is considered disposable; see also col. 5, ll. 4-16).
Regarding claim 10, modified Seo further discloses wherein the radiation source is contained in the disposable component FIG. 2: housing (243) including light-emitting module (210); col. 5, ll. 4-21).
Regarding claim 11, modified Seo further discloses wherein the detector is contained in a bottom piece that mates with the disposable component (FIG. 2: housing (243) is coupled to a bottom piece (sensor unit 240); col. 5, ll. 4-9).
Regarding claim 12, modified Seo further discloses wherein a controller for controlling the probe to resolve the spectral response of contents of the bioreactor bag (FIG. 2: analysis module (250); col. 4, ll. 55-64; col. 6, ll. 45-47).
Furthermore, the limitation “for controlling the probe to resolve the spectral response of contents of the bioreactor bag” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed controller and thus since the structure is the same, the claimed functions are apparent.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schick as applied to claim 1 above, and further in view of Selker et al. (already of record, US 2012/0244609; hereinafter “Selker”).
Regarding claim 2, Schick discloses the in situ probe according to claim 1 as set forth above. Schick further discloses wherein the disposable component is coupled to the bioreactor bag ([0036]), but does not explicitly disclose wherein the disposable component is fused to the bioreactor bag. Selker discloses an optical sensor for use with bioreactors. Selker further discloses wherein the optical sensor can be coupled to the bioreactor by various means including by fusion ([0059]). In view of Selker, it would have been prima facie obvious to one of ordinary skill in the art to have modified the probe of Schick such that the disposable component is fused to the bioreactor bag to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because Selker discloses that the coupling between optical sensor and bioreactors bag can be achieved by various means including by fusion ([0059]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot in view of the new ground of rejection. As discussed above, the applied prior art discloses all of the structural features of the claimed invention.
Applicant argues that Schick fails to disclose the subject matter of independent claims 1, 13, 19 and 20. See Remarks at pages 1 to 2.
Applicant’s argument is not persuasive. The fact that the probe of Schick is capable of being reused does not necessarily mean that it cannot also be disposable. Further, the term “disposable” does not impart any additional structural limitations to the claimed probe and does not distinguish the claims from the prior art, as it merely describes an intended use or end-of-life treatment rather than any specific physical structure, material, or configuration. Further, virtually any components can be construed as disposable at some point after its service life has ended. Further, it should be noted that there is nothing in Schick that precludes the components of the probe/bioreactor/flexible bag from being disposable. As such, Applicant’s argument is not persuasive.
In response to the Applicant’s argument regarding the reference of Seo (page 2-3), the examiner would respectfully reiterate the response to the argument provided in section (44) above regarding why Applicant’s argument is not persuasive and combination of the cited references are proper.
Conclusion
No claim is allowed.
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
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