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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/2026 has been entered.
Status of the Claims
The amendment filed 2/17/2026 has been entered. Claims 1-10, 21, and 23-34 are pending in the application; and claims 11-20 and 22 have been cancelled.
Response to Arguments
Applicant’s arguments filed 2/17/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Specification
The disclosure was objected to because it contained an embedded hyperlink and/or other form of browser-executable code (para. 0047, 0057). Applicant’s amendments to the specification were received 2/17/2026. Accordingly, the objections to the specification have been withdrawn.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 4-7, and 27 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 4 recites the limitation "the hoods" in line 2. It is unclear whether “the hoods” refers to the “at least one hood” recited in claim 1, or the “source hood” or “detector hood” recited in claim 3.
Claim 27 recites the limitation “the patch rim” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination on the merits, the Examiner is interpreting claim 27 as if dependent on claim 24, which provides antecedent basis for a “patch rim”.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 102
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 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 1-10, 21, 23, 26, 28-29, and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bahnemann et al. (US 2010/0035337 A1).
Regarding claim 1, Bahnemann et al. discloses a system for monitoring a process within a bag (abstract; para. 0029), the system comprising: a patch secured to a wall of the bag (Fig. 2 probe receptacle 4, also seen in Fig. 4; para. 0023) and defining a sample gap (Fig. 2 gap between top of probe receptacle 4 and bottom of probe receptacle 4 which holds measuring probe 9, also seen in Fig. 4), wherein the patch includes at least one hood (transmission probe 10) that projects into the bag and is accessible from outside the bag (Fig. 4 transmission probe 10 inserted into probe receptacle; para. 0023); and a probe module for monitoring contents of the bag, the probe module comprising a source element (Fig. 3 first optical fiber 17; para. 0039 “optical signal 16 can be fed via a first optical fiber 17”) and a detector element (Fig. 3 second optical fiber 19) for receiving light transmitted from the source element and through the sample gap after interaction with the contents (paras. 0038-0039).
Regarding claim 2, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the bag is a flexible bag (para. 0029).
Regarding the limitation “of a rocking bioreactor”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Bahnemann et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be a flexible bag (para. 0029) and would be structurally capable of being agitated by rocking absent clear evidence otherwise.
Regarding claim 3, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the patch comprises a source hood (Fig. 3 first optical window 12) and a detector hood (Fig. 3 second optical window 13), which project inward from an outer wall of the bag (Fig. 4; para. 0023), a wall of the source hood and a wall of the detector hood defining the sample gap being between the hoods (Fig. 3 cuvette gap 14 between first optical window 12 and second optical window 13).
Regarding claim 4, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the hoods are each accessible from outside the bag (Fig. 4; para. 0023).
Regarding claim 5, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the probe module inserts into the patch (Fig. 4 transmission probe 10 inserts into probe receptacle) such that the source hood receives a source assembly housing the source element (Fig. 3 first optical fiber 17 connected to first optical window 12) and the detector hood receives a detector assembly housing the detector element (Fig. 3 second optical fiber 19 connected to second optical window 13).
Regarding claim 6, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the source assembly and the detector assembly are both secured to or integral with a common assembly base of the probe module (Fig. 3 first optical fiber 17 connected to first optical window 12 and second optical fiber 19 connected to second optical window 13 are part of transmission probe 10).
Regarding claim 7, Bahnemann et al. discloses a system for monitoring a process within a bag wherein sizes and shapes of the source assembly and the detector assembly and spacing between the source assembly and the detector assembly correspond to sizes and shapes of the source hood and the detector hood and a spacing between the hoods (Fig. 3).
Regarding claim 8, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the patch is secured to the wall of the bag (Fig. 2 probe receptacle 4, also seen in Fig. 4; para. 0023), but is silent to the method of securing the probe receptacle to the bag. However, it has been held that the patentability of a product does not depend on its method of production; if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process (MPEP § 2113 I). Therefore, the probe receptacle disclosed by Bahnemann et al. would anticipate the patch secured by welding, thermo-forming, or adhesive of the claimed invention even if both were made by a different process.
Regarding claim 9, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the bag and patch are disposable (paras. 0028-0029) or single-use components, and the probe module is capable of being reusable with different patches and bags.
Regarding the limitation “the probe module is reusable with different patches and bags”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Bahnemann et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have a probe receptacle which allows a probe to be inserted into without risk of contamination (para. 0024) and would be structurally capable of being reusable with different patches and bags absent clear evidence otherwise.
Regarding claim 10, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the patch comprises one or more window plates for transmitting the light between the sample gap and at least one of a source hood and a detector hood (Fig. 3 first optical window 12, second optical window 13; para. 0039).
Regarding claim 21, Bahnemann et al. discloses a bag for a bioreactor (para. 0029), the bag comprising: a patch secured to a wall of the bag (Fig. 2 probe receptacle 4, also seen in Fig. 4; para. 0023), the patch defining a sample gap (Fig. 2 gap between top of probe receptacle 4 and bottom of probe receptacle 4 which holds measuring probe 9, also seen in Fig. 4) and including at least one hood (transmission probe 10) that projects into the bag (Fig. 4 transmission probe 10 inserted into probe receptacle; para. 0023), wherein a probe module for monitoring contents of the bag comprises a source element (Fig. 3 first optical fiber 17; para. 0039 “optical signal 16 can be fed via a first optical fiber 17”) and a detector element (Fig. 3 second optical fiber 19) for detecting light transmitted from the source element through the sample gap after interaction with the contents (paras. 0038-0039), and wherein the at least one hood is configured to house the source element or the detector element (Fig. 3 transmission probe 10 houses first optical fiber 17 and second optical fiber 19).
Regarding claim 23, Bahnemann et al. discloses a system for monitoring a process within a bag (abstract; para. 0029), the system comprising: a patch secured to a wall of the bag (Fig. 2 probe receptacle 4, also seen in Fig. 4; para. 0023) and defining a sample gap (Fig. 2 gap between top of probe receptacle 4 and bottom of probe receptacle 4 which holds measuring probe 9, also seen in Fig. 4), wherein the patch includes at least one hood (transmission probe 10) accessible from outside the bag (Fig. 4 transmission probe 10 inserted into probe receptacle; para. 0023); and a probe module for monitoring contents of the bag, the probe module comprising a source element (Fig. 3 first optical fiber 17; para. 0039 “optical signal 16 can be fed via a first optical fiber 17”) and a detector element (Fig. 3 second optical fiber 19) for receiving light transmitted from the source element and through the sample gap after interaction with the contents (paras. 0038-0039).
Regarding claim 26, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the source hood defines a source chamber (Fig. 3 first optical window 12, deflection prism 18, UV-LED 8, first optical fiber 17) and the detector hood defines a detector chamber (Fig. 3 second optical window 13, UV-LED 8, second optical fiber 19) within an outer perimeter of the bag (Fig. 4), the source chamber and the detector chamber being accessible from outside the bag (Fig. 4 transmission probe 10 inserted into probe receptacle; para. 0023) and contain ambient air (Fig. 4 transmission probe 10 is outside the bioreactor 1).
Regarding the limitation “the chambers displace contents of the bag”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Bahnemann et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have a transmission probe which projects into the reactor interior and has a cuvette gap which is filled by medium to be evaluated (para. 0025) and would be structurally capable of displacing contents of the bag absent clear evidence otherwise.
Regarding claim 28, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the source hood comprises a source window portion (first optical window 17) and the detector hood comprises a detector window portion (second optical window 19), the source window portion and detector window portion facing each other and defining lateral sides of the sample gap (Fig. 3 first optical window 17 facing second optical window 19 which defines cuvette gap 14).
Regarding claim 29, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the source window portion comprises a first window secured to or forming a wall of the source hood (Fig. 3 first optical window 17) and the detector window portion comprises a second window secured to or forming a wall of the detector hood (Fig. 3 second optical window 19), the first and second windows forming an optical interface between the source chamber and the detector chamber (para. 0039).
Regarding claim 32, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the bag is capable of being rockable about a rocking axis, and wherein the patch is capable of being positioned such that the sample gap forms a channel having an extent that is transverse to the rocking axis and parallel to a dominant direction of fluid motion in the bag, thereby allowing rocking-induced tidal action to wash fluid into and out of the sample gap. Regarding the limitations in the claim, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Bahnemann et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be a flexible bag bioreactor (para. 0029) and would be structurally capable of being rocked so that fluid washes into and out of the sample gap absent clear evidence otherwise.
Regarding claim 33, Bahnemann et al. discloses a system for monitoring a process within a bag further comprising a spectroscopic analyzer configured to monitor an output of the detector element while controlling emission of the source element, to resolve absorption spectra of contents present in the sample gap (paras. 0026, 0039).
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.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Bahnemann et al. (US 2010/0035337 A1).
Regarding claim 31, Bahnemann et al. discloses a system for monitoring a process within a bag further comprising a fixed space between the first window and the second window (Fig. 3), but does not disclose a separate mechanical spacer that maintains a fixed, uniform, predetermined spacing between the first window and the second window. Nonetheless, it has been held that the use of a one piece construction instead of several parts would be merely a matter of obvious engineering choice (MPEP § 2144.04 V). Modifying the device of Bahnemann et al. such that the space between windows includes a separate spacer instead of a fixed space as part of the transmission probe would merely amount to making integral, as such a modification would predictably result in a fixed space between windows to form a gap in which bioreactor medium can enter and be evaluated.
Claims 24-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bahnemann et al. (US 2010/0035337 A1) in view of Barnfield Frej et al. (US 2012/0291238 A1).
Regarding claim 24, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the patch is inserted into an opening in the wall of the bag (Figs. 1-2, and 4), but is silent to the patch comprising a patch rim bonded to the wall to form a seal around the opening. However, Barnfield Frej et al. discloses a sensor holding part that is welded to an opening in a bioreactor bag to prevent any leakage (para. 0025). It would have been obvious to a person of ordinary skill in the art to use the Barnfield Frej et al. configuration of a sensor holding part welded to an opening in a bioreactor bag in Bahnemann et al.’s device with a reasonable expectation that it would prevent leakage. This method for improving Bahnemann et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Barnfield Frej et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bahnemann et al. and Barnfield Frej et al. to obtain the invention as specified in claim 24.
Regarding claim 25, Bahnemann et al. discloses a system for monitoring a process within a bag comprising a patch (probe receptacle 4), but is silent to a patch weld seam formed between the patch rim and the wall of the bag and extends around a perimeter of the opening. However, Barnfield Frej et al. discloses a sensor holding part welded to a bioreactor bag to form an opening for a sensor (para. 0024). Barnfield Frej et al. discloses that a sensor holding part welded around an opening prevents leakage (para. 0025). It would have been obvious to a person of ordinary skill in the art to use the Barnfield Frej et al. configuration of a sensor holding part welded to a bioreactor bag to form an opening for a sensor in Bahnemann et al.’s device with a reasonable expectation that it would prevent leakage. This method for improving Bahnemann et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Barnfield Frej et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bahnemann et al. and Barnfield Frej et al. to obtain the invention as specified in claim 25.
Regarding claim 27, Bahnemann et al. discloses a system for monitoring a process within a bag comprising a patch inserted into an opening in the wall of the bag (Figs. 1-2, and 4), but does not disclose the patch rim comprising one or more alignment pegs projecting outward from an exterior surface of the patch rim, and wherein the common assembly base comprises one or more alignment holes configured to receive the alignment pegs when the probe module is mated with the patch. However, Barnfield Frej et al. discloses alignment pegs projecting outward (Fig. 4a first locking means/hooks 17a-d) and alignment holes configured to receive the alignment pegs (Fig. 4a second locking means 43a-d) which lock the sensor holding part in a locked position (para. 0033). It would have been obvious to a person of ordinary skill in the art to use the Barnfield Frej et al. configuration of alignment pegs projecting outward and alignment holes configured to receive the alignment pegs in Bahnemann et al.’s device with a reasonable expectation that it would lock the sensor holding part in a locked position. This method for improving Bahnemann et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Barnfield Frej et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bahnemann et al. and Barnfield Frej et al. to obtain the invention as specified in claim 27.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Bahnemann et al. (US 2010/0035337 A1) in view of Califorrniaa (US 2008/0097143 A1).
Regarding claim 30, Bahnemann et al. discloses a system for monitoring a process within a bag wherein interior surfaces of the first and second windows have photocatalytic coating (abstract) and wherein exterior surfaces of the first and second windows are refractive index matched to contents of the bag (para. 0016), but does not disclose an anti-reflective coating. However, Califorrniaa discloses anti-reflective coating on glass to minimize reflection losses (para. 0343). It would have been obvious to a person of ordinary skill in the art to use the Califorrniaa configuration of anti-reflective coating in Bahnemann et al.’s device with a reasonable expectation that it would minimize reflection losses. This method for improving Bahnemann et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Califorrniaa. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bahnemann et al. and Califorrniaa to obtain the invention as specified in claim 30.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Bahnemann et al. (US 2010/0035337 A1) in view of Schick et al. (US 2012/0242993 A1) (already of record).
Regarding claim 34, Bahnemann et al. discloses a system for monitoring a process within a bag wherein the source element comprises a UV light source (UV-LED 8), but does not disclose a tunable laser configured to spectrally sweep through at least a portion of a wavelength band in an infrared region. However, Schick et al. discloses a laser (para. 0015) which generates infrared light (para. 0017) which scatters light through the solution so that information can be gathered about a parameter of interest of the solution (para. 0017). It would have been obvious to a person of ordinary skill in the art to use the Schick et al. configuration of a laser which generates infrared light in Bahnemann et al.’s device with a reasonable expectation that it would scatter light through the solution so that information can be gathered about a parameter of interest of the solution. This method for improving Bahnemann et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Schick et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Bahnemann et al. and Schick et al. to obtain the invention as specified in claim 34.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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