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 .
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 19 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.
Claim 19 recites the limitation "second tubing block" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, examiner is treating this as the second tubing holder block of Claim 18.
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 13, 18-20, 22, 24, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yago (WO2018111931A1).
Regarding Claim 13, Yago teaches the following:
A tray (140) having a plurality of side walls (140a) and a bottom surface (142) defining an interior compartment and a generally open top (Fig. 14, below)
At least one opening (145) formed in the bottom surface, the opening having a perimeter (Fig. 14, below)
A first tubing holder block physically associated with one of the sidewalls of the tray (hole 146)
The perimeter of the opening is shaped such that a bioreactor vessel could be positioned above the opening and supported by the bottom surface of the tray within the interior compartment such that a substantial entirety of the bioreactor is positionable over the opening and accessible through the opening (via opening 144 and opening 160) (Fig. 14, below)
The first tubing holder block being configured to receive at least one pump tube and hold the at least one pump tube in position for selective engagement with a peristaltic pump is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The hole 146 (first tubing holder block) of Yago would be capable of receiving and holding a pump tube and therefore meets the claim.
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Further, the at least one pump tube configured to supply fluid to the bioreactor vessel and remove fluid from the bioreactor vessel is and intended use of the device. If the pump tube were being held by the first tubing holder block, it would be capable of supplying fluid as claimed. Note: the one pump tube is not a positively recited limitation.
Regarding Claim 18, Yago teaches all of the limitations of Claim 13 (see above). Yago further teaches a second tubing holder block associated with one of the sidewall of the tray (Fig. 14, below). The second tubing holder block being configured to receive a plurality of pinch valve tubes and hold each pinch valve tube of the plurality of pinch valve tubes in position for selective engagement with a respective actuator of a punch valve array is an intended use of the device. The second tubing holder block would be capable of receiving pinch valves tubes in the claimed manner and therefore meets the
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claim.
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Regarding Claim 19, Yago teaches all of the limitations of Claim 18 (see above). Yago further teaches the second tubing block to include a plurality of slots (Fig. 14, below). The plurality of slots receiving a plurality of tubes is an intended use of the device. Since the slots would be capable of receiving a plurality of tubes, the limitations are met.
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Regarding Claim 20, Yago teaches all of the limitations of Claim 18 (see above). Yago further teaches the second tubing holder block to include a plurality of staggered apertures arranged in a surface (Fig. 14, below). As the pinch valve tubes are not a positively recited limitation, the plurality of staggered apertures are met by being on any surface. Further, the apertures configured to allow passage of an actuator of the array to clamp a pinch valve tube is an intended use of the device. Since the apertures would be capable of allowing the passage of an actuator, the limitations are met.
Regarding Claim 22, Yago teaches all of the limitations of Claim 13 (see above).
As to how the tray is produced, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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 product was made by a different process.” See MPEP § 2113.
Regarding Claim 24, Yago teaches all of the limitations of Claim 13 (see above).
Yago further teaches a removable cover (cover C) attached a top of the tray and enclosing the open top (para 149).
Regarding Claim 28, Yago teaches the following:
A tray (140) having a plurality of side walls (140a) and a bottom surface (142) defining an interior compartment and a generally open top (Fig. 14, below)
At least one opening (145) formed in the bottom surface, the opening having a perimeter (Fig. 14, below)
A first tubing holder block physically associated with one of the sidewalls of the tray (hole 146)
The perimeter of the opening is shaped such that a bioreactor vessel could be positioned above the opening and supported by the bottom surface of the tray within the interior compartment such that a portion of the bioreactor is accessible through the opening in the bottom surface (via opening 144 and opening 160) and an area of the opening would generally corresponds to an area of the bottom surface of the bioreactor
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vessel (Fig. 14, below)
the opening is positioned atop a platform (body member 140) such that a plane defined by the opening is spaced vertically from the bottom surface of the tray (Fig. 14, above)
The first tubing holder block being configured to receive at least one pump tube and hold the at least one pump tube in position for selective engagement with a peristaltic pump is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The hole 146 (first tubing holder block) of Yago would be capable of receiving and holding a pump tube and therefore meets the claim.
Further, the at least one pump tube configured to supply fluid to the bioreactor vessel and remove fluid from the bioreactor vessel is and intended use of the device. If the pump tube were being held by the first tubing holder block, it would be capable of supplying fluid as claimed. Note: the one pump tube is not a positively recited limitation.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yago (WO2018111931A1).
Regarding Claim 14, Yago teaches the following:
A tray (140) having a plurality of side walls (140a) and a bottom surface (142) defining an interior compartment and a generally open top (Fig. 14, below)
At least one opening (145) formed in the bottom surface, the opening having a perimeter (Fig. 14, below)
A first tubing holder block physically associated with one of the sidewalls of the tray (hole 146)
The perimeter of the opening is shaped such that a bioreactor vessel could be positioned above the opening and supported by the bottom surface of the tray within the interior compartment such that a substantial entirety of the bioreactor is positionable over the opening and accessible through the opening (via opening 144 and
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opening 160) (Fig. 14, below)
The first tubing holder block being configured to receive at least one pump tube and hold the at least one pump tube in position for selective engagement with a peristaltic pump is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The hole 146 (first tubing holder block) of Yago would be capable of receiving and holding a pump tube and therefore meets the claim.
Further, the at least one pump tube configured to supply fluid to the bioreactor vessel and remove fluid from the bioreactor vessel is and intended use of the device. If the pump tube were being held by the first tubing holder block, it would be capable of supplying fluid as claimed. Note: the one pump tube is not a positively recited limitation.
The embodiment of Yago being referred to does not teach the perimeter of the opening to include at least one tab or projection that extends laterally into the opening for supporting the bioreactor.
Yago does teach one or more tabs 214 positioned adjacent to the recess of the test plate T (see Fig. 16, below). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body member 140 of Yago with the tabs 214 of the test plate holder. One would have been motivated to make this modification as it would help secure the test plate (or bioreactor vessel) to the body member (para 149).
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Regarding Claim 15, Yago teaches all of the limitations of Claim 14 (see above). Yago further teaches the at least one opening (opening 252) is at least two openings formed in the bottom surface, each opening having a perimeter shaped and/or dimensioned for supporting a bioreactor above each opening (Figs. 19-21).
Claims 16, 21, 23, 25, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Yago (WO2018111931A1) in view of Neagle et al. (US20050051723).
Regarding Claim 16, Yago teaches all of the limitations of Claim 13 (see above).
Yago does not explicitly disclose a plurality of bosses.
Neagle discloses a plurality of bosses (pins 152) extending upwardly from the bottom surface of the tray for inhibiting lateral movement of the bioreactor vessel when it is received above the opening in the bottom surface of the tray as discussed in at least paragraph 86.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yago with a plurality of bosses in order to restrict movement of the test plate, particularly relative to the sample support and/or each other as discussed in paragraphs 30, 53 and 86 of Neagle.
While Neagle does not teach the pins to be located on the tray side, but rather on the insert side (bioreactor side), a rearrangement of parts to locate the pins on the tray side would have been prima facie obvious to one of ordinary skill in the art. See MPEP 2144.04(VI)(C).
Regarding Claim 21, Yago teaches all of the limitations of Claim 21 (see above). Yago does not teach an opening in a rear wall of the tray.
Neagle teaches a housing that may include openings such as perforations 128 in a rear wall of the housing (para 84, and Fig. 4, below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yago with an opening in the rear wall as taught by Neagle. One would have been motivated to make this modification in order to facilitate equilibration with the surrounding chambers (para 84).
Note the engagement plate being received in the opening in the rear wall is not a positively recited limitation of the claim and therefore, as the opening would be capable of receiving an engagement plate, the first and second tubing block holder would be capable of being connected as well.
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Regarding Claim 23, Yago teaches all of the limitations of Claim 13 (see above).
Neagle teaches discloses a support rib (…the pins may hold removable adapters of a suitable diameter. Each adapter may be selected (from a set of supplied adapters of different diameter) according to the perimeter of the container to be retained, to provide a more customized engagement of the retainers with the containers) as discussed in a least paragraph 86.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yago with a support rib integrally formed with a bottom surface of the tray in order to restrict movement of the test plate, particularly relative to the sample support as discussed in paragraphs 30, 53 and 86 of Neagle.
While Neagle does not teach the adaptors to be located on the tray side, but rather on the insert side (bioreactor side), a rearrangement of parts to locate the adapter on the tray side would have been prima facie obvious to one of ordinary skill in the art. See MPEP 2144.04(VI)(C).
Regarding Claim 25, Yago teaches all of the limitations of Claim 24 (see above).
Yago does not explicitly disclose a flange defining a top edge of the tray about the opening.
Neagle discloses a flange defining a top edge of the tray about the opening; wherein the removable cover is attached to the flange (The housing 112 may include a cover that may be removably received on a base section 124 of the housing, for example, by mating with clips 126.) as discussed in at least paragraph 84.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yago with a flange defining a top edge of the tray about the opening such that the removable cover is attached to the flange in order to restrict movement of the test plate, particularly relative to the sample support and/or the removable cover as discussed in paragraphs 30, 53 and 86 of Neagle.
Regarding Claim 29, Yago teaches the following:
A tray (140) having a plurality of side walls (140a) and a bottom surface (142) defining an interior compartment and a generally open top (Fig. 14, below)
at least three openings (openings 252) formed in the bottom surface, each opening having a perimeter (Figs. 19-21)
A first tubing holder block physically associated with one of the sidewalls of the tray (hole 146)
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The perimeter of the opening is shaped such that a bioreactor vessel could be positioned above the opening and supported by the bottom surface of the tray within the interior compartment such that a substantial entirety of the bioreactor is positionable over the opening and accessible through the opening (via opening 144 and opening 160) (Fig. 14, below)
The first tubing holder block being configured to receive at least one pump tube and hold the at least one pump tube in position for selective engagement with a peristaltic pump is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The hole 146 (first tubing holder block) of Yago would be capable of receiving and holding a pump tube and therefore meets the claim.
Further, the at least one pump tube configured to supply fluid to the bioreactor vessel and remove fluid from the bioreactor vessel is and intended use of the device. If the pump tube were being held by the first tubing holder block, it would be capable of supplying fluid as claimed. Note: the one pump tube is not a positively recited limitation.
Yago does teach a peripheral flange bounding the generally open top, the peripheral flange configured to present a surface for receiving a removable cover configured to enclose the generally open top.
Neagle discloses a flange defining a top edge of the tray about the opening; wherein the removable cover is attached to the flange (The housing 112 may include a cover that may be removably received on a base section 124 of the housing, for example, by mating with clips 126.) as discussed in at least paragraph 84.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yago with a flange defining a top edge of the tray about the opening such that the removable cover is attached to the flange in order to restrict movement of the test plate, particularly relative to the sample support and/or the removable cover as discussed in paragraphs 30, 53 and 86 of Neagle.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on page 9 that Yago does not disclose a tray with sidewalls and a bottom surface having an opening that defines an interior compartment for receiving a bioreactor vessel, Yago teaches a tray 140 with sidewalls 140a and a bottom surface 142 that defines an interior compartment. Further, the limitation for receiving a bioreactor vessel is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding Applicant’s arguments on page 12 that Neagle’s pins and adaptors are attached to the flasks (or inserts) rather than the tray, a rearrangement of parts would have been prima facie obvious to one of ordinary skill in the art. See MPEP 2144.04(VI)(C)
The remainder of the arguments have been addressed above with a reinterpretation of previously cited references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796