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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 7, 10-13, and 16 objected to because of the following informalities:
In claim 1 – “manufacture of an engineered cells” should read “manufacture of engineered cells”.
In claim 2 – “accomodated" should read “accommodated”.
In claim 7 – “The apparatus of claim 2, wherein, the fluidic connector…” should read “The apparatus of claim 2, wherein the fluidic connector…”.
In claim 10 – “The apparatus of claims 1…” should read “The apparatus of claim 1”.
In claim 11 – it is suggested to reword the claim as “The apparatus of claim 10, wherein the connector further comprises a corresponding cap for each respective connector in the plurality of connectors, wherein the corresponding cap encompasses the respective connector.
In claim 12 – “configured to accommodating a port of fluidic container” should read “configured to accommodate a port of a fluid container”.
In claim 13 – “the first mating mechanism comprising” should read “the first mating mechanism comprises”.
In claim 16 – “each rigid sidewall” should read “each rigid side wall”.
Appropriate correction is required.
Claim Interpretation
Claim 14 recites “…wherein the first degree of freedom is parallel or substantially parallel to gravity…”. This is interpreted as wherein the first degree of freedom of movement is vertical or substantially vertical.
Claim 15 recites “…wherein the first degree of freedom is not parallel or substantially parallel to gravity…”. This is interpreted as wherein the first degree of freedom of movement is horizontal or substantially horizontal.
Claim Interpretation – 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
In claim 1, “first mating mechanism” is interpreted to include one or more magnets, one or more fasteners, one or more snap-fittings, one or more press-fittings, one or more adhesives, one or more grooves, one or more holes, one or more openings, one or more protrusions, one or more pins, one or more wedges, one or more indica, one or more snap mechanisms, one or more ramps, one or more springs, or a combination thereof – evidenced by [0036] in the disclosure.
In claim 20, “first locking mechanism” appears to be drawn towards the first mating mechanism and will be interpreted as such - evidenced by [00288] in the disclosure.
In claims 1 and 2, “second mating mechanism” is interpreted to include one or more snap-fit mating mechanisms and/or one or more clamp mating mechanisms, one or more rigid rods – evidenced by [00271] in the disclosure.
In claim 19, “second locking mechanism” appears to be drawn towards the second mating mechanism.
In claim 9, “gate mechanism” is interpreted to be a door – evidenced by Figs. 9A and 9B – cartridge back door 506, [0071]-[0072] and [00297] in the disclosure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2, 5-11, 14-15, and 19-20 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 2 recites the limitation “the pair of opposing interior surfaces”. There is insufficient antecedent basis for this limitation in the claim.
Further, it is unclear if the limitation “fourth second mating mechanism” mentioned in claim 2 and the limitation “second mating mechanism” in claim 1 are the same or different. It appears the second mating mechanism mentioned claim 1 is directed to the docking device, while the second mating mechanism mentioned in claim 2 is directed to a soft body bioreactor.
Even further, the meaning of claim 2 cannot be clearly discerned based on the current claim language. It is suggested that the claim be amended to improve clarity. For the purpose of this examination, claim 2 will be interpreted as: “The apparatus of claim 1, wherein the interior surface of the rigid cartridge mates with a mating mechanism of the soft body bioreactor, thereby removably coupling a pair of opposing end portions of the soft body bioreactor with the rigid cartridge.” – evidenced by [00271] in the disclosure.
Claims 5-8 are similarly rejected as they appear to depend upon claim 2.
Further, claims 5-7 each recite the limitation “the fluidic connector” in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears claims 5-7 depend on claim 2, which does not provide antecedent basis for the fluidic connector.
Claim 9 recites the limitation “the rigid housing”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of this examination, the rigid housing recited in claim 9 will be interpreted as the rigid cartridge recited in claim 1, of which claim 9 depends upon.
Claim 10 recites the limitation “wherein each mating mechanism protrudes from the substantially upper planar surface”. It is unclear if the recited mating mechanism refers to the first mating mechanism or second mating mechanism recited in claim 1, of which claim 10 depends upon. For the purpose of this examination, the mating mechanism recited in claim 10 will be interpreted as the first mating mechanism recited in claim 1 – evidenced by Fig. 7A of the disclosure.
Further, claim 10 recites the limitation “rigid housing”. There is insufficient antecedent basis for this limitation in the claim. For the purpose of this examination, the rigid housing recited in claim 10 will be interpreted as the rigid cartridge recited in claim 1, of which claim 10 depends upon.
Claim 11 is similarly rejected as it depends upon rejected claim 10.
Claims 14 and 15 recite the limitation "the first degree of freedom" in lines 1 and 1, respectively. There is insufficient antecedent basis for this limitation in the claim. Claim 1, of which claims 14 and 15 depend upon, recites “at least one degree of freedom” in line 8. For the purpose of this examination, the first degree of freedom will be interpreted as “the at least one degree of freedom” referenced in claim 1.
Claim 19 recites the limitation "the corresponding second locking mechanism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Further, it is unclear if the limitation “second locking mechanism” (interpreted as the second mating mechanism – see 112(f) section above) is the same or different feature as the second mating mechanism recited in each of claims 1 and 2, respectively. For the purpose of this examination, each recited second mating mechanism in claims 1 and 2, respectively, and the second locking mechanism will be interpreted as separate features.
Claim 20 recites the limitation "the first locking mechanism" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Further, it is unclear if the limitation “first locking mechanism” (interpreted as the first mating mechanism – see 112(f) section above) is the same or different feature as the first mating mechanism recited in claim 1, respectively. For the purpose of this examination, each recited first mating mechanism in claims 1 and the first locking mechanism will be interpreted as separate features.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, and 12-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McFarland et al. (US 2022/0325240 A1) (see PTO-892).
Regarding claim 1, McFarland et al. teaches an apparatus for manufacture of engineered cells ([0186], cell therapy manufacturing system (CTMS) 2600), the apparatus comprising:
An apparatus for manufacture of an engineered cells ([0186], cell therapy manufacturing system (CTMS) 2600), the apparatus comprising:
a rigid cartridge (Fig. 23D, cartridge holder 2620 – see annotated figure below) comprising a plurality of rigid walls defining a fixed interior (Fig. 23I shows fixed interior – see annotated figure below); wherein the plurality of rigid walls comprises:
a plurality of rigid side walls (Fig. 23I shows rigid side walls), wherein at least one interior surface of a rigid side wall in the plurality of side walls comprises
a first mating mechanism (Figs. 23D and 23I, receivers 2629) configured to engage a corresponding second mating mechanism (Fig. 23D, receiving element 2630) of a docking device ([0193], lines 7-10), thereby removably coupling the rigid cartridge to the docking device to restrict a movement of the rigid cartridge to at least one degree of freedom (Fig. 23D shows how cartridge holder 2620 can move in system such that there is one degree of freedom), and
a substantially planar upper rigid wall connected to an upper edge portion of each rigid side wall in the plurality of rigid side walls (Fig. 23D shows substantially planar rigid wall), wherein the substantially planar upper rigid wall comprises:
one or more apertures (Fig. 23G, access window 2627 reads on aperture – see annotated figure below), wherein:
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each respective aperture in the one or more apertures is configured to receive and fixedly engage a corresponding connector in one or more connectors (Fig. 23D, connectors 2681 – see annotated figure below), each respective connector in the one or more connectors interfaces with a corresponding portion of a fixed interior of the rigid cartridge ([0203], lines 21-27 – connectors interface with cartridge 2610).
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Regarding claim 3, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. further teaches wherein the one or more connectors comprises a fluidic connector and/or an electrical connector ([0204], lines 1-3, connections for fluid lines or electrical lines (this reads on fluidic or electrical connector)).
Regarding claim 4, McFarland et al. teaches the apparatus of claim 3.
Regarding the limitation “the electrical connector", the limitation is phrased in the alternative. Because at least one of the limitations in claim 3, e.g., fluidic connector, is rejected above, no further rejections are required at this time.
Regarding claim 12, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. further teaches wherein the cartridge holder (i.e., rigid cartridge) further comprises a lower end portion comprising an opening (Fig. 23I, second portion 2620b and openings 2651 – see annotated figure below) configured to accommodating a port of fluidic container ([0191], lines
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21-22).
Regarding claim 13, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. further teaches that the receiver (i.e., first mating mechanism) may comprise one or more grooves ([0193], lines 18-19), one or more holes (Fig. 23D, receiver 2629 – see claim 1 rejection), or one or more protrusions ([0193], lines 18-19).
Regarding claim 14, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. further teaches that it is known in the art to use a mating mechanism wherein the first degree of freedom is vertical or substantially vertical – note: the claim language is interpreted according to the examiner’s understanding, see Claim Interpretation section (Fig. 23C shows vertical mating mechanism; [0190], lines 19-22 and 30-32).
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Regarding claim 15, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. further teaches that it is known in the art to use a mating mechanism wherein the first degree of freedom of movement is horizontal or substantially horizontal – note: the claim language is interpreted according to the examiner’s understanding, see Claim Interpretation section (Fig. 23D shows horizontal degree of freedom, receivers 2629 and receiving element 2630 – see claim 1 rejection above; [0193], lines 7-10).
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.
Claims 2 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. (already referenced) in view of Chotteau et al. (US 2014/0011270 A1) (see PTO-892).
Regarding claim 2, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. further teaches it is known in the art to use connectors (i.e., mating mechanisms) to mate a surface with a bioreactor (Fig. 23C, connectors 2696 and bioreactor 2610 – see annotated figure below; [0230], lines 6-9), but does not explicitly teach the bioreactor having a soft body.
However, Chotteau et al. teaches that soft body bioreactors are known in the art (abstract). Chotteau et al. teaches that soft body bioreactors are capable of culturing cells (abstract).
Though McFarland et al. does not explicitly teach a soft body bioreactor, it would have been obvious to one of ordinary skill in the art to use a soft body bioreactor as is known by Chotteau et al. because the substitution of one known element (bioreactor) for another would have predictably resulted in a device that cultures cells.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of McFarland et al. with the teachings of Chotteau et al. to obtain the invention as specified in claim 2.
Regarding claim 5, modified McFarland et al. teaches the apparatus of claim 2.
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McFarland et al. further teaches wherein the fluidic connector comprises an inlet port (Fig. 24G, injection port 2880-I – see annotated figure below; [0266], lines 8-12), a sampling port (Fig. 24G, ports 2880-B1/2880-B2; [0266], lines 15-17), an outlet port (Fig. 24G, ports 2880-B1/2880-B2; [0266], lines 15-17), or a combination thereof.
Regarding claim 6, modified McFarland et al. teaches the apparatus of claim 2.
McFarland et al. further teaches wherein the fluidic connector is in communication with a manifold ([0204], “…connectors 2681, 2683 include connections for one or more manifolds…”).
The limitation “configured to generate a pressure gradient between a portion of the rigid cartridge and an interior of the manifold” is directed toward the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP §2114 II). The apparatus taught by McFarland et al. would be fully capable of achieving every claimed intended use because the manifold is disclosed to be capable of interfacing pressurized air and/or fluidic components ([0206], lines 25-28) and would be structurally capable of generating a pressure gradient between a portion of the rigid cartridge and an interior of the manifold.
Regarding claim 7, modified McFarland et al. teaches the apparatus of claim 2.
McFarland et al. further teaches that it is known in the art to include a valve configured to control a flow of a fluid through a corresponding fluidic port ([0213], lines 7-8, 14-18 – opening reads on port).
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over McFarland et al. (already referenced) and Chotteau et al. (already referenced) as applied to claim 2 above, and in further view of Kusz et al. (US 2012/0284991 A1) (see PTO-892).
Regarding claim 8, modified McFarland et al. teaches the apparatus of claim 2.
Modified McFarland et al. fails to teach wherein a first internal diameter at an upper end portion of a respective connector is less than a second internal diameter at a lower end portion of the respective connector.
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However, Kusz et al. teaches a connecter wherein a first internal diameter at an upper end portion of a connector is less than a second internal diameter at a lower end portion of the connector (Fig. 7b, connector 12 – see annotated figure below).
Kusz et al. teaches that the connector receives an adapter to interface with an associated bioprocessing vessel ([0006]).
It would have been obvious to one of ordinary skill in the art to modify the device of McFarland et al. to construct the connector with a first internal diameter at an upper end portion of a connector less than a second internal diameter, as taught by Kusz et al., because it would allow users to interface with the interior of the rigid cartridge.
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 modified McFarland et al. and Kusz et al. to obtain the invention as specified in claim 8.
Claim 9 is rejected under 35 U.S.C. 103 as being obvious over McFarland et al. (already referenced) as applied to claim 1 above, and in further view of Thakkar et al. (US 2021/0283606 A1) (see PTO-892).
Regarding claim 9, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. fails to teach wherein at least one rigid wall in the plurality of rigid walls further comprises a gate mechanism configured to provide access to a fixed internal cavity of the rigid housing.
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However, Thakkar et al. teaches a movable barrier (e.g., access, door) (i.e., gate mechanism - note: this claim element was invoked via 35 U.S.C. 112(f)) configured to provide access the interior of a work cell (i.e., rigid housing) ([0243], lines 24-27) on the side of the work cell (Fig. 2A, moveable barrier – see annotated figure below).
Thakkar et al. teaches that the moveable barrier is configured to facilitate access to one or more of the instruments in the work cell, including a bioreactor ([0243], lines 12-14).
It would have been obvious to one of ordinary skill in the art to modify the device of McFarland et al. to incorporate the moveable barrier (i.e., gate mechanism) of Thakkar et al. because it would provide access to a bioreactor within the cartridge.
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 McFarland et al. and Thakkar et al. to obtain the invention as specified in claim 9.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland (already referenced).
Regarding claim 10, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. does not explicitly teach wherein each mating mechanism is protruding from a substantially upper planar surface of at least one rigid wall of the rigid housing – note: the claim language is interpreted according to the examiner’s understanding, see section Claim Rejections - 35 USC § 112.
However, McFarland et al. teaches mating mechanisms protruding from a substantially lower surface of the at least one rigid wall of the cartridge holder (i.e., rigid cartridge) (Fig. 23J, receivers 2629 – see annotated figure below).
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Though McFarland et al. does not explicitly teach the mating mechanisms protruding from the upper planar surface, it would have been obvious to one of ordinary skill in the art to rearrange the features such that the mating mechanisms protrude from the substantially upper planar surface instead of the lower planar surface. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI) and such a modification would predictably result in the mounting of the rigid cartridge to the docking device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of McFarland et al. to obtain the invention as specified in claim 10.
Claim 11 is rejected under 35 U.S.C. 103 as being obvious over McFarland et al. as applied to claim 10 above, and in further view of Cornforth et al. (US 2015/0322397 A1) (see PTO-892).
Regarding claim 11, modified McFarland et al. teaches the apparatus of claim 10.
McFarland et al. fails to teach further comprising a corresponding cap for each respective connector in the plurality of connectors, wherein the corresponding cap encompasses the respective connector.
However, Cornforth et al. teaches a bioprocessing cartridge (i.e., rigid cartridge) with ports (i.e., connector) secured with Luer-lock caps (i.e., caps) ([0081]).
Cornforth et al. teaches that an advantage of having Luer-lock caps preserves sterility during cell harvesting ([0056], [0081]).
It would have been obvious to one of ordinary skill in the art to modify the connectors of McFarland at al. to include the caps as taught by Cornforth et al. because it would preserve sterility during cell harvesting.
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 McFarland et al. and Cornforth et al. to obtain the invention as specified in claim 11.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. as applied to claim 1 above, and further in view of Lundin et al. (US 2024/0182834 A1) (see PTO-892) – note: the secondary reference relied upon claims foreign priority (effective filing date of 04/26/2022) to GB 2021/05909 D0.
Regarding claim 16, McFarland et al. teaches the apparatus of claim 1, but fails to teach wherein an interior angle formed between a substantially planar upper rigid wall and each rigid sidewall in the plurality of rigid side walls is greater than or equal to 90 degrees.
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However, Lundin et al. teaches a removable cassette for bioprocessing with a housing that has side walls perpendicular (i.e., 90 degrees) to a base (Fig. 9 – see annotated figure below; [0113], lines 1-3).
It would have been obvious to one of ordinary skill in the art to construct the rigid cartridge of McFarlane et al. with an interior angle formed between a substantially planar upper rigid wall and each rigid sidewall in the plurality of side walls is greater than or equal to 90 degrees because it has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05). The claimed interior angles are obvious because the interior angle disclosed by Lundin et al. is a well-known angle for a housing used for bioprocessing.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the claimed range from the angle disclosed in the prior art for the purpose of enclosing a desired device for bioprocessing.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. as applied to claim 1 above, and further in view of Clark et al. (US 2009/0162853 A1) (see PTO-892).
Regarding claim 17, McFarland et al. teaches the apparatus of claim 1, but fails to teach wherein an exterior surface of the rigid cartridge comprises one or more identifiers indica configured to uniquely identify the rigid cartridge.
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However, Clark et al. teaches a cartridge (i.e., rigid cartridge) with a barcode or other means of identifying the cartridge (i.e., identifiers indica) (Fig. 4, barcode – see annotated figure below).
Clark et al. teaches that the barcode or other means of identifying the cartridge can be used to facilitate specimen identification for automation ([0049]).
It would have been obvious to one of ordinary skill in the art to modify the device of McFarland et al. to include the identification indica taught by Clark et al. to improve automation capabilities and allow users to easily identify the cartridge.
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 device and teachings of modified McFarland et al. and the teachings of Clark et al. to obtain the invention as specified in claim 17.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. as applied to claim 1 above, and further in view of Morisette et al. (US 2007/0072287 A1) (see PTO-892).
Regarding claim 18, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. fails to teach wherein an exterior surface of a cartridge comprises one or more orientation indica configured to identify an orientation of the rigid cartridge.
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However, Morisette et al. teaches biomems cartridge using alignment pins (i.e., orientation indica) support and align a biochip-PCB assembly within (Fig. 1, alignment pins 107 – see annotated figure below).
Morisette et al. teaches that the alignment pins facilitate correct positioning of the PCB with the biochip ([0036], lines 6-7).
It would have been obvious to one of ordinary skill in the art to modify the device of McFarland et al. to include alignment pins (i.e., orientation indica) because it would align the rigid cartridge with the docking device.
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 McFarland et al. and Takahashi et al. to obtain the invention as specified in claim 18.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. in view of Regen et al. (US 2022/0195372 A1) (see PTO-892).
Regarding claim 19, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. fails to teach wherein the corresponding second locking mechanism comprises a rotating fastener configured to pivot between a first position that restricts a movement of the rigid cartridge and a second position that allows for movement of the rigid cartridge.
However, Regen et al. teaches that it is known in the art of bioreactors to use a fastening element (i.e., second locking mechanism – note: this claim element was invoked via 35 U.S.C. 112(f)) configured to rotate between a first rotational position and a second rotational position (Fig. 8 shows second position and Fig. 9 shows first position, fastening element 20 – see annotated figures below; [0068]).
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It would have been obvious to one of ordinary skill in the art to modify the apparatus of McFarland et al. to incorporate the fastening element (i.e., second locking mechanism) of Regen et al. because it would allow the cartridge to mount to a docking device and lock the cartridge to the docking device thus restricting movement between the two.
The limitation “…configured to pivot between a first position that restricts a movement of the rigid cartridge and a second position that allows for movement of the rigid cartridge.” is directed towards the intended manner of operating the claimed apparatus and does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP §2114 II). The apparatus taught by Regen et al. would be fully capable of achieving every claimed intended use because the prior art locking mechanism is taught to rotate between a first and second rotational position (i.e., pivot between a first and second position) (see annotated figure above) and would be structurally capable of pivoting between a first position that restricts a movement of the rigid cartridge and a second position that allows for movement of the rigid cartridge.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McFarland et al. in view of Regen et al. (US 2022/0195372 A1) and Battrell et al. (US 2012/0115214 A1) (see PTO-892).
Regarding claim 20, McFarland et al. teaches the apparatus of claim 1.
McFarland et al. fails to teach wherein the first locking mechanism and the corresponding second locking mechanism collectively form an undercarriage of the apparatus.
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However, Regen et al. teaches a receiving area (i.e., first locking mechanism – note: this claim element was invoked via 35 U.S.C. 112(f)) and a corresponding fastening element (i.e., second locking mechanism) (Fig. 7, receiving area 24 and fastening element 20 – see annotated figure below).
Additionally, Battrell et al. teaches an inclined mounting plate (i.e., undercarriage) for an apparatus for assays performed in a microfluidic cartridge (i.e., apparatus) (Fig. 3B, inclined mounting plate 330 – see annotated figure below).
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Regen et al. teaches that the first and second locking mechanism facilitates a connection to a vessel (abstract) (i.e., rigid cartridge).
Battrell et al.’s inclined mounting plate presents the benefit of allowing a cartridge to interface with external electronic components ([0079], lines 7-19).
It would have been obvious to one of ordinary skill in the art to modify the device of McFarland et al. to incorporate the receiving area (i.e., first locking mechanism) and corresponding fastening element (i.e., second locking mechanism) of Regen et al. and the inclined mounting plate (i.e., undercarriage) of Battrell et al. because the first and second locking mechanisms would facilitate the connection of the undercarriage, allowing for the rigid cartridge to interface with external electronic components and an inclined mounting plate presents the benefit of allowing a cartridge to interface with external electronic components (claimed undercarriage)([0079], lines 7-19).
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 McFarland et al., Regen et al., and Battrell et al. to obtain the invention as specified in claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Akerstrom (US 2015/0056694 A1) teaches a bioreactor bag locking mechanism.
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/A.J.C./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799