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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-15 have been considered but are moot in view of new grounds of rejection necessitated by amendments to the claims.
The corrections to the drawings and specification are acknowledged.
The claim amendments have overcome the previously presented rejections under 35 U.S.C. 112(b).
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 1 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.
Regarding claim 1, the limitation “wherein the apparatus is capable of withstanding a pressure of at least 20 psi for at least 48 hours” can be interpreted to mean wherein the apparatus is capable of withstanding an internal or external pressure of at least 20 psi for at least 48 hours, thus rendering the claim indefinite.
Claims 2-3 and 5-18 are similarly rejected as they depend upon rejected claim 1.
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.
Claims 1-3, 6-12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dolcet Sanjuan et al. (US 12,414,513 B2) (hereinafter Sanjuan; previously presented) in view of Yuan (CN 201390745 Y) (hereinafter Yuan; already of record; machine translation provided).
Regarding claim 1, Sanjuan teaches an apparatus for the establishment and maintenance of a sample in a controlled environment (claim 13-14; Col. 2, lines 10-15 and col. 5, lines 11- 20), the apparatus comprising:
a sample container (abstract, “sampling container”; Fig 7, receptacle 1);
a lid that attaches to the sample container (Fig. 7, lid 2 attached to receptacle 1), wherein the lid has two orifices (claim 9; Fig. 7, two orifices 5, 9),
a chamber inlet channel inserted into one of the orifices and a chamber outlet channel inserted into the other of the two orifices (Fig. 7, inlet channel and outlet channel shown; Col. 6, lines 44-45 imply requirement of inlet/outlet channels), wherein the insertion produces a seal between each of the channels and respective orifices (Col. 7, lines 42-64 teach that the assembly ensures sterility, requiring a seal between each channels and respective orifices), and
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a sample (Col. 5, lines 34-45; Fig. 7, plant material 11) (see annotated figure below).
Sanjuan fails to teach (d) an inlet valve connected to the chamber inlet channel, (e) an outlet valve connected to the chamber outlet channel, (g) a composition inlet channel connected to the inlet of valve (d), and (h) a composition outlet channel connected to the outlet valve of (e).
Regarding features (d)-(e) and (g)-(h), Yuan discloses a bacterial culture container (abstract) comprising two tubes (i.e., chamber channels) connected to a lid, each connected to a respective valve (Fig. 1 – see annotated figure below) and two pipelines (i.e., composition channels) connected to the valves, extending away from the container.
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It would have been obvious to one of ordinary skill in the art to modify the device of Sanjuan to incorporate valves and composition channels, as taught by Yuan, because the valves would control the flow of medium into or out of the sample container and the composition channels would permit flow to or from the container.
The limitations “outlet” and “inlet” are 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 modified Sanjuan would be fully capable of achieving every claimed intended use because each of the prior art channels and valves would be structurally capable of working for inlet or outlet flow.
Regarding the limitation “wherein the apparatus is capable of withstanding a pressure of at least 20 psi for at least 48 hours”, the apparatus taught by modified Sanjuan would inherently be capable of withstanding a pressure of at least 20 psi for at least 48 hours as the structure as the entirety of the structure has been made obvious (MPEP § 2112).
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 Sanjuan and Yuan to obtain the invention as specified in claim 1.
Regarding claim 2, modified Sanjuan teaches the apparatus of claim 1.
Sanjuan further teaches that the sample container and lid are synergistically threaded (Col. 6, lines 46-48; Fig. 5, container threading 1a and lid threading 2a).
Regarding claim 3, modified Sanjuan teaches the apparatus of claim 1.
Sanjuan further teaches the sample container comprises glass (Col. 6, lines 49-50, “multi-purpose receptacle 1 made of glass or polycarbonate”).
Regarding claims 6 and 7, modified Sanjuan teaches the apparatus of claim 1.
Sanjuan further teaches the receptacle (sample container) connected to a source of gas (Col. 4, lines 1-2, “A gas may be injected through this orifice to modify the inner atmosphere of the receptacle, if necessary.”) and a source of liquid (Col. 6, lines 53-56, “The reactor system includes means (not shown) for pumping liquid culture medium from an external reservoir (not shown) to the receiving container 4 at a predetermined frequency.”).
Regarding claim 8, modified Dolcet Sanjuan et al. teaches the apparatus of claim 1.
Dolcet Sanjuan et al. further teaches wherein the sample comprises living things or parts thereof (abstract, “It comprises a receptacle for the culture of plant material”; Col. 5, lines 25-45).
Regarding claims 9-12, modified Sanjuan teaches the apparatus of claim 8.
Sanjuan further teaches:
Claim 9: wherein the sample comprises a plant (abstract, “It comprises a receptacle for the culture of plant material”).
Claim 10: wherein the sample comprises a microbe (Col. 5, lines 42-45, “Optionally, the plant material may comprise biotic agents, for example bacteria and/or fungi”).
Claim 11: wherein the sample comprises a plurality of living organisms or parts thereof (Col. 5, lines 26-31, “for example…plant tissues, plant organs, seeds and/or plant cells”).
Claim 12: wherein the sample comprises at least one plant and at least one microbe (Col. 5, lines 38-45, “In vitro culture comprises plant material…plant material may comprise biotic agents, for example bacteria and/or fungi”).
Regarding claim 18, such claims are 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 modified Sanjuan would be fully capable of achieving every claimed intended use because the prior art apparatus is taught to support plant material (abstract) in a controllable, sealed environment (abstract; Fig. 6 shows sealed environment with sample) and would be structurally capable of testing the sample in the controlled environment.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sanjuan and Yuan as applied to claim 1 above, and further in view of Clark, II (US 5437202) (hereinafter Clark; already of record)
Regarding claim 5, modified Sanjuan teaches the apparatus of claim 1.
The prior art combination teach the valve being of ballcock form.
However, Clark teaches that using ballcock valve to control fluid flow is known in the art (Col. 3, line 59 - Col. 4, line 10).
It would have been obvious to one of ordinary skill in the art to It has been held that a claim has no patentable significance when substitution of one known element for another yields predictable results (e.g., controlling flow of media) to one of ordinary skill in the art (MPEP § 2143 B).
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 Sanjuan, Yuan, and Clark to obtain the invention as specified in claim 5.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sanjuan and Yuan as applied to claim 1 above, and further in view of Ballew et al. (US 2021/0387176 A1) (hereinafter Ballew).
Regarding claim 13, modified Sanjuan teaches the apparatus of claim 1.
The prior art combination fails to teach wherein the composition outlet channel is connected to a syringe.
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However, Ballew teaches a syringe connected to a flexible tube (i.e., composition outlet channel) extending from a sampling container connected to (Fig. 3, second flexible tube 36 attached to syringe 76 - see annotated figure below).
Ballew teaches that the syringe is a receiving container for sample collection (para. 0032).
It would have been obvious to one of ordinary skill in the art to further modify the apparatus of Sanjuan to connect a syringe to the composition outlet channel, as taught by Ballew, to collect samples for testing.
Regarding claims 14 and 15, modified Sanjuan teaches the apparatus of claim 13.
Ballew teaches it is known in the art to connect a plurality of sampling containers in series ([0039]-[0040]) and in parallel ([0040]).
Ballew teaches that connecting a plurality of sampling containers in series permits several stages of growth and/or differentiation to occur ([0040]).
It would have been obvious to one of ordinary skill in the art to further modify the apparatus of Sanjuan to connect a plurality of the apparatus arranged in series, as taught by Ballew, to study or harvest from several stages of growth.
Ballew teaches that connecting a plurality of sampling containers in parallel for scale-up purposes ([0040]).
It would have been obvious to one of ordinary skill in the art to further modify the apparatus of Sanjuan to connect a plurality of the apparatus arranged in parallel, as taught by Ballew, for scale-up purposes.
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 Sanjuan, Yuan, and Ballew to obtain the inventions as specified in claims 14 and 15.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Sanjuan and Yuan as applied to claim 1 above, and further in view of Radcliffe et al. (US 2022/0304455 A1) (hereinafter Radcliffe; previously presented).
Regarding claim 16, modified Sanjuan teaches the apparatus of claim 1.
The prior art combination fails to teach wherein the seal is produced by a sealant material in or around each of the two orifices into which the chamber inlet channel and chamber outlet channel have been inserted.
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However, Radcliffe teaches a liquid adhesive or bonding material (i.e., sealant material) used inside an orifice used which seals a tube (Fig. 5B – see annotated figure below; [0056], lines 14-16) in a cap for a bottle bioreactor container ([0002]).
It would have been obvious to one of ordinary skill in the art to further modify the apparatus of Sanjuan using the teachings of Radcliffe to use a sealant material in each of the two orifices into which the chamber inlet channel and chamber outlet channel have been inserted to prevent contaminants from entering the container.
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 Sanjuan, Yuan, and Radcliffe to obtain the invention as specified in claim 16.
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sanjuan, Yuan, and Radcliffe as applied to claim 16 above, and further in view Simon et al. (US 2017/0037356 A1) (hereinafter Simon; previously presented).
Regarding claim 17, modified Sanjuan teaches the apparatus of claim 16.
The prior art combination fails to teach wherein the sealant material comprises silicone or epoxy.
However, Simon teaches wherein a sealant material includes silicone or epoxy ([0105], “…a portion of the encloser is formed from a sealant, such as silicone, epoxy…”).
Simon teaches that silicone-based sealant or epoxy can be used to make the housing of a bioprocess sensor leak-proof or leak-resistant by applying silicone-based sealant/epoxy to connections or points of entry on the housing ([0088]).
It would have been obvious to one of ordinary skill in the art to use a silicone or epoxy as the sealant material, as taught by Simon, to seal the orifices on the device of modified Sanjuan.
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 Sanjuan, Yuan, Radcliffe, and Simon to obtain the invention as specified in claim 17.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799