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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 9-18, in the reply filed on February 17, 2026 is acknowledged. The traversal is on the ground(s) that the technical features “circulating gas across a bottom surface of a gas-permeable, liquid impermeable membrane of the cell culture vessel” is a special technical features that neither taught nor suggested by the prior art. This is not found persuasive because Group I does not require a step of circulating gas by using a fan. Further, as set forth in the restriction requirement, the inventions listed as Groups I-III do not relate to a single general inventive concept under PCT Rule 13.1 because they do not relate to one invention only, or to a group of inventions so linked so as to form a single inventive concept. Further, Applicants’ attention is drawn to the fact that the search for method claims requires the identification of processing steps, while the search for apparatus claims requires the identification of structural elements.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “disposable tray having opposed vent openings at a vertical location that corresponds to a vertical position of the membrane of the culture vessel” (claim 16), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. 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 15 and 17 are objected to because of the following informalities: In claims 15 and 17, “the fan” should read -- the at least one fan -- for consistency. Appropriate correction is required.
Claim Interpretation
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 limitation(s) is/are: “a rocking assembly” in claim 10; “a control unit” in claim 11.
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 10, 15 and 16 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 10 recites the limitation "a bioprocessing system" in line 2. It is unclear if said limitation is referring to the bioprocessing system recited earlier in the claim or is an additional bioprocessing system. For examination purposes, the limitation is interpreted to mean that said limitation is referring to the bioprocessing system recited earlier in the claim. Further clarification is requested and appropriate correction is required.
Claim 15 recites the limitation "the fan is located beneath the culture vessel" in line 2. However, the culture vessel itself is not positively recited in the instant claims. Thus the metes and bounds of the claim is unclear.
Claim 16 recites the limitation "the disposable tray having opposed vent openings at a vertical location that corresponds to a vertical position of the membrane of the culture vessel " in lines 2-4. Claim 16 requires the vessel to be arranged at a specific position relative to the vent openings of the tray. However, the culture vessel itself is not positively recited in the claim. Thus, the metes and bounds of the claim is unclear. For examination purposes, the limitation is interpreted to require the culture vessel.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hata et al. (US 2009/0111179; hereinafter “Hata”).
It is noted that while the invention contains a culture vessel, the culture vessel is not positively recited in the instant claims.
Regarding claim 9, a bioprocessing system, comprising: an incubation chamber (FIG. 5: incubator (1); [0056]); a support structure configured to support a culture vessel in an elevated position within
the incubation chamber (FIG. 5: tray (47); [0067]); and at least one fan configured to circulate an atmosphere within the incubation chamber
across a bottom surface of a gas-permeable, liquid impermeable membrane of the culture vessel when the culture vessel is supported by the support structure (Fan (41) of Hata is structurally the same as the instant fan and thus considered to be fully capable “to circulate an atmosphere within the incubation chamber across a bottom surface of a gas-permeable, liquid impermeable membrane of the culture vessel when the culture vessel is supported by the support structure”). See also [0062].
Regarding claim 10, Hata further discloses wherein: the support structure includes a rocking assembly of the bioprocessing system ([0081]).
Regarding claim 11, Hata further discloses wherein:
a control unit (operation control panel (13); [0058]); a carbon dioxide sensor configured to measure a concentration of carbon dioxide in the
atmosphere within the incubation chamber (sensor (25); [0058]); a temperature sensor configured to measure a temperature of the atmosphere within the incubation chamber (sensor (24); [0058]); and wherein the control unit is configured to control a flow rate of circulation of the atmosphere in dependence upon at least one of the concentration of carbon dioxide and/or the
temperature ([0058]).
Regarding claim 12, Hata further discloses wherein the bioprocessing system further comprising: a carbon dioxide source in selective fluid communication with the incubation chamber (gas cylinder (28); [0058]); wherein the control unit is configured to control a flow of carbon dioxide from the carbon dioxide source into the incubation chamber in dependence upon the concentration of carbon dioxide within the incubation chamber ([0058]).
Regarding claim 13, Hata further discloses wherein: the support structure is configured to induce a turbulent interaction between the atmosphere and the membrane (tray (47) of Hata is structurally the same as the instant platform and thus considered to be fully capable “to induce a turbulent interaction between the atmosphere and the membrane”). Applicant is reminded that the culture vessel is not a required element of the claimed bioprocessing system.
Regarding claim 14, Hata further discloses wherein: the support structure is configured to maximize exposure of the bottom surface of the
membrane to the atmosphere within the incubation chamber (tray (47) of Hata is structurally the same as the instant platform and thus considered to be fully capable “to maximize exposure of the bottom surface of the membrane to the atmosphere within the incubation chamber”). Also see [0067]. Applicant is reminded that the culture vessel is not a required element of the claimed bioprocessing system.
Therefore, Hata meets and anticipates the limitations set forth in claims 9-14.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hata as applied to claim 10 above.
Regarding claim 15, Hata discloses the bioprocessing system of claim 10 as set forth above. Hata discloses the claimed at least one fan (41) but does not explicitly disclose wherein the at least one fan is located beneath the culture vessel. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the at least one fan of Hata such that the at least one fan is located beneath the culture vessel, since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see MPEP § 2144.04 VI. C.).
Regarding claim 18, Hata discloses the claimed at least one fan located at one end but does not explicitly disclose wherein the at least one fan is two fans located at opposing ends of the incubation chamber. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the fan of Hata such that the bioprocessing system of Hata includes two fan at opposite ends, since it has been held that a mere duplication of working parts of a device involves only routine skill in the art (see MPEP § 2144.04 VI. B.). One would have been motivated to duplicate the fan for the purpose of enhancing air circulation within the incubator more uniformly.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hata as applied to claim 9 above, and further in view of Griffin et al (WO2019106207; hereinafter “Griffin”).
Regarding claims 16-17, Hata discloses the bioprocessing system of claim 10 as set forth above. Hata further discloses a disposable tray within which the culture vessel is positioned (FIG. 5: platform (46); [0067]), but does not explicitly disclose the disposable tray having opposed vent openings at a vertical location that corresponds to a vertical position of the membrane of the culture vessel, wherein: the disposable tray includes a pair of support legs, each of the pair of support legs being
configured so as to form a flow passage for directing the atmosphere circulated by the fan from
the incubation chamber to a first vent opening of the vent openings, and downwardly from a
second vent opening of the vent openings back to the incubation chamber. Griffin discloses a culture vessel (FIG. 13: vessel (420), and a tray (FIG. 15: tray 610) having opposed vent openings at a vertical location that corresponds to a vertical position of the membrane of the culture vessel (openings FIG. 15: openings (626,628), and vessel positioned above openings), and a pair of support legs, each of the pair of support legs being configured so as to form a flow passage for directing the atmosphere circulated by the fan from the incubation chamber to a first vent opening of the vent openings, and downwardly from a second vent opening of the vent openings back to the incubation chamber (FIGS. 13 and 15: support ribs (636); [0156]-[0159]). In view of Griffin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tray of Hata with the tray of Griffin to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of enhancing gas circulation around the culture vessel and thereby improving the cell culture process.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799