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 .
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 gas exchanger (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.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities: In claim 1, “a bioreactor inlet” should read “a cell culture vessel inlet” for consistency. In claim 1, “a bioreactor outlet” should read “a cell culture vessel outlet” 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: “temperature control system” in claim 4.
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 16 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Dependent claim 16 recites the limitation "gas exchanger," however, said limitation fails to comply with written description requirement. The instant specification, as originally filed, discloses a media conditioning system further comprising a gas exchanger (see paragraph 73 of the application publication). However, the instant specification is silent as to the structure that comprise the claimed gas exchanger. As such, said limitation fails to comply with the written description requirement.
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(s) 12, 14 and 18 is/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 12 recites the limitation "plurality of media cavities" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the plurality of tracheal spaces" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "wherein the media cavity follows a circuitous path through the media conditioning system" in lines 2-3. The media cavity is an element of the media conditioning system. Thus, it is unclear which element of the media conditioning system the media cavity follows a circuitous path through.
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.
Claim(s) 1-6, 9-11, 13 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coger et al. (US 2011/0020863; hereinafter “Coger”).
Regarding claim 1, Coger discloses a cell culture system comprising: a cell culture vessel enclosing an interior configured to culture cells in liquid cell culture media (FIG. 4: bioreactor assembly (10); [0025]), the cell culture vessel comprising a bioreactor inlet for supply of cell culture media to the interior and a bioreactor outlet for removal of cell culture media from the interior (FIG. 4: bioreactor assembly includes an inlet and outlet; [0032]); and a media conditioning system comprising an enclosure enclosing an interior space and a gas exchange system (FIG. 4: incubator (4); [0032]), the gas exchange system comprising a media vessel (FIG. 4: media gas exchanger 50; [0032]), wherein the media vessel comprises at least one media cavity configured to contain cell culture media and a gas permeable membrane separating the media cavity from the interior space (FIG. 4: media gas exchanger (50) is adapted to selectively add or remove gas from media flowing through a tubing of the media gas exchanger; and thus the tubing of the media gas exchanger is inherently gas permeable; [0032]).
Regarding claim 2, Coger discloses all of the structural features of the claimed enclosure and the gas exchange system, and thus Coger is considered to meet the limitation “wherein the enclosure is a reusable component and the gas exchange system is a single-use component.”
Regarding claim 3, Coger further discloses wherein the enclosure is a thermal enclosure (i.e., an incubator that is thermally insulated and/or maintains gas, pressure and temperature at desired levels; [0032]).
Regarding claim 4, Coger further discloses wherein the enclosure comprises a temperature control system (incubator of Coger is adapted to maintain gas, pressure and temperature at desired levels within the incubator, and thus considered to inherently comprise a temperature control system; [0032]).
Regarding claim 5, Coger further discloses wherein the media conditioning system is a closed system (FIG. 4: media conditioning system is enclosed within an enclosure).
Regarding claim 6, Coger further discloses wherein the gas permeable membrane is liquid impermeable (media gas exchanger 50 allows gas exchange but not liquid; [0032]).
Regarding claim 9, Coger further discloses the media conditioning system further comprising a media inlet and a media outlet (FIG. 4: media gas exchanger (50) includes an inlet and outlet).
Regarding claim 10, Coger further discloses wherein the media inlet supplies media to the at least one media cavity (see FIG. 4: media is introduced and removed from the media gas exchanger (50)). Furthermore, it is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform.
Regarding claim 11, Coger further discloses wherein the media outlet is in fluid communication with an inlet of the cell culture vessel and is configured to output media from the at least one media cavity to the cell culture vessel (see FIG. 4: media gas exchanger (50) is in fluid communication with cell culture vessel (10)).
Regarding claim 13, Coger further discloses wherein the cell culture vessel and the media conditioning system are arranged in a perfusion loop (see FIG. 4).
Regarding claim 17, Coger further discloses wherein the gas levels in the system are monitored (Coger at [0032]), and therefore the cell culture system of Coger inherently includes monitoring means in order to ascertain that the necessary gas levels had been reached. Furthermore, the limitation “to measure a quantity of at least one of a gas in the enclosure and a liquid media in the media conditioning system” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114).
Regarding claim 18, Coger further discloses wherein the media cavity follows a circuitous path through the media conditioning system (media vessel) (FIG. 4 of Coger shows a tubing within the media vessel following a circuitous path).
Regarding claim 19, Coger further discloses wherein the media cavity traverses a plurality of gas permeable membranes along the circuitous path, the plurality of gas permeable membranes separating media within the media cavity from a plurality of tracheal spaces (as shown in FIG. 4, the media cavity follows a circuitous path through the media vessel forming “plurality of gas permeable membranes separating media within the media cavity from a plurality of tracheal spaces”.
Regarding claim 20, Coger discloses a media conditioning system for conditioning cell culture media comprising: a reusable enclosure enclosing an interior space (FIG. 4: incubator (4); [0032]); and a gas exchange system, the gas exchange system comprising a media vessel with at least one media cavity configured to contain cell culture media and a gas permeable membrane separating the media cavity from the interior space (FIG. 4: media gas exchanger (50) is adapted to selectively add or remove gas from media flowing through a tubing of the media gas exchanger; and thus the tubing of the media gas exchanger is inherently gas permeable; [0032]), wherein the gas exchange system is a single-use component (gas exchange system of Coger discloses all of the structural features of the claimed gas exchange system and thus meets the limitation “a single-use component”).
Therefore, Coger meets and anticipates the limitations set forth in claim(s) 1-6, 9-11, 13 and 17-20.
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.
Claim(s) 7-8 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coger as applied to claims 1 and 9 above, and further in view of Miyamori et al. (US 5,149,649; hereinafter “Miyamori”).
Regarding claims 7-8 and 12, Coger discloses the cell culture system according to claim 1. Coger further discloses wherein the media cavity containing media is exposed to a gas environment and the gas impermeable membrane separating the media cavity from the gas environment (Coger at FIG. 4 and [0032]), but does not explicitly disclose wherein the media vessel further comprises a plurality of media cavities separated by a plurality of tracheal spaces, the tracheal spaces being exposed to a gas environment in the enclosure and the gas impermeable membrane separating the tracheal spaces from the media cavities, and an inlet manifold that connects the plurality of media cavities in fluid communication with each other, and wherein the media vessel further comprises an outlet manifold that is disposed between the plurality of media cavities and the media outlet, and connects the plurality of media cavities in fluid communication with the media outlet. Miyamori discloses a cell culture system comprising a cell culture vessel (FIG. 2: culture bath 1’; col. 5, ll. 37-44) and media condition system comprising a plurality of media cavities separated by a plurality of tracheal spaces, the tracheal spaces being exposed to a gas environment in the enclosure and the gas impermeable membrane separating the tracheal spaces from the media cavities, and an inlet manifold that connects the plurality of media cavities in fluid communication with each other (see FIG. 2, annotated and reproduced below; col. 5, ll. 29-44),
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and wherein the media vessel further comprises an outlet manifold that is disposed between the plurality of media cavities and the media outlet, and connects the plurality of media cavities in fluid communication with the media outlet (see annotated FIG. 2 above). In view of Miyamori, 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 media vessel of Coger with the media vessel of Miyamori to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of enhancing gas exchange between the media in the media cavity and gas environment by increasing the number of media cavities in the media vessel. Furthermore, 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 incorporate additional media cavities into the media vessel of Coger, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. One of ordinary skill in the art would have made said modification for the purpose of maintaining optimal growth conditions for cell culture process.
Claim(s) 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coger as applied to claim 1 above, and further in view of Barbera-Guillem (US 5,149,649; hereinafter “’595”).
Regarding claim 14, Coger discloses the cell culture system according to claim 1. Coger discloses wherein the media conditioning system is coupled to a gas source (see [0032]), but does not explicitly disclose wherein the gas source is outside the enclosure, and wherein the enclosure comprises a gas inlet configured to supply gas to the interior space. ‘595 discloses a system comprising an enclosure having an interior space accommodating a gas exchange system (FIG. 2: housing (12) having an environment controlling mechanism (16). See col. 7, lines 1-8). The enclosure further comprising a gas inlet configured to supply gas to the interior space (see FIG. 2; col. 7, ll. 20-35). In view of ‘595, 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 media enclosure of Coger with the enclosure of ‘595 to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of providing means for introducing gas into media vessel. Further, one of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known gas introducing means for another for predictable result of introducing gases into the media vessel.
Regarding claim 16, Coger further discloses wherein the media conditioning system further comprises a gas exchanger (see FIG. 2 of ‘595: gas source; col. 7, ll. 20-35).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coger in view of ‘595 as applied to claim 14 above, and further in view of Miyamori et al. (US 5,149,649; hereinafter “Miyamori”).
Regarding claim 15, Coger discloses the cell culture system according to claim 14. Modified Coger discloses wherein the gas is introduced to the media vessel (Coger at [0032]), but does not explicitly disclose wherein the media conditioning system comprises a gas manifold configured to supply gas from the interior space to the plurality of tracheal spaces. Miyamori discloses a cell culture system comprising a cell culture vessel (FIG. 2: culture bath 1’; col. 5, ll. 37-44) and media condition system comprising a plurality of media cavities separated by a plurality of tracheal spaces, the tracheal spaces being exposed to a gas environment in the enclosure and the gas impermeable membrane separating the tracheal spaces from the media cavities (see FIG. 2, annotated and reproduced below; col. 5, ll. 29-44),
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and gas manifold configured to supply gas from the interior space to the plurality of tracheal spaces. (see FIG. 2: gas inlet 4; col. 5, ll. 15-20). In view of Miyamori, 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 media vessel of Coger with the media vessel of Miyamori to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of enhancing gas exchange between the media in the media cavity and gas environment by increasing the number of media cavities in the media vessel. Furthermore, 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 incorporate additional media cavities into the media vessel of Coger, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. One of ordinary skill in the art would have made said modification for the purpose of maintaining optimal growth conditions for 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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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799