DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 cell culture part” in claim 1; “a medium adjustment part” in claim 1; “a gas supply part” in claim 1; “a spacing member” in claim 3; “a support member” 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 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 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the scaffold" in line 2. However, it is unclear which scaffold among the plurality of scaffold recited earlier in the claim the limitation is referring to.
Appropriate correction is required.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over de Bournonville et al. ("Towards self‐regulated bioprocessing: a compact benchtop bioreactor system for monitored and controlled 3D cell and tissue culture." Biotechnology journal 14.7 (2019): 1800545) (hereinafter “Bournonville”) in view of Ma (US 6,875,605) and Goffe et al (WO 9504813-A1; hereinafter “Goffe”).
Regarding claim 1, Bournonville discloses a portable bioreactor (bioreactor system of de Bournonville is considered portable; see page 2; FIGS. 1E-1G), comprising: a frame part (FIGS. 1E and 1G: bioreactor housing; see also section 2.1.2. Bioreactor Housing); a cell culture part having one side mounted on the frame part (FIGS. 1E, 1G and 1H: perfusion chamber coupled to a perfusion holder of the frame; see also sections 2.1. Bioreactor Design; 2.1.2. Bioreactor Housing), a plurality of scaffolds for cell culture disposed therein (scaffolds within the perfusion chamber; see sections 2.1.1. Perfusion Circuit, 2.3. Bioreactor Evaluation and Construct Growth Assessment, 2.3.1 TE Constructs), an inlet through which a medium supplied from the outside is introduced, and an outlet through which the medium inside the cell culture part is discharged to the outside (see FIG. 1A, which shows the perfusion chamber (5) having an inlet and outlet); a medium adjustment part installed at the frame part and configured to store therein a certain amount of medium for cell culture (FIGS. 1A, 1E: a medium reservoir (1) coupled to the holders of the frame; see sections 2.1.1. Perfusion Circuit; 2.1.2. Bioreactor Housing); and a circulation pump installed to be fixed to the frame part for the medium stored in the medium adjustment part to circulate in the cell culture part and the medium adjustment part (FIGS. 1A, 1E: a pump (2) coupled to the frame; see sections 2.1.1. Perfusion Circuit; 2.1.2. Bioreactor Housing). Bournonville a gas supply part (FIG. 1A: gas-exchange unit; see sections 2.1.2. Bioreactor Housing; 3.1. Monitoring and Controllability of the Environment), but does not explicitly disclose wherein the gas supply part is configured to supply a gas to the medium adjustment part for the medium stored in the medium adjustment part to maintain a constant pH level. Ma discloses a bioreactor system comprising a cell culture part (FIGS. 2-3: bioreactors; col. 7, ll. 30-40), a medium adjustment part (FIGS. 2-3: medium reservoir; col. 7, ll. 30-40), a media pump and a gas supply part configured to control pH of the medium (col. 7, ll. 46-50). Goffe discloses that it is well known to provide gases to media through media flowing through tubing and sparging gas directly into the media reservoir (see page 2). In view of Ma, 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 bioreactor of Bournonville such that the gas supply part is configured to supply a gas to the medium adjustment part, as disclosed by Ma (col. 7, ll. 46-50), instead of supplying gas to the medium flowing through the circuit. One of ordinary skill in the art would have made said modification because said modification would have been an alternative means for introducing gases to the media, as disclosed by Goffe (see page 2).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bournonville in view of Ma and Goffe as applied to claim 1 above, and further in view of Piccinini et al. (US 9,765,292; hereinafter “Piccinini”).
Regarding claim 2, modified Bournonville discloses wherein the frame part includes a base plate (FIG. 1E: bottom plate of bioreactor housing), and a mounting plate extending a predetermined height from the base plate for the medium adjustment part and the circulation pump to be mounted (as shown in FIGS. 1A and 1E, medium reservoir (1) and pump (2) are coupled to a wall extending from a bottom plate of the bioreactor housing). Bournonville discloses wherein the cell culture part is mounted to the bioreactor housing while spaced a predetermined height from the base plate (FIGS. 1A and 1E), but does not explicitly disclose a rack extending a predetermined height from the base plate for the cell culture part to be mounted. Piccinini discloses a bioreactor system comprising a rack and a plurality of cell culture parts (bioreactors) mounted on a rack. The rack provides stability during operation and efficient handling of the plurality of bioreactors (col. 5, ll. 52-64). In view of Piccinini, 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 mounting of the cell culture part on the frame of modified Bournonville such that the cell culture part is mounted on a rack as disclosed by Piccinini (col. 5, ll. 52-64). One of ordinary skill in the art would have made said modification because said modification would have resulted in a frame having the added advantage of providing stability to the cell culture part during operation and efficient handling of the cell culture part, as disclosed by Piccinini (col. 5, ll. 52-64).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bournonville in view of Ma and Goffe as applied to claim 1 above, and further in view of Yuan et al. (US 2019/0010437; hereinafter “Yuan”).
Regarding claim 3, modified Bournonville discloses the portable bioreactor of claim 1. Modified Bournonville discloses wherein the perfusion chamber includes a housing having a box-shaped portion (perfusion chamber includes a box-shaped portion; see FIG. 1H), the housing having an accommodation space filled with the medium and adapted to contain one or more scaffolds (see FIG. 1; page 2, 2.1.1. perfusion Circuit), but does not explicitly disclose, a plurality of scaffolds arranged parallel in one direction in the accommodation space for cells to be cultured, and a spacing member configured to space two scaffolds facing each other for the plurality of scaffolds to remain spaced from each other. Yuan discloses a system comprising a cell culture part having an accommodation space (FIG. 1: culture column (100); [0062]), a fixing bracket (FIG. 1: bracket (600); [0062]), a plurality of scaffolds arranged parallel in one direction in the accommodation space for cells to be cultured (FIG. 1), and a spacing member configured to space two scaffolds facing each other for the plurality of scaffolds to remain spaced from each other (e.g., sealing ring (141); [0087]; FIGS. 2-4). In view of Yuan, 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 one or more scaffold of modified Bournonville with the plurality of scaffolds of Yuan to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of securing a plurality of scaffolds within the cell culture part as disclosed by Yuan ([0087]; FIGS. 2-4). Further, one of ordinary skill in the art would have made said modification for the purpose of culturing a plurality of constructs within the cell culture part as suggested by Bournonville (see page 2, 2.1.1. perfusion Circuit). Assuming arguendo that modified Bournonville does not explicitly disclose the cell culture part is a box-shaped. 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 modified the shape of the cell culture part of modified Bournonville to have the claimed shape, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (see MPEP 2144.04 IV.B.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bournonville in view of Ma and Goffe as applied to claim 1 above, and further in view of Jang et al. (WO 2020-101376-A1, with English machine translation; hereinafter “Jang”).
Regarding claim 4, modified Bournonville discloses the portable bioreactor of claim 1. Modified Bournonville does not explicitly disclose wherein the scaffold includes a plate-shaped nanofiber membrane coated with a protein motif and a support member attached to one surface of the nanofiber membrane via an adhesive layer to support the nanofiber membrane. However, modified Bournonville discloses wherein the cell culture part (perfusion chamber) comprising a housing having an accommodation space filled with a medium and adapted to contain one or more scaffolds (see FIG. 1; page 2, 2.1.1. perfusion Circuit). Jang discloses a cell culture device comprising a cell culture part comprising a housing having an accommodation space, and a plurality of scaffold arranged within the accommodation space (FIGS. 3-11; [0008]; [0064]). In view of Jang, 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 cell culture part of modified Bournonville with the cell culture part of Jang to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known scaffold with its supporting means with another for the predictable result of culturing cells.
Claims 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bournonville in view of Ma and Goffe as applied to claim 1 above, and further in view of Ahluwalia et al. (US 7,790,444; hereinafter “Ahluwalia”).
Regarding claim 5, modified Bournonville discloses the portable bioreactor of claim 1. Modified Bournonville further discloses wherein the medium adjustment part includes a storage container having an open portion (medium reservoir; see FIGS. 1A, 1E and 1G; page 2, 2.1.1. perfusion Circuit, of Bournonville), a stopper configured to cover the open upper portion of the storage container (see FIGS. 1A, 1E and 1G; page 5, 2.1.3. Fluidic Components), and a plurality of fittings formed at the stopper, one of the fittings to be connected the circulation pump via connecting tube (connecting tubes and luer connectors are employed in the Bournonville bioreactor to connect components of the bioreactor to one another; see 2.1.1. perfusion Circuit; 2.1.3. Fluidic Components). Modified Bournonville does not explicitly disclose wherein each of the outlet of the cell culture part and the gas supply part via a connecting tube are connected to the plurality of fittings via a connecting tube. However, modified Bournonville does disclose wherein the gas supply part is connected to the medium adjustment part. Ahluwalia discloses a bioreactor comprising a cell culture part (FIG. 1: culture chamber (2); col. 5, ll. 39-42), a circulation pump (30), and the medium adjustment part (premixing chamber (1)). The medium adjustment part includes a stopper having a plurality of fittings, each of the fittings is coupled to the circulation pump (FIG. 1), an outlet of the cell culture part (abstract), and agas supply part via a connecting tube (col. 6, ll. 19-31). In view of Ahluwalia, 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 medium adjustment part of modified Bournonville with the medium adjustment part of Ahluwalia to arrive at the claimed invention. One of ordinary skill in the art would have made said modification 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.). Further, one would have been motivated to rearrange the connection between the components of the bioreactor of modified Bournonville for the purpose of constructing simpler medium adjustment part having one part for connecting the medium adjustment part to the other components of the bioreactor. Modified Bournonville discloses wherein the inside of the storage container is, through the certain amount of medium filled therein, divided into a medium storage space filled with the medium and a gas storage space positioned at an upper side of the medium storage space and filled with air (medium adjustment part of modified Bournonville includes a medium and gases introduced into atop portion of the medium adjustment part); and the medium filled in the medium storage space maintains a constant pH level through the gas supplied from the gas supply part to the gas storage space (it is noted that the medium within the medium adjustment part is maintained at a desired pH level; see (col. 7, ll. 46-50 of Ma). Furthermore, it is noted that the medium and gas are material worked on and not elements of the claimed portable bioreactor. It is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2115.
Regarding claim 7, modified Bournonville discloses wherein the plurality of fittings include a first fitting connected to the circulation pump for the medium of the medium storage space to be supplied to the cell culture part, a second fitting connected to the outlet of the cell culture part for the medium of the cell culture part to be recovered to the medium storage space, and a third fitting connected to the gas supply part for the gas supplied from the gas supply part to be introduced into the gas storage space (stopper of modified Bournonville includes tubings and fittings connecting the outlet of the cell culture part, circulation pump and gas supply part, to the medium adjustment part; see claim 5 above).
Regarding claim 8, modified Bournonville discloses wherein the medium adjustment part includes a first extension tube connected to the first fitting for one end of the first extension tube to be submerged in the medium stored in the medium storage space and a second extension tube connected to the second fitting for one end of the second extension tube to be submerged in the medium stored in the medium storage space (see FIG. 1 of Ahluwalia).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bournonville in view of Ma, Goffe and Ahluwalia as applied to claim 5 above, and further in view of Jing et al (US 2019/0352589; hereinafter “Jing”).
Regarding claim 6, modified Bournonville discloses the portable bioreactor of claim 5. Modified Bournonville does not explicitly disclose wherein the medium adjustment part further includes a vent port provided at the stopper. Jing discloses a bioreactor comprising a cell culture part (FIG. 4: cartridge (200); [0095]), a pump (204), and a medium adjustment part (FIG. 4: reservoir (202); [0095]), and a vent coupled to a lid of the media reservoir (vent (402); [0095]). In view of Jing, 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 employed the vent of Jing with the stopper of modified Bournonville for the purpose of maintaining the pressure within the medium adjustment part as desired level as disclosed by Jing (see [0095]). Furthermore, the limitation “to communicate with the gas storage space to prevent generation of bubbles while the gas is supplied from the gas supply part to the gas storage space” 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Guinn (US 4,918,019) discloses a system comprising a cell culture part, a medium adjustment part, a circulation pump and a gas supply part. Karpusha (EA 029642-B1) discloses a cell culture part, a medium reservoir and circulation pump. 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
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