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
Newly submitted claim 24 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 1 & 24 lack unity of invention because the groups do not share the same or corresponding technical feature. The invention of Claim 1 includes the special technical features of at least one illumination device, and illuminated, by at least one of the at least one illumination device, with a signal of electromagnetic radiation wherein the incubator system further comprises or is in connection with one or more processing units wherein the incubator system regulates the speed of rotation of one or more cell culture chamber devices in response to at least part of the extracted or derived data of the one or more monitoring signals, not required by Claim 24. The invention of Claim 24 includes the special technical feature of a cell culture chamber device comprising an enclosure for a cell culture media; wherein the cell culture chamber device is rotatable about a substantially horizontal axis, and the speed of rotation of the cell culture chamber device is regulated in response to the extracted or derived data, not required by Claim 1. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 24 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim 20 is withdrawn from consideration because the claim is dependent on withdrawn claim 3.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 6, 7, 9-19, 21-23 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.
Claims 1, 2, 6, 7, 9-19, 21-23 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 1 is unclear reciting “illuminated, by at least one of the at least one illumination device, with a signal of electromagnetic radiation selected from the group consisting of incoherent or coherent ultraviolet, visible, infrared, and/or near-infrared light of broad or narrow wavelength spectrum” because it is unclear whether the applicant is claiming a step of illumination, a capability of the at least one illumination device, or the at least one illumination device is an electromagnetic radiation illumination device selected from the group consisting of incoherent or coherent ultraviolet, visible, infrared, and/or near-infrared light of broad or narrow wavelength spectrum. For this reason, dependent claims relating to the recitation are similarly unclear, and/or rejected based on further claim dependency.
Claims 13, 14 and 23 are unclear. For example, claim 13 is unclear reciting “wherein the processing units analyse [...] the amount of a defined biomolecule present” because the amount of a defined biomolecule present is not a positive element of the claim. The claimed biomolecule is a biomarker in claim 14, and biomarker is selected from the group consisting of: a protein, a DNA, and/or an RNA in claim 23 are thereby indefinitely defined.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 6, 7, 9-19 and 21-23 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Suzuki et al. (US 2007/0148764 A1).
Regarding claim 1, Suzuki et al. teach:
Claim 1 An incubator system comprising
at least one illumination device (e.g., light source 10, 34, 281, 381, a plurality of mirrors 278, 279, 282, 283, 284 and 285, and lens), and at least one monitoring device (e.g., monitoring device 130 connected to the computer network ¶ 0045; see also camera 9, 31, 280) that is capable of providing one or more monitoring signals of at least part of an illuminated cell culture media (e.g., 17) or an illuminated cell culture chamber (e.g., 38; see i.e., The function of the controlling and monitoring device 130 is to successively monitor the operations of the device for cell culture explained in FIG. 5 and emit signals to outside in the abnormal case, ¶ 0046),
the at least one illumination device selected from the group consisting of incoherent or coherent ultraviolet, visible, infrared, and/or near-infrared light of broad or narrow wavelength spectrum (see ¶ 0150 for example), and
wherein the incubator system is in connection with one or more processing units (e.g., CPU 122, 362) that is capable of deriving data from the one or more monitoring signals, said data representing one or more aspects of the cellular activity occurring within (see e.g., Step S60 ¶ 0067),
wherein the incubator system is capable of regulating the speed of rotation of one or more cell culture chamber devices in response to at least part of the derived data (see ¶ 0101 for example).
Regarding claim 1, Suzuki et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “for illuminating at least one or more cell culture chamber devices and rotating the at least one or more cell culture chamber devices about a respective substantially horizontal axis, each cell culture chamber device comprising an enclosure for a cell culture media, and at least one viewing area that allows inspection of at least a part of the cell culture media”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claims 1, 6, 7, 9-15, 17-19, 21-23 (e.g., [...] that provides one or more monitoring signals of at least part of an illuminated cell culture media or an illuminated cell culture chamber, illuminated, by at least one of the at least one illumination device, with a signal of electromagnetic radiation selected from the group consisting of incoherent or coherent ultraviolet, visible, infrared, and/or near-infrared light of broad or narrow wavelength spectrum, and wherein the incubator system further comprises or is in connection with one or more processing units that extract and/or derive data from the one or more monitoring signals, said data representing one or more aspects of the cell culture chamber device itself and/or the cellular activity occurring within, wherein the incubator system regulates the speed of rotation of one or more cell culture chamber devices in response to at least part of the extracted or derived data of the one or more monitoring signals, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 6, 9, 12-17 and 23, Suzuki et al. teach:
Claim 2. The incubator system according to claim 1, where at least one of the one or more monitoring signals comprises a video signal or one or more image signals or data (¶ 0223-0225, 0227+).
Claim 6. The incubator system according to claim 1, wherein the one or more processing units is capable of deriving data from the one or more monitoring signals and sorts the data from the one or more monitoring signals into different predetermined categories based on one or more characteristics of the derived data (see ¶ 0252-0253 or example), wherein at least one of the predetermined categories correspond to cells or cell clusters, and provides data about cell proliferation over time (¶ 0246-0253+).
Claim 9. The incubator system according to claim 1, wherein the data derived from the one or more monitoring signals is or comprises one or more digital images and/or a digital video obtained of or for a contained cell culture chamber device (¶ 0246-0253+), and wherein the incubator system is capable of regulating the speed of rotation of the contained cell culture chamber device (see ¶ 0101 for example).
Claim 12. The incubator system according to claim 1, wherein the incubator system comprises at least two axels or drive units (e.g., rotor 22, pinion 28, incubator driving motor 29) that each rotate a respectively connected or received cell culture chamber device (see ¶ 0030 for example).
Claim 13. The incubator system according to claim 1, wherein the processing units is capable of analyzing the one or more monitoring signals of the cell culture media for cells or cell cluster elements in the cell culture chamber (¶ 0246-0253+).
Claim 14. The incubator system according to claim 13, where the biomolecule is capable of having a biomarker (it is noted that a biological cell can have a biomarker).
Claim 15. The incubator system according to claim 1, further comprising at least one sensor (e.g., pH measuring part 177) incorporated into one or more of: the cell culture chamber devices, the cell culture media, and/or the cells present to provide data about a chemical or biological process (see ¶ 0149-0153 & Figs. 21-22 for example).
Claim 16. The incubator system according to claim 15 where the sensor is a pH indicator, a fluorescent biomarker, or a chemical or an enzyme system (e.g., pH measuring part 177).
Claim 17. The incubator system according to claim 1, wherein the one or more processing units is capable of calculating a status of a cell culture process in one or more of the cell culture chambers by deriving data from the one or more monitoring signals from said one or more cell culture chamber device (¶ 0246-0253+), wherein the incubator system is capable of modifying or adjusting the operation of the incubator (see ¶ 0101, 0233, 0282 for example).
Claim 23. The incubator system according to claim 14, wherein the biomarker is capable of being selected from the group consisting of: a protein, a DNA, and/or an RNA (it is noted that a biological cell can have a biomarker).
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground(s) of rejection. The amendments have been considered and 35 USC § 112 rejections have been revised as set forth above.
In response to the Applicant's arguments to the preamble of claim 1, a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
In response to the Applicant's arguments to the process or intended use limitations, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The Courts have held that limitations regarding the contents, intended use or manner of operating an apparatus do not further limit the patentability of apparatus claims. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488,492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is encouraged to amend the claims to include additional structural elements of the system. Applicant is thanked for their thoughtful amendments to the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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