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 of Species C(2)(ii)(2) -- i.e. "[C] wherein the incubator system further [2] is in connection with one or more processing units configured to [ii] derive data from the one or more monitoring signals, said data representing one or more aspects of [2] the cellular activity occurring within in the reply filed on 04/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 2 is objected to because of the following informalities: “An incubator system” in L1 should read “The incubator system”. 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: the at least one monitoring device configured to provide 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, preferably incoherent or coherent ultraviolet, visible, infrared, and/or near-infrared light of broad or narrow wavelength spectrum, and wherein the incubator system further is in connection with one or more processing units configured to derive data from the one or more monitoring signals, said data representing one or more aspects of the cellular activity occurring within in claim 1; wherein the one or more processing units is configured to extract or derive data from the one or more monitoring signals and to sort it into different categories based on one or more characteristics of the extracted or derived data, wherein at least one of these predetermined categories correspond to cells or cell clusters, and to provide data about cell proliferation over time in claim 6; wherein the incubator system is further configured to regulate the speed of rotation of one or more cell culture chamber devices in response to extracted or derived data of the one or more monitoring signals in claim 8; wherein the incubator system is further configured to regulate the speed of rotation of the contained cell culture chamber device by performing image analysis on the one or more digital images and/or a digital video or parts thereof in claim 9; wherein the incubator system is configured to rotate the contained cell culture chamber device about the respective predetermined axis in a clock-wise direction and to [...] in claim 10; wherein the incubator system is configured to rotate the contained cell culture chamber device about the respective predetermined axis in a clock-wise direction and to [...] in claim 11; wherein the incubator system comprises at least two axels or drive units, each configured to rotate a respectively connected or received cell culture chamber device [...] in claim 12; wherein the processing units is configured to analyse [...] in claim 13; wherein the one or more processing units is configured to calculate [...] in claim 17.
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 1, 2, 6-19 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.
Regarding claim 1, the transitional phrase in L5 “further comprising” renders the claim unclear because the phrase “comprising” in preamble (L3) is directed to ‘at least one or more cell culture chamber’, which is not the positive element of the claim. Consequently, it is not clear what elements (an incubator system, or one or more cell culture chamber devices) the applicants intend to claim. For this reason, claims relating to the at least one or more cell culture chamber devices are similarly unclear.
Regarding claim 6, the limitation "it" renders the claim indefinite because it is unclear what the limitation is referring to.
Regarding claim 6, the limitation "these" renders the claim indefinite because it is unclear what the limitation is referring to.
Claim 7 recites the limitation "the information" in L1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the phrase "if [...]" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 10, the phrase "other [...], or similar" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other [...], or similar"), thereby rendering the scope of the claim unascertainable.
Regarding claim 11, the phrase "if [...]" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 11, the phrase "other [...], or similar" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other [...], or similar"), thereby rendering the scope of the claim unascertainable.
Regarding claim 14, the phrase "other biomarker" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other biomarker"), thereby rendering the scope of the claim unascertainable.
Regarding claim 15, the phrase "may require" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 18, the phrase "other electronic message" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other electronic message"), thereby rendering the scope of the claim unascertainable.
Claim limitation “configured to [...]” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6-19 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:
1. An incubator system comprising
at least one illumination device (e.g., 34) and at least one monitoring device (e.g., 130),
the at least one monitoring device 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),
wherein the incubator system further is in connection with one or more processing units (e.g., CPU 122, 362) 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).
Regarding claim 1, Suzuki et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “incubator system configured to illuminate at least one or more cell culture chamber devices and to rotate them about a respective predetermined axis, each cell culture chamber device comprising an enclosure, the enclosure configured to contain a cell culture media, and at least one viewing area configured to allow 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, 6-15, 17-19 (e.g., [...] to provide 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 [...], 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, 8, 9, 12-17, Suzuki et al. teach:
2. An 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+).
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, to provide data about cell proliferation over time (¶ 0246-0253+).
8. The incubator system according to claim 1, wherein the incubator system is further capable of regulating the speed of rotation of one or more cell culture chamber devices in response to extracted or derived data of the one or more monitoring signals (see ¶ 0101 for example).
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 further capable of regulating the speed of rotation of the contained cell culture chamber device (see ¶ 0101 for example).
12. The incubator system according to claim 1, wherein the incubator system comprises at least two axels or drive units (e.g., 28, 29).
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+).
14. The incubator system according to claim 13, where the biomolecule is a protein, DNA, RNA, or other biomarker (e.g., cells).
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), and
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).
17. The incubator system according to claim 1, wherein the one or more processing units is configured to calculate a status of a cell culture process in one or more of the cell culture chambers by extracting or deriving data from the one or more monitoring signals from said one or more cell culture chamber device (¶ 0246-0253+),
Conclusion
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
Prosecution Insights