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 .
DETAILED ACTION
Claims 1-21 are present in this application. Claims 1-17 are cancelled. Claims 18-21 are pending in this office action.
This office action is NON-FINAL.
Drawings
The Drawings filed on 01/27/25 are acceptable for examination purposes.
Specification
The Specification filed on 01/27/25 is acceptable for examination purposes.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 01/27/25 has been considered by the Examiner and made of record in the application file.
Examiner’s Note - 35 U.S.C. § 112
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.
Use of the word “means” (or “step for”) in a claim with functional language
creates a rebuttable presumption that the claim element is to be treated in accordance
with 35 U.S.C. § 112(f). The presumption that 35 U.S.C. § 112(f) is invoked is rebutted
on when the function is recited with sufficient structure, material, or acts within the claim
itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable
presumption that the claim element is not to be treated in accordance with 35 U.S.C. §
112(f). The presumption that 35 U.S.C. § 112(f) is not invoked is rebutted when the
claim element recites function but fails to recite sufficiently definite structure, material or
acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are
presumed to invoke 35 U.S.C. § 112(f) except as otherwise indicated in an Office
action. Similarly, claim elements that do not use the word “means” (or “step for”) are
presumed not to invoke 35 U.S.C. § 112(f) except as otherwise indicated in an Office
action.
Claim 18 limitations, “an imager for imaging the given cell line”, have been interpreted under 35 U.S.C. § 112(f) because they use generic placeholders
“an imager for,” coupled with functional language “imaging,” without reciting sufficient structure to achieve the functions. Furthermore, the generic placeholders are not preceded by structural modifiers.
Since the claim limitations invokes 35 U.S.C. § 112(f), the specification was
reviewed to find a description of the corresponding structure to achieve the claimed
functions. Examiner found that the specification does not explicitly show a specific
corresponding structure.
If Applicants wishes to provide further explanation or dispute the examiner’s
interpretation of the corresponding structure, Applicants must identify the corresponding
structure with reference to the specification by page and line number, and to the
drawing, if any, by reference characters in response to this Office action.
If Applicants does not intend to have the claim limitations treated under 35 U.S.C.
§ 112(f) Applicants may amend the claims so that they will clearly not invoke 35 U.S.C.
§ 112(f) or present a sufficient showing that the claims recites sufficient structure,
material, or acts for performing the claimed functions to preclude application of 35
U.S.C. § 112(f).
For more information, see MPEP § 2173 et seq. and Supplementary Examination
Guidelines for Determining Compliance With 35 U.S.C. § 112 and for Treatment of
Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a patent
therefor, subject to the conditions and requirements of this title.
Claims 18-21 are rejected under 35 U.S.C. 101 because the claimed
invention is directed to an abstract idea without significantly more.
Claim 18 recites “a database of cell line growth condition data for known cell lines, wherein the growth condition data comprises confluence rate as a function of time and cell number rate as a function of time; an imager for imaging the given cell line in the cell culture vessel and generating image data therefrom; an image processor for receiving the image data for the given cell line and determining confluence rate thereof and cell number rate thereof; another processor for comparing the data from the image processor for the given cell line to corresponding data in the database previously collected for that cell line to determine if the confluence rate and/or the number rate differs by a substantial amount from the data in the database and indicating to a user that the given cell line is contaminated or mislabeled”.
The limitation of “a database of cell line growth condition data for known cell lines, wherein the growth condition data comprises confluence rate as a function of time and cell number rate as a function of time; an imager for imaging the given cell line in the cell culture vessel and generating image data therefrom; an image processor for receiving the image data for the given cell line and determining confluence rate thereof and cell number rate thereof; another processor for comparing the data from the image processor for the given cell line to corresponding data in the database previously collected for that cell line to determine if the confluence rate and/or the number rate differs by a substantial amount from the data in the database and indicating to a user that the given cell line is contaminated or mislabeled”. That is, other than reciting, “processor,” nothing in the claim element precludes the step from practically being performed in the mind. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using processor to perform verifying, imaging, receiving, and comparing steps. The processor in each steps is recited at a high-level
of generality such that it amounts no more than mere instructions to apply the exception
using a generic computer component. Accordingly, this additional element does not
integrate the abstract idea into a practical application because it does not impose any
meaningful limits on practicing the abstract idea. The claim is directed to an abstract
idea. The claim does not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to
integration of the abstract idea into a practical application, the additional element of
using processor to perform verifying, imaging, receiving, and comparing steps amounts to no more than mere instructions to apply the exception using a generic computer
component. Mere instructions to apply an exception using a generic computer
component cannot provide an inventive concept. The claim is not patent eligible.
Claim 19 is dependent on claim 18 and includes all the limitations of claim 18. Claim 19 recites wherein the database further comprises morphological data for the known cell lines including cell shape, cell size and/or cell texture and wherein the image processor determines the cell shape, cell size and/or cell texture for the given cell line and wherein said another processor compares the cell shape, cell size and/or cell texture of the given cell line to corresponding data in the database for that cell line to indicate to a user that the given cell line is contaminated or mislabeled.in claim 19. But compares the cell shape, cell size and/or cell texture of the given cell line to corresponding data in the database for that cell line to indicate to a user that the given cell line is contaminated or mislabeled does not go beyond the abstract idea itself. There are no additional components in the claim that would make it significantly more than the abstract idea.
Claim 20 is dependent on claim 18 and includes all the limitations of claim 18. Claim 20 recites wherein the growth condition data further comprises pH data of media in the cell culture vessel in claim 20. But the growth condition data further comprises pH data of media in the cell culture vessel does not go beyond the abstract idea itself. There are no additional components in the claim that would make it significantly more than the abstract idea.
Claim 21 is dependent on claim 18 and includes all the limitations of claim 18. Claim 21 recites wherein the growth condition data further comprises reagent data of reagent in the cell culture vessel in claim 21. But the growth condition data further comprises reagent data of reagent in the cell culture vessel does not go beyond the abstract idea itself. There are no additional components in the claim that would make it significantly more than the abstract idea.
Claim Rejections 35 U.S.C. §103
6. 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 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.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all
obviousness rejections set forth in this Office action:
Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Magnant (US 2025/0321850 A1) in view of Clark (US 2013/0038727 A1).
Regarding claim 18, Magnant an apparatus for verifying whether the identity of a given cell line is correct, (See Magnant [0059], the capability to genotype or sequence cells to confirm the identity of cell lines without the need for human intervention), during the incubation of thereof in a cell culture vessel, (comprising, (See Magnant paragraph [0019], culturing cells comprising incubating cells in the cassette):
a database of cell line growth condition data for known cell lines, (See Magnant paragraph [0051], The computing device is configured to receive a schedule of processes to apply to cell cultures in cassettes; receive and store data regarding environmental conditions within the cassettes), wherein the growth condition data comprises confluence rate as a function of time and cell number rate as a function of time, (See Magnant paragraph [0127], The user can create a schedule of actions with respect to the cell cultures. Some of the actions may be directed to monitoring the cell cultures. For example, the user may configure the incubator to begin beeping every 6 hours, thereby alerting the user to check conditions of the cell cultures);
an imager for imaging the given cell line in the cell culture vessel and generating image data therefrom, (See Magnant paragraph [0075], The incubators provide for automated sampling and imaging of cells in culture. The cassettes and incubator provide significant increases in the efficiency of methods of culturing adhesion cells);
an image processor for receiving the image data for the given cell line, (See Magnant paragraph [0123], The computing device 205 operates the image capturing device to obtain an image of a cell culture), and determining confluence rate thereof and cell number rate thereof; (See Magnant paragraph [0123], the system will have the capability to genotype or sequence cells to confirm the identity of cell lines without the need for human intervention. This technology can further identify the presence of and nature of contaminants);
another processor for comparing the data from the image processor for the given cell line to corresponding data in the database previously collected for that cell line, (See Magnant paragraph [0028], measuring the level of an activity of the cell known to be associated with a disease and/or measuring the level of expression of a marker known to be associated with a disease; and comparing the level of activity or expression before and after the step of culturing).
Magnant does not explicitly disclose to determine if the confluence rate and/or the number rate differs by a substantial amount from the data in the database and indicating to a user that the given cell line is contaminated or mislabeled.
However, Clark teaches to determine if the confluence rate and/or the number rate differs by a substantial amount from the data in the database, (See Clark see paragraph [0003], monitoring and evaluating cell health by visually observing subtle changes in cell morphology, growth patterns, and growth rates that may signal problems with a particular culture), and indicating to a user that the given cell line is contaminated or mislabeled, (See Clark see paragraph [0004], assessing the health of cells by determining cell morphology under a microscope, replacing media (feed), recovering the cells (confluency), dealing with contaminants, monitoring metabolites or cell interactions, and other issues must be carefully addressed).
It would have been obvious to one with ordinary skill in the art before the
effective filing date of the claimed invention was made, to modify if the confluence rate and/or the number rate differs by a substantial amount from the data in the database and indicating to a user that the given cell line is contaminated or mislabeled of Clark in order to allow the remote visual determination of the health and viability of the cells without being in the physical presence of the cells.
Regarding claim 19, Magnant taught the apparatus of claim 18, as described above.
Magnant does not explicitly disclose wherein the database further comprises morphological data for the known cell lines including cell shape, cell size and/or cell texture, and wherein the image processor determines the cell shape, cell size and/or cell texture for the given cell line, and wherein said another processor compares the cell shape, cell size and/or cell texture, of the given cell line to corresponding data in the database for that cell line to indicate to a user that the given cell line is contaminated or mislabeled.
However, Clark teaches wherein the database further comprises morphological data for the known cell lines including cell shape, cell size and/or cell texture, (See Clark see paragraph [0083], The authorization code information 72 for each cell culture vessel 40 would include dimension parameters such as the size, shape, volume, and the like of each cell culture vessel) and wherein the image processor determines the cell shape, cell size and/or cell texture for the given cell line, (See Clark see paragraph [0083], The pod's imaging system 24 first scans the surface of the flask 40 identifying the authorization code information 72. The authorization code information 72 for each cell culture vessel 40 would include dimension parameters such as the size, shape, volume, and the like of each cell culture vessel) and wherein said another processor compares the cell shape, cell size and/or cell texture, (See Clark see paragraph [0017], the user can adjust the gain for edge detection. Once an edge is found, again the shape can be analyzed. Shape comparisons can be made whether to other called shapes or to expected shapes or to a libraries of shapes), of the given cell line to corresponding data in the database for that cell line to indicate to a user that the given cell line is contaminated or mislabeled, (See Clark see paragraph [0004], assessing the health of cells by determining cell morphology under a microscope, replacing media (feed), recovering the cells (confluency), dealing with contaminants, monitoring metabolites or cell interactions, and other issues must be carefully addressed).
It would have been obvious to one with ordinary skill in the art before the
effective filing date of the claimed invention was made, to modify wherein the database further comprises morphological data for the known cell lines including cell shape, cell size and/or cell texture, and wherein the image processor determines the cell shape, cell size and/or cell texture for the given cell line, and wherein said another processor compares the cell shape, cell size and/or cell texture, of the given cell line to corresponding data in the database for that cell line to indicate to a user that the given cell line is contaminated or mislabeled of Clark in order to allow the remote visual determination of the health and viability of the cells without being in the physical presence of the cells.
Regarding claim 20, Magnant taught the apparatus of claim 18, as described above. Magnant further teaches wherein the growth condition data further comprises pH data of media in the cell culture vessel, (See Magnant paragraph [0133], the user can instruct the incubator to flow medium A into the cassettes and allow the cells to incubate for a particular period of time. After the four hours have elapsed, the incubator may flow medium B into the cassettes until the pH level for each cassette has dropped to a user selected level).
Regarding claim 21, Magnant taught the apparatus of claim 18, as described above. Magnant further teaches wherein the growth condition data further comprises reagent data of reagent in the cell culture vessel, (See Magnant paragraph [0052], the computing device is configured to operate the incubator according to received data regarding the temperature, gas levels, pH level, reagent concentrations, or cell density within a cassette. The computing device may be configured to operate the fluidic manifold to passage a cell culture in a cassette).
Conclusions/Points of Contacts
The prior art made of record and not relied upon is considered pertinent to
applicant’s disclosure. See form PTO-892.
Kain et al. (US 2015/0072871 A1), The present invention provides significant improvements in the field of nucleic acid sequencing, especially with regard to instrumentation and analysis methods. The techniques may be used for any desired sequencing, and will typically be most useful in sequencing of DNA and RNA (including cDNA). The techniques are based upon analysis of nucleotide sequences in samples supported on a substrate, and typically containing a multitude of individual sites such as in a nucleic acid array.
Hata et al. (US 2009/0042293 A1) cells sampled from a patient are inoculated to a flask having an antibody (inducer) attached thereto together with a culture medium, and stored in an incubator. Then, the flask is taken out from the incubator every day to observe the culture state (for example, the state of proliferation) using a microscope or the like. When the proliferation is found, or when a predetermined time period has elapsed from the cell inoculation, the culture medium is added to the flask to culture the cell (for example, proliferation).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MULUEMEBET GURMU whose telephone number is (571)270-7095. The examiner can normally be reached M-F 9am - 5pm.
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, Tony Mahmoudi can be reached at 5712724078. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MULUEMEBET GURMU/Primary Examiner, Art Unit 2163
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