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 11 – 22 are pending in this application. Claim 11 is independent.
Election/Restrictions
Applicant’s election of Group II [claim(s) 11 – 22] in the response to Election / Restriction filed 02/20/2026 is acknowledged.
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.
Claim(s) 11 – 14 and 17 – 22 are rejected under 35 U.S.C. 101 because the claimed invention, under its broadest reasonable interpretation, is directed to an abstract idea without significantly more. In the present case, claim(s) 11 – 14 and 17 – 22 (as a whole) are directed to an abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as explained in the analysis (subject matter eligibility test) presented below.
Step 1: Are the claim(s) directed to a process, machine, manufacture or composition of
matter? YES.
Step 2A: Is the claimed concept directed to a law of nature, a natural phenomenon, or an
abstract idea as previously identified (i.e., as judicially recognized exceptions) by the courts? YES.
Claim(s) 11 – 14 and 17 – 22 (as a whole), under the broadest reasonable interpretation of the claims, is/are directed to an abstract idea in the form of merely obtaining data (e.g., images); contacting the plurality of cells with a molecule and/or a biological agent; and determining data (e.g., an effect of the molecule and/or the biological agent).
These steps provide nothing more than mere instructions to implement the said abstract idea on a generic physical hardware. The recited device merely automates conventional monitoring using known devices. Thus, the claim(s) does/do not integrate the judicial exception into a practical application.
Step 2B: Do (es) the claim(s) recite additional elements that amount to significantly more
than the judicial exception? NO.
The elements, individually and in combination, do not amount to significantly more
than the abstract idea. Furthermore, reciting outcomes of, for example, determining data (e.g., an effect of the molecule and/or the biological agent), differentiating structural features, reducing interference in the images, determining a level of metabolic activity – without any details about how the outcomes are accomplished, are no more than mere data gathering and manipulation concepts recited at a high level of generality, and thus are insignificant extra-solution activities which fall within judicially recognized exceptions.
Conclusion: In view of the analysis presented above, the said claim(s) are not directed to
eligible subject matter under 35 U.S.C. §101 because they are directed to an abstract idea and do not recite additional elements that amount to significantly more than the abstract idea. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
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 pre-AIA 35 U.S.C. 112, 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 11 – 22 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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.
The term “effect” in the claims is an unlimited functional claim which renders the claim indefinite (See MPEP § 2173.05(g)). The term “effect” is not defined by any of the claims. Appropriate action is required.
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 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) 11 – 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gimzewski, James K. (US-20180156779-A1, hereinafter simply referred to as James).
Regarding independent claim 11, James teaches:
A method of determining the effect of a molecule and/or biological agent upon a cell (See at least James, ¶ [0064, 0065]; FIGS. 6, 7; "…a cancerous state in a cell is detected in vitro in a biological sample…", "…a method of identifying an agent that affects a biological activity of a cell, the method generally involving contacting a cell with a test agent, and determining the effect, if any, of the agent on the biological activity of the cell…"), comprising: obtaining images of sub-cellular metabolic activity of a plurality of cells (See at least James, ¶ [0049]; FIGS. 6, 7; "…Embodiments of the invention include a system for obtaining an image of a cell…"), wherein the plurality of cells comprise at least one diseased cell and at least one non-diseased cell (See at least James, ¶ [0123]; FIGS. 6, 7; "…cell membrane movement of a myocyte in media containing agents that induce a conditions that mimics a disease state…"), wherein the images comprise time-dependent interferometric images (See at least James, ¶ [0132]; FIGS. 6, 7; "…measuring the nano-mechanical properties of a large number of cells in parallel, based on imaging interferometry…"); contacting the plurality of cells with a molecule and/or a biological agent (See at least James, ¶ [0065, 0072]; FIGS. 6, 7; "…a method of identifying an agent that affects a biological activity of a cell, the method generally involving contacting a cell with a test agent, and determining the effect, if any, of the agent on the biological activity of the cell…", "…the nucleic acid is introduced into the cell, and the inducing agent is added to the cell…"); obtaining a plurality of images over a subsequent period of time, wherein the plurality of images comprises sub-cellular metabolic activity of the plurality of cells (See at least James, ¶ [0026]; FIGS. 6, 7, 9; "…FIG. 9 shows differential LCI images of three indentation cycles at 20, 120 and 200 s…"); and determining an effect of the molecule and/or the biological agent on the at least one diseased cell compared to an effect on the at least one non-diseased cell (See at least James, ¶ [0044]; FIGS. 6, 7, 9; "…methods can comprise for example comparing information derived from a scanning interferometry signal for a first surface location of a test object (e.g. a mammalian cell) to information corresponding to multiple models of the test object…").
Regarding dependent claim 12, James teaches:
obtaining spatially-dependent interferometric images of the plurality of cells (See at least James, ¶ [0132]; FIGS. 6, 7; "…measuring the nano-mechanical properties of a large number of cells in parallel, based on imaging interferometry…"); differentiating structural features of the plurality of cells (See at least James, ¶ [0132]; FIGS. 6, 7; "…measuring the nano-mechanical properties of a large number of cells in parallel, based on imaging interferometry…"); and reducing interference in the images of sub-cellular metabolic activity of the plurality of cells (See at least James, ¶ [0132]; FIGS. 6, 7; "…measuring the nano-mechanical properties of a large number of cells in parallel, based on imaging interferometry…").
Regarding dependent claim 13, James teaches:
wherein obtaining the plurality of images over the subsequent period of time is performed for about 1 hour to about 3 days after contacting the plurality of cells with the molecule and/or the biological agent (See at least James, ¶ [0132, 0146]; FIGS. 6, 7; "…measuring the nano-mechanical properties of a large number of cells in parallel, based on imaging interferometry…", "…The population measurements were conducted over several consecutive days.…").
Regarding dependent claim 14, James teaches:
wherein determining an effect of the molecule and/or the biological agent on the at least one diseased cell compared to an effect on the at least one non-diseased cell comprises determining a level of metabolic activity over the subsequent period of time for the at least one diseased cell and the at least one non-diseased cell (See at least James, ¶ [0044]; FIGS. 6, 7, 9; "…methods can comprise for example comparing information derived from a scanning interferometry signal for a first surface location of a test object (e.g. a mammalian cell) to information corresponding to multiple models of the test object…").
Regarding dependent claim 15, James teaches:
wherein the level of metabolic activity is increased in the diseased cell relative to the level of metabolic activity in a non-diseased cell (See at least James, ¶ [0044, 0174]; FIGS. 6, 7, 9; "…methods can comprise for example comparing information derived from a scanning interferometry signal for a first surface location of a test object (e.g. a mammalian cell) to information corresponding to multiple models of the test object…", "…By comparing optical path length images taken at two consecutive time points, we determined very precisely local shifts of material within the cell…").
Regarding dependent claim 16, James teaches:
wherein the level of metabolic activity is decreased in the diseased cell relative to the level of metabolic activity in the non-diseased cell (See at least James, ¶ [0064, 0065]; FIGS. 6, 7; "…a cancerous state in a cell is detected in vitro in a biological sample…", "…a method of identifying an agent that affects a biological activity of a cell, the method generally involving contacting a cell with a test agent, and determining the effect, if any, of the agent on the biological activity of the cell…").
Regarding dependent claim 17, James teaches:
wherein a level of metabolic activity remains the same for a non-diseased cell (See at least James, ¶ [0064, 0065]; FIGS. 6, 7; "…a cancerous state in a cell is detected in vitro in a biological sample…", "…a method of identifying an agent that affects a biological activity of a cell, the method generally involving contacting a cell with a test agent, and determining the effect, if any, of the agent on the biological activity of the cell…").
Regarding dependent claim 18, James teaches:
wherein the method further comprises identifying an off-target activity of the molecule and/or biological agent upon a non-diseased cell (See at least James, ¶ [0064, 0065]; FIGS. 6, 7; "…a cancerous state in a cell is detected in vitro in a biological sample…", "…a method of identifying an agent that affects a biological activity of a cell, the method generally involving contacting a cell with a test agent, and determining the effect, if any, of the agent on the biological activity of the cell…").
Regarding dependent claim 19, James teaches:
wherein the molecule comprises a biomolecule (See at least James, ¶ [0074]; FIGS. 6, 7; "…Test agents are also found among biomolecules including peptides, saccharides, fatty acids, steroids, purines, pyrimidines, derivatives, structural analogs or combinations thereof.…").
Regarding dependent claim 20, James teaches:
wherein the biomolecule comprises a protein, nucleic acid, a saccharide, or an expressed product of a cell (See at least James, ¶ [0074]; FIGS. 6, 7; "…Test agents are also found among biomolecules including peptides, saccharides, fatty acids, steroids, purines, pyrimidines, derivatives, structural analogs or combinations thereof.…").
Regarding dependent claim 21, James teaches:
wherein the organic molecule comprises an organic compound having a molecular weight less than about 2000 Da (See at least James, ¶ [0074]; FIGS. 6, 7; "…Test agents encompass numerous chemical classes, typically synthetic, semi-synthetic, or naturally-occurring inorganic or organic molecules…Test agents may be small organic compounds having a molecular weight of more than 50 and less than about 2,500 daltons…").
Regarding dependent claim 22, James teaches:
wherein the biological agent is a virus, a phage, a bacterium or a fungus (See at least James, ¶ [0070]; FIGS. 6, 7; "…a bacterium, a fungus, a yeast (e.g., Candida spp.), or a virus…").
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: See the Notice of References Cited (PTO–892)
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/IDOWU O OSIFADE/Primary Examiner, Art Unit 2675
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