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 without traverse of Group I, claims 1-24 in the reply filed on May 27, 2026 is acknowledged.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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: “an imaging device” in claim claims 1 and 2.
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 2-3, 16-19 and 24 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.
Claim 2 recites the limitation "an imaging device" in line 2. It is unclear if the imaging device is the imaging device recited earlier in the claim or is an additional imaging device.
Claim 3 recites the limitation "the imaging device" in line 2. It is unclear which imaging device among the imaging devices recited earlier in the claim is being referred by said limitation.
Regarding claim 16, the limitation "between about 200 μm and about 400 μm" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "between about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Regarding claim 17, the limitation "a volume of up to about 1 mL" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "up to about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Regarding claim 18, the limitation "less than about 10,000 cells" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "less than about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Regarding claim 19, the limitation "between about 3,500 cells and about 7,500 cells" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "between about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Regarding claim 24, the limitation "between about 1 inert particle and about 5,000 inert particles" renders the claim indefinite. The language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "between about." The rejection can be overcome by deleting the term “about.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 7, 9-14 and 16-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Craig et al (US 2018/0133715; hereinafter “Craig”).
Regarding claim 1, Craig discloses a system, comprising: a micro-organosphere generator comprising a microfluidic device and configured to form a set of micro-organospheres from a mixture of a biological sample and a fluid (FIG. 4a: droplet generation region (412); [0183], [0185]-[0186]); and a controller coupled to an imaging device, the controller configured to: receive imaging data corresponding to one or more of the mixture or the set of micro-organospheres (optical detection regions (larger circular regions in FIG. 4a represents optical sensing regions; see also FIGS. 11a-11d, which illustrate optical detection regions coupled to a controller; [0017], [0169], [0184], [0198], [0227]-[0231], [0271]-[0277]); and estimate one or more characteristics of the set of micro-organospheres based at least on the imaging data (number of viable cells, number of cells within droplets can be determined from imaged data; [0017], [0023], [0025]-[0026], [0169], [0174], [0184], [0198]).
Regarding claim 2, Craig further discloses an imaging device configured to generate the imaging data corresponding to the one or more of the mixture or the set of micro-organospheres (optical detection regions (larger circular regions in FIG. 4a represents optical sensing regions; see also FIGS. 11a-11d, which illustrate optical detection regions coupled to a controller; [0017], [0169], [0184], [0198], [0227]-[0231], [0271]-[0277]).
Regarding claim 3, Craig further discloses a cell culture vessel coupled to the imaging device and configured to culture the set of micro-organospheres in a plurality of wells, and the controller further configured to: estimate a number of micro-organospheres in the plurality of wells based at least on the imaging data (number and type of droplets dispensed into each well of a plurally of wells of a culture vessel is determined by an imaging system coupled to a control system; see [0023], [0101], [0140],[0174], [0191]-[0193], [0231]).
Regarding claim 4, Craig further discloses one or more sensors coupled to the microfluidic device and configured to generate sensor data corresponding to the mixture or the set of micro-organospheres (droplet generator incudes a droplet generation control systems comprising a control computer system (1102) coupled to sensors; [0227]), and the controller further configured to: receive the sensor data from the one or more sensors (droplet generator incudes a droplet generation control systems comprising a control computer system (1102) coupled to sensors (1104,1106,1108); see FIG. 11a and [0227]);and estimate one or more characteristics of the set of micro-organospheres based at least on the sensor data (droplet generation control system includes droplet size algorithm; [0227], [0257]).
Regarding claim 5, Craig further discloses one or more pumps coupled to the microfluidic device and configured to control fluid flow to the microfluidic device (droplet generator incudes a pump coupled; see FIG. 11a and [0227]); and a temperature regulator coupled to the microfluidic device, sample source, or fluid source, and configured to control a temperature of the sample source, the fluid source, the mixture, or the set of micro-organospheres (temperature control system adapted to control temperature of the system [0227]-[0029]), and the controller configured to: modify one or more of the pump or the temperature based at least on the imaging data and the sensor data (droplet generator incudes a pump coupled to controller (1102) and pump controlled based on sensed data and imaging data; see FIG. 11a; [0075], [0227]).
Regarding claim 7, Craig further discloses a demulsifier fluidically coupled to the microfluidic device and configured to demulsify the mixture to form the set of micro-organospheres ([0096]).
Regarding claim 9, Craig further discloses wherein the one or more of the characteristics of the set of micro-organospheres comprises one or more of a micro-organosphere diameter, a total number of cells, or a number of living cells (determining whether a droplet contains a viable single entity (or a specific combination or plurality of viable entities only), for example a viable single cell; [0029]).
Regarding claims 10-11, Craig further discloses wherein the controller is configured to estimate one or more characteristics of the mixture based at least on the imaging data, wherein the one or more of the characteristics of the mixture comprises a total number of cells and a number of living cells (number of viable cells, number of cells within droplets can be determined from the imaged data; [0017], [0023], [0025]-[0026], [0169], [0174], [0184], [0198]).
Regarding claims 12-13, Craig further discloses wherein the imaging data corresponds to the biological sample, and the controller is configured to estimate one or more characteristics of the biological sample based at least on the imaging data (number of viable cells, number of cells within droplets can be determined from the imaged data; [0017], [0023], [0025]-[0026], [0169], [0174], [0184], [0198]).
Regarding claim 14, Craig further discloses wherein the demulsifier comprises a flow separator configured to isolate the set of micro-organospheres (droplet dispense having a droplet director; [0087], [0096]).
Regarding claims 16 and 22-24, it is noted that the set of micro-organospheres is material worked on and not an element of the claimed system. 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 claims 17, the micro-organosphere generator of Craig is structurally the same as the instant micro-organosphere generator and thus considered to be fully capable “to form the set of micro-organospheres from the biological sample comprising a volume of up to about 1 mL.”
Regarding claims 18, the micro-organosphere generator of Craig is structurally the same as the instant micro-organosphere generator and thus considered to be fully capable “to form the set of micro-organospheres from the biological sample comprising less than about 10,000 cells.”
Regarding claims 19 and 21, it is noted that the biological sample is material worked on and not an element of the claimed system. 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 claims 20, the micro-organosphere generator of Craig is structurally the same as the instant micro-organosphere generator and thus considered to be fully capable “to form the set of micro-organospheres from the biological sample having a volume of about 5 μL to about 5 mL.”
Therefore, Craig meets and anticipates the limitations set forth in claims 1-5, 7, 9-14 and 16-24.
Claims 1-2, 7-8 and 16-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sylvestre (WO2014140486-A1).
Regarding claim 1, Sylvestre discloses a system, comprising: a micro-organosphere generator comprising a microfluidic device and configured to form a set of micro-organospheres from a mixture of a biological sample and a fluid (main channel (54) having an inlet and an outlet adapted to process microorganisms; FIG. 2; [0027], [0040][0041]); and a controller coupled to an imaging device (microcomputer coupled to a camera; [0043]), the controller configured to: receive imaging data corresponding to one or more of the mixture or the set of micro-organospheres (droplets are monitored with the camera coupled to the microcomputer; [0043]); and estimate one or more characteristics of the set of micro-organospheres based at least on the imaging data (characteristics of the droplets during creation is monitored by camera coupled to microcomputer; [0043]).
Regarding claim 2, Sylvestre discloses an imaging device configured to generate the imaging data corresponding to the one or more of the mixture or the set of micro-organospheres (microcomputer coupled to a camera; [0043]).
Regarding claim 7 Sylvestre further discloses a demulsifier fluidically coupled to the microfluidic device and configured to demulsify the mixture to form the set of micro-organospheres (demulsification chamber (46); [0040], [0051]).
Regarding claim 8 Sylvestre further discloses an agitator (mixer; [0050]). The mixer of Sylvestre is structurally the same as the instant mixer and thus considered to be fully capable “to agitate the micro-organospheres within a fluid at a predetermined concentration.”
Regarding claims 16 and 22-24, it is noted that the set of micro-organospheres is material worked on and not an element of the claimed system. 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 claims 17, the micro-organosphere generator of Sylvestre is structurally the same as the instant micro-organosphere generator and thus considered to be fully capable “to form the set of micro-organospheres from the biological sample comprising a volume of up to about 1 mL.”
Regarding claims 18, the micro-organosphere generator of Sylvestre is structurally the same as the instant micro-organosphere generator and thus considered to be fully capable “to form the set of micro-organospheres from the biological sample comprising less than about 10,000 cells.”
Regarding claims 19 and 21, it is noted that the biological sample is material worked on and not an element of the claimed system. 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 claims 20, the micro-organosphere generator of Sylvestre is structurally the same as the instant micro-organosphere generator and thus considered to be fully capable “to form the set of micro-organospheres from the biological sample having a volume of about 5 μL to about 5 mL.”
Therefore, Sylvestre meets and anticipates the limitations set forth in claims 1-2, 7-8 and 16-24.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Craig as applied to claim 1 above, and further in view of Wang et al. (US 2022/0062791; hereinafter “Wang”).
Regarding claims 6, Craig discloses the system of claim 1. Craig does not explicitly disclose a polymerizer fluidically coupled to the microfluidic device and configured to polymerize the mixture to form the set of micro-organospheres. However, Wang discloses that it is well-known in the art to encapsulate cells in gel droplets ([0019] and [0022]). In view of Wang, 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 system of Craig to comprise polymerizer, because Wang discloses that it is known in the art to encapsulate cells gel droplets.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Craig as applied to claim 14 above.
Regarding claims 15, Craig discloses the system of claim 14. Craig discloses the claimed flow separator but does not explicitly disclose wherein the flow separator extends along a length of the demulsifier. 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 rearranged the flow separator of Craig such that the flow separator extends along a length of the demulsifier, 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 have arranged the flow separator extends along the length of the demulsifier for the purpose of enhancing the flow separation process.
Conclusion
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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