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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/28/2023 and 11/26/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-17 in the reply filed on 11/26/2025 is acknowledged.
Claims 18-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025.
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 12 and 15 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 12 recites the limitation “the at least one light source” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Further, it is unclear how a singular light source can view and/or capture an image, in addition to measuring and/or analyzing a sample/object.
Regarding claim 15, the phrase “for example” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1-7, 9-10 and 12-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Neill et al. (Hereinafter O’Neill) WO 2004/017376 cited in the IDS filed 03/28/2023.
Regarding claim 1, O’Neill discloses a cell deposition and imaging apparatus comprising: a printing mechanism (automated printer 42) comprising at least one channel, the at least one channel of the printing mechanism arranged to: receive a sample of a cell-carrying fluid comprising at least one cell-type; and deposit the sample of the cell-carrying fluid onto a target area of a substrate (liquid handling robotic systems utilize hollow cannulas, e.g., syringe needles 31, for adding and aspirating liquid reagents from the individual wells in the template) as shown in Fig. 1, an imaging system (imaging station 23) arranged to image the target area; and a transportation system (conveyor system 24 to transport the microarray slides (or multiwell templates) from compartment to compartment) arranged to move the target area (template 10) between a printing position, in which the target area is located substantially adjacent to the printing mechanism, and an imaging position, in which the target area is located substantially adjacent to the imaging system; wherein the imaging system comprises an imager (microarray scanner 27) capable of imaging a region (well 28 and microarray substrate 29 ) of the substrate wherein the region is smaller than the target area and the imaging system is arranged to image all of the target area by moving the target area relative to the imager as discussed on at least page 8, line 30-page 9, line 15; and page 10, lines 1-23. Also see pages 11-12.
Regarding claim 2, the rejection of claim 1 above is relied upon. The printing mechanism of O’Neill is capable of receiving multiple samples of cell-carrying fluid and deposit the multiple samples of the cell-carrying fluid onto a target area of a substrate.
Regarding claim 3, the rejection of claim 1 above is relied upon. The microarray scanner of O’Neill is capable of imaging the multiple samples in the target area substantially simultaneously.
Regarding claim 4, O’Neill discloses wherein the printing mechanism comprises a plurality of printheads arranged as an array of printheads, each printhead comprising a channel (The system preferably comprises a robotic microarray printer located in a climate- controlled compartment) as discussed on at least page 7, lines 12-15. Also see Fig. 1.
Regarding claim 5, the rejection of claim 1 above is relied upon. The plurality of printheads of O’Neill are capable of moving together as a single unit. See Fig. 1:42.
Regarding claim 6, the rejection of claim 1 above is relied upon. Each channel of O’Neill in the array of printheads is capable of receiving a respective cell-carrying fluid to be deposited on a substrate, each cell-carrying fluid comprising at least one cell (Typically, such liquid handling robotic systems utilize hollow cannulas, e.g., syringe needles 31, for adding and aspirating liquid reagents from the individual wells in the template.).
Regarding claim 7, O’Neill discloses wherein the printing mechanism is arranged to be mounted on a track to allow the printing mechanism to be moved along the track relative to the transportation system (As illustrated, the core hardware preferably contains three compartments coupled together and mounted around a conveyor system 24 to transport the microarray slides (or multiwell templates) from compartment to compartment. The multiwell microarray template is preferably loaded onto a conveyor mechanism 24, e.g., rails, and fed into the printing compartment 21 of the integrated system. The microarray substrate is indexed into position for printing.) as discussed on at least page 8, line 30-page 9, line 9.
Regarding claim 9, O’Neill discloses an incubator configured to store at least one substrate (The printing station 21 preferably contains a climate-controlled compartment 40 for temperature and humidity control during microarray printing.) as discussed on at least page 9, lines 9-11.
Regarding claim 10, the rejection of claim 1 above is relied upon. The transportation system of O’Neill is capable of moving the target area (microarray substrate) between the printing position and/or the imaging position and an incubating position, in which the target area is located substantially within the incubator(The printing station 21 preferably contains a climate-controlled compartment 40 for temperature and humidity control during microarray printing.) as discussed on at least page 8, line 30-page 9, line 17.
Regarding claim 12, O’Neill discloses wherein the at least one light source is capable of performing dark field microscopy or infrared spectroscopy (One or more of the imaging systems and methods of the present invention are flexible light imaging systems with the ability to produce high-quality images. For example, various biological sample configurations can be used, including, but not limited to: single color fluorescence, multiple color fluorescence, chemi-luminescence, chemi-fluorescence, colorimetric detection, densitometry, or any other technique detectable through imaging.) as discussed on at least page 22, lines 26-32.
Regarding claim 13, O’Neill discloses wherein the imaging system comprises a plurality of light sources (One or more of the imaging systems and methods of the present invention are flexible light imaging systems with the ability to produce high-quality images. For example, various biological sample configurations can be used, including, but not limited to: single color fluorescence, multiple color fluorescence, chemi-luminescence, chemi-fluorescence, colorimetric detection, densitometry, or any other technique detectable through imaging.) as discussed on at least page 22, lines 26-32.
Regarding claim 14, O’Neill discloses wherein the apparatus is contained within a housing as shown in Fig. 1.
Regarding claim 15, O’Neill discloses a control system arranged to control at least one environmental parameter within the housing, for example temperature, pressure, humidity (The printing station 21 preferably contains a climate-controlled compartment 40 for temperature and humidity control during microarray printing…In one embodiment, a cooling device (e.g. peltier) 44 is installed directly below the microarray template to control the temperature after the microarray template has been loaded into the first station…In addition to temperature and humidity control, other preferred embodiments may incorporate additional environment controls.) as discussed on at least page 9, lines 9-11, 15-17 and 27-31.
Regarding claim 16, O’Neill discloses a computer system (microprocessor) arranged to control individual components of the apparatus, including the printing mechanism, the transportation system, and the imaging system as discussed on at least page 10, lines 19-27.
Regarding claim 17, O’Neill discloses computer system further comprises a user interface (an integrated computer system 50) configured to allow a user to interact with at least one component of the apparatus, including the printing mechanism, the transportation system, and the imaging system as discussed on at least page 10, lines 19-27.
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.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over O’Neill WO 2004/017376 as applied above to claims 1-7, 9-10 and 12-17.
Regarding claim 8, O’Neilll does not disclose a lift mechanism configured to adjust a distance between the target area and the imaging system when the target area is in the imaging position.
Absent unexpected results, it would have been prima facie obvious to provide lift mechanism in order to improve the accuracy and/or sensitivity during image capture and analysis when the scanner 27 is installed above the conveyor mechanism, with the scanning surface facing downward, toward the microarrays.
Regarding claim 11, O’Neilll does not disclose wherein the incubator is positioned substantially between the print system and the imaging system.
Absent unexpected results, it would have been prima facie obvious to position the incubator between the print system and an imaging system, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP §2144.04 (VI-C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796