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 .
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.
Claim 7 is 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 7, it is unclear how the hydrogel recited in parent claim 1 can have ORPs embedded within it while still having a polystyrene microsphere claimed in dependent claim 7. The examiner is currently interpreting this combination of limitations as a polystyrene microsphere embedded within a hydrogel.
Claim Rejections - 35 USC § 103
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 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 1-3 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 20190153545) (previously cited) in view of Fodor (US 20170337459) (previously cited) and Wang (US 20040058389) (previously cited).
Regarding claim 1, Chan discloses an apparatus for capturing biological material (abstract, nanoshell-coated barcodes), comprising:
a plurality of optically readable capture particle (ORCP) (abstract “nano-shell coated barcodes” and see Chan’s experiment completed on this in paragraphs [0154]-[0157] “QD540 and QD580 were used to make the 4-plex barcode” and Figs. 17A-17C) each comprising:
one or more optically readable particles (ORPs) (paragraphs [0002] and [0103] coated quantum dots) each ORP comprising an optical barcode (paragraph [0002] emission spectrum) to uniquely identify each of the plurality of ORCPs (abstract nanoshell-coated barcodes); and
a plurality of biological capture sites associated with the one or more ORPs (paragraphs [0129] and [0157]),
each of the plurality of biological capture sites including a nucleotide strand (paragraphs [0110] and [0129] “DNA probes”) configured to capture DNA (paragraph [0149] positive control DNA strand given in paragraph), and each nucleotide strand comprising an oligonucleotide cellular (paragraph [0085] and [0157]) barcode sequence (paragraph [0149] capture probe sequence given in paragraph) uniquely identifies (paragraph [0149], through the DNA strand sequence, for example those present in paragraph [0149] or Table 1) the ORCP (abstract “nano-shell coated barcodes”; and, paragraphs [0129], [0130]-[0131], and [0157]; Table 1 for DNA barcodes) with which the plurality of biological capture sites is associated (paragraphs [0110] and [0129] “DNA probes”).
If it is deemed that Chan does not specifically disclose uniquely identifying each of the plurality of ORCPs, Fodor discloses this limitation.
Fodor discloses uniquely identifying each of the plurality of ORCPs (paragraphs [0008], [0188]-[0189], and [0225] “barcodes on different solid supports can differ by at least one nucleotide”, “The potential diversity of the compound library thus created is determined by the number of unique building blocks (e.g. nucleotides) available for each coupling step, and the number of coupling steps used to create the library”, and “an indexed library of the stochastically barcoded targets”).
In the analogous art of spatially addressable molecular barcoding, it would have been obvious to one skilled in the art before the effective filing date to modify the cellular barcode of Chan with the diverse library of unique barcodes of Fodor in order to determine the unique identities of target molecules, which is important for clinical applications, diagnostics, and biomedical research (Fodor, paragraph [0003]). This would build upon Chan’s invention in an obvious manner, as Chan already describes a 4-plex DNA strand assay (see Chan, [0130]-[0131] and [0154], and, Table 1).
Notably, Chan discloses cellular barcodes that can differentiate species of microorganisms from each other (paragraph [0158]).
Chan does not disclose one or more optically readable particles (ORPs) embedded within a hydrogel.
Fodor discloses one or more optically readable particles (ORPs) (paragraphs [0013] and [0019]) embedded within (paragraph [0124]) a hydrogel (paragraph [0122] for a bead embedded in a hydrogel matrix).
In the analogous art of spatially addressable molecular barcoding, it would have been obvious to one skilled in the art before the effective filing date to modify the ORPs of Chan to be embedded in a hydrogel of Fodor in order to locate the spatial position of a bead within a substrate (e.g., gel, matrix, scaffold, or polymer) using the spatial label present on the stochastic barcode on the bead which can serve as a location address (Fodor, paragraph [0122]).
Regarding the phrase “RNA”, it would have been obvious to one skilled in the art before the effective filing date to modify the oligonucleotide cellular barcode sequence of Chan to capture RNA in order to find the transcriptome of the cell (that is, which genes had been transcribed into RNA under experimental conditions).
If it is deemed that the DNA positive control of Chan would not bind RNA, Wang discloses that DNA/RNA pairs exist (paragraph [0040]).
In the analogous art of microspheres and binding pairs of biological molecules, it would have been obvious to one skilled in the art before the effective filing date to modify the DNA sequence of Chan to bind to the RNA sequence of Wang in order to find the transcriptome of the cell (that is, which genes had been transcribed into RNA under experimental conditions).
Regarding claim 2, Chan discloses wherein the one or more ORPs comprise a resonator (paragraphs [0103] coating for quantum dot, polystyrene) and gain medium (paragraph [0103]), wherein the gain medium comprises a fluorescent material (paragraph [0103] QDs, also known as quantum dots).
Regarding claim 3, Chan discloses wherein the resonator of the one or more ORPs comprises a microsphere (Fig. 1 and microbead from paragraph [0006]), wherein the microsphere is doped with the gain medium (paragraph [0002]).
Regarding claim 6, Chan discloses wherein the fluorescent material is at least one of a fluorescent dye (paragraph [0007] “organic fluorophore”), a quantum dot (paragraph [0103] coating for quantum dot, polystyrene), or a protein (paragraph [0007] “organic fluorophore”).
If it is deemed that Chan does not disclose wherein the fluorescent material is at least one of a fluorescent dye or a protein, Chan certainly discloses wherein the fluorescent material is at least one of a quantum dot (paragraph [0103], see above). Because these limitations are claimed in the alternative, no further rejections would be needed at this time, other than the limitation regarding the already rejected quantum dots.
Regarding claim 7, Chan discloses wherein the microsphere comprises polystyrene (paragraph [0103]).
Regarding claim 8¸ Chan discloses wherein the microsphere has a diameter of at least 3 µm (paragraph [0156]).
Regarding claim 9, Chan discloses wherein the optical barcode includes an emission spectrum including at least one peak (paragraph [0136]).
Regarding claim 10, Chan discloses wherein each of the plurality of ORCPs comprises a plurality of gain media and a plurality of resonators (Fig. 1 and Fig. 17, paragraph [0082] “QD530 and QD580” and also paragraphs [0106]-[0108] sequestered droplets of QDs),
wherein each of the plurality of gain media includes a different emission spectrum (paragraph [0002]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 20190153545) (previously cited) in view of Fodor (US 20170337459) (previously cited) and Wang (US 20040058389) (previously cited) as applied to claim 2, as evidenced by Brogger (US 20010049101) (previously cited).
Regarding claim 11, Chan discloses wherein the one or more ORPs comprise a semiconductor particle (paragraph [0103] inherent to quantum dots, see Brogger as an evidentiary reference paragraph [0015]), wherein the semiconductor particle comprises the resonator (paragraph [0103]) and the gain medium (paragraph [0103] quantum dot).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 20190153545) (previously cited) in view of Fodor (US 20170337459) (previously cited) and Wang (US 20040058389) (previously cited) as evidenced by Brogger (US 20010049101) (previously cited) as applied to claim 11, further in view of Brogger (US 20010049101) (previously cited).
Regarding claim 12, Chan discloses wherein the semiconductor particle (paragraph [0103] inherent to quantum dots, see Brogger as an evidentiary reference paragraph [0015]) is contained within a transparent coating (paragraph [0103] “polystyrene”).
If it is deemed that the polystyrene of Chan does not cite a transparent coating, Brogger discloses a transparent coating of polystyrene (claim 16).
In the analogous art of micro-labeling and reporter molecules, it would have been obvious to one skilled in the art before the effective filing date to modify the transparent coating of Chan with the transparent polystyrene of Brogger in order to identify the particle under a light source (Brogger, paragraph [0033], and for the use of quantum dots paragraphs [0063] and [0070]).
Regarding claim 13, Chan discloses wherein the one or more ORPs comprise a plurality of semiconductor particles (Figs. 1B and 1C, paragraph [0108], inherent to quantum dots, see Brogger as an evidentiary reference paragraph [0015]) contained within the transparent coating (Figs. 1B and 1C, paragraph [0107]-[0108]), wherein each of the plurality of semiconductor particles comprises a gain medium having a different emission spectrum from each of the other of the plurality of semiconductor particles (paragraphs [0064]-[0065] “QD555” and Figs. G, H, and I “QD510” “QD575”, and “QD665” and paragraph [0082] “QD530” and “QD580”).
If it is deemed that the polystyrene of Chan does not cite a transparent coating, Brogger discloses a transparent coating of polystyrene (claim 16).
In the analogous art of micro-labeling and reporter molecules, it would have been obvious to one skilled in the art before the effective filing date to modify the transparent coating of Chan with the transparent polystyrene of Brogger in order to identify the particle under a light source (Brogger, paragraph [0033], and for the use of quantum dots paragraphs [0063] and [0070]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Poetter (US 20110256528) (newly cited) – This invention is based on fluorescently labeled microsphere particles that emit light with narrow emission bands and which have target oligonucleotides. Methods to fabricate fluorescent oligonucleotide modified silica particles can be found (paragraph [0174] and Fig. 6).
Response to Arguments
Applicant’s arguments filed 02/18/2026 have been fully considered but they are not persuasive.
Regarding Applicant arguments on pg. 7 of 8, Chan’s microbeads have a polystyrene bead that would protect the quantum dots from the aqueous environment (Chan, paragraph [0003]). This is in accordance with the rejection to instant claim 7. However, Fodor discloses ORPs embedded within a hydrogel. Nevertheless, Fodor’s polystyrene beads with fluorescent dyes or QDs (Fodor, paragraphs [0009] and [0030]) can still be imaged with Fodor’s polystyrene beads within a hydrogel (Fodor, paragraphs [0122]-[0125]). Additionally, motivation is given above for the combination of Chan in view of Fodor. Therefore, further arguments that Chan in view of Fodor are not combinable are not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807, and whose fax number is 571-273-8464. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799