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 1-7 and 14; and species A. 1 (a microfluidic system), B. 1 (a first type (i.e. a barcode sequence)), and C. 5 (the one or more reservoirs are accessible to fluids, cells, chemicals, and microdroplets by means of channels), in the reply filed on 02/24/2026 is acknowledged.
Claim 7 includes a non-elected species of B. (i.e., a second type) and therefore this limitation has been withdrawn.
Claims 1-7 are being examined.
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 1-7 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.
Claims 1-3, 5, 7 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 1 is unclear reciting “ii. wherein said one or more groups of oligonucleotide groups on said solid support are within separate reservoirs of the microfluidics system, iii. wherein the one or more reservoirs are accessible to fluids, cells, chemicals and microdroplet by means of channels, and iv. wherein each reservoir comprises comprising a group of oligonucleotides on said solid support is also trap for a microfluidic droplet.” The “wherein” clause renders the claim indefinite because it is unclear whether the limitation(s) following the clause are part of the claimed invention, i.e., wherein [...] further oligonucleotide groups, separate reservoirs, the one or more reservoirs, fluids, cells, chemicals and microdroplet, channels, trap, and a microfluidic droplet. See also a cell trapped in said reservoir in claim 3; the cell trap and a cavity in claim 5.
Claim 2 is vague and unclear reciting “the barcode sequence of each group is known and the position on the solid support is known” because it is unclear what is being claimed.
Claim 5 is vague and unclear reciting “dimensions 10 [...].”
Regarding claim 7, the phrase "which may be" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 1 recites the limitation "said group" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the first and further oligonucleotide groups" in L8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "said one or more groups" in L10. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the one or more reservoirs" in L12. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the position" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "said reservoir" in L3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "each group of oligonucleotides" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the cell trap" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "each spatial separation of oligonucleotide groups" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the oligonucleotide [...] said group" in L2. There is insufficient antecedent basis for this limitation in the claim.
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 (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 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) 1-7 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Yanai et al. (US 2018/0023128 A1; incorporated reference Sivan et al. WO 2015/118551 A1).
Regarding claim 1, Yanai et al. teach:
1. A microfluidic system comprising:
a solid support (see i.e., microarray is a solid surface or substrate ¶ 0040+) comprising at least a first group of oligonucleotides (e.g., 302),
wherein each oligonucleotide in said group comprises a nucleic acid sequence of a first type (see ¶ 0009-0023, 0044, 0067+ for example),
wherein said nucleic acid sequence of a first type is a barcode sequence (see ¶ 0009-0023, 0044, 0067+ for example) and
oligonucleotides comprising the same barcode sequence are grouped together in a group of oligonucleotides on said solid support (see ¶ 0038, 0069 for example),
wherein the first and further oligonucleotide groups are spatially separated on said solid support (see Fig. 1C for example),
wherein said one or more groups of oligonucleotide groups on said solid support are within separate reservoirs of the microfluidics system (see Fig. 1C for example),
wherein the one or more reservoirs are capable of being accessible to fluids, cells, chemicals and microdroplet by means of channels (see e.g., 104 and ¶ 0002-0007, 0029, 0075), and
wherein each reservoir comprises comprising a group of oligonucleotides on said solid support is capable of being a trap (see i.e., the small openings has dimensions smaller than the cell, prohibiting the cells from exiting the cell cage into the enclosed reservoir. ¶ 0058; see also Figs. 1A-1E & ¶ 0075).
With regard to limitations in claims 1, 2, 3, 7 (e.g., [...] accessible to fluids, cells, chemicals and microdroplet by means of channels, [...] trap for a microfluidic droplet; [...] allows for [...]; which may be [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-6, Yanai et al. teach:
2. The microfluidic system according to claim 1, wherein the barcode sequence of each group is known (see Fig. 1C & ¶ 0003 for example).
3. The microfluidic system according to claim 1, wherein at least parts of the system is optically transparent (see ¶ 0007 incorporated reference WO 2015/118551 Sivan et al. ¶ 0097 for example).
4. The microfluidic system according to claim 1, wherein each group of oligonucleotides comprises between 104 and 1011 molecules of oligonucleotides (see ¶ 0025, 0033 for example).
5. The microfluidic system according to claim 1, wherein a cavity of dimensions 10 and 100 µm (see ¶ 0058 for example).
6. The microfluidic system according to claim 1, wherein each spatial separation of oligonucleotide groups is at least 100 nm and no more than 1,000 µm (the claim appears to be taught by Yanai et al. at ¶ 0058 since each cell cages are within the claimed limitation).
Claim(s) 1, 2, 4-7 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Blainey et al. (US 2018/0071738 A1).
Regarding claim 1, Blainey et al. teach:
1. A microfluidic system comprising:
a solid support (e.g., solid substrate ¶ 0030+) comprising at least a first group of oligonucleotides (¶ 0047),
wherein each oligonucleotide in said group comprises a nucleic acid sequence of a first type (see ¶ 0047+ for example),
wherein said nucleic acid sequence of a first type is a barcode sequence (see ¶ 0047+ for example) and
oligonucleotides comprising the same barcode sequence are grouped together in a group of oligonucleotides on said solid support (see ¶ 0047-0049, and claims 30, 33 for example),
wherein the first and further oligonucleotide groups are spatially separated on said solid support (see Fig. 5 & ¶ 0046 for example),
wherein said one or more groups of oligonucleotide groups on said solid support are within separate reservoirs of the microfluidics system (see Fig. 5 & ¶ 0046 for example),
wherein the one or more reservoirs are capable of being accessible to fluids, cells, chemicals and microdroplet by means of channels (see ¶ 0046), and
wherein each reservoir comprises comprising a group of oligonucleotides on said solid support is capable of being a trap (see Fig. 5 for example).
With regard to limitations in claims 1, 2, 3, 7 (e.g., [...] accessible to fluids, cells, chemicals and microdroplet by means of channels, [...] trap for a microfluidic droplet; [...] allows for [...]; which may be [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2, 4-6, Blainey et al. teach:
2. The microfluidic system according to claim 1, wherein the barcode sequence of each group is known (see Figs. 5, 8 for example).
4. The microfluidic system according to claim 1, wherein each group of oligonucleotides comprises between 104 and 1011 molecules of oligonucleotides (see ¶ 0025, 0033 for example).
5. The microfluidic system according to claim 1, wherein a cavity of dimensions 10 and 100 µm (see ¶ 0033, 0036 for example).
6. The microfluidic system according to claim 1, wherein each spatial separation of oligonucleotide groups is at least 100 nm and no more than 1,000 µm (the claim appears to be taught by Blainey et al. at ¶ 0033, 0036 since microwells are within the claimed limitation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798