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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on November 19, 2025.
Currently, claims 1-15 and 19-25 are pending and under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Response to Arguments
Applicant’s arguments filed on November 19, 2025 have been considered but are moot because they do not pertain to the new rejections necessitated by claim amendments as set forth below.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. (US 2018/0088112 A1, of record) in view of Agasti et al. (JACS, 2012, 134:18499-18502, of record), Mallick (US 2019/0361017 A1, of record), Shahi et al. (Scientific Reports, 2017, 7:44447, of record), Stoeckius et al. (US 2018/0251825 A1, of record), Jhutty et al. (US 2021/0047677 A1, of record), Espina et al. (US 2013/0137094 A1, of record), Gerlach et al. (Scientific Reports, 2019, 9:1469, of record), Abate et al. (WO 2016/126871 A1, of record), and Chu et al. (US 2014/0256918 A1, of record), further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
The teachings of each of Fan, Agasti, Mallick, Shahi, Stoeckius, Jhutty, Espina, Gerlach, Abate, and Chu are described in the last Office action mailed on August 19, 2025 thus will not be repeated herein.
The cited references of Fan, Agasti, Mallick, Shahi, Stoeckius, Jhutty, Espina, Gerlach, Abate, and Chu do not teach that the plurality of intracellular target-binding reagents comprises two sequences, one of which is a unique molecular label sequence (also referred to as a molecular barcode) comprising at least three repeats of VN and/or NV.
It is noted that Fan also teaches that the plurality of Abseq oligonucleotides comprises “a target binding region and a barcode sequence (e.g., a molecular label sequence), wherein the barcode sequence is from a diverse set of unique barcode sequences.” (emphasis added). See paragraph 0009.
Fan also teaches that “barcodes with unique molecular labels (also referred to as molecular indexes (MIs)) can be used to count the number of molecules” (emphasis added). See paragraph 0274.
It is noted that paragraph 0313 of the instant specification expressly discloses “a unique molecular label sequence (also referred to as a molecular index (MI), “molecular barcode,” or Unique Molecular Identifier (UMI)).” (emphasis added).
Mikkelsen teaches use of an oligonucleotide comprising a barcode sequence comprising a 6-mer (N6) barcode and a 10-mer (N10) UMI, wherein the barcode sequences are unique sequences that provide “a distinct tag”, wherein “the tag can be used to identify the single cell”, wherein the use of barcode sequences is “particularly advantageous” for facilitating target “screening assays.” See paragraph 0070; Figure 3.
Mikkelsen exemplifies 6-mer barcode sequences in Table 1, which lists “AAAACT” and “GGCAAT” thus having the VNVNVN repeats.
The obviousness of the rejected claims, except the newly added limitation, over the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein.
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Fan pertaining to a plurality of oligonucleotides that further comprise “unique barcode sequences” (or barcodes) or “unique molecular labels” (or sequences) and to apply the art-recognized 6-mer barcodes already identified by Mikkelsen. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success in order to count the number of copies of intracellular targets in cells more effectively and efficiently because the unique molecular labels/sequences/indexes/barcodes were taught to enable one of ordinary skill in the art “to count the number of molecules” as evidenced by Fan, and because variable 6-mer unique barcodes having the instantly claimed motifs were already known to be useful to identify targets, thereby facilitating target identification thus imparting “particularly advantageous” utility in “screening assays” as evidenced by Mikkelsen’s teaching including Table 1.
Accordingly, claims 1-15 and 19-25 as currently amended would have been prima facie obvious before the effective filing date.
Double Patenting
The text of the judicially created doctrine not included in this action can be found in a prior Office action.
Claims 1-15 and 19-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,649,497 B2 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘497 patent claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘497 patent claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,661,631 B2 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘631 patent claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘631 patent claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-25, 28, and 30 of copending Application No. 17/147,283 (now allowed) in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Note that this rejection will no longer be provisional once an issue fee is paid in the ‘283 applicatoin.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘283 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘283 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1022-1041 of copending Application No. 17/822,948 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘948 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘948 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-44 of copending Application No. 18/187,449 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘449 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘449 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-41 of copending Application No. 18/187,488 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘488 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘488 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6-17, 19-20, 27, 41-42, 65, and 80 of copending Application No. 18/686,812 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘812 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘812 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-12, 14, 26-28, 31, 35, 38-40, 43, 50, 52, and 61 of copending Application No. 18/686,824 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘824 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘824 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 20-21, 23, 51, 56, 58-60, 62, 65, 78, 80-81, and 94 of copending Application No. 18/687,030 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘030 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘030 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Claims 1-15 and 19-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 20, 25-26, 28-29, 33, and 39 of copending Application No. 18/728,980 in view of Fan et al., Agasti et al., Mallick, Shashi et al., Stoeckius et al., Jhutty et al., Espina et al., Gerlach et al., Abate et al., and Chu et al. (all same citations of record in the last Office action) further in view of Mikkelsen et al. (WO 2014/201273 A1, applicant’s citation).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over and overlap in scope with the ‘980 claims. The obviousness of the rejected claims, except the newly added limitation, over the ‘980 claims in view of the combined teachings of the aforementioned references is explained in the last Office action mailed on August 19, 2025 thus will not be repeated herein. The newly recited unique molecular label sequence, which is also known as a unique barcode sequence, wherein the sequence is a 6-mer with the recited motifs would have been obvious in view of the teachings of Fan and Mikkelsen for the reasons stated in the §103 rejection above, which is fully incorporated by reference herein thus will not be repeated.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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