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 .
DETAILED ACTION
1. The amendment filed May 19, 2025 in response to the Office Action of November 19, 2024 is acknowledged and has been entered.
2. Claims 2, 3, 7, 29, 44, 49, 52, 57 and 60 are pending and under consideration.
Rejections Maintained
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.
3. Claim(s) 2, 3, 7, 29, 44, 49, 52, 57 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0282694 A1 (Wardell et al. Oct. 4, 2018), “Wardell-694 in view of WO 2016/179006 A1 (Gros et al. Nov. 10, 2016), “Gros” and US 2012/0244133 A1 (Rosenberg et al. Sep. 27, 2021, IDS), “Rosenberg” for the reasons of record.
Wardell-694 teaches a method for expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs comprising: (a) obtaining a first population of TILs from a tumor resected from a patient by processing a tumor sample obtained from the patient into multiple tumor fragments; (b) adding the tumor fragments into a closed system; (c) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2 to produce a second population of TILs, wherein the first expansion is performed in a closed container providing a first gas-permeable surface area, wherein the first expansion is performed for about 3-14 days to obtain the second population of TILs, wherein the second population of TILs is at least 50-fold greater in number than the first population of TILs, and wherein the transition from step (b) to step (c) occurs without opening the system; (d) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, OKT-3, and antigen presenting cells (APCs), to produce a third population of TILs, wherein the second expansion is performed for about 7-14 days to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs, wherein the second expansion is performed in a closed container providing a second gas-permeable surface area, and wherein the transition from step (c) to step (d) occurs without opening the system; (e) harvesting the therapeutic population of TILs obtained from step (d), wherein the transition from step (d) to step (e) occurs without opening the system; and (f) transferring the harvested TIL population from step (e) to an infusion bag, wherein the transfer from step (e) to (f) occurs without opening the system. See ¶¶ 0006-0012.
Wardell-694 teaches that the first period in step (c) and the second period in step (e) are each individually performed within a period of 10 days, 11 days, or 12 days. See ¶¶ 0029, 0030.
Wardell-694 teaches as set forth above, but does not teach using OKT-3 in the first expansion step or selecting the PD-1 positive TIL after the expansion.
Rosenberg teaches a method of promoting regression of cancer in a mammal comprising obtaining a tumor tissue sample from the mammal; culturing the tumor tissue sample in a first gas permeable container containing cell medium therein; obtaining tumor infiltrating lymphocytes (TIL) from the tumor tissue sample; expanding the number of TIL in a second gas permeable container containing cell medium therein using irradiated allogeneic feeder cells and/or irradiated autologous feeder cells; and administering the expanded number of TIL to the mammal. See abstract and ¶¶ 0003-0006, 0010, and 0011.
Gros teaches a method of isolating T cells having antigenic specificity for a mutated amino acid sequence encoded by a cancer-specific mutation, the method comprising: obtaining a bulk population of peripheral blood mononuclear cells (PBMCs) from a sample of peripheral blood from a patient; selecting T cells that express programmed cell death 1 (PD-1) from the bulk population; separating the T cells that express PD-1 from cells that do not express PD-1 to obtain a T cell population enriched for T cells that express PD-1; identifying one or more genes in the nucleic acid of a cancer cell of the patient, each gene containing a cancer-specific mutation that encodes a mutated amino acid sequence; inducing autologous antigen presenting cells (APCs) of the patient to present the mutated amino acid sequence; co-culturing T cells from the population enriched for T cells that express PD-1 with the autologous APCs that present the mutated amino acid sequence; and selecting T cells that (a) were co-cultured with the autologous APCs that present the mutated amino acid sequence and (b) have antigenic specificity for the mutated amino acid sequence presented in the context of a major histocompatibility complex (MHC) molecule expressed by the patient. See claim 1 and ¶¶ 0017-0022.
Gros teaches using the anti-PD1 antibody EH12.2H7. See ¶ 0161.
Gros teaches that CD8+, PD-1+ isolated T-cells recognized neoantigens expressed on dendritic cells better than PD-1- T cells . See Examples 12 and 13.
Gros teaches expanding T-cells with OKT3 and IL2. See ¶¶ 0042 and 0164.
Gros teaches that the T cells are administered by infusion. See ¶¶ 0109 and 0194.
Rosenberg teaches methods of promoting regression of cancer and obtaining an expanded number of TIL using gas permeable containers are simpler, less labor-intensive, use less reagents, and can be performed using simpler equipment than procedures using non-gas permeable containers, gas permeable containers may advantageously protect the cells from microbial contamination more effectively than non-gas permeable containers which may be "open" systems and reduce the number of containers that are used compared to methods using non-gas permeable containers, thereby reducing the amount of labor necessary to carry out the methods and also reducing the risk of microbial contamination. See ¶¶ 0011.
Rosenberg teaches rapidly expanding the TIL cells in gas permeable containers using OKT3 and IL-2. See ¶¶ 0021.
Rosenberg teaches that the cultured TIL are rapidly expand which provides an increase in the number of TIL of at least about 50-fold (or 60-, 70-, 80-, 90-, or 100-fold, or greater) over a period of about 10 to about 14 days, preferably about 14 days. See ¶¶ 0020.
Rosenberg teaches that expansion can be accomplished in the gas permeable container by any suitable method. For example, TIL can be rapidly expanded using non-specific T-cell receptor stimulation in the presence of feeder cells (e.g., irradiated allogeneic feeder cells, irradiated autologous feeder cells, and/or artificial antigen presenting cells (e.g., K562 leukemia cells transduced with nucleic acids encoding CD3 and/or CD8)) and either interleukin-2 (IL-2) or interleukin-15 (IL-15), with IL-2 being preferred. In an embodiment of the method, expanding the number of TIL uses about 1x109 to about 4x109 allogeneic feeder cells and/or autologous feeder cells, preferably about 2 x109 to about 3 x109 allogeneic feeder cells and/or autologous feeder cells. The non-specific T-cell receptor stimulus can include, for example, about 30 ng/ml of OKT3, a mouse monoclonal anti-CD3 antibody. See ¶¶ 0021.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Wardell-694, Gros, and Rosenberg and perform the first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs because Gros teaches a method of isolating T cells having antigenic specificity for a mutated amino acid sequence encoded by a cancer-specific mutation using PD-1, Gros teaches that CD8+, PD-1+ isolated T-cells recognized neoantigens expressed on dendritic cells better than PD-1- T cells and Gros and Rosenberg teaches that OKT-3 and IL-2 are routinely used for TIL expansion. Thus, one would have been motivated to use the perform a first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs given the advantages of isolating tumor antigen recognizing T-cells, like TILs using PD-1 selection as taught by Gros and the routine use of OKT-3 and IL-2 for T cell expansion. Additionally, one would have been motivated to transfer the TILs to an infusion bag once the TILs are expanded and are ready to be infused for treatment.
Regarding the number of APC cells and APC cell layers in the gas-permeable flasks, one of skill in the art would have been motivated to optimize the cell density to allow for optimal cell growth and expansion.
4. Claim(s) 2, 3, 7, 29, 44, 49, 52, 57 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0325954 A1 (Wardell et al. Nov. 15, 2018), “Wardell-954” in view of WO 2016/179006 A1 (Gros et al. Nov. 10, 2016), “Gros” and US 2012/0244133 A1 (Rosenberg et al. Sep. 27, 2021, IDS), “Rosenberg” for the reasons of record.
Wardell-954 teaches a method for expanding tumor infiltrating lymphocytes (TILs) into a therapeutic population of TILs comprising: (a) obtaining a first population of TILs from a tumor resected from a patient by processing a tumor sample obtained from the patient into multiple tumor fragments; (b) adding the tumor fragments into a closed system; (c) performing a first expansion by culturing the first population of TILs in a cell culture medium comprising IL-2, and optionally OKT-3, to produce a second population of TILs, wherein the first expansion is performed in a closed container providing a first gas-permeable surface area, wherein the first expansion is performed for about 3-14 days to obtain the second population of TILs, wherein the second population of TILs is at least 50-fold greater in number than the first population of TILs, and wherein the transition from step (b) to step (c) occurs without opening the system; (d) performing a second expansion by supplementing the cell culture medium of the second population of TILs with additional IL-2, optionally OKT-3, and antigen presenting cells (APCs), to produce a third population of TILs, wherein the second expansion is performed for about 7-14 days to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs, wherein the second expansion is performed in a closed container providing a second gas-permeable surface area, and wherein the transition from step (c) to step (d) occurs without opening the system; (e) harvesting the therapeutic population of TILs obtained from step (d), wherein the transition from step (d) to step (e) occurs without opening the system; and (f) transferring the harvested TIL population from step (e) to an infusion bag, wherein the transfer from step (e) to (f) occurs without opening the system. See ¶¶ 0006-0012.
Wardell-954teaches that the first period in step (c) and the second period in step (e) are each individually performed within a period of 10 days, 11 days, or 12 days. See ¶¶ 0029, 0030.
Wardell-954 teaches as set forth above, but does not teach always using OKT-3 in the first expansion step or selecting the PD-1 positive TIL after the expansion.
Gros and Rosenberg teach as set forth above.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Wardell-954, Gros, and Rosenberg and perform the first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs because Gros teaches a method of isolating T cells having antigenic specificity for a mutated amino acid sequence encoded by a cancer-specific mutation using PD-1, Gros teaches that CD8+, PD-1+ isolated T-cells recognized neoantigens expressed on dendritic cells better than PD-1- T cells and Gros and Rosenberg teaches that OKT-3 and IL-2 are routinely used for TIL expansion. Thus, one would have been motivated to perform a first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs given the advantages of isolating tumor antigen recognizing T-cells, like TILs using PD-1 selection as taught by Gros and the routine use of OKT-3 and IL-2 for T cell expansion. Additionally, one would have been motivated to transfer the TILs to an infusion bag once the TILs are expanded and are ready to be infused for treatment.
Regarding the number of APC cells and APC cell layers in the gas-permeable containers, one of skill in the art would have been motivated to optimize the cell density to allow for optimal cell growth and expansion.
Response to Arguments
5. Applicant argues that:
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Applicant’s arguments have been considered, but have not been found persuasive. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, Wardell-694/954 does teach, other than the PD-1 selection step, the two step expansion method with IL-2, OKT-3, and APCs, with the timing as claimed. Thus, Gros does not need to teach the two step expansion method as claimed.
In response to Applicant's argument that Gros does not teach using the PD-1 selection process with the two step expansion method, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Gros teaches that CD8+, PD-1+ isolated T-cells recognized neoantigens expressed on dendritic cells better than PD-1- T cells and Gros and Rosenberg teaches that OKT-3 and IL-2 are routinely used for TIL expansion. Thus, one would have been motivated to perform a first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs given the advantages of isolating tumor antigen recognizing T-cells, like TILs using PD-1 selection as taught by Gros and the routine use of OKT-3 and IL-2 for T cell expansion. Thus, Applicant’s arguments are not found persuasive.
Applicant argues that:
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667
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Applicant’s arguments have been considered, but have not been found persuasive. It would not have been unexpected that the PD-1 selected TILs have increased tumor cell killing activity Gros teaches that CD8+, PD-1+ isolated T-cells recognized neoantigens expressed on dendritic cells better than PD-1- T cells and the process of PD-1 selection would concentrate tumor reactive cells. Thus it would have been expected that the PD-1 selected cells with increased tumor reactivity would have increased tumor cell killing activity compared to unselected TILs given the lower concentration of tumor reactive cells in the unselected TIL population. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. Thus, Applicant’s arguments are not found persuasive and the rejection is maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
6. Claims 2, 3, 7, 29, 44, 49, 52, 57 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the U.S. Patents set forth below in view of WO 2016/179006 A1 (Gros et al. Nov. 10, 2016), “Gros” and US 2012/0244133 A1 (Rosenberg et al. Sep. 27, 2021, IDS), “Rosenberg for the reasons of record.
Claims 2, 3, 7, 29, 44, 49, 52, 57 and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the co-pending applications set forth below in view of WO 2016/179006 A1 (Gros et al. Nov. 10, 2016), “Gros” and US 2012/0244133 A1 (Rosenberg et al. Sep. 27, 2021, IDS), “Rosenberg for the reasons of record.
The conflicting patented and co-pending claims are drawn to or include the steps of a method for expanding tumor infiltrating lymphocytes (TTLs) into a therapeutic population of TILs comprising some or all of : a) obtaining and/or receiving a first population of TTLs from a tumor resected from a subject by processing a tumor sample obtained from the subject into multiple tumor fragments; b) selecting PD-1 positive TILs from the first population of TILs in (a) to obtain a PD-1 enriched TIL population; c) performing a priming first expansion by culturing the PD-1 enriched TIL population in a cell culture medium comprising IL-2, or OKT-3, and optionally comprising antigen presenting cells (APCs), to produce a second population of TILs, wherein the priming first expansion is performed for a first period of about 1 to 11 days to obtain the second population of TILs, wherein the second population of TILs is greater in number than the first population of TILs; d) performing a rapid second expansion by contacting the second population of TILs with a cell culture medium comprising IL-2, OKT-3, and APCs, to produce a third population of TILs, wherein the rapid second expansion is performed for a second period of about 1 to 11 days to obtain the third population of TILs, wherein the third population of TILs is a therapeutic population of TILs; and e) harvesting the therapeutic population of TILs obtained from step (d) and/or using gas-permeable surfaces and/or an infusion bag.
The patented or co-pending claims teach as set forth above, but does not teach using OKT-3 in the first expansion step or selecting the PD-1 positive TIL after the expansion.
Gros and Rosenberg teach as set forth above.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of patented or co-pending claims, Gros, and Rosenberg and perform the first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs because Gros teaches a method of isolating T cells having antigenic specificity for a mutated amino acid sequence encoded by a cancer-specific mutation using PD-1, Gros teaches that CD8+, PD-1+ isolated T-cells recognized neoantigens expressed on dendritic cells better than PD-1- T cells and Gros and Rosenberg teaches that OKT-3 and IL-2 are routinely used for TIL expansion. Thus, one would have been motivated to perform a first and second expansion of the TILs in the presence of OKT-3 and IL-2 after selecting the PD-1 positive TILs given the advantages of isolating tumor antigen recognizing T-cells, like TILs using PD-1 selection as taught by Gros and the routine use of OKT-3 and IL-2 for T cell expansion. Additionally, one would have been motivated to transfer the TILs an infusion bag once the TILs are expanded and are ready to be infused for treatment. Further, one would have been motivated to use a gas-permeable culture container because Rosenberg teaches the advantages of using gas permeable containers
Regarding the number of APC cells and APC cell layers in the gas-permeable flasks, one of skill in the art would have been motivated to optimize the cell density to allow for optimal cell growth and expansion.
No.
Patent
Claims
1
10,130,659
1-29
2
10,166,257
1-20
3
10,272,113
1-23
4
10,363,273
1-29
5
10,398,734
1-15
6
10,420,799
1-11
7
10,463,697
1-20
8
10,639,330
1-11
9
10,646,517
1-23
10
10,695,372
1-15
11
10,894,063
1-46
12
10,918,666
1-30
13
10,925,900
1-15
14
11,713,446
1-26
15
11,384,337
1-28
16
11,007,225
1-29
17
11,007,226
1-20
18
11,013,770
1-24
19
11,026,974
1-24
20
11,040,070
1-14
21
11,052,115
1-22
22
11,052,116
1-24
23
11,168,303
1-29
24
11,168,304
1-30
25
11,058,728
1-19
26
11,083,752
1-20
27
11,123,371
1-20
28
11,141,438
1-21
29
11,179,419
1-21
30
11,202,803
1-20
31
11,202,804
1-20
32
11,241,456
1-20
33
11,254,913
1-28
34
11,266,694
1-20
35
11,273,180
1-19
36
11,273,181
1-19
37
11,291,687
1-16
38
11,293,009
1-22
39
11,304,979
1-19
40
11,304,980
1-20
41
11,311,578
1-20
42
11,337,998
1-19
43
11,344,579
1-20
44
11,344,580
1-20
45
11,344,581
1-24
46
11,351,197
1-20
47
11,351,198
1-20
48
11,351,199
1-25
49
11,364,266
1-25
50
11,369,637
1-25
51
11384337
1-28
52
11401507
1-28
53
11433097
1-23
54
11517592
1-27
55
11529372
1-23
56
11541077
1-24
55
11026974
1-24
56
10517894
1-22
57
11351198
1-20
58
11351199
1-25
59
11529372
1-23
60
11713446
1-26
61
11857573
1-23
62
11865140
1-21
63
10130659
1-29
64
10166257
1-20
65
10272113
1-23
66
11969444
1-22
67
10363273
1-29
68
10398734
1-15
69
10463697
1-21
70
10646517
1-23
71
10695372
1-15
72
10894063
1-15
73
10925900
1-15
74
11007225
1-29
75
11013770
1-24
76
11052115
1-22
77
11052116
1-24
78
11058728
1-19
80
11083752
1-20
81
11123371
1-20
82
11141438
1-21
83
11202803
1-20
84
11202804
1-20
85
11241456
1-20
86
11254913
1-28
87
11266694
1-20
88
11273181
1-19
89
11304980
1-20
90
11311578
1-20
91
11337998
1-19
92
11344579
1-20
93
11344580
1-20
94
11344581
1-24
95
11351197
1-20
96
11364266
1-25
97
11369637
1-25
98
11433097
1-23
s99
11517592
1-27
100
11529372
1-23
101
11541077
1-24
102
11026974
1-24
103
10517894
1-22
104
11351198
1-20
105
11351199
1-25
106
12104172
1-13
107
12031157
1-30
108
12024718
1-30
109
12121541
1-35
110
11939596
1-30
111
11998568
1-23
112
11220670
1-18
113
11357841
1-17
114
11975028
1-21
No.
Application
Claims
1
17/771723
159, 215-236
2
17/050552
65,68-76, 82-98
3
17/610671
367-396
4
17/415175
1-6, 9, 12, 15, 19, 66, 67, 70-73, 82, 83, 85, 88, 89, 91, 96-98, 102, 103, 213-215
5
17/290639
1-31
6
17/810540
1-30
7
17/778309
1-7 and 7-21
8
18/551138
136-150
9
17/110179
1-39
10
17/147080
1-35
11
17/147096
1-13
12
17/147412
1-33
13
17/817207
1-22
14
17/817217
1-19
No.
Application
Claims
15
17/817226
1-23
16
17/817239
1-22
17
17/817247
1-21
18
17/817273
1-24
19
17/817276
1-20
20
17/819209
1-7, 9-15, 17-25
21
17/819214
1-5,7-16, 18-24
22
17/819219
1-5,7-13, 15-23
23
17/819910
1-5,7-13, 15-23
24
17/823419
1-29
25
17/823448
1-27
26
17/823454
1-30
27
17/829087
1-25
28
17/856793
1-27
No.
Application
Claims
29
17/856806
1-30
30
17/819909
1-7,915-17-25
31
17/053,344
1-7,10-13,15-18,20-22,24,32, 34-36,43-44,62, 101
32
16/969362
1, 2, 8, 9, 12-14, 16, 24, 32, 34, 36-38, 41-45, 52
33
18/410900
285-299
34
17/838,127
35, 36, 40, 42-48, 52-55, 57, 60-68, 71
s35
17/997648
2, 7, 160
36
17/997731
30-32, 50, 65-68, 70, 73-76, 81-82, 84, 91-100, 107, 121
37
18/247878
1, 2, 4, 13, 14, 19, 41, 43, 45, 56, 61, 71, 72, 85-90
38
18/256421
162-178
39
18/256798
8 and 20
40
18/256853
86-102
41
18/262365
30, 32, 34, 45, 51, 58, 81, 98, 115, 117, 127, 161, 164, 168, 173, 177, 180, 187, 227
42
18/291536
2-5, 112-116, 119, 120, 141
43
18/411991
285-298
44
18/551586
32
45
18/555513
2
46
18/619119
1-27
47
18/661510
1-30
48
18/693508
1-120
49
18/707719
1-74,76
50
18/745958
71-90
51
18/781928
12-24
52
18/832493
2-24, 26, 61-225
53
18/832901
1-236
54
18/886988
14-30
55
18/674,562
107-122
56
18/262843
1, 2, 7, 8, 10, 11, 21, 22, 29, 33, 34, 37-39, 41, 97, 98, 105, 106, 110, 111, 115-117, 119, 120, 138, 148 and 149
57
18/560,898
19, 46, 89-98, 101-107
58
18/247,877
1, 2, 4, 7, 13, 15, 16, 18-21, 23, 34-45, 56, and 61
59
18/477,810
19,20
60
18/668,092
71,72
61
17/271601
1-41, 125-130
62
18/673,083
1-124
63
17/290710
1-3,9,14,19,26,29,31,33,35,37,39,81-83,89,94,99,109,111,113,115,117,121,125-126
64
17/290708
1, 7, 11-12, 18-19, 66, 68-70, 72, 75, 77, 81-82, 84, 87, 89-91, 96-97, and 99-101
Response to Arguments
7. Applicant argues that they disagree and traverse the rejections. However, Applicant request that the double patenting rejections be held in abeyance until there is an indication of allowable subject matter.
Conclusion
8. All other objections and rejections recited in the Office Action of November 19, 2024 are withdrawn in view of Applicant’s amendments and/or arguments.
9. No claims allowed.
10. 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 extension fee 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Epps-Smith can be reached on 571-272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Peter J Reddig/
Primary Examiner, Art Unit 1642
Prosecution Insights