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 .
Claims 1, 6, 10, 39, 41, 46, 47, 61 and 81-83 are pending in this application and
were examined on their merits.
The rejection of Claim(s) 1, 3, 6, 10, 36, 39, 41, 46, 47, 61 and 81-83 under 35 U.S.C. § 103 as being unpatentable over Clark et al. (2006), cited in the IDS, in view of Hayes (WO 2018/202808 A2) and Wardell et al. (WO 2018/182817 A1), both of record, has been withdrawn due to the Applicant’s amendments to the claims filed 01/12/2026.
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.
Claim(s) 1, 3, 6, 10, 39, 41, 46, 47, 61 and 81-83 are newly rejected under
35 U.S.C. § 103 as being unpatentable over Clark et al. (2006), cited in the IDS, in view
of Hayes (WO 2018/202808 A2) and Wardell et al. (WO 2018/182817 A1), both of
record and Rosenberg et al. (US 2012/0244133 A1), as necessitated by Applicant’s amendment to the claims filed 01/12/2026.
Clark et al. teaches a method comprising culturing a non-intact skin (non-hematopoietic tissue) explant on a synthetic matrix in the presence of a media containing serum and human recombinant IL-2 and human recombinant IL-15 and collecting/isolating a population of migrating lymphocytes from the culture after 21 days (Pg. 1067, Column 1, Lines 3-13 and 17-37);
and wherein the collected/isolated population of lymphocytes comprises a population of γδ T-cells (Pg. 1059, Abstract and 1060, Column 1, Lines 8-9), and reading on Claims 1, 6 and 10.
The teachings of Clark et al. were discussed above.
Clark et al. did not teach wherein the skin explant is additionally cultured in the
presence of IL-21 and IL-4, as required by Claims 1 and 81;
wherein the method is performed in a vessel comprising a liquid sealed container comprising a gas-permeable material at the bottom of the vessel,
or wherein the non-hematopoietic tissue sample comprises an intact biopsy that is not minced before culturing, as now required by Claim 1.
Hayes teaches a method wherein γδ T-cells isolated from non-hematopoietic
tissue are cultured/expanded in the presence of IL-2 or IL-9; IL-15 and IL-21 (Pg. 63,
Claim 1) and IL-4 (Pg. 63, Claim 2).
Wardell et al. teaches a method of isolating lymphocytes from a tumor sample
comprising culturing the sample in the presence of IL-2 in a closed container providing a
gas-permeable surface area (Pg. 286, Claim 1), wherein the container may be G-REX®
flasks and wherein doing so allows cell expansion without addition of fresh cell culture
media (Pgs. 73-74, Paragraph [00384]).
The Specification as filed at Pg. 20 states, "Thus, in certain embodiments, the vessel comprises a liquid sealed container comprising a gas permeable material to allow gas exchange. In further embodiments, said bottom of the gas permeable container is configured to allow gas exchange from the bottom of the vessel. In a yet further embodiment, said vessel comprising a gas permeable material may be a liquid sealed container and further comprise inlet and outlet ports or tubes. Thus, in certain embodiments, the vessel comprising a gas permeable material includes a top, a bottom and optionally at least one sidewall, wherein at least a part of said top and said bottom comprise a gas permeable material and, if present, at least part of the at least one sidewall comprises a gas permeable material. Example vessels are described in WO2005035728 and US9255243 which are herein incorporated by reference. These vessels are also commercially available, such as the G-REX® cell culture devices provided by Wilson Wolf Manufacturing, such as the G-REX®6 well-plate, G-REX®24 well-plate and the G-REX®10 vessel".
Thus, the G-REX® flasks of Wardell et al. would meet the structural limitations of the claimed vessel.
Rosenberg et al. teaches a method comprising: obtaining a tissue sample from a mammal and culturing the sample in a gas permeable chamber containing cell medium and obtaining tumor infiltrating lymphocytes (TIL) from the sample (Pg. 14, Claim 1) (thus does not specifically require a non-intact/minced sample);
wherein the culture medium may further comprise any suitable T-cell growth factor, such as IL-2 (Pg. 2, Paragraph [0013])
wherein the tissue sample can be obtained from biopsy and from any cancer (e.g. any cancerous tissue thereby including non-hematopoietic tissue) (Pg. 2, Paragraph 12).
It would have been obvious to those of ordinary skill in the art to modify the
method of Clark et al. of isolating T-lymphocytes including γδ T-lymphocytes from a
tissue sample by culturing the sample in a media containing IL-2 and IL-15 to include IL-
21 and IL-4 as taught by Hayes because this would eliminate the need to add IL-21 and
IL-4 to the culture when expanding the isolated γδ T-lymphocytes. Those of ordinary skill in the art would have been motivated to make this modification in order to eliminate another step of cytokine addition and/or having to prepare two different culture mediums containing different cytokines. There would have been a reasonable expectation of success in making this modification because both Clark et al. and Hayes are drawn to the same field of endeavor, that is, the isolation and expansion of γδ T-cells from non-hematopoietic tissue.
It would have been further obvious to those of ordinary skill in the art to modify
the method of Clark et al. and Hayes of isolating γδ T-lymphocytes from a tissue sample
to perform the process in a G-REX® vessel comprising a gas-permeable material as
taught by Wardell et al. because this would maintain the medium freshness for a longer
period of time. Those of ordinary skill in the art would have been motivated to make this
modification in order to eliminate the need to add fresh cell culture media during the
culturing. There would have been a reasonable expectation of success in making this
modification because all of the references are drawn to the same field of endeavor, that
is, the isolation and expansion of T-cells from tissue samples.
It would have been obvious to those of ordinary skill in the art to modify the
method of Clark et al. and Hayes of isolating T-lymphocytes including γδ T-lymphocytes from a non-intact non-hematopoietic tissue sample to use an intact tissue sample as taught by Rosenberg et al. because this would eliminate a step of cutting or digesting the tissue sample before isolating lymphocytes. Those of ordinary skill in the art would have been motivated to make this modification in order to eliminate a step of tissue sample preparation. There would have been a reasonable expectation of success in making this modification because at least both Clark et al. and Rosenberg et al. are drawn to the same field of endeavor, that is, the isolation and expansion of T-cells from tissue samples.
With regard to Claim 39, "wherein the synthetic scaffold is configured to facilitate
lymphocyte egress from the non-hematopoietic tissue sample to the bottom of the
vessel", as discussed above, Clark et al. teaches culturing a skin explant on a synthetic
matrix which has been coated with Collagen I (Pg. 1067, Column 1, Lines 3-13 and 17-
37). As the synthetic matrix of Clark et al. meets all of the structural elements of the
claimed synthetic scaffold, it would be expected to function in the same manner as
claimed. See the Specification as filed at Pg. 20, Lines 26-38 and Pg. 21, Lines 1-5.
With regard to Claim 41, as discussed above, Clark et al. teaches a method
comprising culturing a skin explant on a synthetic matrix in the presence of a media
containing serum and human recombinant IL-2 and human recombinant IL-15 and
collecting a population of lymphocytes from the culture after 21 days (Pg. 1067, Column
1, Lines 3-13 and 17-37) and Hayes teaches that the IL-21 may be human (Pg. 21,
Lines 27-28).
With regard to the limitation of Claims 46 and 47; "wherein the population of γδ
lymphocytes collected from the culture of the non-hematopoietic tissue sample
comprises a population of Vγδ T cells" and "wherein the population of Vγδ T cells
express CD27 and/or do not express TIGIT", Hayes teaches that non-hematopoietic
tissue-resident γδ T-cells include Vγδ T-cells (Pg. 18, Lines 1 and 13- 16). Therefore,
the method of Clark et al. which isolates a population of T-cells including γδT-cells
would also include Vγδ T-cells. As the prior art Vγδ T-cells are the same as the claimed
Vγδ T-cells, they would be expected to have the same characteristics.
With regard to Claim 61, Hayes teaches a method wherein γδ T-cells isolated
from non-hematopoietic tissue are cultured/expanded in the presence of IL-2 or IL-9;
IL-15 and IL-21 (Pg. 63, Claim 1) and IL-4 (Pg. 63, Claim 2).
With regard to Claims 82 and 83, Hayes teaches a method wherein γδ T-cells
isolated from non-hematopoietic tissue are cultured in the presence of IL-4 (e.g. a
functional equivalent to human IL-4) (Pg. 63, Claim 2).
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.
Claims 1, 6, 10, 39, 41, 46, 47, 61 and 81-83 are provisionally rejected on the
ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 34, 40,
44, 45, 46, 47, 61 and 76 of copending allowed, but not issued Application No.
17/292,411, in view of Hayes (WO 2018/202808 A2) and Wardell et al. (WO
2018/182817 A1), both of record.
Instant Claim 1 is drawn to a method for the isolation of lymphocytes from a
non-hematopoietic tissue sample comprising the steps of: (i) culturing the non-
hematopoietic tissue sample in the presence of: (a) Interleukin-2 (IL-2) or Interleukin-9
(IL-9); (b) Interleukin-15 (IL-15); (c) Interleukin-21 (IL-21); and (d) Interleukin-4 (IL-4)
and (ii) collecting a population of γδ lymphocytes cultured from the non-hematopoietic tissue sample; wherein the method is performed in a vessel comprising a liquid sealed container comprising a gas permeable material to allow gas exchange, wherein the bottom of the vessel is configured to allow gas exchange from the bottom of the vessel;
wherein the non-hematopoietic tissue sample is skin or gut, and wherein the non-hematopoietic tissue sample comprises an intact biopsy that is not minced prior to culturing.
This is made obvious by Claims 1 and 40 of the co-pending allowed but not issued '411 application which recite: A method for the isolation of lymphocytes from a non-hematopoietic tissue sample comprising the steps of:
(i) placing the non-hematopoietic tissue sample in a vessel comprising a gas permeable silicone material, wherein the bottom of the vessel is configured to allow gas exchange from the bottom of the vessel;
(ii) culturing the non-hematopoietic tissue sample in the presence of Interleukin-2 (IL-2) and Interleukin-15 (IL-15); and
(iii) collecting a population of lymphocytes cultured from the non-hematopoietic tissue
sample;
wherein the non-hematopoietic tissue sample is an intact biopsy obtained by punch biopsy from a non-hematopoietic tissue, and wherein the non-hematopoietic tissue sample has a minimum cross-section of at least 2mm, wherein the non-hematopoietic tissue sample is skin, gut, or gastrointestinal tract.
The '411 application does not teach wherein the population is isolated γδ T-cells
or wherein the culturing of a non-hematopoietic tissue sample takes place in the
presence of IL-21 and IL-4, wherein the vessel comprises a liquid sealed container
comprising a gas permeable material to allow gas exchange and wherein the bottom of
said vessel is configured to allow gas exchange from the bottom of the vessel, as
required by instant Claim 1.
Hayes teaches a method wherein γδ T-cells isolated from non-hematopoietic
tissue are cultured/expanded in the presence of IL-2 or IL-9; IL-15 and IL-21 (Pg. 63,
Claim 1) and IL-4 (Pg. 63, Claim 2).
Wardell et al. teaches a method of isolating lymphocytes from a tumor sample
comprising culturing the sample in the presence of IL-2 in a closed container providing a
gas-permeable surface area (Pg. 286, Claim 1), wherein the container may be G-REX®
flasks and wherein doing so allows cell expansion without addition of fresh cell culture
media (Pgs. 73-74, Paragraph [00384]).
It would have been obvious to those of ordinary skill in the art to modify the
method of the '411 application of isolating lymphocytes from a tissue sample by
culturing the sample in a media containing IL-2 and IL-15 to include IL-21 and IL-4 as
taught by Hayes because this would eliminate the need to add IL-21 and IL-4 to the
culture when expanding the isolated γδ T-lymphocytes.
Those of ordinary skill in the art would have been motivated to make this modification in order to eliminate another step of cytokine addition and/or having to prepare two different culture mediums containing different cytokines. There would have been a reasonable expectation of success in making this modification because both the '411 application and Hayes are drawn to the same field of endeavor, that is, the isolation and expansion of T-cells from non-hematopoietic tissue. Those of ordinary skill would have recognized that the obtaining of a sample by punch biopsy of the co-pending '411 application does not preclude the instant method which is silent with regard to how the non-hematopoietic tissue is obtained.
It would have been further obvious to those of ordinary skill in the art to modify
the method of '411 and Hayes of isolating γδ T-lymphocytes from an intact tissue sample to perform the process in a vessel comprising a gas-permeable material as taught by Wardell et al. because this would maintain the medium freshness for a longer period of time. Those of ordinary skill in the art would have been motivated to make this
modification in order to eliminate the need to add fresh cell culture media during the
culturing.
There would have been a reasonable expectation of success in making this
modification because all of the references are drawn to the same field of endeavor, that
is, the isolation and expansion of T-cells from tissue samples.
Instant Claims 6, 10, 36, 39, 41, 46, 47, 61 and 81-82 are made obvious by
Claims 2, 34, 1, 76, 77, 45, 46, 47, 61 and 2 of the '411 application.
Claims 1, 6, 46, 61 and 83 are newly provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7, 10, 15, 16, 20, 21, 34 and 41 of copending Application No. 17/998,766 in view of Hayes (WO
2018/202808 A2) and Wardell et al. (WO 2018/182817 A1), both of record, as necessitated by Applicant’s amendments to the claims filed 01/12/2026.
Instant Claim 1 is drawn to a method for the isolation of lymphocytes from a
non-hematopoietic tissue sample comprising the steps of: (i) culturing the non-
hematopoietic tissue sample in the presence of: (a) Interleukin-2 (IL-2) or Interleukin-9
(IL-9); (b) Interleukin-15 (IL-15); (c) Interleukin-21 (IL-21); and (d) Interleukin-4 (IL-4)
and (ii) collecting a population of γδ lymphocytes cultured from the non-hematopoietic tissue sample; wherein the method is performed in a vessel comprising a liquid sealed container comprising a gas permeable material to allow gas exchange, wherein the bottom of the vessel is configured to allow gas exchange from the bottom of the vessel;
wherein the non-hematopoietic tissue sample is skin or gut, and wherein the non-hematopoietic tissue sample comprises an intact biopsy that is not minced prior to culturing.
This is made obvious by Claims 1, 3, 15, 16 and 20 of the co-pending '766
application which recite: A method for the isolation of lymphocytes from a non-
hematopoietic tissue sample comprising the steps of: (i) culturing the non-
hematopoietic tissue sample in the presence of Interleukin-18 (IL-1B); and (ii)
collecting a population of lymphocytes cultured from the non-hematopoietic tissue
sample; wherein step (i) further comprises culturing the non-hematopoietic tissue
sample in the presence of Interleukin-2 (IL-2) and Interleukin-15 (IL- 15); wherein step
(1) further comprises culturing the non- hematopoietic tissue sample in the presence of
Interleukin-4 (IL-4) and/or Interferon-γ (IFN-γ); wherein the non-hematopoietic tissue
sample is an intact biopsy; wherein the non-hematopoietic tissue sample is skin; wherein the non- hematopoietic tissue sample is gut or the gastrointestinal tract; and wherein the method is performed in a vessel comprising a gas permeable material.
The '766 application does not teach wherein the population is isolated γδ T-cells
or wherein the culturing of a non-hematopoietic tissue sample takes place in the
presence of IL-21, wherein the vessel comprises a liquid sealed container comprising a
gas permeable material to allow gas exchange and wherein the bottom of said vessel is
configured to allow gas exchange from the bottom of the vessel, as required by instant
Claim 1.
Hayes teaches a method wherein γδ T-cells isolated from non-hematopoietic
tissue are cultured/expanded in the presence of IL-2 or IL-9; IL-15 and IL-21 (Pg. 63,
Claim 1) and IL-4 (Pg. 63, Claim 2).
Wardell et al. teaches a method of isolating lymphocytes from a tumor sample
comprising culturing the sample in the presence of IL-2 in a closed container providing a
gas-permeable surface area (Pg. 286, Claim 1), wherein the container may be G-REX®
flasks and wherein doing so allows cell expansion without addition of fresh cell culture
media (Pgs. 73-74, Paragraph [00384]).
It would have been obvious to those of ordinary skill in the art to modify the
method of the '766 application of isolating lymphocytes from a tissue sample by
culturing the sample in a media containing IL-2 and IL-15 to include IL-21 as taught by
Hayes because this would eliminate the need to add IL-21 to the culture when
expanding the isolated γδ T-lymphocytes. Those of ordinary skill in the art would have been motivated to make this modification in order to eliminate another step of cytokine addition and/or having to prepare two different culture mediums containing different cytokines. There would have been a reasonable expectation of success in making this modification because both the '766 application and Hayes are drawn to the same field of endeavor, that is, the isolation and expansion of T-cells from non-hematopoietic tissue. Those of ordinary skill would have recognized that the obtaining of a sample by punch biopsy of the co-pending '766 application does not preclude the instant method which is silent with regard to how the non-hematopoietic tissue is obtained.
It would have been further obvious to those of ordinary skill in the art to modify
the method of '766 and Hayes of isolating γδ T-lymphocytes from a tissue sample to
perform the process in a vessel comprising a gas-permeable material as taught by
Wardell et al. because this would maintain the medium freshness for a longer period of
time. Those of ordinary skill in the art would have been motivated to make this
modification in order to eliminate the need to add fresh cell culture media during the
culturing. There would have been a reasonable expectation of success in making this
modification because all of the references are drawn to the same field of endeavor, that
is, the isolation and expansion of T-cells from tissue samples.
Claims 1, 6, 39 46, 61 and 83 are newly provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7, 10, 16, 20,
21, 34 and 41 of copending Application No. 17/998,766 in view of Hayes (WO
2018/202808 A2), Wardell et al. (WO 2018/182817 A1) and Clark et al. (2006), all of
record, as necessitated by Applicant’s amendments to the claims filed 01/12/2026.
The teachings of '766, Hayes and Wardell et al. were discussed above.
None of the above references taught wherein the synthetic scaffold is configured to facilitate γδ T-cell egress from the non-hematopoietic tissue sample to the bottom of the vessel, as required by instant Claim 39.
Clark et al. teaches a method comprising culturing a skin explant on a synthetic
matrix in the presence of a media containing serum and human recombinant IL-2 and
human recombinant IL-15 and collecting a population of migrating lymphocytes from the
culture after 21 days (Pg. 1067, Column 1, Lines 3-13 and 17-37) and wherein the
population of lymphocytes comprises γδ T-cells (Pg. 1060, Column 1, Lines 8-9).
It would have been obvious to those of ordinary skill in the art to modify the
method of the '766 application, Hayes and Wardell of isolating γδ T-lymphocytes from a
tissue sample by culturing the sample in a media containing IL-2, IL-15, IL-21 and IL-4
to culture the tissue on a synthetic matrix as taught by Clark et al. because this would
provide a support to hold the tissue in the culture vessel and allow the lymphocytes to
migrate in or onto. Those of ordinary skill in the art would have been motivated to make
this modification in order to isolate lymphocytes from the tissue sample. There would
have been a reasonable expectation of success in making this modification because
both the '766 application, Hayes, Wardell and Clark are all drawn to the same field of
endeavor, that is, the isolation and expansion of T-cells from non-hematopoietic tissue.
Instant Claims 83, 6, 10, 46 and 61, 78 and 80 are made obvious by Claims 4,
10, 7, 21 and 34 of the '766 application.
These are provisional nonstatutory double patenting rejections because the
patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/12/2026, with respect to the rejection(s) of claim(s) 1, 6, 10, 39, 41, 46, 47, 61 and 81-83 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Rosenberg et al. (US 2012/0244133 A1), as set forth above.
Applicant’s arguments have been considered only insofar as they apply to the new rejections above.
The Applicant argues that Clark, Hayes and Wardell all describe non-intact tissue samples and therefore the ordinary artisan would not have expected success in obtaining a population of γδ T-cells from an intact biopsy (Remarks, Pg. 7, Lines 2-7).
This is not found to be persuasive for the following reasons, while the cited references may exemplify non-intact tissue samples, they do not explicitly teach away from the use of intact tissue samples. Further, as discussed above, Rosenberg et al. teaches obtaining tumor infiltrating lymphocytes (TIL) from a tumor sample which is not described as non-intact (Pg. 14, Claim 1) (thus does not require a non-intact/minced tumor sample). Therefore, the ordinary artisan would have expected success in obtaining an isolated population of γδ T-cells from an intact tissue sample.
The Examiner notes that “isolated” has been accorded its broadest, reasonable interpretation of “to set or place apart”. As Clark teaches separating lymphocytes, including γδ T-cells from a tissue sample, it meets the limitation.
The Applicant argues that that Specification discloses an embodiment isolating T-cells from an intact tissue sample resulting in increased cell yield and total Vδ1+ cells, noting isolates up to 22% γδ T cells while Clark (whom utilizes a non-intact tissue sample) only isolates 3% γδ T cells. Applicant asserts that the claimed method demonstrates a 25x increase in number of cells when utilizing a synthetic scaffold in a preamble vessel as compared to a 25 well plate. Applicant concludes these are unexpected results in view of the prior art (Remarks, Pg. 7, Lines 8-22.
This is not found to be persuasive for the following reasons, the Specification
embodiment is more limited than the claimed invention being drawn to culturing skin explants on a specific scaffold in an isolation media containing either 2 (IL-2, IL-15) or 4 (IL-2, II-4, IL-15, IL-21) cytokines in defined amounts and cultured under defined conditions in a particular bioreactor. This is not commensurate in scope with the claimed invention which only requires culturing any non-hematopoietic tissue with 4 cytokines (II-2 or IL-9, IL-15, IL-21 and IL-4) in any amount in any device with the claimed structural features.
Further, Applicant has not shown that the obtained results are unexpectedly and significantly greater than what would be expected from adding another cytokine to the isolation media of Clark (difference in kind rather than degree). The Examiner notes that the Remarks did not specifically address the alleged deficiencies of the obviousness-type Double Patenting Rejections (Remarks. Pg. 8, Lines 10-23 and Pg. 9, Lines 1-4). Thus, the rejections remain in effect for the reasoning set forth above.
Conclusion
No claims are 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 PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653