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
Claims 1, 4-6, 8, 10, 15-21, and 34 are pending.
Claims 1 and 6 are newly amended.
Claims 4-6 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/26/2025 and made FINAL.
Claims 1, 8, 10, 15-17, 19-21, and 34 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejections under 35 USC 103 are maintained but modified to address the claims as newly amended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 10, 15-17, 19, 20, 21, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Hayday et al. (US20180312808A1, 2018, previously cited) in view of Nicoletti et al. (Frontiers in Bioengineering and Biotechnology, 2019, previously cited) as evidenced by Corning (Permeable Supports Product Selection Guide, 2023, previously cited).
In regards to claims 1 and 8, Hayday teaches methods for isolating γδ T cells from non-hematopoietic tissues by being cultured with interleukins, including IL-2 and IL-15 (paragraph [0014, 0181-0182]). Hayday teaches that these γδ T cells can be harvested (collected) (paragraphs [0181-0182, 0186]).
In regards to culturing the non-haematopoietic tissue samples in the presence of IL-1β, as in step (i), Hayday teaches that “lymphocytes” (which includes γδ T cells) may be “cultured” in the “presence” of IL-1B (IL-1β) (paragraph [0111]).
Hayday also broadly teaches that “It is to be understood that the application discloses all combinations of any of the above aspects and embodiments described above with each other, unless the context demands otherwise. Similarly, the application discloses all combinations of the preferred and/or optional features either singly or together with any of the other aspects, unless the context demands otherwise” (paragraph [0176]).
Therefore, since, as above, Hayday teaches that non-hematopoietic tissues (which comprise lymphocytes such as γδ T cells) can be cultured, since Hayday teaches that lymphocytes (which, again, comprise γδ T cells) may be cultured in the presence of IL-1β, and since Hayday explicitly teaches that the application discloses all combinations, a person of ordinary skill in the art would have recognized that culturing non-hematopoietic tissues in the presence of IL-1β, is a combination as suggested by the teachings of Hayday.
While IL-1b is disclosed as an option within a genera of types of cytokines (paragraph [0111]), such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). In the instant case, since Hayday does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
However, according to KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious” and continuing, “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Furthermore, addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id.
Therefore, consistent with the reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected IL-1β from within the disclosure of Hayday to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
Hayday does not explicitly teach culturing the tissue sample in media containing human plasma, or media comprising 2.5% human plasma specifically.
However, a person of ordinary skill in the art would have been motivated to culture tissue samples in 2.5% human plasma because Nicoletti teaches that media enriched with 2.5% human plasma (platelet rich plasma) demonstrates an inhibitory effect on collagen and elastic fiber de-structuration and a favorable modulation of the re-organization of these fibers in skin biopsies and can extend their vitality when cultured ex vivo (Abstract, p1; Discussion, p8; Conclusion, p9)
Furthermore, because Nicoletti teaches that the addition of platelet rich plasma to media is conventional and teaches that ex vivo skin samples can be cultured reliably in media comprising platelet rich plasma (Conclusion, p9), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 10, Hayday teaches that the cells were isolated after 21 days culturing (paragraph [0182]), which is greater than the timing of at least 7 days of culturing.
In regards to claim 15, Hayday teaches that the tissue sample is a 3D skin explant (biopsy) (paragraphs [0095, 0181-0182]). As the instant specification states that an “intact” biopsy will “will have the three-dimensional structure” (instant paragraph [0047]), and since Hayday teaches that the biopsy has a 3D structure, the biopsy as taught by Hayday appears to be intact, absent evidence to the contrary.
In regards to claims 16 and 17, Hayday teaches that the tissue sample can be skin (paragraph [0018]), including at least the epidermal later (paragraph [0095]).
In regards to claim 19, Hayday teaches that the tissue sample can be human (Abstract; paragraph [0016]).
In regards to claim 20, Hayday teaches that cell populations may be separated (isolated) from tissues by being cultured in a transwell culture system (paragraph [0100]), which as evidenced by Corning, as well-known in the art to be (gas) permeable (Transwell Permeable Supports: a Laboratory Standard, p2).
In regards to claim 21, Hayday teaches that the γδ T cells can be γδ T cells Vδ1 T cells specifically (paragraphs [0189-0190]).
In regards to claim 34, as discussed above, Hayday teaches methods for isolating γδ T cells from non-hematopoietic tissues by being cultured with interleukins, including IL-2 and IL-15 (paragraph [0014, 0181-0182]). Hayday teaches that these γδ T cells can be harvested (collected) (paragraphs [0181-0182, 0186]).
In regards to culturing the non-haematopoietic tissue samples in the presence of IL-1β, as in step (i), Hayday teaches that “lymphocytes” (which includes γδ T cells) may be “cultured” in the “presence” of IL-1B (IL-1β) (paragraph [0111]).
Hayday also broadly teaches that “It is to be understood that the application discloses all combinations of any of the above aspects and embodiments described above with each other, unless the context demands otherwise. Similarly, the application discloses all combinations of the preferred and/or optional features either singly or together with any of the other aspects, unless the context demands otherwise” (paragraph [0176]).
Therefore, since, as above, Hayday teaches that non-hematopoietic tissues (which comprise lymphocytes such as γδ T cells) can be cultured, since Hayday teaches that lymphocytes (which, again, comprise γδ T cells) may be cultured in the presence of IL-1β, and since Hayday explicitly teaches that the application discloses all combinations, a person of ordinary skill in the art would have recognized that culturing non-hematopoietic tissues in the presence of IL-1β, is a combination as suggested by the teachings of Hayday.
While IL-1b is disclosed as an option within a genera of types of cytokines (paragraph [0111]), such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). In the instant case, since Hayday does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
However, according to KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious” and continuing, “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Furthermore, addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id.
Therefore, consistent with the reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected IL-1β from within the disclosure of Hayday to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
Hayday does not explicitly teach culturing the tissue sample in media containing human plasma, or media comprising 2.5% human plasma specifically.
However, a person of ordinary skill in the art would have been motivated to culture tissue samples in 2.5% human plasma because Nicoletti teaches that media enriched with 2.5% human plasma (platelet rich plasma) demonstrates an inhibitory effect on collagen and elastic fiber de-structuration and a favorable modulation of the re-organization of these fibers in skin biopsies and can extend their vitality when cultured ex vivo (Abstract, p1; Discussion, p8; Conclusion, p9)
Furthermore, because Nicoletti teaches that the addition of platelet rich plasma to media is conventional and teaches that ex vivo skin samples can be cultured reliably in media comprising platelet rich plasma (Conclusion, p9), it could have been done with predictable results and a reasonable expectation of success.
Therefore, Hayday teaches the method of claim 1, as in claim 34 step (i).
Additionally, Hayday teaches that in specific embodiments, lymphocytes (which include isolated γδ T cells) can be expanded for at least 7 days (paragraph [0186]), which overlaps with the timing of at least 5 days as in claim 34
Therefore, the combined teachings of Hayday and Nicoletti renders the invention unpatentable as claimed.
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 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,655,453 in view of Anjos et al. (KR20180026726A1, 2018, machine translation), Hayday et al. (US20180312808A1, 2018), and Nicoletti et al. (Frontiers in Bioengineering and Biotechnology, 2019, previously cited).
Although the conflicting claims of U.S. Patent No. 11,655,453 are not identical to the currently prosecuted claim 34, they are not patently distinct from each other because said claims of both inventions are drawn to methods of expanding populations of γδ T cells derived from non-haematopoietic tissue which are expanded for at least 5 days.
While U.S. Patent No. 11,655,453 does not explicitly teach a step of isolating the population of γδ T cells from non-haematopoietic tissue by culturing the non-haematopoietic tissue in the presence of IL-1β, IL-2, and IL-15 in media containing human plasma, a person of ordinary skill in the art would have been motivated to culture non-haematopoietic tissue in media comprising IL-1β because Anjos teaches that IL-1β promotes the survival and proliferation of γδ T cells (twelfth page, second to last paragraph). Furthermore, because Anjos teaches that γδ T cells can be cultured with IL-1β and because Hayday broadly teaches that non-haematopoietic tissue samples can be cultured in the presence of IL-1β for obtaining γδ T cells (paragraphs [0111, 0176]) it could have been done with predictable results and a reasonable expectation of success. It would also have been predictably obvious to culture non-haematopoietic tissue in the presence of IL-2 and IL-15 because Hayday teaches that these compounds are suitable for isolating γδ T cells from these tissues (paragraph [0014, 0181-0182]).
A person of ordinary skill in the art would have been motivated to culture tissue samples in 2.5% human plasma because Nicoletti teaches that media enriched with 2.5% human plasma (platelet rich plasma) demonstrates an inhibitory effect on collagen and elastic fiber de-structuration and a favorable modulation of the re-organization of these fibers in skin biopsies and can extend their vitality when cultured ex vivo (Abstract, p1; Discussion, p8; Conclusion, p9)
A person of ordinary skill in the art would have recognized that expanding populations of γδ T cells derived from non-haematopoietic tissue, as taught by U.S. Patent No. 11,655,453 would require collection of those cells.
Claims 1, 8, 10, 15-17, 19-21, and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10, 39, 41, 46-47, 61, 81-83 of copending Application No. 17/292,414 in view of Anjos et al. (KR20180026726A1, 2018, machine translation), Hayday et al. (US20180312808A1, 2018), and Nicoletti et al. (Frontiers in Bioengineering and Biotechnology, 2019, previously cited).
Although the conflicting claims of Application No. 17/292,414 are not identical to the currently prosecuted claim 34, they are not patently distinct from each other because said claims of both inventions are drawn to methods of isolating populations of γδ T cells derived from non-haematopoietic tissue in media comprising IL-2 and IL-15 and collecting a population γδ T cells from the non-haematopoietic tissue.
While Application No. 17/292,414 does not explicitly teach a step of isolating the population of γδ T cells from non-haematopoietic tissue by culturing the non-haematopoietic tissue in the presence of IL-1β, a person of ordinary skill in the art would have been motivated to culture non-haematopoietic tissue in media comprising IL-1β because Anjos teaches that IL-1β promotes the survival and proliferation of γδ T cells (twelfth page, second to last paragraph). Furthermore, because Anjos teaches that γδ T cells can be cultured with IL-1β and because Hayday broadly teaches that non-haematopoietic tissue samples can be cultured in the presence of IL-1β for obtaining γδ T cells (paragraphs [0111, 0176]) it could have been done with predictable results and a reasonable expectation of success.
Additionally, while Application No. 17/292,414 teaches that the media can contain a blood product (serum), Application No. 17/292,414 does not explicitly teach that the media comprises human plasma. However, as above, a person of ordinary skill in the art would have been motivated to culture tissue samples in 2.5% human plasma because Nicoletti teaches that media enriched with 2.5% human plasma (platelet rich plasma) demonstrates an inhibitory effect on collagen and elastic fiber de-structuration and a favorable modulation of the re-organization of these fibers in skin biopsies and can extend their vitality when cultured ex vivo (Abstract, p1; Discussion, p8; Conclusion, p9)
Furthermore, because Nicoletti teaches that the addition of platelet rich plasma to media is conventional and teaches that ex vivo skin samples can be cultured reliably in media comprising platelet rich plasma (Conclusion, p9), it could have been done with predictable results and a reasonable expectation of success.
The dependent claims all recite embodiments known in the art as taught by Hayday as discussed above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues that the claims as amended are not obvious over any combination of Hayday, Corning, or Nicoletti (Remarks, p5-6).
Applicant’s arguments filed 03/17/2026 have been fully considered but are not persuasive.
As discussed above, Hayday teaches methods for isolating γδ T cells from non-hematopoietic tissues by being cultured with interleukins, including IL-2 and IL-15 (paragraph [0014, 0181-0182]). Hayday teaches that these γδ T cells can be harvested (collected) (paragraphs [0181-0182, 0186]).
In regards to culturing the non-haematopoietic tissue samples in the presence of IL-1β, as in step (i), Hayday teaches that “lymphocytes” (which includes γδ T cells) may be “cultured” in the “presence” of IL-1B (IL-1β) (paragraph [0111]).
Hayday also broadly teaches that “It is to be understood that the application discloses all combinations of any of the above aspects and embodiments described above with each other, unless the context demands otherwise. Similarly, the application discloses all combinations of the preferred and/or optional features either singly or together with any of the other aspects, unless the context demands otherwise” (paragraph [0176]).
Therefore, since, as above, Hayday teaches that non-hematopoietic tissues (which comprise lymphocytes such as γδ T cells) can be cultured, since Hayday teaches that lymphocytes (which, again, comprise γδ T cells) may be cultured in the presence of IL-1β, and since Hayday explicitly teaches that the application discloses all combinations, a person of ordinary skill in the art would have recognized that culturing non-hematopoietic tissues in the presence of IL-1β, is a combination as suggested by the teachings of Hayday.
While IL-1b is disclosed as an option within a genera of types of cytokines (paragraph [0111]), such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). In the instant case, since Hayday does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
However, according to KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious” and continuing, “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” Furthermore, addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id.
Therefore, consistent with the reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected IL-1β from within the disclosure of Hayday to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
Hayday does not explicitly teach culturing the tissue sample in media containing human plasma, or media comprising 2.5% human plasma specifically.
However, a person of ordinary skill in the art would have been motivated to culture tissue samples in 2.5% human plasma because Nicoletti teaches that media enriched with 2.5% human plasma (platelet rich plasma) demonstrates an inhibitory effect on collagen and elastic fiber de-structuration and a favorable modulation of the re-organization of these fibers in skin biopsies and can extend their vitality when cultured ex vivo (Abstract, p1; Discussion, p8; Conclusion, p9)
Furthermore, because Nicoletti teaches that the addition of platelet rich plasma to media is conventional and teaches that ex vivo skin samples can be cultured reliably in media comprising platelet rich plasma (Conclusion, p9), it could have been done with predictable results and a reasonable expectation of success.
In regards to Nicoletti, Applicant argues that the reference is drawn to “development of an original, ex vivo human wound skin culture protocol” and therefore, would not be relevant to the claimed invention (Remarks, p7).
Applicant’s arguments filed 03/17/2026 have been fully considered but are not persuasive.
The claimed invention is drawn to skin biopsies, and therefore, a person of ordinary skill in the art would have recognize that the teachings of Nicoletti, who Applicant notes is also in the technical field of using skin biopsies, would be relevant to the claimed invention.
Applicant argues that the data demonstrates that the use if IL-1β particularly in the context of plasma and AB serum isolation has the effect of increasing overall yield of γδ T cells (Remarks, p7; citing instant specification paragraph [0256], Fig. 2).
Applicant’s arguments filed 03/17/2026 have been fully considered but are not persuasive.
In regards to allegations of unexpected results, Applicant should note that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (see MPEP 716.02(d)). In the instant case, the claims do not require any specific results.
Furthermore, it is unclear if the data presented in Fig. 2 in fact demonstrate that the evidence relied upon establishes "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance" (Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992), mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.") as required by MPEP 716.02(b). In particular, it is noted that the data does not appear to show any difference between human plasma as claimed and other supplements such as human AB or serum replacement.
In regards to the ODP rejections, Applicant argues that the Examiner has not pointed to the limitations of claim 1 as amended (Remarks, p8).
Applicant’s arguments filed 03/17/2026 have been fully considered but are not persuasive.
All of the features are predictably obvious modifications as discussed above.
Specifically, as discussed above, Hayday teaches that IL-2 and IL-15 because these compounds are suitable for isolating γδ T cells from non-haematopoietic tissue (paragraph [0014, 0181-0182]). Additionally, as above, in regards to the use of human plasma, a person of ordinary skill in the art would have been motivated to culture tissue samples in 2.5% human plasma because Nicoletti teaches that media enriched with 2.5% human plasma (platelet rich plasma) demonstrates an inhibitory effect on collagen and elastic fiber de-structuration and a favorable modulation of the re-organization of these fibers in skin biopsies and can extend their vitality when cultured ex vivo (Abstract, p1; Discussion, p8; Conclusion, p9)
Furthermore, because Nicoletti teaches that the addition of platelet rich plasma to media is conventional and teaches that ex vivo skin samples can be cultured reliably in media comprising platelet rich plasma (Conclusion, p9), it could have been done with predictable results and a reasonable expectation of success.
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.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631