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
Amendments
In the reply filed 05/22/2026, Applicant has amended claims 1, 4, 7 and 16.
Claim Status
Claims 1-11, 13-24 and 26-28 are pending.
Claims 16-24 and 26-27 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/14/2023.
Claims 1-11, 13-15 and 28 are considered on the merits.
Withdrawn Claim Rejections - 35 USC § 112(b)
The prior rejection of claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reciting a subjective term has been withdrawn in light of Applicant’s amendment to claim 4 to remove the term.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of claims 1-2, 4, 6-8 and 13-15 under 35 U.S.C. 103 as being unpatentable over Wang et al (Cellular & Molecular Immunology. 2020; 17:496-506. Published online June 2019. Prior art of record) in view of Xu et al., (Cell Reports. 2016; 16: 3273-3285. Prior art of record) is withdrawn in light of Applicant’s amendment to claim 1 to recite a human iNKT cell and a human DC, while the primary reference Wang uses mouse cells.
The prior rejection of claims 3 and 5 under 35 U.S.C. 103 as being unpatentable over Wang et al in view of Xu et al., and further in view of Shimizuhira et al (Journal of Investigative Dermatology. 2014; 134: 2709-2718. Prior art of record) and Hongo et al (Blood. 2017; 129(12): 1718-1728. Prior art of record) is withdrawn in light of Applicant’s amendment to claim 1 to recite a human iNKT cell and a human DC, while the primary reference Wang uses mouse cells.
The prior rejection of claims 9-11 and 28 under 35 U.S.C. 103 as being unpatentable over Wang et al in view of Xu et al., and further in view of Shimizuhira et al (Journal of Investigative Dermatology. 2014; 134: 2709-2718. Prior art of record), Van de Ven et al. (Immunotherapy. 2015; 7(6): 655-667. Prior art of record), and O’Neill et al (Journal of Immunology. 2017; 199: 3700-3710. Prior art of record) is withdrawn in light of Applicant’s amendment to claim 1 to recite a human iNKT cell and a human DC, while the primary reference Wang uses mouse cells.
New 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.
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 1-4, 6-8 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al., (Cell Reports. 2016; 16: 3273-3285. Prior art of record).
With respect to claim 1, Xu teaches human iNKT cells and human dendritic cells (DCs) (e.g., p. 3282, para “Monocyte-Derived DCs” and “Primary T cells”) are mixed at a 1:1 ratio and cultured in a 37°C and 5% CO2 chamber (e.g., p. 3283, left col, para. “Analyses of intracellular Ca2+”) and the iNKT cell and DC cell form conjugates (see e.g., Fig 1C and 1F for time-lapse fluorescence microscopy of iNKT+DC conjugates), thus teaches an in vitro-derived multicell conjugate between a human iNKT cell and a human DC.
In regard to the limitation that the iNKT cell and DC remain conjugated after pipetting in PBS, it is noted that there is no special definition on the term “remain”, thus this limitation is being examined as the iNKT cell and DC are conjugated before and after pipetting in a calcium and magnesium-free PBS containing a chelating agent.
Xu teaches an assay for induction of tissue inflammation, in which the iNKT cells and DCs are mixed at a 1:1 ratio and pelleted by centrifugation, re-suspended in PBS and injected subcutaneously into a mouse footpad (p. 3283, left col, para “Induction of tissue inflammation”). It is noted that in this assay, the iNKT cell and DC are conjugated before pipetting in PBS (see e.g., Fig 1C and 1F for microscopy of iNKT+DC conjugates after mixing and culturing), and the iNKT cell and DC are conjugated after pipetting in PBS (i.e., after re-suspending and injecting in PBS, see p. 3277, Result section “Induction of Tissue Inflammation”, right col, para 3, “direct iNKT interactions with the human DCs were required” for the swelling responses in vivo). Thus, Xu teaches that the iNKT cell and DC are conjugated before and after pipetting in a PBS.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have immediately expected that the iNKT cell and DC in Xu’s conjugates would likely remain conjugated after pipetting in a calcium and magnesium-free PBS containing a chelating agent as suggested by Xu with a reasonable expectation of success, because Xu teaches co-culturing iNKT and DC results in formation of a conjugate and the iNKT cell and DC are still conjugated after pipetting in PBS (see above).
Furthermore, Applicant is reminded that the courts have stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” See In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004) and MPEP 2112.I. In the instant case, since the material (i.e., an in vitro-derived multicell conjugate between a human iNKT cell and a human DC) is known as taught by prior art Xu, the discovery of the claimed property, the iNKT cell and DC remaining conjugated after pipetting in a specific buffer, does not make the claimed material novel.
Additionally, Applicant is also reminded that MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Applicant’s specification discloses that the claimed conjugate with the claimed property is formed simply by co-incubation of human iNKT cells and human DCs in the same manner as being done by Xu et al. Thus, the conjugate of Xu would exhibit the properties of Applicant’s claimed conjugate because they are the same compositions.
Since the Patent Office does not have the facilities for examining and comparing applicants' conjugates with the conjugates of the prior art, the burden is upon applicants to show a distinction between the material structural and functional characteristics of the claimed conjugates and the conjugates of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
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In regard to the limitation that at least 80% of the conjugates comprise one live iNKT cell conjugated to one live DC, as stated supra, Xu teaches human iNKT cells and human dendritic cells (DCs) are mixed at a 1:1 ratio and cultured in a 37°C and 5% CO2 chamber (e.g., p. 3283, left col, para. “Analyses of intracellular Ca2+”, Approach (1) for time-lapse fluorescence microscopy in which there is no centrifugation step or fixation step). Xu teaches the iNKT cell and DC form conjugates (see e.g., Fig 1C and 1F for time-lapse fluorescence microscopy of iNKT+DC conjugates that comprise one live iNKT cell conjugated to one live DC, modified and attached herein, green represents DC and red represents iNKT cell). Thus, Xu teaches co-culturing human iNKT cells and human DCs at a 1:1 ratio would result in conjugates that comprise one live iNKT cell conjugated to one live DC.
Although Xu does not teach at least 80% of the conjugates comprise one live iNKT cell conjugated to one live DC, Xu uses the same cell types (i.e., human iNKT cells and human DCs) and the same method steps (i.e., co-culturing at a 1:1 ratio) as instantly claimed and disclosed (e.g., Example 1 in p. 42 of instant specification “DCs were co-incubated with a 1:1 ratio of iNKT cells to allow the formation of conjugates”), thus, these method steps would have prima facie obviously produced the identical results (i.e., at least 80% of the conjugates comprise one live iNKT cell conjugated to one live DC) as claimed. See MPEP 2112. II and In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. “The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.”). Therefore, one of ordinary skill in the art would have immediately expected that Xu’s conjugates generated by co-culturing human iNKT cells and human DCs at a 1:1 ratio would likely have at least 80% of the conjugates comprising one live iNKT cell conjugated to one live DC as suggested by Xu with a reasonable expectation of success, because Xu teaches co-culturing human iNKT cells and human DCs at a 1:1 ratio would result in conjugates that comprise one live iNKT cell conjugated to one live DC (see above).
With respect to claim 2 directed to the conjugate being maintained in culture for at least 30 minutes, as stated supra, Xu teaches in Fig 1C that the iNKT+DC conjugate is maintained in culture for at least 30 minutes (see Fig 1C attached above).
With respect to claim 3 directed to the conjugate being maintained in culture for at least 24 hours, Xu teaches in PGE2 analysis, iNKT cells and DCs are cultured together at a 1:1 ratio for 24 hours (e.g., p. 3283, left col, para “Detection of PGE2”).
With respect to claim 4, directed to the iNKT cell within the conjugate expressing CD3, Xu teaches supernatants from anti-CD3 antibody-stimulated iNKT cells showed higher extracellular ATP levels than those from unstimulated iNKT cells (see p. 3276, last para and Fig 2B for p=0.03), thus indicates the iNKT cell within the conjugate expresses CD3 (thus can be stimulated by anti-CD3 antibody).
With respect to claim 6, directed to the DC expressing MHC molecule I, one of ordinary skill in the art would have immediately expected that the DC of Xu would express MHC class I molecule as it is known to be expressed on the cell surface of all nucleated cells, including DCs.
With respect to claim 7, directed to the DC being autologous to the iNKT cell, Xu teaches the iNKT-enriched T cells are mixed with autologous DCs (p. 3275, left col, Results section, para 1, also see Fig 1A legend).
With respect to claim 8, directed to the multicell conjugate secreting IL-12p70 and IFN-γ into a culture medium, Xu acknowledges previous studies demonstrate iNKT cells can become activated to secrete interferon-γ (IFN-γ) in a TCR-independent manner by exposure to cytokines (e.g., interleukin 12 [IL-12] and IL-18) produced by activated APCs (p. 3273, last para). Therefore, one of ordinary skill in the art would have immediately expected that the iNKT+DC conjugate of Xu would secrete IL-12 (produced by activated DC) and IFN-γ (secreted by iNKT) as suggested by Xu.
With respect to claim 13 directed to the DC loaded with an antigen and claim 14 directed to the antigen being a pathogenic antigen, Xu teaches in a tissue inflammation assay, LPS-pretreated DCs are mixed with iNKT cells for injection (p. 3277, right col, para 2, and see Fig 3A far right panel for LPS-treated DCs+iNKT cells). Thus, Xu teaches the DC is loaded with an antigen in claim 13 and the antigen is a pathogenic antigen (i.e., lipopolysaccharide (LPS)) in claim 14.
With respect to claim 15 directed to a composition comprising the conjugate and a pharmaceutically acceptable carrier, as stated supra, Xu teaches the iNKT cells and DCs are mixed at a 1:1 ratio and re-suspended in PBS and injected subcutaneously into a mouse footpad (p. 3283, left col, para “Induction of tissue inflammation”), thus teaches a composition comprising the conjugate and a pharmaceutically acceptable carrier (e.g., PBS).
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 05/22/2026 are acknowledged.
Applicant first argues that Wang uses mouse cells but does not teach human iNKT cells or human DCs as amended in claim 1. (Remarks, p. 7, last para).
Applicant’s arguments have been fully considered and they are persuasive. Therefore, the prior rejection over Wang has been withdrawn. However, as necessitated by amendment, prior art Xu has been re-applied to make obvious the human iNKT cells and human DCs in amended claim 1. Since the new ground of rejection does not rely on Wang for any teaching or matter specifically challenged in the argument, Applicant’s following arguments regarding Wang become moot.
Applicant further argues that Xu does not describe long-lasting multicell conjugates as claimed, but instead, Xu teaches that "iNKT cells were highly motile and made dynamic contacts with the DCs, such that individual DCs were contacted repeatedly by different iNKT cells during the course of the time-lapse microscopy analysis (see Movie S4)" (Remarks, p. 7-8).
Applicant’s arguments have been fully considered but they are not persuasive. As stated supra, there is no special definition on the term “remain” in the instant specification, thus this limitation is being examined as the iNKT cell and DC are conjugated before and after pipetting in a calcium and magnesium-free PBS containing a chelating agent, which is made obvious by Xu as discussed above. It is noted that the cited Xu’s teaching of the iNKT-DC contact being dynamic and the DCs being contacted repeatedly by different iNKT cells, does not negate Xu’s teaching that the iNKT cell and DC are conjugated before pipetting in PBS, and are conjugated after pipetting in PBS.
Applicant further argues that Xu describes clustering of DCs with iNKT cells (Fig. 1A), and with Xu's showing of clusters of cells and explicit description of iNKT cells as "highly motile" with "dynamic contacts" where "individual DCs were contacted repeatedly by different iNKT cells," one of ordinary skill in the art would not have expected at least 80% of iNKT cells and DCs to form stable conjugates comprising one iNKT cell and one DC as claimed. (Remarks, p. 8-9).
Applicant’s arguments have been fully considered but they are not persuasive. As a first matter, in response to the argument that Xu describes clustering of DCs with iNKT cells (Fig. 1A) (Remarks, p. 8), Xu specifically teaches in this experiment shown in Fig 1A that “The cell mixtures were centrifuged for 20 s and then gently resuspended” (see Fig 1A legend in p. 3275) and “The cell mixtures were briefly centrifuged (20 s) to initiate cell contact and then gently resuspended …. As shown in Figure 1A, the iNKT-enriched T cells formed clusters or cell-cell conjugates with DCs” (p. 3275, left col, Results section, para 1. Underlined by examiner). Thus, Xu actually teaches clustering
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of DCs with iNKT cells in Fig 1A is achieved by centrifugation to initiate cell contact. Even with this centrifugation, cell-cell conjugate (but not clusters) still forms (see e.g., Fig 1A, Example #3 attached herein in which most conjugates (white arrows added by examiner) likely comprise one live iNKT cell and one live DC).
It is noted that Xu teaches three different approaches to assess intracellular Ca2+ levels (see p. 3283, left col, para. “Analyses of intracellular Ca2+”) in which Approach (1) for time-lapse fluorescence microscopy does not have a centrifugation step, while Approach (3) has a centrifugation step “to initiate contact” for flow cytometer analysis. Xu teaches in Fig 1C and 1F time-lapse fluorescence microscopy of iNKT+DC conjugates that comprise one live iNKT cell conjugated to one live DC (see above).
In summary, Xu not only describes clustering of DCs with iNKT cells in Fig. 1A (with centrifugation), but also describes cell-cell conjugates between one live iNKT cell and one live DC demonstrated in Fig 1A, 1C and 1F (with and without centrifugation). Since Xu uses the same cell types (i.e., human iNKT cells and human DCs) and the same method steps (i.e., co-culturing at a 1:1 ratio) as instantly claimed and disclosed (e.g., Example 1 in p. 42 of instant specification “DCs were co-incubated with a 1:1 ratio of iNKT cells to allow the formation of conjugates”), these method steps would have prima facie obviously produced the identical results (i.e., at least 80% of the conjugates comprise one live iNKT cell conjugated to one live DC) as claimed. See MPEP 2112. II and In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007). Therefore, one of ordinary skill in the art would have immediately expected that Xu’s conjugates generated by co-culturing human iNKT cells and human DCs at a 1:1 ratio would likely have at least 80% of the conjugates comprising one live iNKT cell conjugated to one live DC.
Applicant further argues that Xu does not state whether the PBS includes or excludes calcium and magnesium, nor does Xu disclose a chelating agent. There is no teaching or suggestion in Xu that the cells would remain conjugated under such conditions. (Remarks, p. 9).
Applicant’s arguments have been fully considered but they are not persuasive. As stated supra, since the material (i.e., an in vitro-derived multicell conjugate between a human iNKT cell and a human DC) is known as taught by prior art Xu, the discovery of the claimed property, the iNKT cell and DC remaining conjugated after pipetting in a specific buffer, does not make the claimed material novel. See In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004) and MPEP 2112.I.
Additionally, Applicant is also reminded that MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Applicant’s specification discloses that the claimed conjugate with the claimed property is formed simply by co-incubation of human iNKT cells and human DCs (e.g., Example 1 in p. 42 of instant specification “DCs were co-incubated with a 1:1 ratio of iNKT cells to allow the formation of conjugates”), using the same cell types and the same method steps as those of Xu et al,. Thus, the conjugate of Xu would exhibit the properties of Applicant’s claimed conjugate because they are the same compositions.
Since the Patent Office does not have the facilities for examining and comparing applicants' conjugates with the conjugates of the prior art, the burden is upon applicants to show a distinction between the material structural and functional characteristics of the claimed conjugates and the conjugates of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Applicant finally argues that the calcium and magnesium-free PBS containing a chelating agent serves a specific purpose of enabling the selection of the claimed composition in which at least 80% of the cells are in conjugates having one iNKT cell and one DC. Further, the use of this specific buffer to obtain tightly adhered conjugates, when combined with the use of human cells and the ability to select doublets of cells in a 1:1 ratio without the use of an antibody, uniquely positions the claimed conjugates for therapeutic use. Accordingly, the claimed multicell conjugate has both structural and functional characteristics that are not obvious in view of the art and would not be expected based on the teachings in the cited references (Remarks, p. 10-11).
Applicant’s arguments have been fully considered but they are not persuasive.
Applicant seems to argue that claim 1 is directed to a composition selected by using a calcium and magnesium-free PBS containing a chelating agent in combination with the use of human cells. It is noted that the features upon which applicant relies (i.e., being selected by the specific buffer) are not recited in the rejected claims. The instant claim 1 only recites “wherein the iNKT cell and DC remain conjugated after pipetting in a calcium and magnesium-free phosphate buffered saline buffer containing a chelating agent” (being examined as the iNKT cell and DC are conjugated before and after pipetting in a calcium and magnesium-free PBS containing a chelating agent as discussed above), but is silent on a composition being selected by the specific buffer. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See MPEP 2111.01 II.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Xu et al., (Cell Reports. 2016; 16: 3273-3285. Prior art of record), as applied to claim 1 above, and further in view of Hongo et al (Blood. 2017; 129(12): 1718-1728. Prior art of record).
With respect to claim 5 directed to the conjugate being maintained in culture for at least 96 hours, although Xu does not teach the claimed maintenance duration, this limitation is merely a natural property of the conjugates taught by prior art. Since Xu teaches the same cell types (human iNKT cell and human DC) as claimed in the same ratio (one iNKT cell and one DC) as claimed that is conjugated by the same method (co-culturing iNKT cell and DC) as claimed, the claimed functional characteristics of the conjugate would be the same as that of Xu. MPEP 2112.01(II) recites that products of identical composition cannot have mutually exclusive properties. A composition and its properties are inseparable.
Additionally, Hongo teaches that sorted iNKT cells and DCs are cultured for 4 days (i.e., 96 hours, p. 1719, right col, para 2) and coculture of DCs with NKT cells markedly increased IL-4 secretion (p. 1724, left col, para 3, line 5, see Fig 5E and legend for coculture for 5 days), thus teaches that the conjugate can be maintained in culture for at least 96 hours.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have immediately expected that Xu’s conjugates would have been capable of being maintained in culture for at least 96 hours as suggested by Hongo with a reasonable expectation of success, because both the cited prior art teach co-culturing iNKT and DC to form a conjugate and the conjugate can be maintained in culture for at least 96 hours (see e.g. Hongo above).
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 05/22/2026 are acknowledged and have been discussed above.
Claims 9-11 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al., (Cell Reports. 2016; 16: 3273-3285. Prior art of record), as applied to claim 1 above, and further in view of Shimizuhira et al (Journal of Investigative Dermatology. 2014; 134: 2709-2718. Prior art of record), Van de Ven et al. (Immunotherapy. 2015; 7(6): 655-667. Prior art of record), and O’Neill et al (Journal of Immunology. 2017; 199: 3700-3710. Prior art of record).
With respect to claim 9 directed to the DC expressing one or more molecules such as CD80 and CD86, claim 10 directed to the DC expressing co-stimulatory molecules for at least 24 hours in vitro, and part of claim 28 directed the conjugated DC expressing increased CD137L, CD134L and CD215 as compared to unconjugated DC, Xu is silent on the molecules expressed on the DC.
However, Shimizuhira teaches that the expression levels of co-stimulatory molecules including CD40, CD80, and CD86 on DCs 48 hours after cocultivation with a-GalCer-activated NKT cells are markedly increased (p. 2714, left col, para 1, last sentence, also see Fig 6c), thus teaches the DC within the conjugate expresses one or more co-stimulatory molecules such as CD80 and CD86 on its surface in claim 9, for at least 24 hours in vitro in claim 10.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have immediately expected that the conjugated DC in Xu’s iNKT-DC conjugate would have expressed one or more co-stimulatory molecules such as CD80 and CD86 for at least 24 hours in vitro and would likely have expressed increased CD137L, CD134L and CD215 as compared to unconjugated DC as suggested by Shimizuhira with a reasonable expectation of success, because both Xu and Shimizuhira teach co-culturing iNKT and DC to form a conjugate and the conjugated DC expresses co-stimulatory molecules such as CD80 and CD86 for at least 24 hours in vitro at an increased level as compared to unconjugated DC (see e.g., Shimizuhira Fig 6c).
Furthermore, Applicant is reminded that the courts have stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” See In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In the instant case, since the material (i.e., an in vitro-derived multicell conjugate between an iNKT cell and a DC) is known as taught by prior art Xu and Shimizuhira, the discovery of the claimed property, the conjugated DC expresses increased CD137L, CD134L and CD215 as compared to unconjugated DC in claim 28, does not make the claimed material novel.
Additionally, Applicant is also reminded that MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Applicant’s specification discloses that the claimed conjugate with the claimed property is formed simply by co-incubation of iNKT cells and DCs in the same manner as being done by Xu et al. Thus, the conjugate of Xu would exhibit the properties of Applicant’s claimed conjugate because they are the same compositions.
Since the Patent Office does not have the facilities for examining and comparing applicants' conjugates with the conjugates of the prior art, the burden is upon applicants to show a distinction between the material structural and functional characteristics of the claimed conjugates and the conjugates of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
With respect to claim 11 and part of claim 28, directed to the iNKT cell expressing CD70 on the surface after conjugation and the conjugated iNKT cell expressing increased CD70 as compared to unconjugated iNKT cells, however, Xu is silent on CD70 expression in iNKT cell.
Nevertheless, Xu acknowledges previous studies demonstrate iNKT cells can become activated to secrete interferon-γ (IFN-γ) in a TCR-independent manner by exposure to cytokines (e.g., interleukin 12 [IL-12] and IL-18) produced by activated APCs (p. 3273, last para).
Van de Ven et al. (2015) teaches that CD70 is expressed on a variety of immune cells, including T cells and natural killer cell types after activation and is tuned by cytokines such as IL-12 (“Executive summary” in p. 663, also see p. 658, left col, para 2. It is noted that iNKT cell is one type of T cell). Prior art O’Neill teaches that CD70 is expressed on T cells after activation (p. 3700, right col, last para, line 1) and “IFN-γ treatment significantly upregulates CD70 on T cells” (p. 3703, right col, last para, line 10, see Fig 5A-5B).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have immediately expected that the conjugated iNKT cell in Xu’s iNKT-DC conjugate would likely have expressed CD70 on the surface after conjugation and expressed increased CD70 as compared to unconjugated iNKT cells as suggested by Van de Ven and O’Neill with a reasonable expectation of success, because Xu acknowledges previous studies demonstrate iNKT cells can become activated to secrete interferon-γ (IFN-γ) by exposure to cytokines (e.g., interleukin 12 [IL-12] and IL-18) produced by activated APCs (p. 3273, last para), and both Van de Ven and O’Neill teach that CD70 is expressed on activated T cells and is upregulated by IL-12 and IFN-γ (Van de Ven, “Executive summary”, and O’Neill, p. 3703, right col, last para, line 10).
Furthermore, Applicant is reminded that the courts have stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” See In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). In the instant case, since the material (i.e., an in vitro-derived multicell conjugate between an iNKT cell and a DC) is known as taught by prior art Xu, the discovery of the claimed property, the conjugated iNKT cell expresses CD70 on the surface and expresses increased CD70 as compared to unconjugated iNKT cells, does not make the claimed material novel.
Additionally, Applicant is also reminded that MPEP 2112.01(II) recites that "products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable." Applicant’s specification discloses that the claimed conjugate with the claimed property is formed simply by co-incubation of iNKT cells and DCs in the same manner as being done by Xu et al. Thus, the conjugate of Xu would exhibit the properties of Applicant’s claimed conjugate because they are the same compositions.
Since the Patent Office does not have the facilities for examining and comparing applicants' conjugates with the conjugates of the prior art, the burden is upon applicants to show a distinction between the material structural and functional characteristics of the claimed conjugates and the conjugates of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Hence, the claimed invention as a whole was prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention in the absence of evidence to the contrary.
Response to Traversal:
Applicant’s arguments filed on 05/22/2026 are acknowledged and have been discussed above.
Conclusion
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 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Douglas (Doug) Schultz can be reached on (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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