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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Claims 1 and 3 – 12 remain pending and are under consideration.
Withdrawn Rejections
The rejection of claims 1, 3 – 10, and 12 and claim 11 under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendment to claim 1 and Applicant’s arguments regarding Wang teaches purified homogenous ASCs while the claimed composition requires SVF that is a heterogenous, non-lineage selected cell population at page 2, para. 3 of Remarks.
New Claim Objections
Claim 11 is objected to because of the following informalities: in line 1 – 2, “is used in combination with or mixed” should read “further comprises” because the claims are drawn to a composition and not a method of preparing or administering the composition. Appropriate correction is required.
Claim Interpretation
For the purpose of applying prior art, “that enhances interaction between the dendritic cells and T cells, resulting in dendritic-cell-mediated activation of antigen-specific CD4+ and CD8+ T cells” of claim 1 is interpreted to be met by a teaching of a composition comprising a spheroid of SVF and dendritic cells loaded with antigen because the claim is interpreted as not requiring T cells in the composition. Further, this limitation is interpreted as an outcome of a method for enhancing an immune response, but the claims are drawn to a composition.
For the purpose of applying prior art, “wherein the immune response is performed by T cells” of claim 3 is interpreted as the claimed stromal vascular fraction reads on a heterogeneous cell population that comprises dendritic cells and T cells, wherein the immune response is performed by the T cells.
For the purpose of applying prior art, claim 6 is interpreted as the dendritic cells are obtained from an individual because the claims are drawn to a composition and not a method of administering.
For the purpose of applying prior art, claim 11 is interpreted as the composition of claim 1 further comprising an anti-viral agent, an anti-microbial agent, or an anti-cancer agent.
For the purpose of applying prior art, claim 12 is interpreted as the composition of claim 1 that is capable of being administered to a subject.
New Claim Rejections
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim(s) 1, 3, 6, and 7 is/are rejected under 35 U.S.C. 102((a1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Sardi (Sardi, Martina, et. al. Applied in Vitro Toxicology 2.3 (2016): 143-150), hereinafter Sardi as evidenced by Gil-Ortega (Gil-Ortega, Marta, et al. Stem cells 31.7 (2013): 1309-1320.), hereinafter Gil-Ortega and Benezech (Bénézech, Cécile, et al. Immunity 37.4 (2012): 721-734.), hereinafter Benezech.
Regarding claim 1, Sardi teaches a composition of 1 x 106 stromal vascular fraction (ATSVF) cells isolated from adipose tissue (“stromal vascular fraction isolated from adipose tissue”) and dendritic cells stimulated with chicken egg ovalbumin as an antigen (“dendritic cells loaded with an antigen”) in a three-dimensional spheroid culture (“three-dimensional spheroid culture” and “) (page 145, right col. para. 6; page 146, left col. para. 4 and last para. and right col. para. 4; page 147, left col. para. 2 and right col. para. 3 – 5; Figure 4 and 5; Abstract). Sardi teaches the cells from ATSVF comprise stromal cells that are positive for Gp38 (Figure 2A; page 146, right col. last para.; page 147, left col. para. 1; Table 1), which is another name for podoplanin (PDPN) as stated in Applicant’s specification at para. 4. Thus, Sardi teaches SVF contains a population of PDPN+ stromal cells. Sardi is silent regarding the presence or absence of CD45 and CD31 on the stromal cells. However, SVF isolated from adipose tissue contains a population of stromal cells that are CD45- CD31+ that are endothelial cells and a population of stromal cells that are CD45- CD31- as evidenced by Gil-Ortega (page 1311, right col. para. 3; page 1313, left col. para. 4; Figure 1). CD45- stromal cells from fat pads show a similar profile to lymph node stromal cells in that both contain Gp38+ CD31int lymphatic endothelial cells and Gp38+ CD31- cells as evidenced by Benezech (page 722, right col. para. 2; Figure 2A). Further fat pad stromal cells when cocultured with lymphocytes significantly increase the survival of CD4+ and CD8+ T cells similar to fibroblastic reticular cells as evidenced by Benezech (page 725, right col. para. 1).
Regarding claim 3, Sardi teaches the composition comprises lymphocytes (“T cells”) in addition to ATSVF and antigen primed dendritic cells (page 146, right col. para. 3 – 4; Figure 5). Sardi teaches the composition without ATSVF shows immune reactivity (“wherein the immune response is performed by T cells”) but this is enhanced by the addition of SVF (page 146, right col. para. 4; page 147, right col. para. 4 – 5; Figure 4).
Regarding claim 6, Sardi teaches the dendritic cells were from healthy adult donors (page 146, left col. para. 3 – 4).
Regarding claim 7, Sardi teaches the dendritic cells are mature (page 146, left col. para. 4 and right col. para. 4; page 147, right col. para. 2).
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the ATSVF of Sardi comprises PDPN+ CD31- fibroblastic reticular cells and PDPN+ CD31+ endothelial cells. However, Applicant’s specification states that PDPN+ CD31- fibroblastic reticular cells and PDPN+ CD31+ endothelial cells found in lymph node stromal cells are also found in SVF isolated from adipose tissue at para. 98. The prior art discloses SVF in spheroids which is similar to applicant’s claimed SVF in spheroid culture for these reasons: Sardi teaches a 3D culture of SVF and antigen loaded dendritic cells as shown in Figure 5 where the SVF comprises stromal cells that are Gp38+ (PDPN+); the evidentiary reference of Gil-Ortega teaches SVF isolated from adipose tissue contains a population of stromal cells that are CD45-CD31+ that are endothelial cells and a population of stromal cells that are CD45-CD31-; the evidentiary reference of Benezech teaches stromal cells isolated from fat pads function similar to fibroblastic reticular cells. Therefore, the SVF of Sardi would inherently contain the recited populations of CD45- stromal cells as evidenced by Gil-Ortega and Benezech. Where an examiner cannot determine whether or not the reference inherently possesses properties which anticipate, or render obvious, the claimed invention a rejection under §§102/103 is appropriate. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the composition comprising SVF and dendritic cells loaded with antigen in 3D spheroid culture of Sardi is either identical or sufficiently similar to the claimed composition of SVF isolated from adipose tissue and dendritic cells loaded with antigen in a 3D spheroid culture that whatever differences exist, they are not patentably significant. Further, it would have been obvious to combine SVF from adipose tissue with dendritic cells loaded with an antigen in 3D spheroid culture to arrive at the claimed composition as Sardi teaches there has recently been an increasing demand for modeling the human immune system in vitro and the use of such models for testing immune responses against pharmaceutical drugs, cosmetics, and chemicals (Abstract; page 143, left col. para. 1). One would have a reasonable expectation of success in arriving at the claimed composition as Sardi teaches the composition shows significant cell viability and immune reactivity (page 147, right col. para. 4 – 5; Figure 4). Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. See MPEP § 2112(v). Clear evidence that the composition of Sardi does not possess a critical characteristic that is possessed by the claimed composition would advance prosecution and might permit allowance of claims to applicant’s composition. Applicant is requested to specifically point out the support for any amendments made to the disclosure and arguments in response to this Office Action, including the claims. See MPEP §§ 714.02 and 2163.06. Applicant is also requested to refer to pages and line numbers in the as-filed specification. It is noted that other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Claim(s) 1, 3 – 9, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardi (Sardi, Martina, et. al. Applied in Vitro Toxicology 2.3 (2016): 143-150), hereinafter Sardi as evidenced by Gil-Ortega (Gil-Ortega, Marta, et al. Stem cells 31.7 (2013): 1309-1320.), hereinafter Gil-Ortega and Benezech (Bénézech, Cécile, et al. Immunity 37.4 (2012): 721-734.), hereinafter Benezech in view of Wu (20160024469-A1; Filed 07/28/2014; Published 01/28/2016), hereinafter Wu.
Claims 1, 3, 6, and 7 are anticipated by or, in the alternative, under 35 U.S.C. 103 are obvious over the teachings of Sardi as evidenced by Gil-Ortega and Benezech as set forth above.
Sardi teaches a composition of 1 x 106 stromal vascular fraction (ATSVF) cells isolated from adipose tissue and dendritic cells stimulated with chicken egg ovalbumin as an antigen in a three-dimensional spheroid culture page 145, right col. para. 6; page 146, left col. para. 4 and last para. and right col. para. 4; page 147, left col. para. 2 and right col. para. 3 – 5; Figure 4 and 5; Abstract) but does not teach “tumor-derived antigen” of claim 4 or “anti-tumor immune-enhancing composition for tumor treatment or prevention” of claim 5 or “the adipose tissue is a subcutaneous fat tissue” of claim 8 or “the antigen is a tumor-derived antigen” and “the tumor-derived antigen is a tumor cell lysate” of claim 9, or “the composition is a pharmaceutical composition” of claim 12. However, Sardi teaches there has recently been an increasing demand for modeling the human immune system in vitro (Abstract). Sardi teaches in vitro models are used increasingly in the pharmaceutical industry for the understanding and treatment of diseases (page 143, left col. para. 1). Sardi teaches the applications focus on the testing of drug candidates and mechanistic understanding of therapeutic treatments (page 143, left col. para. 1). Sardi teaches the composition is designed to induce and monitor human immune responses in vitro and emulates an in vivo-like system to analyze immune modulation, immunogenicity, and immunotoxicity and it can also be used for efficacy assessment of vaccine candidates to select the most promising one (page 144, left col. para. 2). Sardi teaches it is of fundamental importance in the area of bioengineering of lymph nodes to be able to recreate a microenvironment capable of supporting the immune cells from both an organizational and functional point of view (page 147, right col. para. 6). Sardi teaches this support in vivo is provided by the stromal network as shown in Figure 1 (page 144, left col. para. 1; page 147, right col. para. 6). Sardi teaches ATSVF showed very good network formation in 3D culture in Table 1. Sardi teaches the composition containing the SVF and dendritic cells loaded with antigen secreted cytokines in Figure 4.
Regarding claims 4, 5, 8, 9, and 12, Wu teaches a composition comprising SVF isolated from subcutaneous fat (claim 8) and pancreatic whole cell tumor lysate where the SVF cells were electroporated to introduce pancreatic tumor antigen into the cells (claim 4 and 9) after which the electroporated SVF cells were re-introduced into the same patient ( “a pharmaceutical composition” of claim 12) for immune-cancer therapy (“anti-tumor immune-enhancing composition for tumor treatment or prevention” of claim 5) (page 1, para. 0009 – 0010). Wu teaches prior art has solely focused on pure populations of dendritic cells but Wu teaches: that their method utilizes a plurality of immune cells generated from isolation of stromal vascular fraction from lipoaspiration (page 1, para. 0005).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to substitute the chicken egg ovalbumin antigen of Sardi with a pancreatic tumor antigen of Wu to arrive at the claimed composition wherein the antigen is a tumor-derived antigen from a tumor cell lysate for treating pancreatic cancer. One would have been motivated to make the substitution to provide a model of the human immune system with a pancreatic tumor antigen as Sardi teaches there has recently been an increasing demand for modeling the human immune system in vitro and in vitro models are used increasingly in the pharmaceutical industry for the understanding and treatment of diseases and Wu teaches the composition was used for immune-cancer therapy. One would have a reasonable expectation of success in making the substitution as Sardi teaches the composition is designed to induce and monitor human immune responses in vitro and emulates an in vivo-like system to analyze immune modulation, immunogenicity, and immunotoxicity and it can also be used for efficacy assessment of vaccine candidates to select the most promising one and Sardi teaches the composition containing the SVF and dendritic cells loaded with antigen secreted cytokines.
Claim(s) 1, 3, 6, 7, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardi (Sardi, Martina, et. al. Applied in Vitro Toxicology 2.3 (2016): 143-150), hereinafter Sardi as evidenced by Gil-Ortega (Gil-Ortega, Marta, et al. Stem cells 31.7 (2013): 1309-1320.), hereinafter Gil-Ortega and Benezech (Bénézech, Cécile, et al. Immunity 37.4 (2012): 721-734.), hereinafter Benezech in view of Cho (Cho NH, et. al. Nat Nanotechnol. 2011 Sep 11;6(10):675-82; previously cited), hereinafter Cho.
Claims 1, 3, 6, and 7 are anticipated by or, in the alternative, under 35 U.S.C. 103 are obvious over the teachings of Sardi as evidenced by Gil-Ortega and Benezech as set forth above.
Sardi teaches a composition of 1 x 106 stromal vascular fraction (ATSVF) cells isolated from adipose tissue and dendritic cells stimulated with chicken egg ovalbumin as an antigen in a three-dimensional spheroid culture page 145, right col. para. 6; page 146, left col. para. 4 and last para. and right col. para. 4; page 147, left col. para. 2 and right col. para. 3 – 5; Figure 4 and 5; Abstract) but does not teach “tumor-derived antigen” that is CEA of claim 10. However, Sardi teaches there has recently been an increasing demand for modeling the human immune system in vitro (Abstract). Sardi teaches in vitro models are used increasingly in the pharmaceutical industry for the understanding and treatment of diseases (page 143, left col. para. 1). Sardi teaches the applications focus on the testing of drug candidates and mechanistic understanding of therapeutic treatments (page 143, left col. para. 1). Sardi teaches the composition is designed to induce and monitor human immune responses in vitro and emulates an in vivo-like system to analyze immune modulation, immunogenicity, and immunotoxicity and it can also be used for efficacy assessment of vaccine candidates to select the most promising one (page 144, left col. para. 2). Sardi teaches it is of fundamental importance in the area of bioengineering of lymph nodes to be able to recreate a microenvironment capable of supporting the immune cells from both an organizational and functional point of view (page 147, right col. para. 6). Sardi teaches this support in vivo is provided by the stromal network as shown in Figure 1 (page 144, left col. para. 1; page 147, right col. para. 6). Sardi teaches ATSVF showed very good network formation in 3D culture in Table 1. Sardi teaches the composition containing the SVF and dendritic cells loaded with antigen secreted cytokines in Figure 4.
Regarding “CEA” of claim 10, Cho teaches loading dendritic cells with the tumor-derived antigen CEA using a nanoparticle that can both deliver CEA into dendritic cells while simultaneously acting as an imaging agent (Abstract; page 677, right col. para. 1; Figure 3 and 4). Cho teaches no significant changes in viability were observed in the cells and surface expression of maturation markers was not significantly affected (page 677, right col. last para.). Cho teaches the nanoparticle-labelled dendritic cells were injected into the footpads of mice and migration of the cells into lymph nodes was observed by MRI (page 678, left col. last para. and right col.). Cho teaches the immunizing mice with the dendritic cells loaded with nanoparticle-CEA resulting in prominent cytotoxic responses against CEA-expressing cancer cells (page 679, left col. para. 1; Figure 5). Cho teaches IFN-gamma-secreting CD8+ T cells in spleen increased ~tenfold in the mice compared to control mice indicating that the dendritic cells with nanoparticle-CEA can efficiently generate CEA-specific cellular immunity in vivo (page 679, left col. para. 2 and right col. para. 1; Figure 5). Cho teaches tumor growth in the treated mice was significantly suppressed (page 679, right col. para. 2; Figure 6).
Cho teaches DCs have been used as potent therapeutic vaccines against human cancers and ex vivo-generated DCs that are pulsed with tumor antigens show therapeutic immunity in some cancer patients but clinical trials have demonstrated poor efficacy (page 675, left col. para. 1). Cho teaches the DCs were pulsed with nanoparticles containing CEA and could be applied in diverse DC-based immunotherapies that need to monitor antigen loading in vitro and track DCs in vivo to ensure consistent clinical efficacy (page 680, right col.).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to substitute the chicken egg ovalbumin antigen of Sardi with the nanoparticle-CEA complex of Cho to arrive at the claimed composition wherein the antigen is a tumor-derived antigen that is CEA. One would have been motivated to make the substitution to provide a model of the human immune system with a tumor antigen where the location of the dendritic cells can be monitored visually using the nanoparticle as Sardi teaches there has recently been an increasing demand for modeling the human immune system in vitro and in vitro models are used increasingly in the pharmaceutical industry for the understanding and treatment of diseases and Cho teaches the DCs were pulsed with nanoparticles containing CEA and could be applied in diverse DC-based immunotherapies that need to monitor antigen loading in vitro. One would have a reasonable expectation of success in making the substitution as Cho teaches visualization of the nanoparticles in the dendritic cells in vitro by microscopy and MRI.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardi (Sardi, Martina, et. al. Applied in Vitro Toxicology 2.3 (2016): 143-150), hereinafter Sardi as evidenced by Gil-Ortega (Gil-Ortega, Marta, et al. Stem cells 31.7 (2013): 1309-1320.), hereinafter Gil-Ortega and Benezech (Bénézech, Cécile, et al. Immunity 37.4 (2012): 721-734.), hereinafter Benezech in view of Wu (20160024469-A1; Filed 07/28/2014; Published 01/28/2016), hereinafter Wu as applied to claims 1, 3 – 9, and 12 above, and further in view of Kimura (Kimura, Yukino, et al. Pancreas 41.2 (2012): 195-205.), hereinafter Kimura.
Claim 1 is anticipated by or, in the alternative, under 35 U.S.C. 103 are obvious over the teachings of Sardi as evidenced by Gil-Ortega and Benezech as set forth above. Sardi and Wu do not teach the tumor antigen is HER2 or CEA of claim 10 or the composition comprises an anti-cancer agent of claim 11.
Kimura teaches treating patients with pancreatic cancer with dendritic cell based immunotherapy in combination with gemcitabine and/or S-1 (an oral form of 5-FU) referred to as chemoimmunotherapy (claim 11) (Abstract; page 195, right col. para. 2; Table 1; page 198, left col. para. 3 and right col. para. 1; Figure 1; page 199, left col. para. 3 – 5 and right col.). Kimura teaches the dendritic cells were loaded with tumor antigens where the tumor antigen is Her2 (claim 10), CEA (claim 10), or tumor lysate (page 198, right col.; Table 1). Kimura teaches the dendritic cells were loaded with multiple antigens and some were loaded with multiple antigens and tumor lysate in Table 1. Kimura teaches in patient 1 treated with dendritic cells, gemcitabine, and S-1, neither primary cancer nor liver metastasis was detected and serum levels of the pancreatic cancer antigen were reduced to basal levels (page 200, left col.; Figure 2). Kimura teaches the number of Tregs were reduced after dendritic cell vaccination in combination with gemcitabine and gemcitabine and S-1 but were not reduced by vaccination and S-1 (page 201, right col. last para.). Kimura teaches this suggests that gemcitabine might improve the immunological environment in patients with advanced pancreatic cancer by reducing the number of Tregs (page 201, right col. last para.; page 202, left col. para. 1). Kimura teaches because prognosis of advanced pancreatic cancer is extremely poor, establishment of an effective therapeutic modality for advanced pancreatic cancer is an urgent issue (page 203, left col. para. 2).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of Sardi regarding a composition of SVF and antigen loaded dendritic cells in a 3D spheroid culture with the teachings of Wu regarding SVF loaded with tumor cell lysate antigens for treating pancreatic cancer with the teachings of Kimura regarding combining dendritic cells loaded with tumor antigens with chemotherapy to arrive at the claimed composition where the antigen is a tumor-derived antigen and the composition is mixed with an anti-cancer agent. One would have been motivated to combine the teachings of Sardi, Wu, and Kimura in a composition to model human immunity to a combination of dendritic cells loaded with a tumor antigen and chemotherapy as Sardi teaches there has recently been an increasing demand for modeling the human immune system in vitro and in vitro models are used increasingly in the pharmaceutical industry for the understanding and treatment of diseases and Kimura teaches Kimura teaches because prognosis of advanced pancreatic cancer is extremely poor, establishment of an effective therapeutic modality for advanced pancreatic cancer is an urgent issue and Kimura teaches gemcitabine might improve the immunological environment in patients with advanced pancreatic cancer by reducing the number of Tregs. One would have a reasonable expectation of success in combining the teachings as Sardi teaches the composition is designed to induce and monitor human immune responses in vitro and emulates an in vivo-like system to analyze immune modulation, immunogenicity, and immunotoxicity and it can also be used for efficacy assessment of vaccine candidates to select the most promising one.
Applicant’s Arguments/ Response to Arguments
Applicant Argues: Applicant asserts that Wang does not teach the SVF heterogenous population of amended claim 1.
Response to Arguments: This is found persuasive and the previous rejection the claims citing the teachings of Wang have been withdrawn. In the new rejection, Sardi teaches a 3D composition of SVF organoids and antigen loaded dendritic cells. Evidence is provided that SVF contains a population of CD45- stromal cells containing the recited PDPN+ CD31- and PDPN+ CD31- cells as set forth above.
Conclusion
No claim is allowed.
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/Z.M.B./Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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