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
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 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.
Election/Restrictions
Applicant’s election of Group I, claims 1-15, in the reply filed on Jan. 10, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-31 remain pending in the current application, claims 16-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-15 have been considered on the merits.
Status of the Claims
Claims 1-15 are currently pending.
Claims 16-31 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-15 have been considered on the merits.
Note to Applicant
Applicant is advised that should claim 14 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms: Lonza MycoAlert® Mycoplasma Detection Kit on pg. 19 lines 10, 16-17; Promega Cell Titer-Glo® 3D Cell Viability Assay on pg. 19 lines 21 and 24; Matlab® on pg. 23 line 17, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Suggestions
The following suggestions are suggest to improve claim form.
It is suggest in claims 2, 3, 5, and 10 to remove the capitalization of the polymers, substances and cells, since these words are typically not capitalized. For example, “Alginate”, “Calcium Sulfate”, “Laminin”, “Hyaluronic Acid”, “Vascular Endothelial Cells” are normally not capitalized.
Appropriate correction is appreciated.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 1 is objected to containing a list with two recitations of “and”, and in the interest of improving claim form, it is suggested that the first “and” in line 3 be deleted to conform with modern grammatical conventions.
Claim 3 is objected to in the recitation of “wherein the Alginate ranges from 0.5 to 2.5 % and the Calcium Sulfate ranges from 7mM to 15mM or 0mM to 15 mM”, and in the interest of improving claim form, it is suggested that the recited phrase be amended to recite “wherein the concentration of the solution of Alginate ranges from 0.5 to 2.5 % and the concentration of the solution of Calcium Sulfate ranges from 7mM to 15mM or 0mM to 15 mM”.
Claim 7 is objected to because of the following informalities: the first time an acronym is utilized in a claim-set, said acronym should be spelled out in its entirety followed by said acronym in parenthesis (e.g. tumor growth factor (TGF), tumor necrosis factor (TNF)).
Claims 14 and 15 is objected to the recitation of “fluidably” in line 2. This does not appear to be recognized word. It is suggested that “fluidably” be deleted.
Appropriate correction is appreciated.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation the “Calcium Sulfate ranges from… 0mM to 15mM”, and the claim also recites “Calcium Sulfate ranges from 7mM to 15mM” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In claim 14, the phrase “wherein the mixer is a dual syringe mixer distinguishing two connectable syringes for fluidably mixing the solutions and the cancer cells”, renders the claim and its dependents indefinite, since it is unclear how the mixer distinguishes the two connectable syringes. For the purposes of compact prosecution, the phrase will be interpreted to mean “wherein the mixer is a dual syringe mixer with two connectable syringes for mixing the solutions and the cancer cells”.
In claim 15, the phrase “wherein the mixing uses a dual syringe mixer distinguishing two connectable syringes for fluidably mixing the solutions and the cancer cells”, renders the claim and its dependents indefinite, since it is unclear how the mixer distinguishes the two connectable syringes. For the purposes of compact prosecution, the phrase will be interpreted to mean “wherein the mixer is a dual syringe mixer with two connectable syringes for mixing the solutions and the cancer cells”.
In claim 15, line 1, the phrase "wherein the mixing uses" lacks sufficient antecedent basis and renders the claim and its dependents indefinite. The claim depends from a kit or a composition in claim 1 and not to a method.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-6, 8, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serban et al. (Current Protocols in Cell Biology, 2008).
With respect to claim 1, Serban teaches the components for a tumor inoculation kit for developing a tumor model (abstract and pg. 1 para. 1). With respect to claim 1 (a), Serban teaches solutions to form a self-assembled hydrogel (abstract, pg. 2 para. 2-3, pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (b), Serban teaches the kit including cancer cells (pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (c), Serban teaches the kit including a shaking or rocking incubator (mixer) for mixing the solutions and cancer cells (pg. 3-4 Materials and pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (d), Serban teaches a syringe for injecting the cancer cells encapsulated by the self-assembled hydrogels (pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials, pg. 15 step 10).
With respect to claim 4, Serban teaches the solutions to form the self-assembled hydrogel include extra-cellular matrix components (pg. 2 para. 4, pg. 6 last para.). With respect to claim 5, Serban teaches the extra-cellular matrix components can be collagen, laminin, fibronectin, and vitronectin (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 6, Serban teaches the solutions to form the self-assembled hydrogel include growth factors (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 8, Serban teaches the cancer or tumor cells are human (pg. 12 last para.).
It is noted that Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress above 10 Pa as recited in claim 11. Similarly, Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress of 20-60 Pa and an elastic storage modulus of 50-1000 Pa at 10 rad/s as recited in claim 12. Although the Serban does not teach the claimed use of forming hydrogels with particular rheological properties as recited in claims 11 and 12, the tumor inoculation kit of Serban is the same as that claimed by applicant. Thus, the intended use of the tumor inoculation kit is also inherent in the tumor inoculation kit of Serban. It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Furthermore, Serban teaches that the compliance or stiffness of the hydrogel can be adjusted (pg. 17 para. 2).
With respect to claim 13, Serban teaches the kit where the cell density is 5x106 cells/ml in 100 µL of hydrogel volume (pg. 14 step 6).
Therefore, the reference anticipates the claimed subject matter.
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, 4-8, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Serban et al. (Current Protocols in Cell Biology, 2008) in view of Chekhonin et al. (Current Cancer Drug Targets, 2013).
With respect to claim 1, Serban teaches the components for a tumor inoculation kit for developing a tumor model (abstract and pg. 1 para. 1). With respect to claim 1 (a), Serban teaches solutions to form a self-assembled hydrogel (abstract, pg. 2 para. 2-3, pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (b), Serban teaches the kit including cancer cells (pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (c), Serban teaches the kit including a shaking or rocking incubator (mixer) for mixing the solutions and cancer cells (pg. 3-4 Materials and pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (d), Serban teaches a syringe for injecting the cancer cells encapsulated by the self-assembled hydrogels (pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials, pg. 15 step 10).
With respect to claim 4, Serban teaches the solutions to form the self-assembled hydrogel include extra-cellular matrix components (pg. 2 para. 4, pg. 6 last para.). With respect to claim 5, Serban teaches the extra-cellular matrix components can be collagen, laminin, fibronectin, and vitronectin (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 6, Serban teaches the solutions to form the self-assembled hydrogel include growth factors (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 8, Serban teaches the cancer or tumor cells are human (pg. 12 last para.).
It is noted that Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress above 10 Pa as recited in claim 11. Similarly, Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress of 20-60 Pa and an elastic storage modulus of 50-1000 Pa at 10 rad/s as recited in claim 12. Although the Serban does not teach the claimed use of forming hydrogels with particular rheological properties as recited in claims 11 and 12, the tumor inoculation kit of Serban is the same as that claimed by applicant. Thus, the intended use of the tumor inoculation kit is also inherent in the tumor inoculation kit of Serban. It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Furthermore, Serban teaches that the compliance or stiffness of the hydrogel can be adjusted (pg. 17 para. 2).
With respect to claim 13, Serban teaches the kit where the cell density is 5x106 cells/ml in 100 µL of hydrogel volume (pg. 14 step 6).
Serban is silent with respect to which growth factors to include and does not teach the growth factors are any of the ones listed in claim 7.
However, Chekhonin teaches growth factors that aid in tumor progression include Vascular Endothelial Growth Factor (VEGF) and stromal-derived factor-1 (SDF-1); and that Fibroblast Growth Factors (FGF), Platelet-derived growth factor (PDGF), , tumor growth factor (TGF); tumor necrosis factor (TNF) elevate VEGF expression (abstract, pg. 425 Col. 2 para. 3, pg. 429 Col. 1 last para.).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the kit of Serban to include the growth factors listed in claim 7 to promote tumor growth as taught by Chekhonin. It would have been obvious to one of ordinary skill in the art to include growth factors known to promote tumor growth as taught by Chekhonin in the tumor inoculation kit of Serban. Furthermore, for these reasons one of ordinary skill in the art would have had a reasonable expectation of success in including the claimed growth factors in the kit of Serban.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1-6, 8, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Serban et al. (Current Protocols in Cell Biology, 2008) in view of Allen et al. (Journal of Materials Chemistry, 2016).
With respect to claim 1, Serban teaches the components for a tumor inoculation kit for developing a tumor model (abstract and pg. 1 para. 1). With respect to claim 1 (a), Serban teaches solutions to form a self-assembled hydrogel (abstract, pg. 2 para. 2-3, pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (b), Serban teaches the kit including cancer cells (pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (c), Serban teaches the kit including a shaking or rocking incubator (mixer) for mixing the solutions and cancer cells (pg. 3-4 Materials and pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (d), Serban teaches a syringe for injecting the cancer cells encapsulated by the self-assembled hydrogels (pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials, pg. 15 step 10).
With respect to claim 4, Serban teaches the solutions to form the self-assembled hydrogel include extra-cellular matrix components (pg. 2 para. 4, pg. 6 last para.). With respect to claim 5, Serban teaches the extra-cellular matrix components can be collagen, laminin, fibronectin, and vitronectin (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 6, Serban teaches the solutions to form the self-assembled hydrogel include growth factors (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 8, Serban teaches the cancer or tumor cells are human (pg. 12 last para.).
It is noted that Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress above 10 Pa as recited in claim 11. Similarly, Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress of 20-60 Pa and an elastic storage modulus of 50-1000 Pa at 10 rad/s as recited in claim 12. Although the Serban does not teach the claimed use of forming hydrogels with particular rheological properties as recited in claims 11 and 12, the tumor inoculation kit of Serban is the same as that claimed by applicant. Thus, the intended use of the tumor inoculation kit is also inherent in the tumor inoculation kit of Serban. It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Furthermore, Serban teaches that the compliance or stiffness of the hydrogel can be adjusted (pg. 17 para. 2).
With respect to claim 13, Serban teaches the kit where the cell density is 5x106 cells/ml in 100 µL of hydrogel volume (pg. 14 step 6).
Serban does not teach the tumor inoculation kit where the solutions for forming the self-assembled hydrogel are alginate and calcium sulfate as recited in claim 2. Similarly, Serban does not the alginate solution concentration of 0.5 to 2.5 wt% and the calcium sulfate solution concentration of 7 mM to 15 mM or 0 mM to 15 mM as recited in claim 3.
However, Allen teaches a self-assemble hydrogel for delivering cells containing alginate and calcium sulfate (pg. 3596 Col. 1 para. 2). Allen teaches the alginate at a concentration of 2% w/v and the calcium sulfate is at a concentration of 8.4 mg/ml (61.7 mM) (pg. 3596 Col. 1 para. 2).
Accordingly, at the time of the claimed invention, one of ordinary skill in the art would have been motivated to modify the teachings of Serban in such a way that the solutions to form a self-assembled hydrogel are alginate and calcium sulfate for the purpose being part of a tumor inoculation kit. Furthermore, it would have been obvious to one skilled in the art to have further modified Serban such that the solutions to form a self-assembled hydrogel are alginate and calcium sulfate, since similar hydrogels for containing cells were known to be composed from solutions of alginate and calcium sulfate as taught by Allen. Such a modification merely involves the substitution of one known solution of self-assembled hydrogel for another for being part of a tumor inoculation kit. Furthermore the substitution of one known material (hydrogel solutions to form a self-assembled hydrogel) for another known material (alginate and calcium sulfate solutions which form hydrogels) would have yielded predictable results (e.g. solutions to form a self-assembled hydrogel) to one of ordinary skill in the art.
Serban does not teach the kit where the mixer is a dual syringe mixer with two connectable syringes for mixing the solutions and the cancer cells as recited in claims 14 and 15.
However, Allen teaches a dual-syringe mixer for delivering cells with an alginate hydrogel with subsequent calcium sulfate (pg. 3596 Col. 1 para. 2).
Accordingly, at the effective time of filing one of ordinary skill in the art would have been motivated to modify the kit of Serban so that the mixer is a dual-syringe mixer for the benefit of having a mixer and a syringe capable of mixing the hydrogel solutions and delivering the cells as taught by Allen. It would have been obvious to one of ordinary skill in the art to include other mixers known to be used to mix cells with hydrogel solutions such as a dual-syringe mixer as taught by Allen in the kit of Serban. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success including a dual-syringe mixer with two connectable syringes in the kit of Serban, since this form of mixer was known in the art for mixing cells and hydrogel solutions as taught by Allen.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1, 4-6, and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Serban et al. (Current Protocols in Cell Biology, 2008) in view of Cassidy et al. (Cancer Research, 2015).
With respect to claim 1, Serban teaches the components for a tumor inoculation kit for developing a tumor model (abstract and pg. 1 para. 1). With respect to claim 1 (a), Serban teaches solutions to form a self-assembled hydrogel (abstract, pg. 2 para. 2-3, pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (b), Serban teaches the kit including cancer cells (pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (c), Serban teaches the kit including a shaking or rocking incubator (mixer) for mixing the solutions and cancer cells (pg. 3-4 Materials and pg. 7-8 Materials, pg. 14-15 Materials). With respect to claim 1 (d), Serban teaches a syringe for injecting the cancer cells encapsulated by the self-assembled hydrogels (pg. 3-4 Materials, pg. 7-8 Materials, pg. 14-15 Materials, pg. 15 step 10).
With respect to claim 4, Serban teaches the solutions to form the self-assembled hydrogel include extra-cellular matrix components (pg. 2 para. 4, pg. 6 last para.). With respect to claim 5, Serban teaches the extra-cellular matrix components can be collagen, laminin, fibronectin, and vitronectin (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 6, Serban teaches the solutions to form the self-assembled hydrogel include growth factors (pg. 2 para. 4-5, pg. 6 last para.). With respect to claim 8, Serban teaches the cancer or tumor cells are human (pg. 12 last para.).
It is noted that Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress above 10 Pa as recited in claim 11. Similarly, Serban does not teach that the solutions in kit can be used in the manner instantly claimed for forming a hydrogel with a yield stress of 20-60 Pa and an elastic storage modulus of 50-1000 Pa at 10 rad/s as recited in claim 12. Although the Serban does not teach the claimed use of forming hydrogels with particular rheological properties as recited in claims 11 and 12, the tumor inoculation kit of Serban is the same as that claimed by applicant. Thus, the intended use of the tumor inoculation kit is also inherent in the tumor inoculation kit of Serban. It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112). Furthermore, Serban teaches that the compliance or stiffness of the hydrogel can be adjusted (pg. 17 para. 2).
With respect to claim 13, Serban teaches the kit where the cell density is 5x106 cells/ml in 100 µL of hydrogel volume (pg. 14 step 6).
Serban does not teach the kit where the cancer cells are a mixture of different types of cancer cells as recited in claim 9. Likewise, Serban does not teach the kit where the cancer cells any of those listed in claim 10.
However, Cassidy teaches the importance of patient-derived tumor xenografts to represent the heterogeneity within a tumor or containing a mixture of different types of cancer cells to be a representative model of the heterogeneity found in tumors (abstract and introduction). Cassidy further teaches the tumor xenograft should include patient-matched stromal components such as fibroblasts (pg. 7 para. 3). Cassidy teaches co-engraftment with matched stromal components such as fibroblasts to retain the complex heterogeneity found in patient samples (pg. 5 para. 3). In addition, Cassidy teaches the co-engraftments of immune components in PDX models will facilitate the study of novel therapies targeting tumor-immune interactions and allow of research into the patient specific cross-talk between tumor progression and immune surveillance (pg. 6 para. 1). Cassidy further teaches this can include bone marrow derived stem cells (bone-marrow mesenchymal stromal cells) along with liver and thymus fragments (these would at least include vascular endothelial cells and fibroblasts) (pg. 6 para. 2).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the kit of Serban to include a mixture of different types cancer cells and to include additional cells that are not cancer that are found in tumors for the benefit to better represent the tumor as taught by Cassidy. It would have been obvious to include a mixture of cancer cells in the kit of Serban, since tumors were known to contain a mixture of cancer cells as taught by Cassidy. Similarly, it would have been obvious to include non-cancer cells in the kit of Serban, since tumors were known to contain other cell types including fibroblast as taught by Cassidy. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the kit of Serban, since Cassidy teaches a mixture of cancer cells and additional non-cancer cell types can be used to form tumor models and improves the tumor model.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632