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
Applicant’s election without traverse of Group I in the reply filed on 7/1/26 is acknowledged.
“Applicant elects Group I, claims 1-3, 4-9, 11-12, 17, 19, 36-37, 40 and 42, directed to a method for identifying therapeutic agents or a combination thereof for treating a tumor in a patient. New claims 95-96 are believed to be within the elected
group.“ Claims 95-96 are included with Group I.
“Applicant notes that claims 2 and 12 that were included in Group I above are believed to be in Group II, as they are also directed to bioprinting methods.” Applicant is correct- claims 2 & 12 are moved to Group II.
“Applicant respectfully requests that the Examiner reconsider and include Group III, claim 43, with the elected group, or rejoin Group III, claim 43, upon an indication of
allowability of the claims of Group I.” Rejoinder will be considered at the moment of allowability.
Claims 1,3, 7-9, 11, 17, 19, 36-37, 40 and 42 & 95-96 are examined on the merits.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1,3, 7-9, 17, 19, 36-37 and 42 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by 20170023550 (Organovo).
Organovo teaches a method for identifying therapeutic agents or a combination thereof for treating a tumor in a patient [0158] [0172] . The constructs were treated
with 10 uM compound for 3 days, followed by 100 uM compound for 24 hours. Referring to FIG. 14, viability was assessed by alamarBlue assay, with higher fluorescence intensity indicative of metabolically active cells. Cisplatin and paclitaxel decreased construct viability relative to media or vehicle controls"), comprising the steps of i) obtaining a sample of tumor cells [0162]. MCF7 cells were used optionally in single cell suspension, or as aggregates or clusters from the tumor of the patient; ii) extruding a collection of said tumor cells into tissue culture wells [0163]. The stromal compartment of the constructs was comprised of 65% NHMF, 25% HUVEC, and 10% SPA (partially pre-differentiated). The cancer compartment of the constructs was comprised of 75% MCF7, 25% HUVEC. For each compartment, cells were mixed together at the indicated ratio and resuspended in Novogel(R) 3.0 at a concentration of 150 million cells/ml. Constructs were printed as 3 layered structures with a dimension of 3 mmx3 mmx0.75 mm., printing and forcing cells into 3D space is extruding), such that the tumor cells form one or more shaped, three-dimensional organoid extrudates [0163]. Constructs were printed as 3 layered structures with a dimension of 3 mmx3 mmx0.75 mm. Immediately following bioprinting, constructs were stabilized via crosslinking comprising said tumor cells (Para [0163]. Organovo teaches co-culturing said shaped organoid extrudate with a population of assay cells in said tissue culture wells in the presence of therapeutic agents or combination thereof [0172] Constructs were treated with 10 uM compound for 3 days, followed by 100 uM compound for 24 hours. Referring to FIG. 14, viability was assessed by alamarBlue assay, with higher fluorescence intensity indicative of metabolically active cells. Cisplatin and paclitaxel decreased construct viability relative to media or vehicle controls, wherein reduced tumor cell functions or increased assay cell functions in the presence of said therapeutic agents or combination thereof identifies the therapeutic agents or combination thereof for treating the tumor in the patient [0172]. Organovo further teaches the method wherein said tumor cell functions comprise tumor cell growth, tumor cell [0172]. Organovo discloses that the tumor cells and assay may comprise immune cells [0111]. It is inherent to the immune cells of Orangovo functions comprise cytokine production or immune cell growth. Organovo discloses that liver cells can be used [0133]. Oganovo teaches said shaped organoid extrudates comprise a hydrogel [0158] and wherein the dispensing of the shaped organoid or cell extrudates is performed manually or by automated bioprinting [0143].
Oganovo teaches therapeutic agents comprise chemotherapeutic agents, e.g. cisplatin [0172]. Organovo discloses that in a separate embodiment the breast cancer cells come directly from a patient tumor (Para
[0010] "In other embodiments, the breast cancer cells are primary cancer cells from a patient tumor
The reference anticipates the claim subject matter.
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 1,3, 7-9, 11, 17, 19, 36-37, 40 and 42 & 95-96 are rejected under 35 U.S.C. 103 as being unpatentable over 20170023550 (Organovo) and 20170198275 (Lee)
Organovo teaches a method for identifying therapeutic agents or a combination thereof for treating a tumor in a patient [0158] [0172] . The constructs were treated
with 10 uM compound for 3 days, followed by 100 uM compound for 24 hours. Referring to FIG. 14, viability was assessed by alamarBlue assay, with higher fluorescence intensity indicative of metabolically active cells. Cisplatin and paclitaxel decreased construct viability relative to media or vehicle controls"), comprising the steps of i) obtaining a sample of tumor cells [0162]. MCF7 cells were used optionally in single cell suspension, or as aggregates or clusters from the tumor of the patient; ii) extruding a collection of said tumor cells into tissue culture wells [0163]. The stromal compartment of the constructs was comprised of 65% NHMF, 25% HUVEC, and 10% SPA (partially pre-differentiated). The cancer compartment of the constructs was comprised of 75% MCF7, 25% HUVEC. For each compartment, cells were mixed together at the indicated ratio and resuspended in Novogel(R) 3.0 at a concentration of 150 million cells/ml. Constructs were printed as 3 layered structures with a dimension of 3 mmx3 mmx0.75 mm., printing and forcing cells into 3D space is extruding), such that the tumor cells form one or more shaped, three-dimensional organoid extrudates [0163]. Constructs were printed as 3 layered structures with a dimension of 3 mmx3 mmx0.75 mm. Immediately following bioprinting, constructs were stabilized via crosslinking comprising said tumor cells (Para [0163]. Organovo teaches co-culturing said shaped organoid extrudate with a population of assay cells in said tissue culture wells in the presence of therapeutic agents or combination thereof [0172] Constructs were treated with 10 uM compound for 3 days, followed by 100 uM compound for 24 hours. Referring to FIG. 14, viability was assessed by alamarBlue assay, with higher fluorescence intensity indicative of metabolically active cells. Cisplatin and paclitaxel decreased construct viability relative to media or vehicle controls, wherein reduced tumor cell functions or increased assay cell functions in the presence of said therapeutic agents or combination thereof identifies the therapeutic agents or combination thereof for treating the tumor in the patient [0172]. Organovo further teaches the method wherein said tumor cell functions comprise tumor cell growth, tumor cell [0172]. Organovo discloses that the tumor cells may comprise immune cells [0111]. It is inherent to the immune cells of Orangovo functions comprise cytokine production or immune cell growth. Organovo discloses that liver cells can be used [0133]. Oganovo teaches said shaped organoid extrudates comprise a hydrogel [0158] and wherein the dispensing of the shaped organoid or cell extrudates is performed manually or by automated bioprinting [0143].
Oganovo teaches therapeutic agents comprise chemotherapeutic agents, e.g. cisplatin [0172]. It would have been obvious to one of skill in the art at the time the invention was made to use any known cells (such as liver cells) in the method of Organovo to identify wherein the assay cells are cells correlating to the cancer cells (such as liver cancer cells). Organovo discloses that in a separate embodiment the breast cancer cells come directly from a patient tumor [0010] thus strongly suggesting the use of a patient’s cells in the assay. Organovo also teaches that many stromal cells are suitable for inclusion in the engineered tumor models. For example, in various embodiments, the engineered tumor models suitably include one or more of: fibroblasts, endothelial cells, epithelial cells, adipocytes, and immune cells such as macrophages [0111].
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Organovo doesn’t specifically teach treating the microwell with plasma to improve hydrophilicity however it would have been obvious at the time the invention was filed to do so within the method of Oganovo because Lee teaches If the microwell made of a hydrophobic polymer, it may need to be treated so that it is hydrophilic. Accurately printing biological samples into a small, hydrophobic microwell is challenging due to high surface tension and associated problems such as air bubble entrapment. The microwell may be changed from hydrophobic to hydrophilic by treating with plasma [0027].
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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