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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 8-12 & 33-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a liver organoid. This judicial exception is not integrated into a practical application because the claims are drawn to the organoid per se. The claims are drawn to a composition of matter however the claims are drawn to a natural phenomenon, namely the occurrence in nature of liver organoids. The instant specification describes the invention as being composed of all those cells naturally occurring in the liver.
The specification contains no evidence, that the method of making or culturing of the cells imparts characteristics markedly different from those cells as they exist and function in nature. As such, there is no evidence that the claimed population or composition of the population has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells and molecules. For these reasons, the claimed invention does not appear to have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention does not include any additional features that could add significantly more to the exception, so the claim does not qualify as eligible subject matter.
Concluding the analysis, the claimed invention is drawn to a judicial exception to the statute and must be rejected as ineligible under 35 USC101.
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.
Claim(s) 8-12 and 33-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HCS Pharma: "Applications for 3D in vitro models with BIOMIMESYS Liver - March 2021", , 26 March 2021 (2021-03-26), XP055930623; AND
KUMAR ET AL ", BIORXIV,2020-09-04: AND and OUCHI ET AL: CELL METABOLISM, CELL PRESS, UNITED STATES, vol. 30, no. 2, 30 May 2019 (2019-05-30), page 374,
HCS discloses a liver organoid obtained from iPSC grown on a 3D scaffold. The
cells of express the markers as claimed (from 13:40, disclosing the structure of the scaffold comprising hyaluronic acid and RGD peptides from collagen, and 18:30 for the gene expression).
Kumar discloses a liver organoid derived from the co-culture of pre-differentiated
hepatoblast, stellate cells, endothelial cells and macrophages in a cross-linked
hydrogel (figure 4).
Ouchi discloses a liver organoid obtained from iPSC embedded in Matrigel and
comprising stellate and cholangiocytes (figure 1).
Note that MPEP § 706.3(e) states that:
"[w]hen the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 35 U.S.C. 102 or 35 U.S.C. 103 of the statute is appropriate. As a practical matter, the Patent and Trademark Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. A lesser burden of proof is required to make out a case of prima facie obviousness for product-by-process claims because of their peculiar nature than when a product is claimed in the conventional fashion. In re Brown, 59 CCPA 1063, 173 USPQ 685 (1972) ; In re Fessmann, 180 USPQ 324 (CCPA1974)."
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not Applicants' organoids differ and, if so, to what extent, from that discussed in the references. Therefore, with the showing of the references, the burden of establishing non-obviousness by objective evidence is shifted to Applicants.
[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on `inherency' under 35 U.S.C. 102, on `prima facie obviousness' under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same...[footnote omitted]." The burden of proof is similar to that required with respect to product - by - process claims. Quoting In re Fitzgerald, 619 F. 2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (itself quoting In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 - 34 (CCPA 1977)).
The references anticipate the claimed invention.
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.
Claim(s) 1-12 & 15-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/227711 (FUJI) HCS Pharma: "Applications for 3D in vitro models with BIOMIMESYS Liver - March 2021", , 26 March 2021 (2021-03-26), XP055930623; AND
KUMAR ET AL ", BIORXIV,2020-09-04: AND and OUCHI ET AL: CELL METABOLISM, CELL PRESS, UNITED STATES, vol. 30, no. 2, 30 May 2019 (2019-05-30), page 374,
FUJI discloses the differentiation of iPSC into hepatocytes using successive culture medium comprising defined cytokines and normal and hypoxic conditions (figures 1-5).
Fuji does not perform their culture on a a 3D porous scaffold however it would have been obvious to culture the cells of FUJI on a 3-D porous scaffold because each of HCS, Kumar & Ouchi teach culturing the same cells on such a scaffold to create a liver organoid. HCS discloses a liver organoid obtained from iPSC grown on a 3D scaffold. The cells of express the markers as claimed (from 13:40, disclosing the structure of the scaffold comprising hyaluronic acid and RGD peptides from collagen, and 18:30 for the gene expression). HCS teaches that 3D structures of endodermic progenitors improve the functionality of hepatocytes (see D1, from 15:00). Kumar discloses a liver organoid derived from the co-culture of pre-differentiated hepatoblast, stellate cells, endothelial cells and macrophages in a cross-linked hydrogel (figure 4). Ouchi discloses a liver organoid obtained from iPSC embedded in Matrigel and comprising stellate and cholangiocytes (figure 1). Ouchi further teaches the advantage of 3D scaffold to differentiate hepatocytes (p 172).
All references cited discuss the obvious use of the cells as an in vitro assay to test liver affecting drugs and the concept of transplantation of the cells or organoids to replace damaged liver tissue.
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.”
"[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).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made 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