DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to a claim set filed 10/9/2025. Claims 1-19 are pending.
This application is a U.S. national phase entry under 35 U.S.C. § 371 of PCT International Application No. PCT/US2023/066409, filed April 28, 2023, which claims the benefit of priority of U.S. Provisional Application No. 63/363,894, filed April 29, 2022.
Information Disclosure Statement
An IDS filed 10/28/2024 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through. In the case that only an English abstract was identified, this is indicated.
Drawings
Figure 24 and 43D is objected to under 37 CFR 1.83(a) because they fail to show any details as described in the specification. Specifically, Figure 24 has text that is not legible
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Figure 43D is simply 3 circles.
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Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). A proposed drawing correction or corrected drawings are required in reply to the Office action to avoid abandonment of the application. The objection to the drawings will not be held in abeyance.
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 1-19 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.
The dependent claims are included in the rejection because they fail to address or clarify the basis of the rejection as discussed in detail for the independent claims.
Claims 1-19 contain the name MicroOrganoSphere and MOS which is according to the internet a registered trademark. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe MOS and, accordingly, the identification/description is indefinite.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: what steps are entailed by the process of “generating MOSs” from the hepatocytes. The claims simply recite a desired outcome without the means to accomplish the outcome.
Claim 2 recites the limitation "the cell density" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-11 and 13-19 recite a use of the MOS to drug screen wherein the claim indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). The method recites an outcome without providing means to accomplish drug screening using a MOS. This is compounded by recitation in claim 19 that in the method of drug screening, the MOS models liver regeneration. IN a method of drug screening, it is not clear how this will also allow liver regeneration.
Claim 11 is vague in reciting “long-term”. The term “long-term” is a relative one not defined by the claim, no single set of conditions is recognized by the art as being “long-term” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established. This is complicated by the assay in what appears to be culture wherein it is not known how long to mediate this administration to mimic long term administration.
Claim 12 similarly recites “use of a MOS” in a method of drug screening without any indication of what is encompassed by “use”. Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. In this case, the claim sets forth a use without any active steps such that one would know how the use is to proceed.
The term “donor” in claim 15 is used to describe the source of the hepatocyte. However, it is a relative term that has no basis in the claim. The claim does not deal with what the donor status is based on or to whom the donor is for and hence this is a relative term. In claim 16, the donor is a patient in need of treatment but it is not clear for what.
Claim 5 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 4. 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). Claim 1 due to the lack of steps simply recites the same thing as that recited in claim 5, MOS generated from hepatocytes as this is the only recitation of claim 1.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Following the decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) 101 USPQ2d 1961, 1965-1966 (SC March 2012), the US Patent & Trademark Office published 2012 Interim Procedure for Subject Matter Eligibility Analysis of Process Claims Involving Laws of Nature (Guidelines). The Guidelines set forth a set of three inquiries that are to be conducted on the claim as a whole to determine whether the claim is drawn to patent-eligible subject matter.
Step 1: This part of the eligibility analysis evaluates whether the claims falls within any statutory category MPEP 2106. 03. Here, the claim is directed to a product of nature in that MOS are biopsies from individual patients grown into tiny versions of unique organs and tumors.
Step 2 Prong One: This step determines if the claim recites a judicial exception. Because the claims recite a nature based product limitation, the markedly different characteristics analysis is used to determine if the nature based product limitation is a product of nature exception. MPEP 2106.04(c (II). The products are simply cells removed from a subject/individual.
Step 2 Prong Two: This step evaluates whether the claims as a whole integrates the recited judicial exception into a practical application of the exception. The claim does not recite additional elements that integrate the judicial exception into a practical application by reciting that the sequence. Under the broadest reasonable interpretation, the terms of the claims are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. Sep MPEP 2111. The disclosure states that cells are dissociated from primary tissue cells including cancer and normal tissues and grown and while the disclosure states that in some embodiments the cells can be encased in a liquid matric material, the disclosure is not so limited. Hence, the product can be just a cell.
Step 2B: This step evaluates whether the claim as a whole amounts to significantly more than the recited exception i.e. whether any additional elements or combinations of additional elements adds an inventive concept to the claim MPRP 2106.05. The claimed MOS is present in claims 1-5 and is simply a mini-tumor or organ. This does not indicate any difference from the native state of the same cells and the cells once they are isolated to be grown. The claims drawn to growing the MOS and using the MOS do not provide any steps or components that would distinguish the product from a native cell, organ or tumor.
Claim Rejections - 35 USC § 112, first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-19 recite a number of limitations that are not sufficiently described to provide the support for the genus of claimed inventions. Claims 1-5 are drawn to methods for generating MOSs from hepatocytes and MOS generated thereof. As a first issue, MOSs are not specifically defined in the disclosures and hence not particularly limited. The claims thus are drawn to any product generated from hepatocytes. These MOS are used in claims 6-19 for drug screening wherein the steps as set forth above are missing. Claim 11 requires assessing long-term administration. There are no details in the disclosure of how to determine what long-term administration in culture or how to assess the effect to mimic long term administration is performed. Claim 19 recites that the MOS models liver regeneration. How the MOS performs this function is unclear as set forth above but also the disclosure does not describe any methods of drug screening that also allows modeling of liver regeneration. It is noted that there is no disclosure related to liver regeneration in the specification.
Turning to the MOS, the generic nature of the claims is not reflected in the disclosure wherein as set forth above, this lack of claimed elements leads to an interpretation of mini-organs that read on products of nature. However, the examples detail an apparatus into which is mixed dissociated biopsy or normal cells with a fluid matrix material to form an unpolymerized mixture which then polymerizes to form a MOS. As to drug screening and related methods, the disclosure different from the claims which provides no steps teaches that MOS are cultured in a multi-well device, cultured and then dosed with drug compounds and effects measured (see ¶0177-0179).
The claims lack adequate description to link structure to these required functions. The Court indicated that while applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a precise definition of a representative number of members of the genus, such as by reciting the structure. Structural features that could distinguish the compounds of the claimed genus from others not encompassed by the genus are missing from the disclosure. In this case, there are specific elements referenced but the claims reference these structures with broad generic functional terms that represent a large and diverse genus of elements. To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art). As recited, the method lacks critical elements that provide necessary function. What is necessary is 1) a promoter prior to the therapeutic coding sequence that responds to a transcription factor and 2) a transcription factor or co-factor coding sequence preceded by a promoter with Gal4 response elements. But, this would still not demonstrate modulation of expression.
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.
Claims 1-13 and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al (US 20200377861) as evidenced by Mosedale and Watkins (Clin Pharmacol Ther. 2017 April ; 101(4): 469–480).
Shen et al teach generating MOSs from hepatocytes (see figure 5 and description) and hence reads on claims 1, 4 and 5.
As claimed in claims 2 and 3, figure 14 shows that the size includes 50-500 mM in diameter i.e. 300 mM (see ¶0088) and 1-200 cells/droplet (¶0014).
Shen teaches use for drug screening such as high throughput as recited in claim 6, 8 and 12 (see e.g. ¶0008). Toxicity is studied (see e.g. ¶0029 and 0159) and a drug response profile (see e.g. ¶0080) as recited in claims 7 and 9.
Shen teaches assessing DILI following acetaminophen (as evidenced by Mosedale and Watkins this is a DILI analysis, see abstract) as recited in claims 10 and 11.
The hepatocytes can be from patients (hence primary hepatocytes and also from a donor) as recited in claims (see e.g. ¶ 0009 and 0119).
Figure 18 demonstrates that the MOS is viable for at least 3 weeks and the cells are liver specific properties (see e.g. ¶0183).
Claims 1, 4, 5, 6 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitrani (US 20030129736).
Mitrani et al teach generation of mini-organs from hepatocytes (¶0045) as recited in claims 1, 4 and 5. Figure 24 demonstrates drug testing as recited in claim 6 and 7. The organ displays liver specific biological functions (see e.g. ¶0136) and is viable for up to 4 weeks wherein the cells are derived from adult cells, primary cultures or a donor (pig) (see ¶0032, 228) as recited in claims 13, 17 and 18.
The cells by demonstrating liver function appear to teach liver regeneration goals and the liver function being restored can be after toxic effects (see e.g. ¶0008, 0010 and 0236) The hepatocytes can be from the patient (see e.g. 0010 and 0136).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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