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 .
Status of the Claims
Claims 1-16 are pending (claim set as filed on 06/09/2023).
Priority
This application is a 371 of PCT/JP2021/040342 filed on 11/02/2021, which has a foreign application to JP 2020-206130 filed on 12/11/2020.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 06/09/2023 and 07/18/2023 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Drawings
The drawings filed on 06/09/2023 have been accepted.
Claim Interpretation
The MPEP 2103(I)(C) states that “For products, the claim limitations will define discrete physical structures or materials. Product claims are claims that are directed to either machines, manufactures or compositions of matter” and “For processes, the claim limitations will define steps or acts to be performed”. The statutory class of invention for the instant claimed invention is drawn to a product or composition of matter and not a method or process of using or making.
Regarding claim 1’s preamble, the recitation of “for use in prevention or treatment of liver fibrosis or liver cirrhosis” has been considered but not given patentable weight because it is an intended use of a composition or product. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone (MPEP 2111.02: Effect of Preamble). Dependent claims 8-12 and 15 are embodiments or merely further describe the intended use application and thus, also do not limit the pharmaceutical composition.
Regarding claims 13-14 and 16, the recitation of the phrase “is prepared” invokes the interpretation of a product-by-process claim. The MPEP 2113 states that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. As stated above, the emphasis of analysis of a product claim is primarily based upon its discrete physical structures or material and not the steps to make the product or composition.
Claim Rejections - 35 USC §101, Subject Matter Eligibility
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 1-16 are rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter (based on the 2019 Revised Patent Subject Matter Eligibility Guidance).
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a composition of matter.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
YES, the claims are considered to be “product of nature” exceptions. The courts have held that “products of nature” fall under the laws of nature and/or natural phenomena exceptions.
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the additional elements or a combination of elements in the claims does not impose a meaningful limit on the judicial exception. Note that the markedly different characteristics analysis is used to determine if a nature-based product is a “product of nature” exception. Thus, the markedly different characteristics analysis is part of Step 2A, i.e., it helps answer the question of whether a claim is directed to an exception as further explained below.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to a law of nature and/or natural phenomena (i.e., a product of nature) without significantly more. Note that the claims must be interpreted under the broadest reasonable interpretation (BRI) standard when evaluating for a marked difference. Under BRI, the claims broadly read on natural cells that are found in the body:
the instant specification discloses that the adipose tissue-derived regenerative cells (ADRCs) “of the present disclosure may be isolated from adipose tissue” (see pre-grant specification at ¶ [0018], [0104]-[0109]).
There is no indication that the claimed composition has any markedly different characteristic (e.g., structure, function, phenotype, etc.) that is different than what is found in nature. Thus, it appears that Applicant is claiming a naturally occurring product.
Therefore, the claims are interpreted under the BRI standard, wherein the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
Therefore, the claims, as a whole, are considered as products of nature which are directed to judicially recognized exceptions without amounting to significantly more from what occurs in nature and thus, are not eligible subject matter under 35 U.S.C. §101.
Claim Rejections - 35 USC §102, Anticipation
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 and 6-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakai (Phase I clinical study of liver regenerative therapy for cirrhosis by intrahepatic arterial infusion of freshly isolated autologous adipose tissue-derived stromal/stem (regenerative) cell, 2016 - cited by the ISA and in the IDS filed on 06/09/2023).
Sakai teaches “a clinical study to investigate freshly isolated autologous adipose tissue-derived stromal/stem (regenerative) cell (ADRC) therapy for liver cirrhosis and conducted treatment in four cirrhotic patients. ADRCs were isolated from autologous subcutaneous adipose tissue obtained by the liposuction method, followed with use of the Celution system adipose tissue dissociation device. The primary endpoint is assessment of safety one month after treatment. We also characterized the obtained ADRCs” (see abstract).
Regarding claims 3-4, Sakai teaches “adipose tissue contains a substantial number of stem cells in its stromal fraction. Mesenchymal stromal cells (MSCs) are somatic stem cells capable of differentiating into various types of cells including hepatocytes” (see page 53, left col., and see page 53, right col.: Section 2.3).
Regarding claim 4, Sakai teaches “the freshly obtained cells were infused through a catheter, the tip of which was placed in the common hepatic artery, and the maximal number of cells administered was 6.6 x 105 cells/kg” (i.e., uncultured cells) (see page 53, left col.).
Regarding claim 6, Sakai teaches “a regenerative therapy clinical study using autologous freshly isolated adipose tissue-derived stromal/stem (regenerative) cells (ADRCs) for liver cirrhosis” (see page 53, left col.).
Regarding claim 7, Sakai teaches surface antigens expression of the ARDCs include CD45 (see Tables 3-4).
Regarding claims 8-12 and 15 pertaining to the intended use, Sakai teaches “liver cirrhosis is the end-stage condition of a variety of chronic liver diseases, including viral hepatitis, primary biliary cirrhosis, alcoholic hepatitis, and nonalcoholic steatohepatitis” (see page 52, right col. and Table 2).
Regarding claims 13-14 and 16, Sakai teaches “we administered 3.3 x 105 cells/kg and 6.6 x 105 cells/kg of the freshly isolated ADRCs in two patients, respectively, using an intravascular catheter, which was subcutaneously inserted through the femoral artery and guided to the common hepatic artery” (see page 53, right col.).
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fraser (US Patent no. 9,198,937 B2).
Regarding claims 1-3, Fraser’s general disclosure relates to the field of regenerative medicine and “cells derived from adipose tissue, and more particularly, to adipo-derived stem cells, methods of using adipo-derived stem cells, compositions containing adipo-derived stem cells, and systems for preparing and using adipo-derived stem cells” (see col. 1, lines 20-25).
Regarding claim 4, Fraser teaches that in some embodiments, cells are not processed for culturing (see col. 14, lines 6-24).
Regarding claim 5, Fraser teaches one of the units is cryopreserved material that contains, for example, an increased concentration of active cells (see col. 14, lines 45-50).
Regarding claim 6, Fraser teaches that autologous adipose is common procedure (see col. 15, lines 41-45, and Example 1).
Regarding claim 13, Fraser teaches “the concentrated cells may be loaded into a delivery device, such as a syringe, for placement into the recipient by either subcutaneous, intravenous, intramuscular, or intraperitoneal techniques. In other words, cells may be placed into the patient by any means known to persons of ordinary skill in the art, for example, they may be injected
into blood vessels for systemic or local delivery, into tissue” (see col. 15, lines 1-10).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4 and 13 are rejected on the ground of non-statutory double patenting as being unpatentable over at least claims 1-4, 6, 8, and 14 of U.S. Patent no. 9,198,937.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘937 teaches “a method of treating alcohol-induced liver injury in a patient in need thereof, comprising: (a) identifying a patient with alcohol-induced liver injury; (b) providing a tissue removal system; (c) removing adipose tissue from a patient using the tissue removal system; (d) processing at least part of the adipose tissue to obtain a concentrated population of adipose-derived cells comprising stem cells, wherein the concentration of stem cells is at least 0.1% of the adipose-derived cell population, wherein the processing comprises disaggregating the adipose tissue to free adipocytes and other cell populations from adipose tissue matrix to obtain a cell suspension; reducing the presence of free adipocytes in the cell suspension; and concentrating the cell suspension, to obtain the concentrated population of adipose-derived cells comprising stem cells; and (e) administering the concentrated population of adipose derived cells comprising stem cells to the patient with alcohol-induced liver injury” (see claims 1-2).
Regarding claim 2, ‘937 teaches the stem cells comprise more than 0.1 % of the cellular component of the concentrated population of adipose-derived cells (see claim 14).
Regarding claim 4, ‘937 teaches the stem cells are not cultured prior to administration to the patient (see claim 6).
Regarding claim 13, ‘937 teaches intravenous administration (see claims 3-4).
Conclusion
No claims were allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NGHI V NGUYEN/Primary Examiner, Art Unit 1653