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 Status
Amendments to claims 3-11 filed 06 Feb 2025 are acknowledged. Claims 1-11 are pending and under consideration.
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.
Claim 10 is rejected under 35 U.S.C. § 101 because the claimed invention is directed to a natural product without significantly more. The claim recites a cell aggregate produced by filling a mixture of mesenchymal stem cells (MSC), endothelial cells, and organ cells into a microfiber and subjecting the cells to floating culture within the microfiber. This judicial exception is not integrated into a practical application because the cell aggregate comprising MSC, endothelial cells, and organ cells is a product-by process that is indistinguishable from animal organs, such as liver. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I). The claim does not include additional elements sufficient to amount to significantly more than the judicial exception because the process of forming the cell aggregate recited in claim 1, from which claim 10 depends, do not impose structural differences that render the cell aggregate markedly different from animal tissue. The specification provides that "'organ cells' refers to functional cells that constitute an organ or undifferentiated cells that differentiate into functional cells" (par. 27). Therefore, the term "organ cell" is interpreted to be a parenchymal cell, which is a term recognized in the art. Each tissue comprises at least one parenchymal cell that performs the key functions of the tissue. Endothelial cells line the lumen of all blood vessels and are, therefore, found in all vascularized organs. MSC are found in nearly all tissues (Y. Wang, et al. Cell Stem Cell, 2022). Therefore, the cell aggregate encompasses any tissue comprising at least MSC, endothelial cells, and at least one other parenchymal cell or progenitor thereof. Thus, the cell aggregate is not markedly different from any vascularized tissue found in an animal.
The Office published the guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published 16 Dec 2014. Step 2A was revised to include two prongs (Federal Register / Vol. 84, No. 4 / 07 Jan 2019).
Analysis is as follows:
Step 1: Is the claim to a process, machine, article of manufacture, or composition of matter?
The claim is directed to a composition of matter (cell aggregate).
Step 1: Yes.
Step 2A, Prong One: Is the claim directed to a judicial exception to a statutory category?
The composition of matter (cell aggregate) is directed to a natural product. The claim recites a composition that is not markedly different from any vascularized animal tissue.
Step 2A, Prong One: Yes.
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into practical application of the exception?
This exception is not integrated into practical application because the claim does not recite additional elements that integrate the judicial exception into practical application. The claim recites that the cell aggregate is "produced by the method according to claim 1". However, the cell aggregate is a product-by-process and the process recited in claim 1 does not impose structural differences that render the cell aggregate markedly different from animal tissue. The process of forming the cell aggregate merely links the judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(h).
Step 2A, Prong Two: No.
Step 2B: Does the claim recite additional elements that individually or in combination amount to significantly more than the judicial exception (i.e., whether the additional elements provide an inventive concept)?
The additional elements recited in the claim do not add an inventive step to add significantly more than linking the judicial exception to a particular technological environment or field of use when considered alone or in combination.
Step 2B: No.
The markedly different characteristics analysis performed in Step 2A, Prong One is a comparison of the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See MPEP § 2106.04(b)(II). If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a product of nature exception, and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. In accordance with this analysis, a cell aggregate comprising MSC, endothelial cells, and organ cells, for example, is eligible when there is a resultant change in characteristics sufficient to show a marked difference from any vascularized animal tissue comprising MSC. It is concluded here that the claimed cell aggregate is not markedly different from its naturally occurring counterpart, vascularized animal tissue comprising MSC, as the claim does not recite structural limitations that distinguish the cell aggregate composition from the composition of vascularized animal tissue comprising MSC.
The Supreme Court has identified several considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may qualify as significantly more when recited in a claim with a judicial exception include: improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Limitations that were found not to be enough to qualify as significantly more when recited in a claim with a judicial exception include: adding the words ‘apply it’ (or an equivalent) with the judicial exception; mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception; adding insignificant extra-solution activity to the judicial exception; or generally linking the use of the judicial exception to a particular technological environment or field of use.
In the instant case, the limitations of the claims do not impose limits on the scope of the claim such that the claimed cell aggregate is markedly different from a naturally occurring product. Accordingly, based on analysis of the claim as a whole, claim 10 does not recite additional elements adding significantly more than the judicial exception. Thus, claim 10 is rejected under 35 U.S.C. § 101 because the claimed invention is not directed to patent eligible subject matter.
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.
Claim 10 is rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Guirevich (US 2022/0220440 A1, 14 Jul 2022).
Regarding claim 10, Guirevich discloses a liver organoid (cell aggregate) comprising hepatocytes (organ cells), endothelial cells (vascular endothelial cells), and mesenchymal stem cells (par. 181). The cell aggregate recited in claim 10 is a product-by-process claim. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
Claims 10-11 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Takebe (T. Takebe, et al., Nature, 2013).
Regarding claim 10, Takebe discloses a liver bud (cell aggregate) comprising induced pluripotent stem cell (iPSC)-derived hepatic endodermal cells (organ cells), human umbilical cord vascular endothelial cells (vascular endothelial cells), and mesenchymal stem cells (p. 481). The cell aggregate recited in claim 10 is a product-by-process claim. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
Regarding claim 11, Takebe discloses transplantation of the liver bud (cell aggregate) comprising induced pluripotent stem cell (iPSC)-derived hepatic endodermal cells (organ cells), human umbilical cord vascular endothelial cells (vascular endothelial cells), and mesenchymal stem cells into mice to rescue drug-induced liver failure (pp. 481 and 483-484 and Fig. 3).
Claims 10-11 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Pleniceanu (O. Pleniceanu, et al., J Am Soc Nephrol, 2020).
Regarding claim 10, Pleniceanu discloses a 3D nephrosphere (a cell aggregate) comprising human renal tubule forming cells (RTFC, organ cells), mesenchymal stem cells (MSC), and endothelial colony forming cells (ECFC, progenitors of vascular endothelial cells) (Results p. 2764). It is noted in the specification that the vascular endothelial cells of claim 10 may be in an undifferentiated state (par. 29), and thus, the ECFC disclosed by Pleniceanu anticipate the vascular endothelial cells of claim 10. The cell aggregate recited in claim 10 is a product-by-process claim. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
Regarding claim 11, Pleniceanu discloses injection of the 3D nephrosphere to generate de novo renovascular units in a partial nephrectomy model (method for treating damage to an organ comprising administering an effective amount of the cell aggregate) (p. 2764).
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.
Claims 1-10 are rejected under 35 U.S.C. § 103 as being unpatentable over Guirevich (US 2022/0220440 A1, 14 Jul 2022) in view of Nie (M. Nie, et al., Biofabrication, 2020).
Guirevich discloses a liver organoid (cell aggregate) comprising hepatocytes (organ cells), endothelial cells (vascular endothelial cells), and mesenchymal stem cells (MSC) as discussed above in the rejection of claim 10 under 35 U.S.C. § 102(a)(1).
Regarding claims 1-2, Guirevich discloses a method of producing a liver organoid (cell aggregate) comprising mixing hepatocytes (organ cells), endothelial cells (vascular endothelial cells), and mesenchymal stem cells (MSC) and plating the mixture into ultra-low attachment plates (floating culture) (par. 181).
Regarding claims 3-4 and 9, the hepatocytes taught by Guirevich were derived from induced pluripotent stem cells (iPSC) differentiated through a definitive endoderm stage before differentiation into mature hepatocytes (par. 161-162). Note that deriving cells from induced pluripotent stem cells is a product-by-process limitation. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
Guirevich does not teach formation of the liver organoid by seeding the cell mixture into a microfiber as required by claims 1-9, a cell density in the microfiber of 5 x 106 to 4 x 108 cells/mL as required by claim 6, a proportion of MSC in the mixture of 1% to 20% as required by claim 7, or a proportion of endothelial cells in the mixture of 10% to 60% as required by claim 8.
However, regarding claim 1, Nie teaches a method for generating spheroids (cell aggregates) by filling microfibers with cells, wherein the cells aggregate because the cells are suspended in the lumen cannot adhere to the shell of the microfiber (floating culture) (p. 7). Nie further teaches that the method is desirable when it is essential to handle and manipulate biomaterials on a small scale and can reduce time and cost for cell preparation by reducing the number of cells required (Introduction p. 1 and Conclusions p. and 9). Nie further teaches that the method is broadly applicable to different cell types and demonstrates formation of cell aggregates comprising primary hepatocytes, skeletal myocytes, and HepG2 (a hepatocellular carcinoma cell line) (pp. 7-9 and Fig. 4).
Regarding claim 5, the microfiber taught by Nie has a core diameter of 100 μm (Conclusions p. 9).
Regarding claims 6-8, Guirevich teaches generation of liver organoids by seeding 106 cells/mL comprising hepatocytes, macrophages, MSC, and endothelial cells at a ratio of 1.0 : 0.5 : 2.0 : 0.2, respectively, which equates to 27.0% hepatocytes, 54.1% MSC, and 5.4% endothelial cells (par. 181). The density of cells falls outside of the claimed range 5 x 106 to 4 x 108 cells/mL as required by claim 6. The proportion of MSC falls outside of the claimed range of 1% to 20% as required by claim 7. The proportion of endothelial cells falls outside of the claimed range of as required by claim 8. However, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). It is routine procedure to optimize component amounts to arrive at an optimal product that is superior for its intended use, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See MPEP § 2144.05.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to improve the method of producing a cell aggregate comprising hepatocytes, endothelial cells, and MSC as taught by Guirevich with by applying the known method of producing a cell aggregate by filling a microfiber with cells and subjecting the cells to floating culture as taught by Nie to arrive at the claimed invention. One would be motivated to make such a combination as Nie teaches that the method of producing cells by filling a microfiber allows for smaller scale tissue formation, which reduces the cost and complexity of preparing cells. One would be motivated to optimize the cell density and ratio of cell types taught by Guirevich because optimization of concentrations is prima facie obvious to a skilled artisan. One would have a reasonable expectation of success in making the combination as Nie teaches that the improved method of forming cell aggregates using microfibers is broadly applicable to different cell types, including hepatocytes, and demonstrates successful formation of cell aggregates.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12,012,616 B2 ('616 hereafter) in view of Takebe (T. Takebe, et al., Nature, 2013) and as evidenced by Hager (G. Hager, et al. Cytotherapy, 2013).
Claim 6 of '616 is drawn to an organ bud (a cell aggregate) comprising induced pluripotent stem cell (iPSC)-derived hepatic endoderm cells (organ cells), mesenchymal cells, and vascular cells that are CD31-positive and CD144-positive. CD31 and CD144 (also termed vascular endothelial cadherin, VE Cadherin) are canonical pan-endothelial cell markers and progenitors thereof (Hager pp.1426 and 1428).
Claim 10 of the immediate application recites vascular endothelial cells rather than CD31+CD144+ vascular cells and mesenchymal stem cells (MSC) rather than mesenchymal cells as required by claim 6 of '616. Note that the cell aggregate recited in claim 10 is a product-by-process claim. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
However, Takebe teaches that addition of endothelial cells to liver buds (cell aggregates) comprising iPSC-derived hepatic endodermal cells vascularize the liver buds to provide nutrients and gas exchange and improves engraftment upon transplant (p. 483). Takebe further teaches that MSC added to liver buds differentiate into perivascular cells that stabilize and prolong vasculature (p. 483). Takebe further teaches that endothelial cells and MSC contribute to stromal paracrine support of hepatic cells to replicate organ-level liver functions (p. 482). Takebe further teaches that liver buds comprising hepatic endodermal cells, endothelial cells, and MSC recapitulate liver structure and functions and can repopulate the liver in a model of drug-induced liver failure (pp. 482-484).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute CD31+CD144+ vascular cells and mesenchymal cells of claim 6 of '616 for vascular endothelial cells and mesenchymal stem cells as taught by Takebe to arrive at the claimed invention. One would be motivated to make such a substitution as Takebe teaches that endothelial cells vascularize hepatic cell aggregates and improve engraftment upon transplantation, because MSC stabilize and prolong hepatic cell aggregate vasculature, and together endothelial cells and MSC contribute to stromal paracrine support of hepatic cells in the aggregates. One would have a reasonable expectation of success in making the substitution as Takebe teaches that hepatic cell aggregates comprising hepatic endodermal cells, endothelial cells, and MSC recapitulate liver organ structure and function and readily repopulate failing livers.
Claims 10-11 of this application is patentably indistinct from claims 21, 24, and 28 of Application No. 18/670,347. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Claim 10-11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 24, and 28 of copending Application No. 18/670,347 ('347 hereafter) in view of Takebe (T. Takebe, et al., Nature, 2013). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claim 21 of '347 is drawn to an organ bud (a cell aggregate) comprising induced pluripotent stem cell (iPSC)-derived hepatocytes that are HNF4A positive (organ cells), mesenchymal cells, and vascular cells. Claim 24 of '347 is further recites that the vascular cells are vascular endothelial cells. Claim 28 of '347 is drawn to a method of regeneration of function recovery of a tissue or an organ (treating damage or disease of a tissue or an organ) comprising transplanting the organ bud (cell aggregate).
Claim 10 recites all the elements of claims 21 and 28 of '347 except that claim 10 recites vascular endothelial cells rather than vascular cells and mesenchymal stem cells (MSC) rather than mesenchymal cells. Claim 10 recites all the elements of claim 24 of '347 except that claim 10 recites MSC rather than mesenchymal cells. Note that the cell aggregate recited in claim 10 is a product-by-process claim. "[E]ven 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." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
However, Takebe teaches that MSC added to liver buds differentiate into perivascular cells that stabilize and prolong vasculature (p. 483). Takebe further teaches that MSC contribute to stromal paracrine support of hepatic cells to replicate organ-level liver functions (p. 482). Takebe further teaches that liver buds comprising hepatic endodermal cells, endothelial cells, and MSC recapitulate liver structure and functions and can repopulate the liver in a model of drug-induced liver failure (pp. 482-484).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute mesenchymal cells of claims 21, 24, and 28 and vascular cells of claims 21 and 28 of '347 for mesenchymal stem cells and vascular endothelial cells, respectively, as taught by Takebe to arrive at the claimed invention. One would be motivated to make such a substitution as Takebe teaches that endothelial cells vascularize hepatic cell aggregates and improve engraftment upon transplantation, because MSC stabilize and prolong hepatic cell aggregate vasculature, and together endothelial cells and MSC contribute to stromal paracrine support of hepatic cells in the aggregates. One would have a reasonable expectation of success in making the substitution as Takebe teaches that hepatic cell aggregates comprising hepatic endodermal cells, endothelial cells, and MSC recapitulate liver organ structure and function and readily repopulate failing livers.
Conclusion
No claim is allowed.
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Eric B Wright, PhD
Examiner
Art Unit 1632
/Eric B Wright/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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