DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/01/2026 has been entered.
Claims 24 and 53 have been amended.
No claims newly canceled or newly added.
Claims 24, 26-27, 35-37, 39-42, 44, and 47-53 are currently pending.
Claim 44 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2019.
Claims 37 and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2019.
Claims 24, 26-27, 35-36, 40-42, and 47-53 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Claim 24 is a product-by-process claim. M.P.E.P. § 2113 reads, “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
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. The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product.
The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. The lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when 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 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent 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.
Applicant’s claims require that the organoids contain at least some cells that are derived from an adult epithelial stem cell from an adult tissue, however this does not preclude the presence of other epithelial cells being present in the claimed compositions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 24, 26-27, 35, 40, 41, 47-52 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Amour et al (WO 2007/127454-from IDS filed 10/23/2017) in view of Green et al (US 2010/011269), Moore et al (Gender Medicine, 2006), Kim et al (Molecular Biology of the Cell, June 2008) and Semler et al (Biotechnology and Bioengineering 2000-from IDS filed 10/23/2017) and as evidenced by Tsai et al (Cellular and Molecular Gastroenterology and Hepatology, 2016).
Regarding claims 24, 26-27, 35, 40, 41, 47-51, D’Amour et al teach a culture composition that comprises cell aggregates formed from human foregut endoderm (which contains multipotent adult stem cells with the capacity to differentiate into epithelial cells) along with culture medium that comprises 50 ng/ml of FGF10 (mitogenic growth factor), noggin (BMP inhibitor) and Wnt3a (Wnt agonist) (page 116 para 422).
D’Amour are silent with regard to expression of Lgr5 in their human endoderm cells, however Tsai et al teach that Lgr5 is expressed in the human definitive endoderm (page 848 Results and page 657-658) and thus is deemed to be inherently present in the human endoderm cell cultures of D’Amour.
D'Amour do not specifically teach the use of epithelial stem cells from adult tissue.
Green teach a method of producing cell aggregates from stem cells and specifically teach that “one skilled in the art can choose an appropriate cell type(s) for the cell aggregates, based on the type of three-dimensional tissue or organ to be desired. Non-limiting examples of suitable cell types include stem cells (e.g. adult and embryonic)” as well as epithelial cells (page 9 para 83). D’Amour is also included as an inventor in the Green reference.
Moore teach that adult stem cells are an alternative to embryonic stem cells motivated by the moral and ethical debate surrounding the origins of human life (abstract, page 166 conclusion).
One of ordinary skill in the art would have been motivated to use adult stem cells as an alternative to embryonic stem cells in the method of D’Amour because Moore teach that one of the advantages of adult stem cells is that they do not have the moral and ethical concerns that embryonic stem cells have and because Green indicate that cell aggregates can be formed from adult stem cells or embryonic stem cells. One of ordinary skill in the art would have been motivated to select adult epithelial stem cells because D’Amour indicate that multipotent cells that have the potential to differentiate into epithelial cells are desired and useful in their methods (page 30 para 207-208). One of ordinary skill in the art would have had a reasonable expectation of success because D’Amour is also an inventor for the Green reference method. D’Amour specifically state that their methods are not limited to the preferred embodiments and are exemplary. Changes therein will occur to those skilled in the art including varying substitutions and modifications (page 117 para 425).
D’Amour et al do not specifically teach r-spondin proteins as alternatives or additions to Wnt proteins.
Kim teach that the R-spondin (RSpo) family of secreted proteins is implicated in the activation of the Wnt signaling pathway (abstract). Rspo proteins are taught to dramatically synergize with Wnt3A (page 2588, column 1, page 2589 last paragraph to page 2590 first paragraph). Treating cells with either varying amounts of Wnt3A or RSpo 1-4 alone was taught to be insufficient to trigger a robust response and co-treatment of RSpo with Wnt3A significantly increased TCF reporter activity (approximately 150-fold) (page 2590 first paragraph).
Therefore, one of ordinary skill in the art would have been motivated to include R-spondin 1 to R-spondin 4 as in addition to or as an alternative to Wnt3a in the culture composition of D'Amour et al because Kim et al teach that they are art recognized equivalents for the purpose of activating the Wnt pathway and provide a synergistic effect when combined with Wnt3A. One of ordinary skill in the art would have had a reasonable expectation of success because D’Amour et al suggest that alternatives are suitable for inclusion in their invention.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Also it is deemed obvious to substitute art recognized equivalents for the same purpose and an express suggestion to make such a substitution is not necessary to render it obvious (see MPEP 2144.06, I-II).
D’Amour et al do not explicitly describe the culture composition with an exogenous extracellular matrix, however one of ordinary skill in the art would have been motivated to add an extracellular matrix component as Semler et al teach that Matrigel (a commercial exogenous extracellular matrix that is obtained from EHS mouse sarcoma cells and contains collagen and/or laminin as per Applicant’s Specification) is beneficial to the formation and differentiation of hepatocyte cellular aggregates (page 359 column 2). One of ordinary skill in the art would have had a reasonable expectation of success because D’Amour et al suggest that it is suitable and beneficial to add extracellular matrix proteins to their embodiments (page 79 para 314).
While D’Amour et al do not specifically describe all the claimed features (sealed central lumen lined by epithelial stem cells that are capable of expansion of at least three months, random orientation of the cells, and free of myofibroblasts), D’Amour et al use the same claimed cells (tissue containing adult stem cells that have the potential to differentiate into epithelial cells) and when modified by Green, Moore, Kim and Semmler as described above, would include the same cell type, culture method steps and culture medium as recited in claims 24, 47-51 which are indicated as expanding cells and forming the organoid composition of claim 24 and therefore these claimed features are deemed to be inherent.
Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) provides "that since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims."
Regarding the issue of inherency, see Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020). (see MPEP 2112 (IV)).
Applicant’s claims require that the organoids contain at least some cells that are derived from an adult epithelial stem cell from an adult tissue, however this does not preclude the presence of other epithelial cells being present in the claimed compositions. In addition, whether the epithelial stem cells are primary (derived from adult epithelial tissue) or derived from foregut endoderm is only significant if Applicant can prove that the final product is structurally different when contacted with the same culture medium and matrix. In any event, the prior art provides a motivation and reasonable expectation of success to obtain epithelial stem cells from adult tissue as an alternative to deriving them from pluripotent stem cells as described above by Green and Moore.
Regarding claim 52, the culture medium of D’Amour includes FGF10, but does specifically include EGF, R-spondin 1-4, HGF or nicotinamide. However, D’Amour does include Wnt-3a (which is an alternative Wnt agonist to R-spondin 1-4 as recited in claim 33) and FGF (which is an alternative mitogenic growth factor to EGF and HGF as recited in claim 32) and thus appears to have the essential culture media ingredients to form the composition of claim 24. The addition of nicotinamide improves culture efficiency and lifespan of the cells (page 91 lines 20-24 of Applicant’s specification), but does not appear to be required for the formation of the composition or its structural features. Evidence that culturing with nicotinamide provides a structural or functional difference to the final composition would overcome the rejection of this claim.
Regarding claim 41, D’Amour are silent with regard to presence of nuclear beta-catenin in their human endoderm cells, however Applicant’s specification teaches that when a Wnt agonist is added to the culture medium that this results in enriched nuclear beta-catenin (page 8 line 28-page 29 line 2). Since D’Amour includes a Wnt agonist in their culture medium (page 116 para 422), the nuclear beta-catenin is deemed to be inherently enriched as well.
Therefore, the combined teachings of D’Amour et al, Green et al, Moore et al, Kim et al and Semmler et al render obvious Applicant’s invention as claimed.
Claim 52 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Amour et al (WO 2007/127454-from IDS filed 10/23/2017) in view of Green et al (US 2010/011269), Moore et al (Gender Medicine, 2006), Kim et al (Molecular Biology of the Cell, June 2008) and Semler et al (Biotechnology and Bioengineering 2000-from IDS filed 10/23/2017) and as evidenced by Tsai et al (Cellular and Molecular Gastroenterology and Hepatology, 2016) as applied to claims 24, 26-27, 35, 40, 41, 47-52 above, and further in view of Chen et al (US 2004/0229355).
The combined teachings of D’Amour et al, Green et al, Moore et al, Kim et al and Semler et al render obvious Applicant’s invention as described above and D’Amour et al suggest that nicotinamide is a suitable protein additive to their culture medium (page 80 para 315, pages 86-87 para 328).
D’Amour et al do not explicitly include epidermal growth factor (EGF) and hepatocyte growth factor (HGF) in their culture composition.
Semler et al teach that epidermal growth factor (EGF) and hepatocyte growth factor (HGF) can systematically enhance aggregation kinetics and modulate liver-specific function (page 365 Discussion). A suitable concentration of EGF and HGF are taught (abstract, page 360 column 2, page 362 figure 2) especially when used with another growth factor.
Therefore, one of ordinary skill in the art would have been motivated to use EGF and HGF in the culture composition of D’Amour et al because Semler et al teach that these growth factors enhance cellular aggregation and that cellular aggregation plays a critical role in the establishment of functional tissue (page 365). One of ordinary skill in the art would have had a reasonable expectation of success because D'Amour et al suggest that one or more growth factors can be included in their embodiments and that EGF is a suitable growth factor (page 79 para 315).
Chen et al teach culture media for long term culture of hepatocytes (epithelial cells) and specifically teach that nicotinamide helps to stimulate replication and improve viability and cell function (page 2 para 13).
Therefore, one of ordinary skill in the art would have been motivated to use nicotinamide in the culture composition of D’Amour et al because Chen et al teach that this compound helps to stimulate replication and improve viability and cell function (page 2 para 13). One of ordinary skill in the art would have had a reasonable expectation of success because D'Amour et al suggest that one or more growth factors can be included in their embodiments and that nicotinamide is deemed to be a suitable and beneficial growth factor for inclusion (page 80 para 315, pages 86-87 para 328).
Therefore, the combined teachings of D’Amour et al, Green et al, Moore et al, Kim et al, Semler et al, and Chen et al render obvious Applicant’s invention as claimed.
Claim 42 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Amour et al (WO 2007/127454-from IDS filed 10/23/2017) in view of Green et al (US 2010/011269), Moore et al (Gender Medicine, 2006), Kim et al (Molecular Biology of the Cell, June 2008) and Semler et al (Biotechnology and Bioengineering 2000-from IDS filed 10/23/2017) and as evidenced by Tsai et al (Cellular and Molecular Gastroenterology and Hepatology, 2016) as applied to as applied to claims 24, 26-27, 35, 40, 41, 47-52 above and further in view of Brockbank et al (Thermofisher Cryopreservation Guide 2007).
D’Amour et al teach a culture composition that comprises cell aggregates formed from foregut endoderm (contains epithelial stem cells) along with culture medium that comprises 50 ng/ml of FGF10 (mitogenic growth factor), noggin (BMP inhibitor) and Wnt3a (Wnt agonist) (page 116 para 422).
Regarding claim 42, D’Amour do not specifically describe freezing their cell aggregates (organoids).
Brockbank et al teach that it is beneficial to cryopreserve cells for the purposes of research and biomedical processes (page 1 column 1, 1st paragraph). Small cell aggregates are taught to be successfully frozen when following published protocols (page 1, column 1, 2nd paragraph). Freezing at temperatures below -40F (which is also less than -5 degrees C) is recommended (page 6 column 1, 2nd paragraph).
One of ordinary skill in the art would have been motivated to freeze the cell aggregates of D’Amour to less than -5 degrees C because Brockbank et al suggest that this is beneficial to allow further use of the cells. One of ordinary skill in the art would have had a reasonable expectation of success because Brockbank et al suggest that freezing small aggregates is suitable and suggest DMSO as a cryoprotectant for the cells (page 2 column 1, 1st paragraph) and D’Amour suggest DMSO as a suitable additive to their cells as well (page 80 para 315, page 86-87 para 328).
Therefore, the combined teachings of D’Amour et al, Green et al, Moore et al, Kim et al, Semler et al and Brockbank et al render obvious Applicant’s invention as claimed.
Claim 53 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kuo et al (US 2010/0047853-previously cited).
Regarding claim 53, Kuo disclose a composition comprising a three- dimensional organoid having a lumen surrounded by cells that comprise a combination of in vitro expanded Lgr5+ adult epithelial stem cells and differentiated epithelial stem cell progeny, wherein the cells are derived from one or more Lgr5+ adult epithelial stem cells from an adult tissue and further comprising an exogenous extracellular matrix (a feature of in vitro expansion of Kgr5+ adult epithelial stem cells)(page 1 para 8, page 2 para 23, page 3 para 33 para 36, page 4 para 46 para 50, page 13 example 4 para 128-132).
The specific combination of features claimed is disclosed within the broad genera of epithelial cell types, sources, culture and storage conditions taught by Kuo, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of epithelial cell types, sources, culture and storage conditions from within the disclosure of Kuo to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that Kuo suggests that all these cited variables are suitable for inclusion in their method/composition.
Therefore, the teaching of Kuo renders obvious Applicant’s invention as claimed.
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 24, 26-27, 35-36, 40-42, and 47-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,752,124.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are also drawn to an organoid obtainable by a similar method that does not appear to be structurally different from the currently claimed organoid.
The patented composition comprises a three-dimensional organoid obtained by in vitro expansion of one ore more adult adenoma stem cells with a sealed central lumen lined by epithelial cells comprising cells expressing Lgr5, with an exogenous extracellular matrix and a culture medium.
The lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art (or in this case the co-pending application) 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 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent 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.
Therefore, the claim of the co-pending application anticipates the claim of the current application.
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered but they are not fully persuasive. Applicant’s arguments have been addressed in so far as they relate to the rejections above.
Applicant argues that because claim 53 describes an organoid consisting of epithelial stem cells and progeny thereof that claim 53 inherently describes an organoid free of myofibroblasts and is thus non-obvious over Kuo.
This is not found persuasive. Myofibroblasts can arise from epithelial cell progeny through a process called epithelial-mesenchymal transition (EMT), where polarized epithelial cells lose their markers (like E-cadherin) and acquire mesenchymal features, eventually differentiating into contractile alpha-smooth muscle actin (α-SMA)-positive myofibroblasts (see Willis, Proc Am Thorac Soc., 2006).
Therefore, since claim 53 allows for epithelial stem cell progeny to be included in the claimed organoid and myofibroblasts can be considered epithelial stem cell progeny, the fact that the organoid described by Kuo includes myofibroblasts does not prevent Kuo from rendering the claimed organoid obvious.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Willis et al., “Epithelial Origin of Myofibroblasts during Fibrosis in the Lung”, PROCEEDINGS OF THE AMERICAN THORACIC SOCIETY, 2006, Vol. 3, pp. 377-382.
(Discloses that myofibroblasts can be considered epithelial cell progeny).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached on 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631
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