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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-19) in the reply filed on 2/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 20-26 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-19 have been considered on the merits.
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 10 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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 Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 6 and 16-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 discloses that the claimed organism comprises a sensor for detecting a target molecule. The scope of “a sensor for detecting a target molecule” is extremely broad to encompass any cell surface receptor mediating any signaling pathway endogenously present in the ciliated cells of the organism but also any known or unknown machinery to detect any signal, environmental cue, etc. The scope of “target” molecule is extremely broad as the nature of the target molecule is not particularly limited.
The instant specification does not particularly disclose what the scope of the sensor is, and there is no disclosure how the claimed sensor would be present or how to make the claimed organism to possess such sensor to detect any molecule.
Claim 16 is directed to the organism being configured for moving a target object. The instant specification fails to provide sufficient written description how the organism is configured for the claimed purpose. The scope of “target object” is extremely broad and there is no example or any detail description how such configuration is mediated. The specification merely discloses an example of by pushing a target object (para. 40). However, the exemplified “pushing a target object” does not appear to be any structural modification made to the organism.
Claim 17 is directed to the organism being configured to have a cavity for capturing and/or transporting a target object. The scope of “a cavity” is extremely broad as it can be a structural feature of the organism or a receptor or any mechanical feature shaping as a cavity on the surface of the organism to receive a target molecule. According to the instant specification, the formation of the apical-out aggregates is based on self-assembly. There is no indication that the self-assembled aggregates of the claimed product have any cavity. Thus, the cavity as claimed would be manipulated to form within the aggregates. However, the instant specification does not provide any written description how to make such a cavity or any example or working embodiment to support that the inventor had possession on the entire scope of the limitation.
Claim 18 discloses that a plurality of the organism exhibits collective and/or coordinated behavior. The scope of “collective or coordinated behavior” is not particularly limited what they are, and thus, the scope of the term is considered any behavior and yet the specification fails to provide sufficient detail with regard to the “collective and/or coordinated behavior” which is further limited as “collective and/or coordinated movement” in claim 19. Even if the “collective and/or coordinated movement” is considered as one example of the claimed behavior in claim 18, however, it is not sufficiently disclosed what the collective and/or coordinated movement is.
M.P.E.P. §2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.”
M.P.E.P. § 2163 also recites, “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention… one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.” and further, “The description needed to satisfy the requirements of 35 U.S.C. 112 "varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084.< Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art. In most technologies which are mature, and wherein the knowledge and level of skill in the art is high, a written description question should not be raised for claims >present in the application when originally filed,< even if the specification discloses only a method of making the invention and the function of the invention. See, e.g., In re Hayes Microcomputer Products, Inc. Patent Litigation, 982 F.2d 1527, 1534-35, 25 USPQ2d 1241, 1246 (Fed. Cir. 1992) ("One skilled in the art would know how to program a microprocessor to perform the necessary steps described in the specification. Thus, an inventor is not required to describe every detail of his invention. An applicant's disclosure obligation varies according to the art to which the invention pertains. Disclosing a microprocessor capable of performing certain functions is sufficient to satisfy the requirement of section 112, first paragraph, when one skilled in the relevant art would understand what is intended and know how to carry it out."). In contrast, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.”
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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “organism” in claim 1 and its dependent claims is used by the claim to mean “a cellular aggregate of ciliated cells such as epithelial cells,” or while the accepted meaning is “a living thing, such as an animal, a plant, a bacterium or a fungus” according to the definition from the dictionaries of the National Cancer Institute. The term is indefinite because the specification does not clearly redefine the term. For search purpose, the term “organism” is interpreted as an aggregate of cells.
Regarding claim 5, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 discloses the term “other organisms”. It is not clear if this term intends to point out other aggregates of ciliated cells or it is meant to point out any other organisms such as bacteria, fungi, plant and/or animal, etc. known in the art. Clarification is required.
Claim 9 discloses the term “effective”. It is not clear what the claimed diameter is effective for, or the term “effective diameter” intends to point out average diameter. Clarification is required. Applicant is advised to delete the term “effective”.
Claims 18-19 discloses “collective and/or coordinated behavior”. It is not clear what the scope of this term intends to point out. Claim 19 discloses “collective and/or coordinated movement”. This term does not particularly point out what it is either. The language of a claim must make it clear what subject matter the claim encompasses to adequately delineate its "metes and bounds". See, e.g., the following decisions: In re Hammack, 427 F 2d. 1378, 1382, 166 USPQ 204, 208 (CCPA 1970); In re Venezia 530 F 2d. 956, 958, 189 USPQ 149, 151 (CCPA 1976); In re Goffe, 526 F 2d. 1393, 1397, 188 USPQ 131, 135 (CCPA 1975); In re Watson, 517 F 2d. 465, 477, 186 USPQ 11, 20 (CCPA 1975); In re Knowlton 481 F 2d. 1357, 1366, 178 USPQ 486, 492 (CCPA 1973).
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.
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-9, 11-12 and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahudeen et al. (2020, Nature; published on 11/25/2020; IDS ref.) as evidenced by Shah et al. (2009, Science) and Veland et al. (2014, BioScience).
Salahudeen et al. teach human distal lung organoids comprising apical-out polarity to present ACE2 on the exposed external surface (Abstract). Salahudeen et al. further teach that within 48 h in suspension, organoids reorganized into apical-out epithelial spheroids with microvilli, apical junctions, and motile cilia facing the organoid exterior (p.673, 2nd col.). This teaching would meet the apical-out aggregate of ciliated cells.
Salahudeen et al. do not particularly teach the organism, i.e. cell aggregate, is self-motile. However, they teach the identical method steps of making the claimed organism, the apical-out motile cell aggregate, and the self-motile feature is due to the cilia formed outside of the organism. As Salahudeen et al. teach that the apical-out epithelial spheroids having motile cilia facing the organoid exterior, thus, the apical-out ciliated epithelial cell aggregates of Salahudeen et al. would inherently have identical characteristics as the claimed organism, i.e. self-motile, in the absence of any evidence to the contrary. Furthermore, Veland et al. teach that primary cilium including those of epithelial cells is involved in cell migration. Veland et al. teach that it is now evident that the position and orientation of primary cilia in the extracellular environment crucially define their function in a variety of different cell types and tissues and prominent examples include the unique placement of primary cilia on the apical surface of apicobasally polarized epithelial cells, as well as the positioning, projection, orientation, and even bending of cilia in deep tissues (p.1118, 1st col.). Thus, it is considered that the cilium on the surface of the 3D epithelial aggregates having the apical-out configuration as taught by Salahudeen et al. would have the same function as the claimed product and thus, it is expected that the aggregates of Salahudeen et al. would be inherently self-motile.
Regarding claim 5 directed to the organism consisting of biological material and/or does not comprise any inorganic material, the apical-out ciliated epithelial cell aggregates of Salahudeen et al. do not comprise any inorganic material and it is made with only biological materials.
Regarding the sensor of claim 6, Salahudeen et al. teach that the aggregate contains motile cilia. It is known in the art that the motile cilia of human airway epithelial contain sensors (sensory bitter taste receptors) to detect the external environment according to Shah et al. (see Abstract). Thus, it is considered that the motile cilia of the apical-out ciliated epithelial cell aggregates taught by Salahudeen et al. would inherently possess the sensors detecting the external environment. Furthermore, any receptors mediating external signals expressed on the apical surface of the cell aggregate would inherently meet the sensor as claimed.
Regarding claim 7, the apical-out ciliated epithelial cell aggregates are formed by reorganizing basal-out configuration of the cell aggregate upon suspension culture according to Salahudeen et al. This process is considered as self-assembly as claimed.
Furthermore, whether it is made by self-assembly or not, the limitation is directed to product-by-process. 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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
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. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)
The use of 35 U.S.C. §§ 102 and 103 rejections for product-by-process claims has been approved by the courts. “[T]he 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.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Thus, the step of self-assembly is not considered to provide any structure to the claimed product other than apical-out ciliated cell aggregate.
Regarding claim 8, the wherein clause is directed to the characteristics of the claimed product. As the apical-out ciliated epithelial cell aggregates of Salahudeen et al. is identical to the claimed product, the characteristic of the apical-out ciliated epithelial cell aggregates is expected the same as the claimed product.
Regarding claim 9 directed to the diameter of the organism, Salahudeen et al. show the aggregates in Figure 1l and 1m, and the scale bar is 200 mm (l) and 50 mm (m), respectively. Based on the scale bar, the diameter of the aggregates is within the claimed range.
Regarding claims 11-12 directed to heterologous molecule including a therapeutic agent, it is noted that the term “therapeutic” is interpreted as an intended purpose, and thus, claim 12 is interpreted as the heterologous molecule being any agent. As Salahudeen et al. teach the epithelial cells in the apical-out lung organoids express GFP and mCherry (p.677, 2nd col; Extended Data Fig. 1 at p.680).
Regarding claim 15 directed to the aggregate of cells reaggregates after the aggregate is subjected to deaggregation, this limitation is considered as a product-by-process limitation. As discussed above, a product-by-process limitation is considered only for the structure given by the process step. In this case, the wherein clause does not provide any structure to the claimed product. Thus, claim 15 is interpreted the same as claim 1, and Salahudeen et al. meet the limitation.
Regarding claim 16 directed to the organism being configured for moving a target object, this limitation is interpreted as an inherent property of the claimed product due to the presence of cilia on the exterior of the aggregates. As the apical-out lung organoids of Salahudeen et al. comprise cilia identical to those of the claimed product, and the apical-out lung organoids would have identical characteristics, i.e. moving a target object, as the claimed product.
Regarding claim 17 directed to the cavity, it is understood that the cavity is the lumen of the claimed apical-out cell aggregates. Thus, the lumen of the lung organoids of Salahudeen et al. (see Fig. 1m) would meet the limitation.
Regarding claims 18-19 directed to the plurality of the organism, Figure 1l and 1m of Salahudeen et al. show multiple organoids, and thus, meet the plurality of the organisms. Regarding the wherein clause, the limitation is directed to the characteristics of the organism in multiple numbers, and it is considered as a characteristics of the claimed product. As the apical-out ciliated epithelial cell aggregates of Salahudeen et al. are identical to the claimed product, the characteristics of the cell aggregates of Salahudeen et al. would be the same as the claimed product.
Thus, the reference anticipates the claimed invention.
Claim(s) 1-10 and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gentzsch et al. (US2017/0242033A1; IDS ref.) as evidenced by Shah et al. (supra) and Veland et al. (supra)
Gentzsch et al. teach a cellular aggregate comprising epithelial cells, wherein the cellular aggregate is in the form of a spheroid. The cellular aggregate and/or spheroid taught by Gentzsch et al. has a multicellular structure (i.e., a cellular structure of two or more cells) (para. 32). The epithelial cells in the spheroid of Gentzsch et al. are human (para. 35) and bronchial epithelial cells (para. 34). The diameter of the spheroids is about 10 mm to about 50,000 mm (para. 33).
Gentzsch et al. do not particularly teach the organism, i.e. cell aggregate, is self-motile. However, they teach the identical method steps of making the claimed organism, the apical-out motile cell aggregate, and the self-motile feature is due to the cilia formed outside of the organism. As Gentzsch et al. teach that the apical membrane out (AMO) epithelial spheres having motile cilia facing the organoid exterior, thus, the AMO spheres of Gentzsch et al. would inherently have identical characteristics as the claimed organism, i.e. self-motile, in the absence of any evidence to the contrary. Furthermore, Veland et al. teach that primary cilium including those of epithelial cells is involved in cell migration. Veland et al. teach that it is now evident that the position and orientation of primary cilia in the extracellular environment crucially define their function in a variety of different cell types and tissues and prominent examples include the unique placement of primary cilia on the apical surface of apicobasally polarized epithelial cells, as well as the positioning, projection, orientation, and even bending of cilia in deep tissues (p.1118, 1st col.). Thus, it is considered that the cilium on the surface of the AMO epithelial spheres having the apical-out configuration as taught by Gentzsch et al. would have the same function as the claimed product and thus, it is expected that the AMO spheres of Gentzsch et al. would be inherently self-motile.
Regarding claim 5, based on the procedure to form AMO spheres, there is no non-biological material in the spheres (para. 103-104).
Regarding the sensor of claim 6, Gentzsch et al. teach that the AMO spheres have epithelial cells having cilia. It is known in the art that the cilia of human airway epithelial is motile and contain sensors (sensory bitter taste receptors) to detect the external environment according to Shah et al. (see Abstract). Thus, it is considered that the motile cilia of the apical-out ciliated epithelial cell aggregates taught by Salahudeen et al. would inherently possess the sensors detecting the external environment. Furthermore, any receptors mediating external signals expressed on the apical surface of the cell aggregate would inherently meet the sensor as claimed.
Regarding claim 7, Gentzsch et al. teach that apical membrane out (AMO) spheres are self-assembling (para. 104).
Regarding claim 8, the wherein clause is directed to the characteristics of the claimed product. As the AMO spheres of Gentzsch et al. are identical to the claimed product, the characteristic of the AMO spheres of Gentzsch et al. is expected the same as the claimed product.
Regarding claim 15 directed to the aggregate of cells reaggregates after the aggregate is subjected to deaggregation, this limitation is considered as a product-by-process limitation. As discussed above, a product-by-process limitation is considered only for the structure given by the process step. In this case, the wherein clause does not provide any structure to the claimed product. Thus, claim 15 is interpreted the same as claim 1, and Gentzsch et al. meet the limitation.
Regarding claim 16 directed to the organism being configured for moving a target object, this limitation is interpreted as an inherent property of the claimed product due to the presence of cilia on the exterior of the aggregates. As the AMO spheres/spheroids of Gentzsch et al. comprise cilia identical to those of the claimed product, and the apical-out lung organoids would have identical characteristics, i.e. moving a target object, as the claimed product.
Regarding claim 17 directed to the cavity, it is understood that the cavity is the lumen of the claimed apical-out aggregates. Thus, the lumen of the AMO spheres/organoids of Gentzsch et al. (para. 92 and 112) would meet the limitation.
Regarding claims 18-19 directed to the plurality of the organism, Gentzsch et al. teach plurality of spheroids (para. 33) and thus, meet the plurality of the organisms. Regarding the wherein clause, the limitation is directed to the characteristics of the organism in multiple numbers, and it is considered as a characteristics of the claimed product. As the AMO spheres/spheroids having ciliated epithelial cell taught by Gentzsch et al. are identical to the claimed product, the characteristics of the plurality of spheroids taught by Gentzsch et al. would be the same as the claimed product.
Thus, the reference anticipates the claimed invention.
Claim(s) 1-10 and 15-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Parigoris et al. (US20230194506 A1; priority date of 5/22/2020) as evidenced by Veland et al. (supra)
Parigoris et al. teach an inverted spherical 3D tissue or organoid with a hollow lumen and epithelial cells exposed to the exterior surface, i.e. apical-out (para. 6). The organoid of Parigoris et al. comprises ciliated cells on the first side which is positioned outward to be exposed to the external environment of the organoid (para. 138).
Parigoris et al. do not particularly teach the 3D tissue or organoid, is self-motile. However, they teach the apical-out cell aggregate having ciliated cells, and produced by substantially similar method of self-assembly of human bronchial epithelial cells. As the self-motile feature as claimed is understood due to the cilia formed outside of the organism, the apical-out epithelial organoid of Parigoris et al. having ciliated cells the organoid exterior would inherently have identical characteristics as the claimed organism, i.e. self-motile, in the absence of any evidence to the contrary. Furthermore, Veland et al. teach that primary cilium including those of epithelial cells is involved in cell migration. Veland et al. teach that it is now evident that the position and orientation of primary cilia in the extracellular environment crucially define their function in a variety of different cell types and tissues and prominent examples include the unique placement of primary cilia on the apical surface of apicobasally polarized epithelial cells, as well as the positioning, projection, orientation, and even bending of cilia in deep tissues (p.1118, 1st col.). Thus, it is considered that the cilium on the surface of the 3D epithelial organoid having the apical-out configuration as taught by Parigoris et al.would have the same function as the claimed product and thus, it is expected that the organoid of Parigoris et al. would be inherently self-motile.
Regarding claims 2-4 and 10, Parigoris et al. teach that the epithelial cells comprise bronchial cells (para. 32), and exemplified normal human lung bronchial epithelial cells (para. 128).
Regarding claim 5, based on the method of making the 3D epithelial organoid taught by Parigoris et al., it is considered to meet the limitation.
Regarding claim 6 directed to a sensor detecting a molecule, it is interpreted as any receptor that can bind to its cognate ligand would meet the claimed sensor. Parigoris et al. teach that the cells express transmembrane receptor (para. 10).
Regarding claim 7, Parigoris et al. teach that 3D organoids are self-organized cell structures (para. 4-5), and thus, the inverted spherical 3D organoid is considered as self-assembled.
Regarding claim 8, the wherein clause is directed to the characteristics of the claimed product. As the inverted spherical 3D tissue or organoid of Parigoris et al. is identical to the claimed product, the characteristic of the inverted spherical 3D tissue or organoid is expected the same as the claimed product.
Regarding claim 9 directed to the diameter, Parigoris et al. teach the diameter of the 3D structure being about 100 mm to about 5 mm (para. 23).
Regarding claim 15 directed to the aggregate of cells reaggregates after the aggregate is subjected to deaggregation, this limitation is considered as a product-by-process limitation. As discussed above, a product-by-process limitation is considered only for the structure given by the process step. In this case, the wherein clause does not provide any structure to the claimed product. Thus, claim 15 is interpreted the same as claim 1, and Parigoris et al. meet the limitation.
Regarding claim 16 directed to the organism being configured for moving a target object, this limitation is interpreted as an inherent property of the claimed product due to the presence of cilia on the exterior of the aggregates. As the inverted spherical 3D tissue or organoid of Parigoris et al. comprise cilia identical to those of the claimed product, and the apical-out lung organoids would have identical characteristics, i.e. moving a target object, as the claimed product.
Regarding claim 17 directed to the cavity, it is understood that the cavity is the lumen of the claimed apical-out lung organoids. Thus, the lumen of the inverted spherical 3D tissue or organoid of Parigoris et al. (para. 6) would meet the limitation.
Thus, the reference anticipates the claimed invention.
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.
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 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahudeen et al. (supra) in view of Parigoris et al. (supra)
Salahudeen et al. anticipate the subject matter of claims 1-3, 5-9, 11-12 and 15-19, and thus render them obvious (see above).
Regarding claims 4 and 10 directed to the ciliated cells being human bronchial epithelial cells, Salahudeen et al. do not particularly teach the limitation.
Parigoris et al. teach an inverted spherical 3D tissue or organoid with a hollow lumen and epithelial cells exposed to the exterior surface, i.e. apical-out (para. 6). The organoid of Parigoris et al. comprises ciliated cells on the first side which is positioned outward to be exposed to the external environment of the organoid (para. 138). Parigoris et al. teach that the epithelial cells comprise bronchial cells (para. 32), and exemplified normal human lung bronchial epithelial cells (para. 128).
It would have been obvious to a person skilled in the art to use human bronchial epithelial cells taught by Parigoris et al. for the cell aggregates of Salahudeen et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the human bronchial epithelial cells of Parigoris et al. can be used to study pathologies caused by SARS-CoV-2 because Parigoris et al. teach the 3D tissue/organoid can be used in viral infection (para. 138; Fig. 1D).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-9 and 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahudeen et al. (supra) in view of Shah et al. (supra)
Salahudeen et al. anticipate the subject matter of claims 1-3, 5-9, 11-12 and 15-19, and thus render them obvious (see above).
Regarding claims 13-14 directed to the ciliated cells expressing a heterologous molecule, which is an enzyme metabolizing a target substrate or a receptor, Salahudeen et al. do not teach the limitation.
Shah et al. teach that the motile cilia present in the human airway epithelia are chemosensory and express sensory bitter taste receptors (T2R) and the T2R signal transduction pathway comprises enzyme phospholipase C-b2 and transient receptor potential channel-M5 (TRPM5) (p.1-2). Shah et al. teach that these receptors might defend human airways, and this signaling pathway might also play a role in airway disease including cystic fibrosis, and airway cilia lost in some viral infections and cigarette smoking would disrupt this defensive system (p.3).
It would have been obvious to a person skilled in the art to express the bitter taste receptors and associated enzyme PLC-b2 and/or channel (TRPM5) in the epithelial cells obtained from the patients having cystic fibrosis, viral infections and/or damage lung due to the cigarette smoking, etc. to study potential involvement in their role in therapeutic potential in treating the lung disease and/or damage.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gentzsch et al. (supra) in view of Li et al. (2020, Cell Regen.; published on 11/2/2020).
Gentzsch et al. anticipate the subject matter of claims 1-10 and 15-19, and thus render them obvious (see above).
Regarding claims 11-14 directed to the ciliated cell expressing heterologous molecule including a therapeutic agent, enzyme metabolizing a target substance, or a receptor, Gentzsch et al. teach the expression of CFTR (cystic fibrosis transmembrane conductance regulator gene) in AMO spheres prepared from cystic fibrosis lung having mutant CFTR.
It would have been obvious to a person skilled in the art to genetically engineer the epithelial cells in the AMO spheres to express normal CFTR (i.e. therapeutic agent) to rescue the mutant CFTR. A person of ordinary skilled in the art would have been motivated to do so because personalized medicine based on organoid model is known in the art according to Li et al. According to Li et al., the patient-derived organoids (PDO) including airway organoid from CF patient can be used in gene repair using CRISPR technology (p.23, 1st col; Fig. 10).
Regarding the heterologous molecule being a therapeutic agent or an enzyme metabolizing a target substrate or a receptor, Gentzsch et al. in view of Li et al. do not particularly teach the limitation. It is noted that the term “therapeutic” is interpreted as an intended purpose, and thus, claim 12 is interpreted as the heterologous molecule being an agent.
However, it would have been obvious to a person skilled in the art to use the lung organoid such as AOM spheres of Gentzsch et al. to express any desired molecule including enzymes or receptors for various drug testing or disease study with a reasonable expectation of success. Genetic engineering of any cells to express desired molecules including therapeutic agent is well known in the art. Thus, overexpressing desired enzymes, therapeutic agent, and/or receptors on epithelial cells in the organoids is within the purview of a skilled person in the art.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631
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