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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/14/2026 has been entered.
Status of the Claims
The amendment filed 1/14/2026 has been entered. Claims 25-32, 35-38, 51, and 53-57 are pending in the application, and claims 1-24, 33-34, 39-50, and 52 are cancelled.
Regarding claim 51, Applicant’s amendment to the claim has overcome the 112 rejection previously set forth in the Final Office Action mailed 10/14/2025, and accordingly, the 112(a) rejection to claim 51 has been withdrawn.
Response to Arguments
Applicant’s arguments filed 1/14/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant added limitations to independent claim 25 for a cell culture vessel that is “inset and embedded in a gas-impermeable material” and “coated with a cell adhesion coating agent selected from the group consisting of Matrigel, collagen, polylysine, fibronectin, vitronectin, laminin, and a combination thereof, such that the cells in the cell culture vessel are adherent cultured on the cell adhesion coating agent”. These new limitations do not distinguish the claimed invention over the prior art. The Examiner acknowledges that neither Veraitch et al. nor Chang teach the newly added limitations, however, it would have been obvious to modify the device of Veraitch et al. in view of Blanchard (US 2018/0320122 A1), which will be discussed in further detail in the 35 USC § 103 section below.
Applicant argues on p. 8 of Remarks that the containers described by Veraitch et al. are not designed to culture cells adhered to the inner surface of the container, and as such, one of ordinary skill in the art would not have been motivated to coat in interior of the containers. This is not persuasive as Veraitch et al. discloses that the internal surface of the culture container can be cultured with biologically active agents which can act on the cells in culture and/or induce differentiation (p. 14, lines 29-30) and that the cells attach to the walls of the container (p. 16, line 4). Thus, one of ordinary skill in the art would have been motivated to coat the interior of the containers as Veriatch et al. discloses that the cells attach to the walls of the container, and Blanchard discloses that coating the container with collagen increases adhesion properties for cell growth and differentiation (para. 0077).
Specification
The disclosure is objected to because of the following informalities: it is recommended that "This application claims benefit to PCT application PCT/JP2020/022843, filed June 10, 2020; which claims benefit to U.S. provisional application 62/859,320, filed June 10, 2019; said applications incorporated herein by reference." be added on page 1 after the Title.
Appropriate correction is required.
The use of the term "Matrigel" (para. 0169), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-32, 35-38, 51, and 53-57 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.
Claim 25 contains the trademark/trade name "Matrigel" in line 19. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe basement membrane matrix for cell culture and, accordingly, the identification/description is indefinite.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 25-32, 36-37, 51, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Veraitch et al. (WO 2018/087558 A1) (already of record) in view of Chang (US 2003/0143727 A1) (already of record) and Blanchard (US 2018/0320122 A1).
Regarding claim 25, Veraitch et al. teaches a cell culture device (abstract “culturing and/or modifying cells”) comprising: a cell culture vessel for culturing cells (p. 2, line 9 “primary container”; Fig. 1(a) 10 primary container); a first variable-volume container (p. 2, line 16 “a plurality of auxiliary containers”; Fig. 1(a) 16(a) auxiliary container) connected to the cell culture vessel (p. 2, line 29 “auxiliary containers may be detachably connected to the primary container”); a first flow channel connecting the first variable-volume container to the cell culture vessel (p. 13, lines 26-28 “auxiliary containers may be in fluid communication with the primary container… by means of a corrugated tube”); a second variable-volume container (p. 2, line 16 “a plurality of auxiliary containers”; Fig. 1(a) 16(b) auxiliary container) connected to the cell culture vessel (p. 2, line 29 “auxiliary containers may be detachably connected to the primary container”); and a second flow channel connecting the second variable-volume container to the cell culture vessel (p. 13, lines 26-28 “auxiliary containers may be in fluid communication with the primary container… by means of a corrugated tube”), wherein transfer of a fluid within the first variable volume container to the cell culture vessel through the first flow channel contracts a volume of the first variable-volume container and expand a volume of the second variable-volume container (p. 7, lines 6-8), and wherein the cell culture vessel is inset (abstract “A container for use in growing, culturing and/or modifying cells has a primary container (10) and defines an internal lumen”).
Regarding the limitation “a first pump disposed in the first flow channel for transferring a fluid within the first flow channel”, Veraitch et al. teaches a lever, plunger or bellows configured to compress the containers (p. 5, lines 5-7) to transfer the contents of one container to another (p. 7, lines 37-39), but does not teach a first pump disposed in the flow channel for transferring a fluid within the first channel, wherein the first pump is configured to transfer a fluid within the first variable-volume container in to the cell culture vessel through the first flow channel in order to contract a volume of the first variable-volume container and expand a volume of the second variable-volume container. However, Chang teaches a pump disposed in a flow channel (Fig. 17A 1743 pump) which delivers fresh medium through a connector tube to a first chamber of the cell-cultivating device to replace the spent medium after cell culture (para. 0141-0142).
It would have been obvious to a person of ordinary skill in the art to use the Chang configuration of a first pump disposed in a flow channel in Veraitch et al.’s device with a reasonable expectation that it would deliver fresh medium through a connector tube to a first chamber of the cell-cultivating device to replace the spent medium after cell culture. This method for improving Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Chang. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Veraitch et al. and Chang to obtain the invention as specified in claim 25.
Regarding the limitation “embedded in a gas-impermeable material”, Veraitch et al. does not teach a culture container embedded in a gas-permeable material. However, Blanchard discloses a container for enclosing a cell culture vessel wherein each of the walls is impermeable to gas (para. 0007) which regulates the interior environment and only allows appropriate gases and vapors to be provided via access points (para. 0007). It would have been obvious to a person of ordinary skill in the art to use the Blanchard configuration of container for enclosing a cell culture vessel wherein each of the walls is impermeable to gas in Veraitch et al.’s device with a reasonable expectation that it would regulate the interior environment and only allow appropriate gases and vapors to be provided. This method for improving Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Blanchard. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Veraitch et al. and Blanchard to obtain the invention as specified in claim 25.
Regarding the limitation “wherein an interior of the cell culture vessel is coated with a cell adhesion coating agent selected from the group consisting of Matrigel, collagen, polylysine, fibronectin, vitronectin, laminin, and a combination thereof, such that cells in the cell culture vessel are adherent cultured on the cell adhesion coating agent”, Veraitch et al. discloses that the internal surface of the culture container can be cultured with biologically active agents which can act on the cells in culture and/or induce differentiation (p. 14, lines 29-30) and that the cells attach to the walls of the container (p. 16, line 4), but is silent to the coating being selected from the group consisting of Matrigel, collagen, polylysine, fibronectin, vitronectin, laminin, and a combination thereof. However, Blanchard teaches that a collagen coating is known in the art (para. 0077). Blanchard teaches that a collagen coating increases adhesion properties for cell growth and differentiation (para. 0077). Though Veraitch et al. does not explicitly teach a collagen coating, it would have been obvious to a person of ordinary skill in the art to use a collagen coating because the substitution of one known element for another would have predictably resulted in a coating that increases adhesion properties for cell growth and differentiation, with reasonable expectation. 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 the teachings of Veraitch et al. with the teachings of Blanchard to obtain the invention as specified in claim 25.
Regarding claim 26, Veraitch et al. teaches a cell culture device wherein the interior of the cell culture vessel, an interior of the first variable-volume container, and an interior of the second variable-volume container can be closed off from outside air (p. 15, lines 22-23 “the chambers can be permanently sealed”).
Regarding claim 27, Veraitch et al. teaches a cell culture device wherein the first variable-volume container holds a substance (p. 7, lines 35-38).
Regarding claim 28, Veraitch et al. teaches a cell culture device further comprising a third flow channel for supplying cells into the cell culture vessel (p. 13, lines 26-28 “one or more auxiliary containers may be in fluid communication with the primary container… by means of a corrugated tube”).
Regarding claim 29, Veraitch et al. teaches a cell culture device, but does not teach a second pump for supplying cells into the cell culture vessel. However, Chang teaches a second pump capable of supplying cells into a culture vessel (Fig. 17A 1744 pump). Chang teaches that the pump delivers spent medium through a connector tube to a storage container of the cell-cultivating device to harvest the protein produced by cell culture (para. 0141-0142).
Regarding the limitation “for supplying cells into the cell culture vessel”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Chang would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have pumps for transferring a substance from one container into another through a tube (para. 0141-0142) and would be structurally capable of supplying cells into a cell culture vessel absent clear evidence otherwise.
It would have been obvious to a person of ordinary skill in the art to use the Chang configuration of a second pump in Veraitch et al.’s device with a reasonable expectation that it would deliver spent medium through a connector tube to a storage container of the cell-cultivating device to harvest the protein produced by cell culture. This method for improving Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Chang. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Veraitch et al. and Chang to obtain the invention as specified in claim 29.
Regarding claim 30, Veraitch et al. teaches a cell culture device further comprising a fluid container (p. 2, line 16 “plurality of auxiliary containers”) that holds a fluid to be supplied into the cell culture vessel (p. 7, lines 35-38).
Regarding claim 31, Veraitch et al. teaches a cell culture device wherein the fluid held in the fluid container is a somatic cell culture medium or a stem cell culture medium (p. 7, lines 35-38 “culture medium”).
Regarding the limitations “somatic cell culture medium” and “stem cell culture medium”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Veraitch et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be a cell culture device (abstract) that cultures somatic cells or stem cells (p. 19, lines 8-9) and would be structurally capable of holding somatic cell culture medium or stem cell culture medium absent clear evidence otherwise.
Regarding claim 32, Veraitch et al. teaches a cell culture device further comprising a temperature control element that controls a temperature in the cell culture vessel (p. 5, line 12 “temperature control means”).
Regarding claim 36, Veraitch et al. teaches a cell culture device wherein the first flow channel connects the first variable-volume container to the cell culture vessel (p. 13, lines 26-28 “auxiliary containers may be in fluid communication with the primary container… by means of a corrugated tube”) such that cells in the cell culture vessel can be transferred to the first variable-volume container through the first flow channel (p. 13, lines 29-34 “tube may have a port… permits the contents of the primary or further container to be ejected into an auxiliary container”).
Regarding claim 37, Veraitch et al. teaches a cell culture device further comprising: a third flow channel connected to the cell culture vessel (p. 13, lines 26-28 “auxiliary containers may be in fluid communication with the primary container… by means of a corrugated tube”). Veraitch et al. does not teach a second pump disposed in the third flow channel, wherein the third flow channel and the second pump are configured such that, at least one of passaging and expansion culture of cells in the cell culture vessel is carried out by suctioning the cells in the cell culture vessel into the third flow channel and returning the cells in the third flow channel to the cell culture vessel by the second pump. However, Chang teaches a second pump capable of supplying cells into a culture vessel (Fig. 17A 1744 pump). Chang teaches that the pump delivers spent medium through a connector tube to a storage container of the cell-cultivating device to harvest the protein produced by cell culture (para. 0141-0142).
Regarding the limitation “at least one of passaging and expansion culture of cells in the cell culture vessel is carried out by suctioning the cells in the cell culture vessel into the third flow channel and returning the cells in the third flow channel to the cell culture vessel by the second pump”, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Chang would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have pumps for transferring a substance from one container into another through a tube (para. 0141-0142) and would be structurally capable of supplying cells into a cell culture vessel absent clear evidence otherwise.
It would have been obvious to a person of ordinary skill in the art to use the Chang configuration of a second pump in Veraitch et al.’s device with a reasonable expectation that it would deliver spent medium through a connector tube to a storage container of the cell-cultivating device to harvest the protein produced by cell culture. This method for improving Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Chang. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Veraitch et al. and Chang to obtain the invention as specified in claim 37.
Regarding claim 51, Veraitch et al. teaches a cell culture device comprising a member (Fig. 1(a) primary container 10) having an inscribed recess (abstract “defines an internal lumen”) and the recess forms at least a portion of the interior of the cell culture vessel (p. 5, lines 30-32).
Regarding claim 57, Veraitch et al. discloses that the internal surface of the culture container can be cultured with biologically active agents which can act on the cells in culture and/or induce differentiation (p. 14, lines 29-30) and that the cells attach to the walls of the container (p. 16, line 4), but is silent to the coating being selected from the group consisting of Matrigel, collagen, polylysine, fibronectin, vitronectin, laminin, and a combination thereof. However, Blanchard teaches that a collagen coating is known in the art (para. 0077). Blanchard teaches that a collagen coating increases adhesion properties for cell growth and differentiation (para. 0077). Though Veraitch et al. does not explicitly teach a collagen coating, it would have been obvious to a person of ordinary skill in the art to use a collagen coating because the substitution of one known element for another would have predictably resulted in a coating that increases adhesion properties for cell growth and differentiation, with reasonable expectation. 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 the teachings of Veraitch et al. with the teachings of Blanchard to obtain the invention as specified in claim 57.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Veraitch et al. (WO 2018/087558 A1) (already of record) in view of Chang (US 2003/0143727 A1) (already of record) and Blanchard (US 2018/0320122 A1) as applied to claim 25 above, and further in view of Shevitz (US 2017/0002305 A1) (already of record).
Regarding claim 35, Veraitch et al. teaches a cell culture device further comprising a microporous filter disposed in the cell culture vessel (p. 15, lines 26-36), but does not explicitly teach a hollow fiber membrane disposed in the cell culture vessel. However, Shevitz teaches a hollow fiber filter disposed in a cell culture vessel (Fig. 1a 5 filter element; para. 0100 “hollow fiber filter”). Shevitz teaches that the hollow fiber filter is selectively permeable for retaining cells but allowing metabolites and other molecules or molecular complexes to filter through the pores (para. 0064).
It would have been obvious to a person of ordinary skill in the art to use the Shevitz configuration of a hollow fiber filter in modified Veraitch et al.’s device with a reasonable expectation that it would be selectively permeable for retaining cells but allow metabolites and other molecules or molecular complexes to filter through the pores. This method for improving modified Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Shevitz. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Veraitch et al. and Shevitz to obtain the invention as specified in claim 35.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Veraitch et al. (WO 2018/087558 A1) (already of record) in view of Chang (US 2003/0143727 A1) (already of record) and Blanchard (US 2018/0320122 A1) as applied to claim 37 above, and further in view of Tseng et al. (US 2020/0123484 A1) (already of record).
Regarding claim 38, modified Veraitch et al. teaches a cell culture device comprising a structure that dissociates cells (p. 29, lines 23-27; Fig. 14(c) 140 filter membrane), but does not teach a structure for dissociating cell masses in the third flow channel. However, Tseng et al. teaches a structure for dissociating cell masses disposed in a flow channel (Fig. 1A 110 obstruction structure). Tseng et al. teaches that the obstruction structure reduces the width of the channel and increases flow rate through the channel (para. 0035).
It would have been obvious to a person of ordinary skill in the art to use the Tseng et al. configuration of a structure for dissociating cells in modified Veraitch et al.’s device with a reasonable expectation that it would reduce the width of the channel and increases flow rate through the channel. This method for improving modified Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Tseng et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Veraitch et al. and Tseng et al. to obtain the invention as specified in claim 38.
Claims 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over Veraitch et al. (WO 2018/087558 A1) (already of record) in view of Chang (US 2003/0143727 A1) (already of record) and Blanchard (US 2018/0320122 A1) as applied to claim 25 above, and further in view of Martin et al. (US 2021/0222103 A1) (already of record).
Regarding claim 53, modified Veraitch et al. teaches a cell culture device comprising a first pump, but does not teach wherein the first pump is a reciprocating pump or a rotary pump. However, Martin et al. teaches a reciprocating pump (para. 0048 “plunger pump”) and a rotary pump (para. 0048 “gear pump”). Martin et al. teaches that the pump circulates fluid and media to increase oxygenation (para. 0050).
It would have been obvious to a person of ordinary skill in the art to use the Martin et al. configuration of a reciprocating pump or a rotary pump in modified Veraitch et al.’s device with a reasonable expectation that it would circulate fluid and media to increase oxygenation. This method for improving modified Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Martin et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Veraitch et al. and Martin et al. to obtain the invention as specified in claim 53.
Regarding claim 54, modified Veraitch et al. teaches a cell culture device comprising a first pump, but does not teach wherein the first pump is a reciprocating pump and is selected from the group consisting of a piston pump, a plunger pump, and a diaphragm pump. However, Martin et al. teaches a plunger pump (para. 0048). Martin et al. teaches that the pump circulates fluid and media to increase oxygenation (para. 0050).
It would have been obvious to a person of ordinary skill in the art to use the Martin et al. configuration of a gear pump in modified Veraitch et al.’s device with a reasonable expectation that it would circulate fluid and media to increase oxygenation. This method for improving modified Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Martin et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Veraitch et al. and Martin et al. to obtain the invention as specified in claim 54.
Regarding claim 55, modified Veraitch et al. teaches a cell culture device comprising a first pump, but does not teach wherein the first pump is a rotary pump and is selected from the group consisting of a gear pump, a vane pump, and a screw pump. However, Martin et al. teaches a gear pump (para. 0048). Martin et al. teaches that the pump circulates fluid and media to increase oxygenation (para. 0050).
It would have been obvious to a person of ordinary skill in the art to use the Martin et al. configuration of a gear pump in modified Veraitch et al.’s device with a reasonable expectation that it would circulate fluid and media to increase oxygenation. This method for improving modified Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Martin et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Veraitch et al. and Martin et al. to obtain the invention as specified in claim 55.
Regarding claim 56, modified Veraitch et al. teaches a cell culture device comprising a first pump, but does not teach wherein the first pump is a peristaltic pump or a tubing pump. However, Martin et al. teaches a peristaltic pump (para. 0048). Martin et al. teaches that the pump circulates fluid and media to increase oxygenation (para. 0050).
It would have been obvious to a person of ordinary skill in the art to use the Martin et al. configuration of a peristaltic pump in modified Veraitch et al.’s device with a reasonable expectation that it would circulate fluid and media to increase oxygenation. This method for improving modified Veraitch et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Martin et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Veraitch et al. and Martin et al. to obtain the invention as specified in claim 56.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799