DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16 in the reply filed on December 12, 2024 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Arguments
Applicant's arguments filed July 7, 2025 have been fully considered but they are not persuasive.
As to the 112 rejections, applicant asserts the claims are not indefinite and all follow antecedent basis conventions and are clear on their face. There is no reasonable interpretation that renders these features indefinite. The examiner disagrees. Applicant has not amended the claims to address each of the issues/claims and does not specify what is the proper antecedent basis for each of the terms recited in the rejections.
For example, in 1b) the claim recites “a plurality of reactant chambers carrying a plurality of reactants” and “said plurality of reaction sites comprise a plurality of reactants”. Therefore, it is unclear which/what plurality of reactions is being referenced by the later recited phrase “said plurality of reactants”.
The plurality of reaction sites are not listed, positively claimed as elements of the apparatus. In 1a), it presumed that “in fluid communication with a plurality of reaction sites” refers to the sample collection unit. However, reciting that a positively claimed element is in fluid communication with structures not previously claimed (a plurality of reactions sites) does not require the plurality of reaction sites to be structural elements of the apparatus. The plurality of reaction sites do not further structurally limit the apparatus. If applicant intends for the invention to comprise a plurality of reaction sites, then the claim should clearly recite such.
It is unclear what/which reaction sites are being referenced by “said reaction sites” in 1b) and 2. It such is intended to refer to the a plurality of reaction sites, then the claims should clearly recite “said plurality of reaction sites”.
Applicant has not indicated what the pronoun “thereto” references. To resolve such issue and for clarity, the claim can be amended to replace “thereto” with what the term specifically references.
If “the fluid” in claim 6 is meant to refer to “the biological fluid”, the claim should be amended to recite such (same as recited in claim 4). However, the biological fluid (and amount of the biological fluid) is not a structural element of the apparatus and does not further structurally limit the claimed apparatus.
The 112 rejections are proper and maintained for reasons previously stated in the prior Office Action and herein. Rejections not repeated herein have been withdrawn.
As to the art rejections based upon Glezer and Parce, applicant states:
“Neither Glezer nor Parce disclose or suggest at least that "at least one channel located between said plurality of reaction sites comprises an optical barrier to reduce the amount of optical cross-talk between said plurality of said reaction sites during detection of said analyte," as recited in claim 1. And the Office does not adequately address such features in its rejection. Indeed, Glezer specifies different procedures for handling cross-talk - using blocking reagents or minimizing diffusion of an unbound assay reagent (Glezer, 3:16-30, 36:36 42). And Parce does not address optical cross-talk at all.”
The examiner disagrees. The claims are directed to an apparatus not any procedure/method that requires any reduction of any cross-talk. However, there is no indication, relative basis provided for in the claim as what is considered as a reduction in cross-talk. According to claim 1 an “optical barrier” is at least one channel and according to claim 5 an optical barrier is a nonlinear fluidic channel. The apparatuses of both Glezer and Parce comprise fluidic channels including nonlinear fluidic channels as stated in the rejections.
Therefore, the rejections are hereby maintained.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Priority
The Cross-Reference paragraph should be updated to reflect the current status of all related applications, including those not currently mentioned in the passage.
Claim Interpretations
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claimed apparatus is stated as being for detecting an analyte in a biological fluid. However, no biological fluid is claimed as an element of the device. The claims also mention a plurality of analytes, a list of what the immunoassay reagents can detect, a detectable signal. Claim 1 mentions also a plurality of reaction sites. However, none of the prior are structural elements of the claimed invention, but are materials and/or articles intended be/can be worked upon and/or used with the claimed apparatus. The plurality of reaction sites are not listed as elements of the invention nor claimed as being any positively claimed elements. In 1a) it presumed that “in fluid communication with a plurality of reaction sites” refers to the sample collection unit. However, reciting that a positively claimed element is in fluid communication with structures not previously claimed (a plurality of reactions sites) does not require the plurality of reaction sites to be structural elements of the apparatus. If applicant intends for the invention to comprise a plurality of reaction sited, then the claim should clearly recite such.
Furthermore, there is no reader/detector structure claimed. As such, the "for detecting" and “during detection” phrases are directed to intended use of the device. Therefore claims 8-11 are directed to the intended use/process steps of the claimed apparatus. However, it is noted that the apparatus is not required to be used to perform any method, process steps, including detecting and any other process steps. The various “to allow…”, “to flow…” and “to reduce…” phrases are directed to intended use.
It is noted that the term “plurality” only requires 2.
As to claim 1, it is noted that the claims do not specify the distribution of the reactants within the plurality of chambers/sites. In other words the claims do not require that each of the plurality of chambers/sites to include a plurality of reactants. Furthermore, it is noted that the claims are directed to an apparatus not a process of use. It is not required that the apparatus be used for any detection of analytes. However, it is noted that there is no requirement for any detecting to be performed.
As to claim 1, it is noted that the phrase “at least one channel” does not preclude more than one channel from being located between two reaction sites.
As to the phrase "waste chambers" in claim 2, it is noted that the claims do not provide for any structural distinction between waste chambers and reactant chambers. It appears that the term “waste” is directed to the intended use of the chamber rather than any specific structural requirement of the chamber.
It is noted that claim 3 recites “each channel”, however it is not required that the device comprise more than one such channel, for a device comprising 2 sites would only require 1 channel therebetween.
Furthermore, claims 4 and 6 are not further structurally limiting because the claims are directed to an unclaimed biological fluid and fluid (presuming the phrase, "the fluid" in claim 6 refers to the biological fluid).
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 1-11 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 pre-AIA the applicant regards as the invention.
As to claims 1 and 2, it is unclear what is the structural connectivity of each of the structural elements to each other because the claims do not clearly recite such. It is noted that the phrases “located between” does not provide for, require any structural connectivity of any structures. A list of structures that are not structurally connected to not define a single apparatus, but are a list of structures that can be possibly used together. Therefore, it is unclear how the list of structures that are not structurally connected are considered as defining a single apparatus.
As to claims 1-2, it is unclear which plurality of reactants are being referenced by the phrases "said plurality of reactants" and what/which reaction sites are being reference by the phrase, “said reaction sites”.
As to claim 1, it is unclear what the pronoun, “thereto” references.
As to claims 1 and 3, it is unclear what further structure the at least one channel and each channel respectively comprise that applicant is referring to as an optical barrier. It appears that the channel itself doesn't comprise an optical barrier, but actually can function as an optical barrier.
As to claim 1, in c) it is unclear what is the structural nexus of the “at least one channel” to the prior “system of fluidic channels” because the claim does provide for such. It is unclear if the at least one channel is amongst the system of fluidic channels or different from such fluidic channels.
As to claims 1 and 7, it is noted that the invention being defined is “an apparatus”. Therefore, it is unclear how the invention being defined in the claims can be defined relative to itself as by the phrase “said apparatus” employed in claims 1 and 7. The phrase “said apparatus” does not refer to any specific positively claimed element of the invention.
As to claim 3, it is unclear what/which channel(s) is/are being referenced by the phrase “each channel…” because claim 1 previously recites a system of fluidic channels and at least one channel.
It is unclear how claims 4 and 6, further structurally limit the claimed apparatus for the biological fluid nor any other fluid has been positively claimed as elements of the invention. The claims appear to be directed to intended use with unclaimed fluids.
Claim 6 recites the limitation "the fluid" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which/what fluid is being reference by the phrase "the fluid". No fluid has been previously claimed as an element of the apparatus.
As to claim 5, it is unclear how now the optical barrier comprises a nonlinear fluidic channel, when previously claim 1 states, at least one channel comprises an optical barrier. Clam 5 contradicts claim 1. The most accurate description appears to be than the device comprises non-linear channels located between…..that can function as optical barriers.
As to claim 7, and 9-10, it is unclear what reactants are being referenced by the phrase “the reactants” for claim 1 mentions a plurality of reactants at two different locations and it is not been previously established if the reactants at both locations are the same or different.
It is unclear what is structurally require, meant by claims 8-11 because the claims do not provide for any additional structural element nor provide for any further structure of an previously positively claimed element. The claims are directed process steps of what the invention can be employed to do relative to unclaimed plurality of analytes, what the immune assay reagents can be used to detect, and a signal that is not structure.
It is unclear how claim 8, further structurally limits the claimed apparatus for the plurality of analytes have not been positively claimed as elements of the invention. Furthermore, it is unclear what "distinct signals" are being referenced. Signals are not elements of the apparatus. Furthermore, it is unclear what is being reference by the phrase "range of 3 orders of magnitude". Range of what? Relative to what? Who or what determines such magnitude or any other determination. The apparatus has not been claimed as comprising a detector or any other structure for making and measurement of any type of signals. It appears moreso as if applicant is referring to how the device can be used with some unspecified analytes and detector.
It is unclear how the reagents of claim 9-10 "detect". The reagents do not detect anything. It appears that applicant may be referring to ability of the reagents to react with specific substances and such reactions can be detected by a detector/reader.
Claim 11 recites the limitation "the detectable signal" in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is noted that “a signal” a used in this application is not a physical structure and cannot be claimed as an element of the apparatus presently drafted.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-11 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Glezer et al, US 7,497,997.
Glezer et al. disclose assay modules, preferably assay cartridges, are described as are reader apparatuses which may be used to control aspects of module operation. The modules preferably comprise a detection chamber with integrated electrodes that may be used for carrying out electrode induced luminescence measurements. Methods are described for immobilizing assay reagents in a controlled fashion on these electrodes and other surfaces. Assay modules and cartridges are also described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. (abstract).
The invention relates in part to assay cartridges. An assay cartridge of the invention incorporates one or more fluidic components such as compartments, wells, chambers, fluidic conduits, fluid ports/vents, valves, and the like and/or one or more detection components such as electrodes, electrode contacts, sensors (e.g., electrochemical sensors, fluid sensors, mass sensors, optical sensors, capacitive sensors, impedance sensors, optical waveguides, etc.), detection windows (e.g., windows configured to allow optical measurements on samples in the cartridge such as measurements of absorbance, light scattering, light refraction, light reflection, fluorescence, phosphorescence, chemiluminescence, electrochemiluminescence, etc), and the like. A cartridge may also comprise reagents for carrying out an assay such as binding reagents, detectable labels, sample processing reagents, wash solutions, buffers, etc. The reagents may be present in liquid form, solid form and/or immobilized on the surface of solid phase supports present in the cartridge. (column 37, lines 31-48).
The cartridge as seen in Figure 14A comprise a sample chamber 1420 (sample collection unit); detection chambers 1445/1446 (reactant chambers) including bound reagents (plurality of reaction sites) in fluid communication with reagent chambers 1425/1426 via a plurality of nonlinear fluidic channels 1140/1441 (system of fluidic channels), and waste chambers1430/1431. (column 57, line 8 - column 58 line 50).
The detection chamber is designed to accommodate sample volumes between 0.1-1000 uL, more preferably, 1-200 uL, more preferably, 2-50 uL, most preferably, 5-25 uL. In embodiments that are limited by sample volume (e.g., cartridges measuring blood from finger pricks), especially preferred detection chamber volumes are less than 10 uL, more preferably 0.5-10 uL, even more preferably 2-6 uL. (column 49, lines 44-51).
The apparatus comprises a barcode reader 2365 (an identifier detector) is incorporated on/within the cartridge reader (reader assembly) to preferably automatically scan an identifying mark/label 2370 (identifier) on the cartridge; e.g., as it is drawn into the reader. The label may contain encoded information relating to the specific assays that are to be performed, calibration parameters and/or any other information required to perform the assay. (column 53, lines 5-11).
As to claims, 7-11, the immunoassay reagents are used to detect a number various specific substances within biological samples. (column 75, line 38 – column 77, line 9).
Claim(s) 1-11 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Parce et al., US 5,942,443.
Regarding claims 1 and 3, Parce teaches an apparatus structure 300 comprising: a sample collection unit (e.g., sample injection channel 304) for introducing a biological fluid in fluid communication with a plurality of reaction sites; (b) a plurality of reaction chambers ( e.g., bead resting wells 326-338) carrying a plurality of reactants in fluid communication with the reaction sites, wherein the plurality of reaction sites comprise a plurality of reactants bound thereto; and (c) a system of fluidic channels (e.g., reaction channels 312-324, seeding channel 306, etc.) to permit fluid flow within the apparatus, wherein at least one channel located between the plurality of reaction sites comprise an optical barrier (see figures 3 and 4A - 4F; col. 16, lines 1 - 65). The plurality of reaction sites comprising a plurality of test compounds or reactants can be bound or immobilized on beads that are contained within bead resting wells 326 - 338 (see, e.g., col. 7, lines 3 - 19; col. 16, line 47 - col. 17, line 67; col. 18, lines 31 - 50). Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function.
Regarding claim 2, Paree teaches the incorporation of an additional chamber structure (e.g., indicated at 344) in fluidic communication with at least one of the reaction sites (see figure 3).
Regarding claim 4, Paree teaches the incorporation of nonlinear fluidic channels, such as serpentine or saw tooth fluidic channels, with the disclosed apparatus (see, e.g., col. 8, lines 43 -57).
Regarding claims 5 and 6, the volume amount of biological fluid that can be processed is considered a statement of intended use. These claims do not recite any specific channel dimensions, such as channel width or length, that would enable the claimed device to process the recited volume amount of biological fluid. Since these claims are drawn to an apparatus· statutory class of invention, the structure of the apparatus must be positively recited.
Regarding claims 7 and 9, Paree anticipates the use and incorporation of immunoassay reagents, e.g., antibody/antigen binding pairs, with the disclosed apparatus. Paree additionally anticipates the detection of complementary nucleic acids (see, e.g., col. 6, lines 8 - 22).
Regarding claim 8, this claim is considered a statement of intended use or a functional attribute of the apparatus. This claim does not positively recite any kind of structure that would enable the recited detection function. Paree does teach the incorporation of an optical detection system (see, e.g., col. 10, lines 5 - 17).
Regarding claim 10, Paree anticipates the detection of various biomarkers, such as growth factors and enzymes, or drugs comprising small organic or inorganic molecules, etc. (see, e.g., col. 5, line 10 - col. 7, line 39; col. 4, lines 49 - 67).
Regarding claim 11, Paree teaches the incorporation of a luminescent or fluorescent detection system (see, e.g., col. 7, lines 40 - 65).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,727,291. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the Patent provide for each of the structural elements or equivalents of the elements of the instant application such scope of the instant claims are encompassed within the claims of the Patent. The claims of the Patent are:
1. An apparatus for detecting an analyte in a biological fluid of a subject, comprising: a plurality of reaction sites; a sample collection unit for introducing a biological fluid in fluid communication with the plurality of reaction sites; a plurality of reactant chambers comprising a plurality of reactants in fluid communication with said plurality of reaction sites, wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting said analyte; a system of fluidic channels to allow said biological fluid and said plurality of reactants to flow in said apparatus; and a wall of at least one of said plurality of reaction sites comprise an optically opaque material so that light will not escape said at least one of said plurality of reaction sites through said wall; wherein said at least one of said plurality of reaction sites comprises a reaction surface with bound reactants around a center of the at least one of said plurality of reaction sites and said bound reactants are spaced apart from a wall of the at least one of said plurality of reaction sites by a concentric ring-shaped area, said at least one of said plurality of reaction sites configured to reduce signal from any unbound conjugates remaining in the at least one of said plurality of reaction sites.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-9 of U.S. Patent No. 9,075,046. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the Patent provide for each of the structural elements or equivalents of the elements of the instant application such scope of the instant claims are encompassed within the claims of the Patent. The claims of the Patent are:
1. An apparatus comprising: a plurality of adjacent reaction sites; a sample collection unit, for introducing a biological fluid, in fluid communication with the plurality of adjacent reaction sites; a plurality of reagent chambers, including a plurality of reagents, in fluid communication with said reaction sites, wherein each of said plurality of reaction sites comprise one or more reactants bound thereto for detecting an analyte; and a system of fluidic channels to allow said biological fluid and said plurality of reagents to flow in said apparatus; wherein at least one of said plurality of adjacent reaction sites is between two optical barriers, said two optical barriers comprise two non-linear channels configured to not allow photons to pass through the two non-linear channels and contaminate signals produced from the plurality of adjacent reaction sites; walls of the at least one reaction site comprise optically opaque materials so that light will not escape said at least one reaction site through said walls, and the two nonlinear channels provide fluid communication between the plurality of adjacent reaction sites
2. The apparatus of claim 1, further comprising a plurality of waste chambers in fluid communication with at least one of said adjacent reaction sites.
3. The apparatus of claim 1 wherein each of said non-linear channels located between said plurality of adjacent reaction sites is configured as an optical barrier defining a fluid pathway with at least three bends between said adjacent reaction sites.
4. The apparatus of claim 1 wherein the sample collection unit is sized to contain biological fluid that is less than about 500 microliters.
6. The apparatus of claim 1, wherein the plurality of reagents comprise immunoassay reagents.
7. The apparatus of claim 6, wherein said plurality of reagents are configured to react to detect a plurality of different analytes.
8. The apparatus of claim 6, wherein the immunoassay reagents configured to react to detect a polypeptide glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.
9. The apparatus of claim 6, wherein the immunoassay reagents are configured to react to detect a member selected from the group consisting of drug, drug metabolite, biomarker indicative of a disease, tissue specific marker, and biomarker specific for a cell or cell type.
10. The apparatus of claim 1 wherein said at least one of said reaction sites is fluidically coupled by a) at least a first of said non-linear channels to another of said reaction sites and b) at least a second of said non-linear channels to yet another of said reaction sites.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798