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 .
Status of Claims
The amendments to the claims filed March 21, 2024 are acknowledged and entered. Claims 1-23 are pending.
Priority
This application is a 371 of PCT/US22/31485, filed May 30, 2022, which is a CIP of PCT/US21/51965, filed September 24, 2021 which claims benefit of 63/083,277, filed September 25, 2020.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on March 21, 2024; January 6, 2025; August 11, 2025; and February 20, 2026. All references have been considered except where marked with a strikethrough.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 13, line 20). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all additional possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Election/Restriction
Applicant’s election of a species of GABA-receptor agonist corresponding to homotaurine in the reply filed on June 3, 2026 is acknowledged. Applicant states they believe Claims 1-3, 6-8, 10-20, 22 and 23 read on the elected species. 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)). Therefore this restriction is considered proper and thus made FINAL.
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species.
The elected species was found in the prior art. The search has therefore been limited to the elected species, homotaurine.
Claims 4-5, 9 and 21 (in full) and claims 1-3, 6-8, 11-20 and 23 (all in part, other than the above indicated subgenus) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
The full scope of claims 10 and 22 are under examination as being drawn to the elected species.
Claim Rejections - 35 USC § 112a
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 1-3, 6-8 and 11-18 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.
The claims require a “GABA-receptor agonist”. The claims do not require that the “GABA-receptor agonist” possess any particular conserved structure, or other distinguishing feature. Additionally, the specification does not describe or teach any particular conserved structure, or other distinguishing feature which defines this genus of compounds. Therefore, the full breadth of the claims fails to meet the written description provision of 35 U.S.C. §112, first paragraph.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.” The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision
Applicant may overcome this rejection by amending the claims to recite a specific compound or compounds which are regarded a “GABA-receptor agonist” and for which Applicant has written support in the specification.
Claim Rejections - 35 USC § 112b
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 8 and 20 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. The claims are indefinite for the reasons that follow:
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8 and 20 recite the broad recitation “alcohol”, and the claim also recites “(ethanol)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 8 and 20 recite the phrase “certain carbamates” which is indefinite because it is not clear what compounds are embraced by this phrase. The specification provides three examples of “certain carbamates” (carisoprodol, lorbamate and meprobamate; see page 10 of the specification); however, these compounds correspond to different classes of drugs with different effects. The meaning of “certain carbamates” is ambiguous. Examiner suggests amending the claim to recite specific compounds for which Applicant has written support.
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.
Claim(s) 1-3, 10-14 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bossu et al. (Frontiers in Aging Neuroscience 2018, Vol 10, Article 285)(hereinafter “Bossu”) in view of Divani et al. (Journal of Stroke and Cerebrovascular Diseases August 2020, Vol. 29, No. 8, 104941)(hereinafter “Divani”).
The instant claims are drawn to a method for ameliorating a coronavirus-related, coronavirus-induced, pneumotropic virus-related, or pneumoptropic virus-induced medical condition, comprising administering to a patient in need thereof an effective amount of a GABA-receptor agonist. The specification does not provide a definition of “ameliorating”. Merriam-Webster online dictionary defines ameliorate or ameliorating as to make better or more tolerable. The claimed invention is thus understood to be a method of making better or more tolerable a coronavirus-related medical condition. The specification does not define a medical condition embraced by the claims. The scope of the method includes any condition that is a coronavirus-related, coronavirus-induced, pneumotropic virus-related, or pneumoptropic virus-induced medical condition.
Bossu discloses the use of homotaurine, the elected species of GABA-receptor agonist, in the treatment of Amnesic Mild Cognitive Impairment (aMCI) (Title, Abstract). Bossu teaches homotaurine controls brain inflammation (Abstract, homotaurine supplementation in individuals with aMCI may have positive effects due to homotaurine anti-inflammatory effect). Bossu teaches homotaurine has been found to have neuroprotective effects following stroke (Introduction, col 1). Bossu teaches that supplementation with homotaurine is specifically associated with a decrease in pro-inflammatory cytokines in aMCI patients (Discussion on page 5). Bossu teaches wherein homotaurine was administered orally to patients with aMCI (Materials and Methods, page 3, col 1, patients were treated with homotaurine tablets).
Bossu does not teach wherein the brain inflammation or increased secretion of inflammatory factors is related to coronavirus infection; however, Divani teaches coronavirus disease 2019 (COVID-19) is a global threat wherein some COVID-19 patients have exhibited widespread neurological manifestations including stroke (Abstract). Divani teaches COVID-19 associated coagulopathy is recognized as a result of acute infection and is likely caused by inflammation (Abstract). Davani teaches SARS-CoV2 can decrease activation of the alternative RAS pathway in the brain and that the consequent neuroinflammation may contribute to the pathophysiology of stroke during SARS-CoV-2 infection (Abstract). Divani teaches COVID-19 leads to increased secretion of inflammatory factors (Introduction, col 2).
The difference between the prior art and the instant claims is that the instant claims require amelioration of a medical condition that is related to coronavirus comprising administration of homotaurine. The prior art does not explicitly teach administration of homotaurine to a patient to alleviate coronavirus related medical conditions (e.g. inflammation, increased secretion of inflammatory factors, COVID-19). However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the teachings of prior art into the claimed method because homotaurine was known in the art to be useful for treating inflammation, reducing inflammatory factors, and improving the outcomes of stoke (Bossu), and inflammation, increased secretion of inflammatory factors and stroke were all medical conditions known to be related to coronavirus (Divani).
One would have been motivated because COVID-19 was a known global threat. One would have administered homotaurine simply as a matter of treating inflammation and stroke associated with the infection. One would have been motivated to treat COVID-19 because the condition was known to lead to an increase in secretion of inflammatory factors (Divani) and homotaurine was known to decrease pro-inflammatory cytokines (Bossu).
One would have had a reasonable expectation of success because homotaurine was known to treat inflammation, increased secretion of inflammatory markers and stroke and at the time these were medical conditions known to be related to coronavirus.
Claim(s) 1-3, 6-8 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bossu et al. (Frontiers in Aging Neuroscience 2018, Vol 10, Article 285)(hereinafter “Bossu”) and Divani et al. (Journal of Stroke and Cerebrovascular Diseases August 2020, Vol. 29, No. 8, 104941)(hereinafter “Divani”) as applied to claims 1-3 above, and further in view of Yang et al. (Clinical Microbiology and Infection June 12, 2020, 26, 1171-1177)(hereinafter “Yang”) as evidenced by Chen et al (Neurosurgery 1996, 38(2), Abstract)(hereinafter “Chen”)
The teachings of Bossu and Divani were discussed above and are incorporated herein by reference. Bossu and Divani do not teach wherein a positive allosteric modulator (PAM) or an anti-inflammatory compound is also administered; however, Yang teaches corticosteroids are commonly used for acute respiratory distress and administration to some COVID-19 patients has resulted in improvement in clinical symptoms and oxygenation (Abstract). Yang teaches corticosteroid therapy improved clinical features for some cases and that further study of methylprednisolone therapy is necessary to confirm safety and effectiveness (Conclusion and future perspectives, page 1175). As evidenced by Chen, methylprednisolone is active in the brain (see Abstract MP is neuroprotective. We conclude MP crosses the BBB). Methylprednisolone therefore would be regarded as a neuroactive steroid embraced by the claims.
The difference between the prior art and the instant claims is that the instant claims require further administration of a PAM concurrently or in staggered format (claims 6-8), an anti-inflammatory compound ( claim 15) or corticosteroid (claim 16). However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine Bossu, Divani and Yang into the claimed invention because a PAM, which includes corticosteroids, was known to potentially be useful for the treatment of some cases of COVID-19. Moreover, administration would have included either concurrent administration or administration in a staggered format.
One would have been motivated as a matter of treating inflammation associated with COVID-19.
One would have had a reasonable expectation of success because corticosteroids (e.g. methylprednisolone) were anti-inflammatory PAMs known to potentially have use in treating COVID-19.
Claim(s) 19 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (ChemRxiv (2020) 1-40, published September 14 2020)(hereinafter “Bandyopadhyay”) in view of Bossu et al. (Frontiers in Aging Neuroscience 2018, Vol 10, Article 285)(hereinafter “Bossu”).
Bandyopadhyay teaches GABA agonists inhibit coronavirus (Title, Abstract: Key findings: Extensive screening of the molecules identified 5 leads for NSP9, 23 for Furin, 18 for ORF3a, and 19 for interleukin-6; These compounds… have the potential to be drug candidates for the treatment of SARS-CoV-2 infection that may possibly act on multiple pathways simultaneously to inhibit viral entry and replication as well as disease progression; see Table 4, page 17, EGCG; EGCG corresponds to (-)-epigallocatechin-3-gallate which is a GABA agonist of the claims, see page 10 of the specification). Bandyopadhyay teaches the current study comes up with convincing evidence about the antiviral and anti-inflammatory indications of these phytochemicals with great potential to inhibit simultaneous viral entry, replication, and disease progression. Bandyopadhyay teaches that at the time COVID-19 had caused 832,002 deaths (page 3, introduction).
Bandyopadhyay is silent regarding wherein the GABA agonist is homotaurine; however, Bossu teaches homotaurine has anti-inflammatory effects (Abstract, homotaurine supplementation in individuals with aMCI may have positive effects due to homotaurine anti-inflammatory effect).
The difference between the prior art and the instant claims is that the instant claims require a administering to a patient in need a GABA-receptor agonist wherein the agonist is homotaurine. The prior art does not specifically teach administration of homotaurine; however, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant claims to combine the prior art references into the claimed method because at the time it was known that GABA-agonists inhibited coronavirus and homotaurine was a known GABA-agonist with anti-inflammatory properties.
One would have been motivated to choose homotaurine as a matter of treating COVID-19. Bandyopadhya taught that the antiviral and anti-inflammatory indications of the compounds screened, which included a GABA agonist, may be useful in treating the condition (great potential to inhibit simultaneous viral entry, replication, and disease progression). One thus would have been motivated to select homotaurine because it was a known GABA agonist with anti-inflammatory properties and therefore may also be useful at inhibiting coronavirus and treating the condition.
One would have had a reasonable expectation of success because homotaurine was a known GABA agonist and such compounds where known to inhibit coronavirus.
Claim 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bandyopadhyay et al. (ChemRxiv (2020) 1-40, published September 14 2020)(hereinafter “Bandyopadhyay”) and Bossu et al. (Frontiers in Aging Neuroscience 2018, Vol 10, Article 285)(hereinafter “Bossu”) as applied to claim 19 above, and further in view of Yang et al. (Clinical Microbiology and Infection June 12, 2020, 26, 1171-1177)(hereinafter “Yang”) as evidenced by Chen et al (Neurosurgery 1996, 38(2), Abstract)(hereinafter “Chen”).
The teachings of Bandyopadhyay and Bossu were discussed above and are incorporated herein by reference. Bandyopadhyay and Bossu do not teach administration of a positive allosteric modulator (PAM); however, Yang teaches corticosteroids are commonly used for acute respiratory distress and administration to some COVID-19 patients has resulted in improvement in clinical symptoms and oxygenation (Abstract). Yang teaches corticosteroid therapy improved clinical features for some cases and that further study of methylprednisolone therapy is necessary to confirm safety and effectiveness (Conclusion and future perspectives, page 1175). As evidenced by Chen, methylprednisolone is active in the brain (see Abstract MP is neuroprotective. We conclude MP crosses the BBB). Methylprednisolone therefore would be regarded as a neuroactive steroid embraced by the claims.
The difference between the prior art and the instant claims is that the instant claims require additional administration of a PAM. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine Yang with Bandyopadhyay and Bossu into the claimed invention because a PAM, which includes corticostereoids, was known to potentially be useful for the treatment of some cases of COVID-19.
One would have been motivated to combine as a matter of treating COVID-19.
One would have had a reasonable expectation of success because corticosteroids (e.g. methylprednisolone) were PAMs known to potentially have use in treating COVID-19.
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, 6-8, 10-20 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 59-77 of copending Application No. 18/028,311(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the reference application.
The reference claims recite a method for ameliorating and/or treating coronavirus-induced medical condition, comprising administering to a patient in need thereof an effective amount of a GABA-receptor agonist. The limitations set forth in reference claims 59-77 overlap those recited in instant claims 1-3, 6-8, 10-18.
As per instant claims 19-20 and 22-23, the reference specification teaches the invention inhibits viral replication. Accordingly, practicing the reference method in an infected patient would intrinsically include wherein the virus is inhibited.
The reference application teaches the claimed limitations and therefore anticipates the invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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June 23, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
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