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
Claims 5-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group of inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
Applicant’s election without traverse of the peptide having SEQ ID NO: 10, a polynucleotide that codes for a peptide of SEQ ID NO: 10, and acute and chronic cutaneous wounds for the medical condition in the reply filed on 11/14/2025 is acknowledged.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/01/2023 and 02/03/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11 and 13-14 are is rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring peptide without significantly more.
Claim 11 is drawn to a composition comprising a peptide having length equal to or lower than 30 amino acids and comprising SEQ ID NO: 10, a naturally occurring sequence, in combination with a pharmaceutically acceptable excipient. Here, a pharmaceutically acceptable excipient can, as defined by the specification, include any and all solvents, diluents, or other vehicle, dispersion or suspension aids, surface active agents, isotonic agents, thickening or emulsifying agents, preservatives, solid binders, lubricants and the like, as suited to the particular dosage form desired. The specification further provides non-limiting examples such as lactose, glucose and sucrose; starches such as corn starch and potato starch; cellulose and its derivatives such as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate; powdered tragacanth; malt; gelatine; talc; excipients such as cocoa butter and suppository waxes; oils such as peanut oil, cottonseed oil; safflower oil; sesame oil; olive oil; corn oil and soybean oil; glycols; such a propylene glycol; esters such as ethyl oleate and ethyl laurate; agar; buffering agents such as magnesium hydroxide and aluminum hydroxide; alginic acid; pyrogen-free water; isotonic saline; Ringer's solution; ethyl alcohol, and phosphate buffer solutions, other non-toxic compatible lubricants such as sodium lauryl sulfate and magnesium stearate, coloring agents, releasing agents, coating agents, sweetening, flavoring and perfuming agents, preservatives and antioxidants. Many of these examples are natural products, and the excipient could be water, as it includes any solvent. This judicial exception is not integrated into a practical application because the claim language is drawn to the peptide sequence itself in combination with other naturally occurring products like water, rather than an integration of that sequence into an application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are integrated beyond the sequence itself in a solution that could include water, as well as a limitation on the length of the sequence in terms of amino acids that does not exclude naturally occurring forms of the peptide or fragments thereof. This is as evidenced by US 20090306186 A1, hereinafter Jackson et al., wherein the inventors describe and list the sequences as natural human EPO proteins (see sequence listing SEQ ID NO: 165-175). The combination of the naturally occurring peptide with a naturally occurring excipient does not integrate the judicial exception into a practical application, and the combination does not change the structure or function of the judicial exception beyond its natural properties.
Claims 13 and 14 recite a peptide having length equal to or lower than 30 amino acids and comprising SEQ ID NO: 10, a naturally occurring sequence. This judicial exception is not integrated into a practical application because the claim language is drawn to the peptide sequence itself, rather than an integration of that sequence into an application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are integrated beyond the sequence itself and a limitation on the length of the sequence in terms of amino acids that does not exclude naturally occurring forms of the peptide or fragments thereof. This is as evidenced by US 20090306186 A1, hereinafter Jackson et al., wherein the inventors describe and list the sequences as natural human EPO proteins (see sequence listing SEQ ID NO: 165-175).
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 1-4 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating acute or chronic cutaneous wounds, does not reasonably provide enablement for prevention of acute or chronic cutaneous wounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
With regard to the breadth of the claims, the nature of the invention, and the state of the prior art, the invention of claims 1-4 and 10 is drawn to a method of treating or preventing acute or chronic cutaneous wounds, but, given the breadth of the claims and the nature of the disease as including conditions like cuts and burns, the prior art does not indicate that it is possible to prevent conditions like cuts and burns by administering to a subject a peptide. In other words, it is recognized as impossible to completely prevent conditions like cuts and burns through the administration of a peptide to the subject. Similarly, with regard to the level of one of ordinary skill in the art and the level of predictability in the art, one having ordinary skill in the art is not equipped or able to make or use a peptide capable of completely preventing acute or chronic cutaneous wounds, as these wounds are unpredictable and not directly a result of any factor that can be mitigated with a peptide. With regard to the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention based on the disclosure, Applicant does not provide sufficient evidence or detail that the claimed method of administering a peptide can completely prevent any acute or chronic cutaneous wounds. Further, the disclosure does not provide working examples or directions for how to prevent said conditions. As such, a person having ordinary skill in the art would not be enabled to make or use the claimed invention, specifically with regard to preventing acute or chronic cutaneous wounds. It is advised that Applicant amend the claims to limit the scope to treating, rather than preventing, acute and chronic cutaneous wounds.
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.
The following is a quotation of the appropriate paragraphs of 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 –
(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.
Claims 1-2, 4, and 10-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20110263504 A1, hereinafter Cerami et al.
With regard to claim 1, Cerami et al. claim a method of treating a subject suffering from a disease associated with tissue damage, the method comprising administering to the subject an isolated peptide of SEQ ID NO: 15 of the reference application, which can read XDSRVLERYLLEXXXXXXXXXXXXXXXXX and has fewer than 30 amino acids (see claims 7, 27). Here, SEQ ID NO: 15 of the reference application comprises SEQ ID NO: 10, DSRVLERYLLE, of the instant application.
With regard to claim 2, Cerami et al. claim a method of treating a subject suffering from a disease associated with tissue damage, the method comprising administering to the subject an isolated peptide of SEQ ID NO: 15 of the reference application, which can read XDSRVLERYLLEXXXXXXXXXXXXXXXXX and has fewer than 30 amino acids (see claims 7, 27). Here, SEQ ID NO: 15 of the reference application comprises SEQ ID NO: 10, DSRVLERYLLE, of the instant application. Cerami et al. teach that the tissue-related diseases or disorders that can be treated by tissue protective peptides include diseases associated with angiogenesis like Hemangioma, Hemangiosarcoma, hemangiopericytoma, and angiosarcoma (see Table 1).
With regard to claim 4, Cerami et al. claim a method of treating a subject suffering from a disease associated with tissue damage, the method comprising administering to the subject an isolated peptide of SEQ ID NO: 15 of the reference application, which can read XDSRVLERYLLEXXXXXXXXXXXXXXXXX and has fewer than 30 amino acids (see claims 7, 27). Here, SEQ ID NO: 15 of the reference application comprises SEQ ID NO: 10, DSRVLERYLLE, of the instant application. Cerami et al. further teach that the tissue-related diseases or disorders that can be treated by tissue protective peptides include diseases that can be characterized as acute or chronic cutaneous wounds like burns (see Table 1).
With regard to claim 11, Cerami et al. claim a pharmaceutical composition comprising the isolated peptide of SEQ ID NO: 15 of the reference application, which can read XDSRVLERYLLEXXXXXXXXXXXXXXXXX and has fewer than 30 amino acids, along with a pharmaceutically acceptable carrier, which they teach can include a pharmaceutically acceptable excipient (see [0532] and claims 7, 24). Here, SEQ ID NO: 15 of the reference application comprises SEQ ID NO: 10, DSRVLERYLLE, of the instant application.
With regard to claim 12, Cerami et al. claim a nucleic acid comprising the nucleotide sequence encoding the isolated peptide of SEQ ID NO: 15 of the reference application, which can read XDSRVLERYLLEXXXXXXXXXXXXXXXXX and has fewer than 30 amino acids (see claims 7, 56). Here, SEQ ID NO: 15 of the reference application comprises SEQ ID NO: 10, DSRVLERYLLE, of the instant application.
With regard to claim 13, Cerami et al. teach at least the following peptides having length equal to or lower than 30 amino acids and explicitly comprising SEQ ID NO: 10: APPRLICDSRVLERYLLEAKEAE (SEQ ID NO: 14), CDSRVLERYLLEAKEAENITTGCAEH (SEQ ID NO: 16), PPRLICDSRVLERYLLEAKEAENITTGC (SEQ ID NO: 17), PPRLICDSRVLERYLLEAKEAENI (SEQ ID NO: 28), APPRLICDSRVLERYLLEAKE (SEQ ID NO: 32), and DSRVLERYLLEAKE (SEQ ID NO: 41).
Claims 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20040063917 A1, hereinafter Carr et al.
With regard to claim 11, Carr et al. teach the following peptides with erythropoietin (EPO) activity that comprise SEQ ID NO: 10 and are shorter than 30 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see Table 1). Carr et al. further claim a pharmaceutical composition comprising a molecule with EPO activity in combination with a pharmaceutically acceptable carrier, excipient, or diluent (see claim 20).
With regard to claim 12, Carr et al. teach the peptides discussed above, and they further claim deoxyribonucleic acid sequences for said peptides with EPO activity (see claim 19).
With regard to claim 13, Carr et al. teach the following peptides with erythropoietin (EPO) activity that comprise SEQ ID NO: 10 and are shorter than 30 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see Table 1).
Claims 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20040082039 A1, hereinafter Gillies et al. (370).
With regard to claim 11, Gillies et al. (370) teach the following peptides with erythropoietin (EPO) activity that comprise SEQ ID NO: 10 and are shorter than 30 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see [0288]). Gillies et al. (370) further claim a pharmaceutical composition comprising a molecule with EPO activity in combination with a pharmaceutically acceptable carrier, excipient, or diluent (see claim 27).
With regard to claim 12, Gillies et al. (370) also teach deoxyribonucleic acid sequences for the peptides taught that can be used in fusion proteins, which include the EPO peptides discussed above (see [0128], [0288], and claim 1).
With regard to claim 13, Gillies et al. (370) teach the following peptides with erythropoietin (EPO) activity that comprise SEQ ID NO: 10 and are shorter than 30 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see [0288]).
Claims 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20070269435 A1, hereinafter Gillies et al. (878).
With regard to claim 11, Gillies et al. (878) teach the following peptides with erythropoietin (EPO) activity that comprise SEQ ID NO: 10 and are shorter than 30 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see [0262]). Gillies et al. (878) further claim a pharmaceutical composition comprising a molecule with EPO activity in a fusion protein in combination with a pharmaceutically acceptable carrier, excipient, or diluent (see [0262], claim 38, and claim 43).
With regard to claim 12, Gillies et al. (878) also teach deoxyribonucleic acid sequences for the peptides taught that can be used in fusion proteins, which include the EPO peptides discussed above (see [0132, [0262], claim 38, and claim 42).
With regard to claim 13, Gillies et al. (878) teach the following peptides with erythropoietin (EPO) activity that comprise SEQ ID NO: 10 and are shorter than 30 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see [0262]).
Claims 11-13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20090197801 A1, hereinafter Berezin et al.
With regard to claim 11, Berezin et al. teach the following peptide that comprises SEQ ID NO: 10 of the instant application and is shorter than 30 amino acids in length: DSRVLERYLLEAKE (see Table 1). Berezin et al. further teach that formulations of the compounds of their invention can be prepared in pharmaceutical compositions like injections that can contain excipients (see [0194]-[0196]).
With regard to claim 12, Berezin et al. teach that the peptides of their invention are produced by the use of DNA sequences via recombinant DNA technologies, and they give directions for how to prepare and attain the DNA sequences for the peptides of the invention, thereby necessarily teaching the sequences that encode the peptides (see [0130]-[0134]).
With regard to claim 13, Berezin et al. teach the following peptide that comprises SEQ ID NO: 10 of the instant application and is shorter than 30 amino acids in length: DSRVLERYLLEAKE (see Table 1).
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.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 20110263504 A1, hereinafter Cerami et al., as applied to claim 1 above, in view of Nardo et al. (Nardo, Luciano, and Spyridon Chouliaras. “Adjuvants in IVF-evidence for what works and what does not work.” Upsala journal of medical sciences vol. 125,2 (2020): 144-151).
With regard to claim 10, Cerami et al. teach the methods and products discussed above, but they do not explicitly teach the use of the as an adjuvant therapy in assisted reproduction therapy. Nardo et al. teach that adjuvants that increase blood flow in assisted reproduction technology, specifically in vitro fertilization (IVF), may enhance implantation rates and enhancement of the endometrium (see page 146, paragraph 1). Here, Nardo et al. provide a clear motivation to use an adjuvant to increase the blood flow or blood supply in assisted reproductive technology like IVF. Given the fact Cerami et al. teach that their claimed method can be used to treat angiogenesis-associated conditions, as discussed above (see Table 1), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the instant application to try to use the peptides of Cerami et al. as adjuvants in assisted reproductive technology.
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20110263504 A1, hereinafter Cerami et al., as applied to claim 1 above, in view of US 20040063917 A1, hereinafter Carr et al.
With regard to claim 3, Cerami et al. claim a method of treating a subject suffering from a disease associated with tissue damage, the method comprising administering to the subject an isolated peptide of SEQ ID NO: 15 of the reference application, which can read XDSRVLERYLLEXXXXXXXXXXXXXXXXX and has fewer than 30 amino acids (see claims 7, 27). Here, SEQ ID NO: 15 of the reference application comprises SEQ ID NO: 10, DSRVLERYLLE, of the instant application. They further teach that the peptides of Formula I of the reference application, which includes SEQ ID NO: 15 of the reference (see [0102]), can be truncated to 11 amino acids (see [0130]) and still maintain the desired function. Cerami et al. do not, however, teach which 11 amino acids SEQ ID NO: 15 of the reference can maintain the function after truncation. Here, Carr et al. teach the following peptides that comprise SEQ ID NO: 10 of the instant application and are 13 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see Table 1). Carr et al. teach that these are known sequences of human erythropoietin (EPO), and they can function in potential human MHC class II binding activity (see Table 1). Although Cerami et al. teach that the sequence XDSRVLERYLLEXXXXXXXXXXXXXXXXX can be truncated to 13, 12, 11, or even 10 amino acids in length and maintain its function, they don’t explicitly teach which domains of the sequence need to be present to maintain function. Given that Carr et al. teach that the following 13 amino acids maintain biological activity for human EPO, ICDSRVLERYLLE and CDSRVLERYLLEA, it would have been obvious to one having ordinary skill in the art to use the functional domains taught by Carr et al. to attempt to maintain biological function of a truncated EPO. Carr et al. do not, however, teach truncation to 11 amino acids. Although Carr et al. do not teach an 11 amino acid form of the sequence, there exist very few ways to truncate the 13 amino acid sequences ICDSRVLERYLLE and CDSRVLERYLLEA to 11 amino acids. Specifically, there are three ways to truncate each of these sequences to 11 amino acids (remove two amino acids from either end or one from each end). As such, given that it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the instant application to use the domains taught by Carr et al. to maintain the biological function of the EPO in truncating to 13 amino acids, it also would have been obvious to try the 11 amino acid sequence of SEQ ID NO: 10 of the instant application, DSRVLERYLLE, given that there are only three ways to truncate the 13 amino acid sequences (ICDSRVLERYLLE and CDSRVLERYLLEA) to 11 amino acids.
With regard to claim 14, as discussed above, Cerami et al. teach that the peptides of Formula I of the reference application, which includes SEQ ID NO: 15 of the reference, XDSRVLERYLLEXXXXXXXXXXXXXXXXX (see [0102]), can be truncated to 11 amino acids (see [0130]) and still maintain the desired function. Cerami et al. do not, however, teach which 11 amino acids SEQ ID NO: 15 of the reference can maintain the function after truncation. Here, Carr et al. teach the following peptides that comprise SEQ ID NO: 10 of the instant application and are 13 amino acids in length: ICDSRVLERYLLE, CDSRVLERYLLEA (see Table 1). Carr et al. teach that these are known sequences of human erythropoietin (EPO), and they can function in potential human MHC class II binding activity (see Table 1). Although Cerami et al. teach that the sequence XDSRVLERYLLEXXXXXXXXXXXXXXXXX can be truncated to 13, 12, 11, or even 10 amino acids in length and maintain its function, they don’t explicitly teach which domains of the sequence need to be present to maintain function. Given that Carr et al. teach that the following 13 amino acids maintain biological activity for human EPO, ICDSRVLERYLLE and CDSRVLERYLLEA, it would have been obvious to one having ordinary skill in the art to use the functional domains taught by Carr et al. to attempt to maintain biological function of a truncated EPO. Carr et al. do not, however, teach truncation to 11 amino acids. Although Carr et al. do not teach an 11 amino acid form of the sequence, there exist very few ways to truncate the 13 amino acid sequences ICDSRVLERYLLE and CDSRVLERYLLEA to 11 amino acids. Specifically, there are three ways to truncate each of these sequences to 11 amino acids (remove two amino acids from either end or one from each end). As such, given that it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the instant application to use the domains taught by Carr et al. to maintain the biological function of the EPO in truncating to 13 amino acids, it also would have been obvious to try the 11 amino acid sequence of SEQ ID NO: 10 of the instant application, DSRVLERYLLE, given that there are only three ways to truncate the 13 amino acid sequences (ICDSRVLERYLLE and CDSRVLERYLLEA) to 11 amino acids.
Summary
Claims 1-4 and 11-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated. Claim 10 is rejected under 35 U.S.C. 103 on the grounds of obviousness. Claims 1-4 and 10 are rejected under 3 U.S.C. 112(a) for failing to fulfill the requirements of scope of enablement. Claims 11 and 13-14 are rejected under 35 U.S.C. 101 as being drawn to a judicial exception without significantly more.
Conclusion
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/BRENDAN P. OLISS/Examiner, Art Unit 1658
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654