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 .
Status of the Claims
Claims 1-20 were originally filed June 22, 2022.
The amendment received December 16, 2022 amended claims 2, 4, 5, and 9-10; canceled claims 6-8; and added new claim 21.
The amendment received September 24, 2025 amended claims 1 and 14 and cancelled claims 2-4.
The amendment received February 10, 2026 amended claims 1, 19, and 21 and canceled claims 5 and 20. Please note: the status identifier for claim 21 should be “(Withdrawn – Currently Amended)”.
Claims 1, 9-19, and 21 are currently pending.
Claims 1 and 19 are currently under consideration.
Election/Restrictions
Applicants elected, with traverse, Group I (claims 1, 5, 19, and 20) in the reply filed on September 24, 2025. The traversal is on the grounds that all pending claims have the same technical feature of S-arrestin peptides of SEQ ID NOs: 1-3. This is not found persuasive because applicants neglected to traverse the prior art made of record which was utilized to break Unity of Invention (i.e. WO 2018/127830 which discloses all of present SEQ ID NOs: 1-3).
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-18 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 24, 2025.
Applicants elected, with traverse, SEQ ID NO: 1 for all of species A-C in the reply filed on September 24, 2025. The traversal is on the grounds that all pending claims have the same technical feature of S-arrestin peptides of SEQ ID NOs: 1-3. This is not found persuasive because applicants neglected to traverse the prior art made of record which was utilized to break Unity of Invention (i.e. WO 2018/127830 which discloses all of present SEQ ID NOs: 1-3).
Please note: SEQ ID NO: 1 is not a function. Therefore, it is unclear why SEQ ID NO: 1 was elected for species B.
Please note: the election of SEQ ID NO: 1 does not fit with the amended claims received September 24, 2025 since the composition now requires each of SEQ ID NOs: 1-3 (i.e. see “and”).
Please note: due to the election of SEQ ID NO: 1 for species A-C, dependent claims 5, 19, and 20 should be withdrawn. However, due to the issues with the claims (see below) and in order to provide compact prosecution, the claims have been examined. This does not preclude withdrawal of additional claims which may be added during prosecution and/or the necessity of a secondary restriction and/or species requirement in the future.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Priority
The present application is a 371 (National Stage) of PCT/IB2020/062285 filed December 21, 2020 which claims foreign priority to UK 1919222.8 filed December 23, 2019.
Withdrawn Objections
The objection to claim 1 regarding “A composition which consisting of” should read “A composition consisting of” is withdrawn in view of the amendment received February 10, 2026.
The objection to claim 1 regarding a single conjunction should be present (i.e. delete “and” at line 5) is withdrawn in view of the amendment received February 10, 2026.
Maintained Objection
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See pages 9 and 26.
Arguments and Response
Applicants contend that the browser-executable codes have been deleted in the amendment received February 10, 2026.
The is not found persuasive because browser-executable code is still present at pages 9 and 26. Applicants should simply refer to the websites by name.
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.
New Objections Necessitated by Amendment
Specification
The amendment filed February 10, 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: at page 26, the linkers GK and KG, EK and KE, KK and KK, and K and K. In the originally filed specification, support is present for 3mers (i.e. GXX or XXG wherein X is K or E and KKK). Therefore, the 2mers or 1mers are new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 19 is objected to because of the following informalities: “the kit comprise” should read “the kit comprises”. Appropriate correction is required.
New Rejections Necessitated by Amendment
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.
Claim 19 is 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. One of skill in the art would not be able to determine the scope of the presently claimed composition. For example, it is unclear how the peptides of the composition can be in individual containers when the composition consists of SEQ ID NOs: 1-3 in combination. Dependency on claim 1 suggests that the composition is part of the kit.
Withdrawn Rejections
The rejection of claim 5 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 is withdrawn in view of the amendment received February 10, 2026 which canceled the claim.
The rejection of claim 20 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 is withdrawn in view of the amendment received February 10, 2026 which canceled the claim.
The rejection of claim 5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the amendment received February 10, 2026 which canceled the claim.
The rejection of claim 20 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of the amendment received February 10, 2026 which canceled the claim.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wraith et al. WO 2018/127830 published July 12, 2018 (provided with the Restriction Requirement mailed on July 30, 2025).
For present claims 1 and 19, Wraith et al. teach compositions of S-arrestin peptides of SEQ ID NOs: 34, 38, and 15 which are respectively present SEQ ID NOs: 1, 2, and 3 (i.e. 100% identity and the same length) wherein the peptides bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis and kits thereof for simultaneous, separate, sequential, or combined administration wherein the kit may comprise peptides in separate containers (please refer to the entire specification particularly the abstract; pages 1, 2, 8-13, 16-19, 21-23).
Therefore, the teachings of Wraith et al. anticipate the presently claimed composition.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102(a)(1) as being anticipated by Wraith et al. for claims 1 and 19 were considered but are not persuasive for the following reasons.
Applicants contend that since Wraith et al. disclose 36 peptides which would result in a multitude of combinations (i.e. not “countless” as applicants describe – see page 10, section VIII of the response received February 10, 2026), that one of skill in the art could not find out any specific combination of only three peptides without doing an inventive work. Applicants contend that since Wraith et al. has suggested preferred peptides of SEQ ID NOs: 15, 19, 25, 34, 36, and 46, one of skill in the art would not select SEQ ID NOs: 15, 34, and 38 of Wraith et al. Applicants refer to motivation. Applicants argue unexpected results of reducing S-Ag-specific responses.
Applicants’ arguments are not convincing since the teachings of Wraith et al. anticipate the composition and kit of the instant claims.
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." See In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
When a species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’").
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
"Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
It is respectfully noted that the present rejection is an anticipation rejection under 35 USC 102(a)(1). Thus, motivation is not a factor.
It is respectfully noted that arguments regarding unexpected results are not pertinent to 35 USC 102(a)(1) rejections. However, for clarity of the record, it is respectfully noted that Example 3 fails to provide all of the proper controls (i.e. 9K1K – SEQ ID NO: 1 is not shown in Figure 7A or 7B and 17JIK – SEQ ID NO: 2 and 15N3K – SEQ ID NO: 3 are not shown in Figure 8). In addition, it appears that the combination may be additive, at best, but not synergistic. Thus, the results are not unexpected. Of course, a control for each of SEQ ID NO: 1- SK1K, 17JIK – SEQ ID NO: 2, and 15N3K – SEQ ID NO: 3 would be necessary to fully determine this. In Figure 7A with a 17JIK – SEQ ID NO: 2 shows an 80% reduction while the combination of SEQ ID NOs: 1-3 (i.e. ATX975) show a 97% reduction in DR3tg mice. It is not out of the realm of possibility, especially considering the results in Figure 7B and Figure 8, that a 17% difference is not synergistic. Figure 7B in DR3tg mice shows a 52% reduction with 17JIK – SEQ ID NO: 2, a 74% reduction with 15N3K – SEQ ID NO: 3, and an 89% reduction with SEQ ID NOs: 1-3 (i.e. ATX975). First, it is unclear why there is such a large difference between the results in Figures 7A and 7B with 17JIK – SEQ ID NO: 2 (i.e. 80% in Figure 7A and 52% in Figure 7B). Furthermore, the combination of 17JIK – SEQ ID NO: 2 and 15N3K – SEQ ID NO: 3 would be expected to have a 126% reduction alone (i.e. results in Figure 7B added) while the combination of SEQ ID NOs: 1-3 (ATX975) only has an 89% reduction. Regarding Figure 8, 9K1K – SEQ ID NO: 1 has a 51% reduction while SEQ ID NOs: 1-3 (i.e. ATX975) have a 78% reduction. While Figures 7A (DR3tg mice), 7B (DR3tg mice), and 8 (DR3tg mice) have different mouse models, comparison of the percent reduction would lead one of skill in the art to conclude that the combination is not even additive, let alone synergistic (i.e. unexpected).
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 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,542,316 in view of Wraith et al. WO 2018/127830 published July 12, 2018 (provided with the Restriction Requirement mailed on July 30, 2025).
U.S. Patent No. 11,542,316 claims compositions comprising one or more peptides of SEQ ID NOs: 15 and 34 (i.e. present SEQ ID NOs: 3 and 1; 100% identity and the same length) wherein the peptides bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis.
Wraith et al. teach compositions of S-arrestin peptides of SEQ ID NOs: 34, 38, and 15 which are respectively present SEQ ID NOs: 1, 2, and 3 (i.e. 100% identity and the same length) wherein the peptides bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis and kits thereof for simultaneous, separate, sequential, or combined administration (please refer to the entire specification particularly the abstract; pages 1, 2, 8-13, 16-19, 21-23).
All the claimed elements were known in the prior art (i.e. present SEQ ID NOs: 1-3 and combinations thereof) and one skilled in the art could have combined the elements as claimed by known methods (i.e. making a composition with three peptides) with no change in the respective functions (i.e. bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis) and the combination would have yielded predictable results (i.e. bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. third S-arrestin of a different sequence) for another (i.e. S-arrestin of present SEQ ID NO: 2) would have yielded predictable results (i.e. bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. making a composition of present SEQ ID NOs: 1-3) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,542,316 in view of Wraith et al. for claims 1 and 19 were considered but are not persuasive for the following reasons.
Applicants contend that Wraith et al. do not teach the specific combination of present SEQ ID NOs: 1-3 and incorporate the above arguments for the 35 USC 102(a)(1) rejection.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,542,316 in view of Wraith et al. renders obvious the composition of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." See In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
When a species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’").
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
"Products of identical chemical composition cannot have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
All the claimed elements were known in the prior art (i.e. present SEQ ID NOs: 1-3 and combinations thereof) and one skilled in the art could have combined the elements as claimed by known methods (i.e. making a composition with three peptides) with no change in the respective functions (i.e. bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis) and the combination would have yielded predictable results (i.e. bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. third S-arrestin of a different sequence) for another (i.e. S-arrestin of present SEQ ID NO: 2) would have yielded predictable results (i.e. bind to an MHC molecule in vitro and are presented to a T cell without antigen binding which may be utilized to treat uveitis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. making a composition of present SEQ ID NOs: 1-3) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
It is respectfully noted that Example 3 fails to provide all of the proper controls (i.e. 9K1K – SEQ ID NO: 1 is not shown in Figure 7A or 7B and 17JIK – SEQ ID NO: 2 and 15N3K – SEQ ID NO: 3 are not shown in Figure 8). In addition, it appears that the combination may be additive, at best, but not synergistic. Thus, the results are not unexpected. Of course, a control for each of SEQ ID NO: 1- SK1K, 17JIK – SEQ ID NO: 2, and 15N3K – SEQ ID NO: 3 would be necessary to fully determine this. In Figure 7A with a 17JIK – SEQ ID NO: 2 shows an 80% reduction while the combination of SEQ ID NOs: 1-3 (i.e. ATX975) show a 97% reduction in DR3tg mice. It is not out of the realm of possibility, especially considering the results in Figure 7B and Figure 8, that a 17% difference is not synergistic. Figure 7B in DR3tg mice shows a 52% reduction with 17JIK – SEQ ID NO: 2, a 74% reduction with 15N3K – SEQ ID NO: 3, and an 89% reduction with SEQ ID NOs: 1-3 (i.e. ATX975). First, it is unclear why there is such a large difference between the results in Figures 7A and 7B with 17JIK – SEQ ID NO: 2 (i.e. 80% in Figure 7A and 52% in Figure 7B). Furthermore, the combination of 17JIK – SEQ ID NO: 2 and 15N3K – SEQ ID NO: 3 would be expected to have a 126% reduction alone (i.e. results in Figure 7B added) while the combination of SEQ ID NOs: 1-3 (ATX975) only has an 89% reduction. Regarding Figure 8, 9K1K – SEQ ID NO: 1 has a 51% reduction while SEQ ID NOs: 1-3 (i.e. ATX975) have a 78% reduction. While Figures 7A (DR3tg mice), 7B (DR3tg mice), and 8 (DR3tg mice) have different mouse models, comparison of the percent reduction would lead one of skill in the art to conclude that the combination is not even additive, let alone synergistic (i.e. unexpected).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
WO 2021/102182 – SEQ ID NOs: 92, 96, and 73 have 100% identify and the same length as present SEQ ID NOs: 1, 2, and 3.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Future Communications
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/AMBER D STEELE/Primary Examiner, Art Unit 1658