DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/8/26 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 6/8/26 are acknowledged. Any objection or rejection from the 12/8/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the compound 3-PhPh-AQTGTGKT were elected.
Claims 14-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/27/25.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Since the elected species is such that X is 3PhPh, claims 9 and 11 are drawn to non-elected species.
Claims 9 and 11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/27/25.
Claims 3-8, 10, 13 and 16-17 have been canceled.
Claims 1-2 and 12 are being examined.
Priority
The priority information is found in the filing receipt of 2/15/23.
Claim Rejections - 35 USC § 103
The first rejection below is a new rejection necessitated by amendment. Since the claims have been amended the 2nd rejection below is updated to correspond to the instant claims.
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.
Claim(s) 1-2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772; previously cited).
Yeon teach the peptide AQTGTGKT and states that the results present evidence that the peptide could overcome resistance of non-small cell lung cancers to anti-cancer drugs (abstract). Yeon teach that the peptide was synthesized and purified (page 2 section ‘Peptides’) and used in various assays (page 3 last complete paragraph for example). Yeon teach the inclusion of protease inhibitors (page 3 first paragraph).
Yeon does not teach the X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites phenyl as a protecting group (section 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Yeon because Yeon teach the peptide AQTGTGKT and states that the results present evidence that the peptide could overcome resistance of non-small cell lung cancers to anti-cancer drugs (abstract). Since Yeon teach beneficial results with AQTGTGKT and suggest uses of the peptide, one would have been motivated to prepare in an appropriate form. Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035) and specific benefits including increased half-lives (section 0055). Since Ben-Sasson recites phenyl-CO as a protecting group (section 0055) one would have been motivated to use such protecting group based on the known beneficial effects on the peptide of Yeon resulting in phenyl-CO-AQTGTGKT. Since Yeon suggest uses of the peptide and the peptide in various assays (page 3 last paragraph for example) one would have been motivated to make compositions with the peptide. One would have had a reasonable expectation of success since Yeon teach that the peptide was synthesized and purified (page 2 section ‘Peptides’) and used in various assays (page 3 last paragraph for example).
In relation to the peptide of claims 1-2, Yeon teach the peptide AQTGTGKT (abstract).
In relation to the X group of claims 1-2 and 12, Ben-Sasson teach phenyl-CO (section 0035) which is the second to last option for X of claims 1-2 and 12. In relation to any functionality recited in the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites phenyl as a protecting group (section 0055).
In relation to the composition of claim 2, Yeon teach that the peptide was synthesized and purified (page 2 section ‘Peptides’) and used in various assays (page 3 last paragraph for example).
Claim(s) 1-2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772) in view of Yu et al. (US 2004/0229882; ‘Yu’).
Yeon teach the peptide AQTGTGKT and states that the results present evidence that the peptide could overcome resistance of non-small cell lung cancers to anti-cancer drugs (abstract). Yeon teach that the peptide was synthesized and purified (page 2 section ‘Peptides’) and used in various assays (page 3 last complete paragraph for example). Yeon teach the inclusion of protease inhibitors (page 3 first paragraph).
Yeon does not teach the X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Yu also teach additional dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0276). Yu teach compound 151 which includes a specific R19 group (3-PhPh) (page 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Yeon because Yeon teach the peptide AQTGTGKT and states that the results present evidence that the peptide could overcome resistance of non-small cell lung cancers to anti-cancer drugs (abstract). Since Yeon teach beneficial results with AQTGTGKT and suggest uses of the peptide, one would have been motivated to prepare in an appropriate form. Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035) and specific benefits including increased half-lives (section 0055). Since Ben-Sasson recites biphenyl as a protecting group (section 0055) one would have been motivated to use the known configurations as taught by Yu. Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Thus, one would have been motivated to include the 3-PhPh-C(O)- group at the N-terminus of AQTGTGKT. Since Yeon suggest uses of the peptide and the peptide in various assays (page 3 last paragraph for example) one would have been motivated to make compositions with the peptide. One would have had a reasonable expectation of success since Yeon teach that the peptide was synthesized and purified (page 2 section ‘Peptides’) and used in various assays (page 3 last paragraph for example).
In relation to the peptide of claims 1-2, Yeon teach the peptide AQTGTGKT (abstract).
In relation to the X group of claims 1-2 and 12, Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). The 3-PhPh-C(O)- group corresponds to the 3rd X group of claims 1-2.
In relation to the composition of claim 2, Yeon teach that the peptide was synthesized and purified (page 2 section ‘Peptides’) and used in various assays (page 3 last paragraph for example).
In relation to the functionality recited in any of the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Response to Arguments - 103
Applicant's arguments filed 6/8/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue about the teachings of Ben-Sasson alone, the rejections set forth above are multiple reference 103 rejections and as such any single reference does not necessarily anticipate the claims. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Although applicants argue that there is no reason to select a group from Ben-Sasson, Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell and specifically recites phenyl-CO (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites phenyl as a protecting group (section 0055). Thus, one would have been motivated by the benefits suggested by Ben-Sasson and the specific suggestions.
Although applicants argue that Ben-Sasson does not provide any half-life data, the instant claims are product claims and are not drawn to methods of determining half-life.
Although applicants argue that Yu’s dipeptide cannot be extrapolated to the half-life stability and anti-cancer activity of an octapeptide, Yeon teach the peptide AQTGTGKT and states that the results present evidence that the peptide could overcome resistance of non-small cell lung cancers to anti-cancer drugs (abstract). Thus, the anti-cancer activity was known. Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives (section 0055). Thus, beneficial effects were known. MPEP 2143.02 recognizes that absolute predictability or conclusive proof of efficacy is not required.
Although applicants argue about previous statements, it is also noted that applicants have previously stated on the record that ‘The differences in the substituent group X represent structural variations and do not affect the fundamental therapeutic action of the compounds. The structural modifications are predictable variants’ (page 9 of 6/27/25 reply).
Although applicants argue about alleged marked improvements in stability, MPEP 716.02(b) states that the burden is on the applicant to establish that results are unexpected and significant. MPEP 716.02(c) recognizes that expected beneficial results are evidence of obviousness and MPEP 716.02 states that the issue is whether the properties differ to an extent that the difference is really unexpected.
With respect to the data, applicants state that values are derived from Example 3 and figures 19-26 (pages 10-11 of reply). Example 3 (page 62-63 of the 11/3/25 specification) refers to putting compounds into human blood and the residual amount in blood was measured at time points when 0, 5, 10, 15, 30, 60 and 120 minutes had elapsed. As such, the specification refers to 7 data points for each compound. Figures 20-25 show at best 5 data points. Figure 26 shows at best 6 data points. Figure 19 shows data points but it is unclear which data point corresponds to 10 minutes (one would expect the 10 minute data point to be halfway between 0 and 20 but there is no data point at that location). Figures 20-26 appear to show an initial data point at 100% at a time other than 0 minutes which is different from figure 19. MPEP 716.02(b) expressly states that applicants have the burden of explaining the data. In the instant case, there are numerous discrepancies in the data making the data unclear.
MPEP 716.02(b) states that the burden is on the applicant to establish that results are in fact unexpected and unobvious and of both statistical and practical significance. With respect to an expectation of modifying the N-terminus with a protecting group, Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives (section 0055). Thus, a showing of longer biological half-lives when using a protecting group is not necessarily adequate.
With respect to statistical significance, as noted above the data is unclear because although there were supposed to be 7 time points the figures do not show 7 time points. Further, there does not appear to be any showing of statistical significance. It is unclear if any of the experiments were tried more than once. In addition, based on the plain meaning of half-life, one would not necessarily recognize figure 22 as having a half-life of 52 minutes because the actual line in the data shows 50% remaining at around 25 minutes and figure 22 further appears to show the data starting at a non-zero timepoint which would offset the data and make the half life appear larger than it actually would be if the data started at time 0.
Further, with respect to significance of the data, on page 9 (lines 1-2) of the 6/8/26 reply applicants refer to a particular compound that ‘achieves 100 to 150 minutes of half life’. Such statement appears to suggest large variability in the half life although it is completely unclear where applicants came up with a range of 100 to 150 minutes.
Although many of applicants arguments are based on a half life of less than 1 (figure 19) and making fold comparisons to the value of 1, ‘less than one’ includes 0.5, 0.1 and 0.0000001. Thus, the argument that certain comparisons are 2.5x are not necessarily accurate as they could be 25000000x (2.5/0.0000001) (pages 10-11 of 6/8/26 reply).
Although applicants argue that PEGylation and lipidation failed, page 10 of the 6/8/26 reply states that all values are derived from example 3 and figures 19-26. There are no examples of PEGylation of lipidation in example 3 or figures 19-26. As discussed in the previous paragraph, what applicants are calling 2.5x could be 25000000x. Further, it is noted that example 3 appears to be an in vitro example. An in vitro example is not necessarily representative of what happens in the body. PEGylation is known to reduce renal clearance but such mechanism of action would not show up in an in vitro assay.
Although applicants argue about a common modification and assert unexpected results, the mere fact that a modification is common does not shed light on the motivation to use such modification. If a modification is less costly and easier to produce it may be more common even if the magnitude of its beneficial effect was not the same as a more costly or difficult to product option. With respect to the assertion of unexpected results, Ben-Sasson teach protecting groups to allow for longer biological half-lives (section 0055).
Although applicants argue that PEGylation and lipidation are near-complete failures, page 10 of the 6/8/26 reply states that all values are derived from example 3 and figures 19-26. There are no examples of PEGylation of lipidation in example 3 or figures 19-26. As discussed previously, what applicants are calling 2.5x could be 25000000x.
Although applicants argue that a figure on tumor retention is provided, the figure provided is not legible. MPEP 716.02(b) states that the burden is on the applicant to establish that results are in fact unexpected and unobvious and of both statistical and practical significance. There is no way to make an assessment based on the information provided. MPEP 716.02(b) states that the burden is on the applicant to establish results are in fact unexpected and of statistical significance and the burden is on the applicant to explain the data. The picture shown on page 13 of the 6/8/26 reply is not legible and the details of the experiment have not been set forth. Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives (section 0055). Further, any unexpected results are to be commensurate in scope with the claimed invention (MPEP 716.02(d)), (it appears that applicants argue about the tumor retention data with respect to a single compound).
In summary, there are inadequate facts to establish unexpected results. As discussed in detail above, the prior art recognizes certain modifications that are suggested to improve stability and half-life. Expected beneficial results are evidence of obviousness.
Double Patenting
Claims were previously rejected based on the applications/patents and references cited below. Since the claims have been amended the rejections are updated to correspond to the instant claims.
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 1-2 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-48 of copending Application No. 18550775 (reference application; ‘775’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
775 recites compositions comprising the compound X-AQTGTGKT where a finite number of X residues are recited (claim 48).
In relation to the peptide of claims 1-2, 775 recites compositions comprising the compound X-AQTGTGKT (claim 48).
In relation to the X group of claims 1-2 and 12, 775 recites compositions comprising the compound X-AQTGTGKT (claim 48 including the 3rd option for X; compare MPEP 2131.02 III 2nd-3rd paragraph).
In relation to the composition of claim 2, 775 recites compositions (claim 48).
In relation to the functionality recited in any of the claims, the prior art teach a compound as claimed so it would function as claimed.
Claims 1-2 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8-18, 20, 22-23 and 25 of copending Application No. 18692883 (883).
This is a provisional nonstatutory double patenting rejection.
883 teach the peptide AQTGTGKT (claim 2) and refers to compositions (claim 25) and teach methods of administering (claim 1). 883 suggests an X group including an acylated phenyl group (claim 2 chemical formula 3 when R2, R3 and R4 are H).
883 does not recite a specific compound with an X group on the peptide as in instant claims 1-2.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 883 because 883 teach the peptide AQTGTGKT and specifically suggest X groups on the peptide (claim 2) including phenyl-CO (i.e. phenyl-CO- AQTGTGKT). Since 883 teach compositions (claim 25) one would have been motivated to make compositions with the peptide. One would have had a reasonable expectation of success based on the express teachings and suggestions of 883.
In relation to the peptide of claims 1-2, 883 teach the peptide AQTGTGKT (claim 2).
In relation to the X group of claims 1-2 and 12, 883 suggests an X group including an acylated phenyl group (claim 2 chemical formula 3 when R2, R3 and R4 are H) which is the 2nd to last option for X of claims 1-2 and 12.
In relation to the composition of claim 2, 883 recites compositions (claim 25).
In relation to the functionality recited in any of the claims, the prior art teach a compound as claimed so it would function as claimed.
Claims 1-2 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8-18, 20, 22-23 and 25 of copending Application No. 18692883 (883) in view of Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772) in view of Yu et al. (US 2004/0229882; ‘Yu’).
This is a provisional nonstatutory double patenting rejection.
883 teach the peptide AQTGTGKT (claim 2) and refers to compositions (claim 25) and teach methods of administering (claim 1). 883 suggests an X group including an acylated phenyl group (claim 2 chemical formula 3)
883 does not recite a specific compound with an X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Yu also teach additional dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0276). Yu teach compound 151 which includes a specific R19 group (3-PhPh) (page 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 883 because 883 teach the peptide AQTGTGKT and specifically suggest X groups on the peptide including phenyl-CO (i.e. phenyl-CO- AQTGTGKT). Further, Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035) and specific benefits including increased half-lives (section 0055). Since Ben-Sasson recites biphenyl as a protecting group (section 0055) one would have been motivated to use the known configurations as taught by Yu. Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Thus, one would have been motivated to include the 3-PhPh-C(O)- group at the N-terminus of AQTGTGKT. Since 883 teach compositions (claim 25) one would have been motivated to make compositions with the peptide. One would have had a reasonable expectation of success since Ben-Sasson teach peptides can be produced using known techniques (section 0067).
In relation to the peptide of claims 1-2, 883 teach the peptide AQTGTGKT (claim 2)
In relation to the X group of claims 1-2 and 12, 883 teach the peptide AQTGTGKT and specifically suggest X groups on the peptide (claim 2) including phenyl-CO (i.e. phenyl-CO- AQTGTGKT) which corresponds to the 2nd to last option for X of claims 1-2 and 12. Further, Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). The 3-PhPh-C(O)- group corresponds to the 3rd X group of claims 1-2.
In relation to the composition of claim 2, 883 teach the peptide AQTGTGKT and compositions thereof (claim 2).
In relation to any functionality recited in the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Claims 1-2 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,233,221 (221) in view of Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772).
221 teach the peptide AQTGTGKT and compositions thereof (claim 1) and teach methods of treating (claim 5).
221 does not teach the X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites phenyl as a protecting group (section 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 221 because Yeon teach the peptide AQTGTGKT and teach uses thereof (claims 1 and 5). Since 221 suggest uses of the peptide, one would have been motivated to prepare in an appropriate form. Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035) so one would have been motivated to make such compound (phenyl-CO-AQTGTGKT). Since 221 teach compositions (claim 1) one would have been motivated to make compositions with the peptide. One would have had a reasonable expectation of success since Ben-Sasson teach peptides can be produced using known techniques (section 0067).
In relation to the peptide of claims 1-2, 221 teach the peptide AQTGTGKT (claim 1)
In relation to the X group of claims 1-2 and 12, Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035) which is the 2nd to last option for X of claims 1-2 and 12.
In relation to the composition of claim 2, 221 teach the peptide AQTGTGKT and compositions thereof (claim 1).
In relation to any functionality recited in the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Claims 1-2 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,233,221 (221) in view of Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772) in view of Yu et al. (US 2004/0229882; ‘Yu’).
221 teach the peptide AQTGTGKT and compositions thereof (claim 1) and teach methods of treating (claim 5).
221 does not teach the X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO or a substituted phenyl (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Yu also teach additional dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0276). Yu teach compound 151 which includes a specific R19 group (3-PhPh) (page 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 221 because Yeon teach the peptide AQTGTGKT and teach uses thereof (claims 1 and 5). Since 221 suggest uses of the peptide, one would have been motivated to prepare in an appropriate form. Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035) so one would have been motivated to make such compound (phenyl-CO- AQTGTGKT). Further, Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035) and specific benefits including increased half-lives (section 0055). Since Ben-Sasson recites biphenyl as a protecting group (section 0055) one would have been motivated to use the known configurations as taught by Yu. Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Thus, one would have been motivated to include the 3-PhPh-C(O)- group at the N-terminus of AQTGTGKT. Since 221 teach compositions (claim 1) one would have been motivated to make compositions with the peptide. One would have had a reasonable expectation of success since Ben-Sasson teach peptides can be produced using known techniques (section 0067).
In relation to the peptide of claims 1-2, 221 teach the peptide AQTGTGKT (claim 1)
In relation to the X group of claims 1-2 and 12, Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). The 3-PhPh-C(O)- group corresponds to the 2nd X group of claims 1-2.
In relation to the composition of claim 2, 221 teach the peptide AQTGTGKT and compositions thereof (claim 1).
In relation to any functionality recited in the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Claims 1-2 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,239,924 (924) in view of Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772).
924 teach the peptide AQTGTGKT (claim 1) and teach methods of administering (claim 1).
924 does not teach the X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be phenyl-CO (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites phenyl as a protecting group (section 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 924 because Yeon teach the peptide AQTGTGKT and teach uses thereof (claims 1 and 9). Since 924 suggest uses of the peptide, one would have been motivated to prepare in an appropriate form. Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a phenyl-CO (section 0035) and specific benefits including increased half-lives (section 0055) so one would have been motivated to make phenyl-CO- AQTGTGKT. One would have had a reasonable expectation of success since Ben-Sasson teach peptides can be produced using known techniques (section 0067).
In relation to the peptide of claims 1-2, 924 teach the peptide AQTGTGKT (claim 1)
In relation to the X group of claims 1-2 and 12, Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a phenyl-CO (section 0035) which is the 2nd to last option for X of claims 1-2 and 12.
In relation to the composition of claim 2, 924 teach methods of administering (claim 1) so one would have been motivated to include in an appropriate form.
In relation to any functionality recited in the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Claims 1-2 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,239,924 (924) in view of Yeon et al. (NPL cite 2 of IDS of 10/21/22; ‘Yeon’) in view of Ben-Sasson (US 2002/0028772) in view of Yu et al. (US 2004/0229882; ‘Yu’).
924 teach the peptide AQTGTGKT (claim 1) and teach methods of administering (claim 1).
924 does not teach the X group on the peptide as in instant claims 1-2.
Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035). Ben-Sasson teach that protecting groups can facilitate transport of a peptide into a cell (section 0035). Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Yu also teach additional dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0276). Yu teach compound 151 which includes a specific R19 group (3-PhPh) (page 37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 924 because Yeon teach the peptide AQTGTGKT and teach uses thereof (claims 1 and 9). Since 924 suggest uses of the peptide, one would have been motivated to prepare in an appropriate form. Ben-Sasson teach the use of N-terminal protecting groups including acyl groups where the acyl group can be a substituted phenyl (section 0035) and specific benefits including increased half-lives (section 0055). Since Ben-Sasson recites biphenyl as a protecting group (section 0055) one would have been motivated to use the known configurations as taught by Yu. Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). Thus, one would have been motivated to include the 3-PhPh-C(O)- group at the N-terminus of AQTGTGKT. One would have had a reasonable expectation of success since Ben-Sasson teach peptides can be produced using known techniques (section 0067).
In relation to the peptide of claims 1-2, 924 teach the peptide AQTGTGKT (claim 1)
In relation to the X group of claims 1-2 and 12, Yu teach dipeptide compounds where the N-terminal amino acid includes an acyl group (R19-C(O)-) (section 0274). Yu teach compound 96 which includes a specific R19 group (3-PhPh) (page 34). The 3-PhPh-C(O)- group corresponds to the 2nd X group of claims 1-2.
In relation to the composition of claim 2, 924 teach methods of administering (claim 1) so one would have been motivated to include in an appropriate form.
In relation to any functionality recited in the claims, the prior art suggest a compound as claimed so it would function as claimed. Ben-Sasson teach protecting groups to allow for longer biological half-lives and specifically recites biphenyl as a protecting group (section 0055).
Response to Arguments – double patenting
Applicant's arguments filed 6/8/26 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants request that the rejection be held in abeyance, nothing has been done to overcome the rejections of record so they remain of record.
Although applicants argue about a situation in which the double patenting rejections are the only remaining rejections, claims are currently rejected under 103 so that situation does not currently exist.
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
Prosecution Insights