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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 24, 2025 has been entered.
Status of the Claims
Claims 1-35 were originally filed August 6, 2021.
The preliminary amendment received August 6, 2021 amended claims 5, 8, 31, and 32 and canceled claims 10-30 and 33-35.
The amendment received November 12, 2024 amended claims 3 and 4.
The amendment received May 12, 2025 canceled claims 1 and 2; amended claims 3-5 and 8; and added new claims 36-44.
The amendment received October 24, 2025 amended claims 3 and 4.
Claims 3-9, 31, 32, and 36-44 are currently pending.
Claims 3, 4, 36, and 37 are currently under consideration.
Election/Restrictions
Applicants elected, with traverse, Group I (claims 1-4; now claims 3, 4, 36, and 37) in the reply filed on November 12, 2024. The traversal is on the grounds that a serious search burden does not exit. Applicant’s representative also mentions linking claims. This is not found persuasive because a serious search burden exists. Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process for using the product as claimed can be practiced with another materially different product (e.g. any FDA approved cancer treatment).
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112.
The present claims do not contain a linking claim. Therefore, discussion of linking claims is moot. See MPEP § 809.
The requirement is still deemed proper and is therefore made FINAL. Claims 5-9, 31, 32, and 38-44 (new claims 38-44 are withdrawn as an election by original presentation) 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 November 12, 2024.
Applicant's election with traverse of AVR-235/SEQ ID NO: 3 (now indicated as SEQ ID NO: 25 which has 100% identity to original SEQ ID NO: 1 in the sequence listing – i.e. duplicate sequence in the sequence listing) in the reply filed on November 12, 2024. The traversal is on the grounds that a serious search burden does not exist. This is not found persuasive because a serious search burden exists.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
(b) the species may have separate status in the art;
(c) the species may raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112;
(d) the species are structurally and/or functionally different.
The requirement is still deemed proper and is therefore made FINAL.
Please note: any amendments to the claims may require an additional restriction requirement. Claim 4 has not been withdrawn since the art of record still reads on sequences in the claim.
Priority
The present application is a CON of PCT/US2020/017375 filed February 8, 2020 which claims the benefit of 62/869,687 filed July 2, 2019 and 62/803,170 filed February 8, 2019.
Nucleotide and/or Amino Acid Sequence Disclosures
It is unclear why applicants added new SEQ ID NO: 25 when new SEQ ID NO: 25 is a duplicate of present and originally filed SEQ ID NO: 1.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Please note: any amended specification should be indicated as “Marked Up Copy” and the clean version should be indicated as “Clean Version”. In addition, applicants may wish to only submit amended paragraphs for any future amendments instead of the entire specification. See MPEP § 714 B.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 4, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
For present claims 3, 4, 36, and 37, Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 16-19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
However, Schally et al. do not specifically teach carriers.
For present claims 3, 4, 36, and 37, Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 16-19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
However, Schally et al. do not teach fluorinated (5F) PhAC-Ada.
For present claims 3, 4, 36, and 37, Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6). See present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1).
However, Schally et al. do not teach C-terminal NHCH3.
For present claims 3, 4, 36, and 37, Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2). See present SEQ ID NOs: 16, 17, and 25 (100% identity to original SEQ ID NO: 1).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions; specific amino acids at specific residues in growth hormone releasing hormone antagonists) 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. N-terminal PhAC-Ada, C-terminal NH2; one specifically taught amino acid at one specific residue) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3; another specifically taught amino acid at the same specific residue) would have yielded predictable results (i.e. additional stability, changing one protecting group for another; retention of activity) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions; making growth hormone releasing hormone antagonists with specific amino acids at specific residues) 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 under 35 USC 103 as being unpatentable over Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants contend that the amended claims do not teach SEQ ID NOs: 5 or 25 or any of the sequences recited in claim 4. Applicants contend that there are hundreds of possible combinations since Schally et al. teach a variable subgenus. Applicants contend that SEQ ID NOs: 11, 58, 65, and 85 are different from the presently claimed sequences. Applicants contend that there is no motivation to utilize one amino acid at one residue for another amino acid at the same residue. Applicants cite case law that predates KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). Applicants again refer to unexpected results.
Applicants’ arguments are not convincing since the teachings of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. render the peptides of the instant claims prima facie obvious. It is respectfully noted that “new” SEQ ID NO: 25 has 100% identity to original SEQ ID NO: 1. Schally et al. teach a variety of hGH-RH antagonist peptides with variability at several positions (i.e. variable sequence subgenus and individual species) as indicated in the above rejection of record which read on present SEQ ID NOs: 1/25, 5, and 16-18. "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). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component).
Schally et al. and Schally et al. teach a common core structure necessary for activity and residues that can be mutated to specific amino acids while retaining activity (please refer to the entire specification particularly paragraphs 24 and 25 of WO 2009/120831 and paragraphs 23-53 of U.S. Patent Application Publication 2013/0261055). SEQ ID NOs: 11, 58, 65, 85, and 86 are referred to in order to show which specific amino acids may be present at specific residues in the variable sequence taught by Schally et al. and Schally et al.
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions; specific amino acids at specific residues in growth hormone releasing hormone antagonists) 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. N-terminal PhAC-Ada, C-terminal NH2; one specifically taught amino acid at one specific residue) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3; another specifically taught amino acid at the same specific residue) would have yielded predictable results (i.e. additional stability, changing one protecting group for another; retention of activity) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions; making growth hormone releasing hormone antagonists with specific amino acids at specific residues) 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).
Figures 1A-1N show that Schally et al.’s MIA-602 has similar results compared to SEQ ID NOs: 1/25, 4, 5, 6, and 7. The results also appear to be dependent on which type of cancer is being tested (see Figure 2A – lung cancer verses Figure 2B – pancreatic cancer or Figure 2D – colon cancer verses Figure 2C – stomach cancer).
In Figure 2A (human lung cancer) there is no difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25.
In Figure 2D (human colon cancer) there is no difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25.
In Table 3A, there appears to be no or little difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25 in KATOIII stomach cancer cells or Panc-1 pancreatic cancer cells. In addition, MIA602/SEQ ID NO: 84(Schally et al.) was tested in additional cancer cells in which AVR235/present SEQ ID NO:1/25 was not tested.
In Table 3B, there appears to be no or little difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25 in HCC827 or HT-29 cells.
It is unclear why all of the results for MIA602/SEQ ID NO: 84(Schally et al.) are the same (i.e. 1). Were the results for MIA602/SEQ ID NO: 84(Schally et al.) converted to a baseline and all other results were compared?
Table 4 shows that while MIA602/SEQ ID NO: 84(Schally et al.) had a statistically significant decrease in tumor growth, the results for AVR235/present SEQ ID NO:1/25 are NOT statistically significant (see B – Lung Ca HCC827; 7 weeks).
Furthermore, applicants are pointing to a single species taught by Schally et al. and ignoring the subgenus taught by Schally et al. which encompasses present SEQ ID NOs: 4, 5, 16-19, and 25 (100% identity to original SEQ ID NO: 1).
"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.
In addition, applicants are focused solely on present SEQ ID NO: 1/25 and not the full scope of the present claims. Unexpected results must be commensurate in scope with the claims.
Claims 3, 4, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
For present claims 3, 4, 36, and 37, Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 16-19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
However, Schally et al. do not teach fluorinated (5F) PhAC-Ada.
For present claims 1-4, Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
However, Schally et al. do not teach C-terminal NHCH3.
For present claims 1-4, Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability) 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. N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups) 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 under 35 USC 103 as being unpatentable over Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants contend that the amended claims do not teach SEQ ID NOs: 5 or 25 or any of the sequences recited in claim 4. Applicants contend that there are hundreds of possible combinations since Schally et al. teach a variable subgenus. Applicants contend that SEQ ID NOs: 11, 58, 65, and 85 are different from the presently claimed sequences. Applicants contend that there is no motivation to utilize one amino acid at one residue for another amino acid at the same residue. Applicants cite case law that predates KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). Applicants again refer to unexpected results.
Applicants’ arguments are not convincing since the teachings of Schally et al.; Salwiczek et al.; and Rosenkranz et al. render the peptides of the instant claims prima facie obvious.
It is respectfully noted that “new” SEQ ID NO: 25 has 100% identity to original SEQ ID NO: 1. Schally et al. teach a variety of hGH-RH antagonist peptides with variability at several positions (i.e. variable sequence subgenus and individual species) as indicated in the above rejection of record which read on present SEQ ID NOs: 1/25, 5, and 16-18. "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). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component).
Schally et al. teach a common core structure necessary for activity and residues that can be mutated to specific amino acids while retaining activity (please refer to the entire specification particularly paragraphs 24 and 25 of WO 2009/120831 and paragraphs 23-53 of U.S. Patent Application Publication 2013/0261055). SEQ ID NOs: 11, 58, 65, 85, and 86 are referred to in order to show which specific amino acids may be present at specific residues in the variable sequence taught by Schally et al. and Schally et al.
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions; specific amino acids at specific residues in growth hormone releasing hormone antagonists) 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. N-terminal PhAC-Ada, C-terminal NH2; one specifically taught amino acid at one specific residue) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3; another specifically taught amino acid at the same specific residue) would have yielded predictable results (i.e. additional stability, changing one protecting group for another; retention of activity) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions; making growth hormone releasing hormone antagonists with specific amino acids at specific residues) 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).
Figures 1A-1N show that Schally et al.’s MIA-602 has similar results compared to SEQ ID NOs: 1/25, 4, 5, 6, and 7. The results also appear to be dependent on which type of cancer is being tested (see Figure 2A – lung cancer verses Figure 2B – pancreatic cancer or Figure 2D – colon cancer verses Figure 2C – stomach cancer).
In Figure 2A (human lung cancer) there is no difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25.
In Figure 2D (human colon cancer) there is no difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25.
In Table 3A, there appears to be no or little difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25 in KATOIII stomach cancer cells or Panc-1 pancreatic cancer cells. In addition, MIA602/SEQ ID NO: 84(Schally et al.) was tested in additional cancer cells in which AVR235/present SEQ ID NO:1/25 was not tested.
In Table 3B, there appears to be no or little difference between MIA602/SEQ ID NO: 84(Schally et al.) and AVR235/present SEQ ID NO:1/25 in HCC827 or HT-29 cells.
It is unclear why all of the results for MIA602/SEQ ID NO: 84(Schally et al.) are the same (i.e. 1). Were the results for MIA602/SEQ ID NO: 84(Schally et al.) converted to a baseline and all other results were compared?
Table 4 shows that while MIA602/SEQ ID NO: 84(Schally et al.) had a statistically significant decrease in tumor growth, the results for AVR235/present SEQ ID NO:1/25 are NOT statistically significant (see B – Lung Ca HCC827; 7 weeks).
Furthermore, applicants are pointing to a single species taught by Schally et al. and ignoring the subgenus taught by Schally et al. which encompasses present SEQ ID NOs: 4, 5, 16-19, and 25 (100% identity to original SEQ ID NO: 1).
"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.
In addition, applicants are focused solely on present SEQ ID NO: 1/25 and not the full scope of the present claims. Unexpected results must be commensurate in scope with the claims.
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 3, 4, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, and 5 of copending Application No. 18/639,779 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; and Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171.
Copending Application No. 18/639,779 claims hGHRH(1-29)NH2 with DArg at residue 2, 5FPhe or Cpa at residue 6, Abu at residue 15, Nle at residue 27, and Har, Har-NH2, or Har-NHCH3 at residue 29.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada) for another (i.e. N-terminal 5FPhAC-Ada) would have yielded predictable results (i.e. additional stability) 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. fluorination for stability; utilization of carriers in pharmaceutical compositions) 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).
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/639,779 in view of Schally et al.; Schally et al.; and Salwiczek et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the provisional rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/639,779 in view of Schally et al.; Schally et al.; and Salwiczek et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/554,144 (reference application) in view of Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/554,144 (reference application) are drawn to AVR-235.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. utilization of carriers in pharmaceutical compositions) 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. utilization of carriers in pharmaceutical compositions) 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/554,144 in view of Schally et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the provisional rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/554,144 in view of Schally et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 and 9 of copending Application No. 18/050,355 (reference application) in view of Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/050,355 (reference application) are drawn to SEQ ID NOs: 1-20 (100% identity, same length, same variables).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. utilization of carriers in pharmaceutical compositions) 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. utilization of carriers in pharmaceutical compositions) 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/050,355 in view of Schally et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the provisional rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/050,355 in view of Schally et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent 12,377,135 (Application No. 17/648,137) in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; and Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent 12,377,135 (Application No. 17/648,137) claims PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr Ala Har (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala His (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilizing carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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).
This is a provisional nonstatutory double patenting rejection.
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 12,377,135 (Application No. 17/648,137) in view of Schally et al.; Schally et al.; and Salwiczek et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 17/648,137 in view of Schally et al.; Schally et al.; and Salwiczek et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 6,057,422 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 6,057,422 claims peptides comprising PhAC Tyr DArg Asp Ala Ile Phe Thr (Ala or Asn) (Arg or Har) Tyr(Me) Arg Lys Val Leu Abu Gln Leu Ser Ala Arg Lys Leu Leu Gln Asp Ile Nle DArg Har absent/NH2
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F, addition of 5F to Phe, and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, addition of 5F to Phe, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, 5FPhe, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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. 6,057,422 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 6,057,422 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 7,026,281 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 7,026,281 claims peptides comprising PhAC Tyr DArg Asp Ala Ile Phe Thr (Ala or Asn) (Arg or Har) Tyr(Me) Arg Lys Val Leu Abu Gln Leu Ser Ala Arg Lys Leu Leu Gln Asp Ile Nle DArg Har absent/NH2
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F, addition of 5F to Phe, and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, addition of 5F to Phe, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, 5FPhe, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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. 7,026,281 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 7,026,281 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,227,405 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 8,227,405 claims peptides comprising (PhAc-Ada or 5FPhAc-Ada) Tyr DArg Asp Ala Ile Xaa/Fpa4 Thr Xaa/Me-Ala (DArg or Har) Xaa/Fpa5 His (Lys or Orn) Val Leu Xaa/His Gln Xaa/Glu Ser Ala His Lys Leu Leu Gln Asp Ile Nle DArg Har NH2
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. mutations taught by Schally et al., N-terminal addition of 5F, addition of 5F to Phe, and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. Xaa; N-terminal PhAC-Ada, addition of 5F to Phe, C-terminal NH2) for another (i.e. Xaa taught by Schally et al., N-terminal 5FPhAC-Ada, 5FPhe, C-terminal NHCH3) would have yielded predictable results (i.e. GHRH antagonists, additional stability, changing one protecting group for another) 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. mutagenesis, fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositons) 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. 8,227,405 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 8,227,405 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,227,421 in view of Schally et al. WO 2009/120831 published October 1, 2009 and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 8,227,421 claims peptides comprising (PhAc-Ada or 5FPhAc-Ada) Tyr DArg Asp Ala Ile Cpa Thr (Ala or Asn) (Arg or Har) polyfluorinated Phe (His or Arg) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala Arg Lys Leu Leu Gln Asp Ile Nle DArg Har absent/NH2 and pharmaceutically acceptable carriers.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. C-terminal addition of NHCH3 to enhance stability) 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. C-terminal NH2) for another (i.e. C-terminal NHCH3) would have yielded predictable results (i.e. changing one protecting group for another) 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. adding C-terminal protecting groups) 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. 8,227,421 in view of Schally et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 8,227,421 in view of Schally et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,691,942 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 8,691,942 claims peptides comprising (PhAC or Ac-Ada) Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr Ala Har Tyr(Me) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala His (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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. 8,691,942 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 8,691,942 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,260,504 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 9,260,504 claims peptides comprising PhAc-Ada Tyr DArg Asp Ala Ile 5FPhe Thr Ala Har Tyr(Me) His Orn Val Leu Abu Gln Leu Ser Ala His Orn Leu Leu Gln Asp Ile Nle DArg Har Agm.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. altering X30 to absent/NH2, NHCH3, or Ada-NH2; N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilizing carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilizing carriers in pharmaceutical compositons) 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. 9,260,504 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,260,504 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,393,271 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 9,393,271 claims various peptides which are GHRH antagonists.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) Tyr(Me) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. adding PhAc-Ada, N-terminal addition of 5F, mutations taught by Schally et al., and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminus, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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. 9,393,271 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 9,393,271 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,201,588 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 10,201,588 claims MIA-602 (PhAc-Ada) Tyr DArg Asp Ala Ile 5FPhe Thr Ala Har Tyr(Me) His Orn Val Leu Abu Glu Leu Ser Ala His Orn Leu Leu Glu Asp Ile Nle DArg Har NH2.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. changing one hydrophilic amino acid for another – Glu replaced by Gln, N-terminal addition of 5F, and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. Glu, N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. Gln, N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. still functions as a GHRH antagonist, additional stability, changing one protecting group for another) 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. conservative amino acid substitutions; fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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. 10,201,588 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,201,588 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
Claims 3, 4, 36, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,993,640 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
U.S. Patent No. 11,993,640 claims peptides comprising PhAc-Ada Tyr DArg Asp Ala Ile 5FPhe Thr Ala Har Tyr(Me) His Orn Val Leu Abu Gln Leu Ser Ala His Orn Leu Leu Gln Asp Ile Nle DArg Har NH2.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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. 11,993,640 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. for claims 3, 4, 36, and 37 were considered but are not persuasive for the following reasons.
Applicants request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,993,640 in view of Schally et al.; Schally et al.; Salwiczek et al.; and Rosenkranz et al. renders obvious the peptides 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).
New Rejection
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.
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Claims 3, 4, 36, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 19/255,898 in view of Schally et al. WO 2009/120831 published October 1, 2009; Schally et al. U.S. Patent Application Publication 2013/0261055 published October 3, 2013; Salwiczek et al., 2012, Fluorinated amino acids: compatibility with native protein structures and effects on protein-protein interactions, Chem Soc Rev, 41: 2135-2171; and Rosenkranz et al., 1983, Conjugates of Catecholamines. IV. In Vitro and in Vivo Pharmacological Activity of Monodisperse Oligopeptide Conjugates, The Journal of Pharmacology and Experimental Therapeutics, 227(2): 267-273.
Copending Application No. 19/255,898 claims SEQ ID NO: 2.
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs 1 and 8 (please refer to the entire specification particularly the abstract; paragraphs 16, 18, 21, 24-26, 34, 36-38, 47, 48, 51, 94, 142, 149, 168; SEQ ID NOs: 11, 58, 65, 84, 86; claims).
Schally et al. teach peptides comprising PhAC-Ada Tyr DArg Asp Ala Ile (5FPhe or Cpa) Thr (Ala or Asn) (Arg or Har) (Tyr(Me) or 5FPhe) (Arg or His) (Lys or Orn) Val Leu Abu Gln Leu Ser Ala (Arg or His) (Lys or Orn) Leu Leu Gln Asp Ile Nle DArg Har (absent/NH2 or Ada-NH2) which read on present SEQ ID NOs: 4, 5, 19, and 25 (100% identity to original SEQ ID NO: 1) (please refer to the entire specification particularly the abstract; paragraphs 15, 17-19, 23-55, 61-146; Tables A-C; SEQ ID NOs: 11, 58, 65, 84, 86; Examples I and V; claims). Schally et al. also teach carriers (please refer to the entire specification particularly paragraphs 173-176).
Salwiczek et al. teach the benefits of fluorinating amino acids/peptides (please refer to the entire reference particularly the abstract; Introduction; Summary and overview). In addition, Schally et al. teach 5F (i.e. 5FPhe at X6).
Rosenkranz et al. teach utilizing NHCH3 to protect the C-terminus of peptides (please refer to the entire reference particularly the abstract; Tables 1 and 2).
All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. N-terminal addition of 5F and C-terminal addition of NHCH3 to enhance stability; utilization of carriers in pharmaceutical compositions) 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. N-terminal PhAC-Ada, C-terminal NH2) for another (i.e. N-terminal 5FPhAC-Ada, C-terminal NHCH3) would have yielded predictable results (i.e. additional stability, changing one protecting group for another) 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. fluorination for stability; adding C-terminal protecting groups; utilization of carriers in pharmaceutical compositions) 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).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent 5,942,489
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/AMBER D STEELE/Primary Examiner, Art Unit 1658