DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, claims 26-35 in the reply filed on 4/17/26 is acknowledged. The traversal is on the ground(s) that “there would be no serious search and examination burden associated with examining Groups I and II together because the searches for each of these groups would be co-extensive. Group II is directed to a method that requires the peptide of Group I. As such, search and examination of Groups I and II would be co-extensive since the both groups would entail search and examination of the system of Group I.” This is not found persuasive because there would be a clearly serious and excessive examination burden by examining the very broad method of claim 36, of “treating a subject [who] suffers from a disease or condition associated with LRP1”, which disease or condition at least per claims 42 and 43 extend broadly including viral diseases, Alzheimer’s Disease, acute lung injury, and eosinophilic esophagitis. Adding the examination for treating such a range of diseases/conditions when any of the peptides of claim 26 are to be administered to treat these clearly, very clearly, would and does represent a serious examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 36-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/17/26.
Applicant's election with traverse of SEQ ID NO:44 as the single species of peptide, and an anti-viral agent as the species of additional therapeutic agent, for species election in the reply filed on 4/17/26 is acknowledged. The traversal, apparently is on the same ground(s) as Group traversal (since no specific basis for traversal of species election was found), so that “there would be no serious search and examination burden associated with examining Groups I and II together because the searches for each of these groups would be co-extensive. Group II is directed to a method that requires the peptide of Group I. As such, search and examination of Groups I and II would be co-extensive since the both groups would entail search and examination of the system of Group I.” This is not found persuasive because there would be a clearly serious and excessive examination burden by examining the very broad method of claim 36, of “treating a subject [who] suffers from a disease or condition associated with LRP1”, which disease or condition at least per claims 42 and 43 extend broadly including viral diseases, Alzheimer’s Disease, acute lung injury, and eosinophilic esophagitis, even when considering that only a single peptide, corresponding to SEQ ID NO:44, would/could treat all such diseases/conditions, this leading to a serious examination burden when considering the very large genus of claim 26 peptides beyond the elected species. Adding the examination for treating such a range of diseases/conditions with such peptide that is to be administered to treat such a diverse range of diseases and conditions would and does represent a serious examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Please note that the species election of an anti-viral agent as the species of additional therapeutic agent, for species election in the reply filed on 4/17/26, appears moot because claim 34, the only claim that referred to one or more additional therapeutic agents has been cancelled.
Please note that contrary to applicant’s listing of claims 26-33 and 35 as encompassing the elected species, because the elected species does not comprise a D-amino acid claim 29 does not encompass the elected species.
The elected species of peptide, corresponding to SEQ ID NO:44, has been searched and found free of the art.
In accordance with MPEP 803.02 III A, the search was extended to a nonelected species, this species being the peptide VKFNKPFVFLMIEQNTK, which comprises an amino acid sequence FLMI of instant SEQ ID NO:32 (please see Claim Interpretation below).
The examiner has withdrawn all claims that do not read on this nonelected species. See MPEP 803.02 III A. The prior art search is not extended unnecessarily to cover all nonelected species. Claims 29, 30, 31 are withdrawn as not reading on the above-indicated nonelected species.
Considering the above, claims 29, 30, 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/17/26.
Claim Status
Claims 26-33, 35-44 are pending.
Claims 1-25, 34 are cancelled.
Claims 36-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/17/26.
Claims 29, 30, 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/17/26.
Claims 26-28, 32, 33 and 35 are pending and under examination.
Claims 26-28, 32, 33 and 35 are rejected.
Priority
The instant application, filed 08/22/2023 is a Continuation of 17753013 , filed 02/15/2022 ,now U.S. Patent # 11779630 and having 1 RCE-type filing therein
17753013 is a National Stage entry of PCT/US2021/040572 , International Filing Date: 07/06/2021
PCT/US2021/040572 Claims Priority from Provisional Application 62705591, filed 07/06/2020.
Information Disclosure Statement
The Examiner has considered the reference(s) provided in the 5/7/24 and 5/15/25 Information Disclosure Statements, and provides a signed and dated copy of each herewith.
Claim Interpretation
The claim limitations are given their broadest reasonable interpretation (BRI) consistent with the specification, MPEP 2111, and under the BRI, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification, MPEP 2111.01.
The transitional term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements. See MPEP 2111.03.
“an amino acid sequence of” in lines 1 to 2 of claim 26 refers to the entire sequence of each of the following listed SEQ ID Numbers, and additionally could refer to any shorter sequence within any of the peptides that correspond to the listed SEQ ID Numbers. Especially because claim 27 allows for peptides shorter than each of the entire sequences of claim 26’s listed SEQ ID Numbers, “an amino acid sequence of” in lines 1 to 2 of claim 26 is interpreted to include sequences as short as two consecutive amino acids within any of the claim 26 listed SEQ ID Number sequences. The whole peptide of claim 26 can be longer than this portion which it comprises.
Given the extent of rejections below, applicant may reconsider the breadth of what its claims claim.
The examiner notes that claim 26 also includes broad and narrow limitations as to the number of basic amino acids of Z1 and Z2. Please see MPEP 2173.05(c). The examiner has considered whether what is claimed is clear, and considers it clear because each of the overlapping ranges is reasonably understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 26-28, 32, 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9951104, inventors Mogelsvang and Gelber, issued 4/24/18 (“MG”).
MG teaches and claims, see claim 1, a composition comprising a peptide, wherein the peptide consists of the amino acid sequence of VKFNKPFVFLMIEQNTK (SEQ ID NO: 1), which is the nonelected species, which comprises an amino acid sequence FLMI of claim 26’s SEQ ID NO:32 (see Claim Interpretation above).
MG’s claim 1 composition comprising VKFNKPFVFLMIEQNTK thus anticipates claim 26, and also anticipates claim 27, being between 5 and 30 amino acids in size, and also anticipates claim 28, having a size less than 20 amino acids.
Based on MG claims 7 and 9, instant claim 32, an independent claim, is anticipated.
Based on MG claims 1 and 4, instant claim 33, an independent claim, is anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over US 9951104, inventors Mogelsvang and Gelber, issued 4/24/18 (“MG”), as applied to claim 33 above, and further in view of US 8975224, Mogelsvang and Gelber, issued 3/10/15 (“MG2”).
The rejection of claim 33 is set forth above.
Claim 35 modifies the pharmaceutical composition of claim 33 by stating “wherein the pharmaceutical composition is formulated for oral administration.
MG does not explicitly teach this.
The level of ordinary skill in the art of pharmaceutical formulations of therapeutic peptides is high.
MG2 teaches peptides very similar to those of MG (including the same) and the instant claims, see paras 11, 12, and teaches pharmaceutical compositions that comprise such peptides as an oral formulation, para 178.
One of ordinary skill in the art would have readily understood that by combining the teachings of MG2 with those of MG the MG peptide VKFNKPFVFLMIEQNTK in a pharmaceutical composition would be, in some alternatives of administering, formulated for oral administration, such as in the form of tablets, capsules or pills, see MG2 para 178. The rationale is use of known technique to improve similar methods or products in the same way, see MPEP 2143 I C. MG teaches a peptide upon which the claimed composition formulated for oral administration can be seen as an improvement. MG2 teaches a comparable composition, also used in methods, that has been improved in the same way as the claimed invention by teaching oral administration and forms of oral administration such as tables, capsules and pills, para 178. One of ordinary skill in the art could have applied the known "improvement" technique, formulating for oral administration, in the same way to the "base" method, or product and the results would have been predictable to one of ordinary skill in the art, this additionally supported by the knowledge in the art including that found in the referenced texts in para 178, “Remington: The Science and Practice of Pharmacy, 20th edition, 2000, ed. A. R. Gennaro, Lippincott Williams & Wilkins, Philadelphia, and Encyclopedia of Pharmaceutical Technology, eds. J. Swarbrick and J. C. Boylan, 1988-1999, Marcel Dekker, New York, incorporated, herein, by reference in its entirety.”
Accordingly, claim 35 would have been obvious and is rejected under this section.
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 26-28, 32, 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9 of U.S. Patent No. 9951104 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims 1-4, 7-9 teach compositions comprising a peptide that consists of the amino acid sequence of VKFNKPFVFLMIEQNTK, which comprises FLMI so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claims 2, 3, 7-9 claim the addition of an epitope tag, a half-life extender, or both, fused to the peptide, meeting the limitations of instant claim 32, so this claim is rejected under this section, and reference patent claims 1 and 4, providing for the composition further comprising a pharmaceutically acceptable carrier, meets and forms the basis for rejection of instant claim 33.
Claim 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 9951104 (reference patent), as applied to claim 33, and further in view of US 8975224, Mogelsvang and Gelber, issued 3/10/15 (“MG2”).
The rejection of claim 33 is set forth above.
Claim 35 modifies the pharmaceutical composition of claim 33 by stating “wherein the pharmaceutical composition is formulated for oral administration.
Reference patent claims 1 and 4 do not explicitly teach this.
The level of ordinary skill in the art of pharmaceutical formulations of therapeutic peptides is high.
MG2 teaches peptides very similar to those of MG (including the same) and the instant claims, see paras 11, 12, and teaches pharmaceutical compositions that comprise such peptides as an oral formulation, para 178.
One of ordinary skill in the art would have readily understood that by combining the teachings of MG2 with the claimed inventions of the reference patent claims that include the peptide VKFNKPFVFLMIEQNTK in a pharmaceutical composition would be, in some alternatives of administering, formulated for oral administration, such as in the form of tablets, capsules or pills, see MG2 para 178. The rationale is use of known technique to improve similar methods or products in the same way, see MPEP 2143 I C. Reference patent claim 1 claims a peptide upon which the claimed composition formulated for oral administration can be seen as an improvement. MG2 teaches a comparable composition, also used in methods, that has been improved in the same way as the claimed invention by teaching oral administration and forms of oral administration such as tablets, capsules and pills, para 178. One of ordinary skill in the art could have applied the known "improvement" technique, formulating for oral administration, in the same way to the "base" method or product and the results would have been predictable to one of ordinary skill in the art, this additionally supported by the knowledge in the art including that found in the referenced texts in para 178, “Remington: The Science and Practice of Pharmacy, 20th edition, 2000, ed. A. R. Gennaro, Lippincott Williams & Wilkins, Philadelphia, and Encyclopedia of Pharmaceutical Technology, eds. J. Swarbrick and J. C. Boylan, 1988-1999, Marcel Dekker, New York, incorporated, herein, by reference in its entirety.”
Accordingly, claim 35 would have been obvious and is rejected under this section.
Claims 26-28, 32, 33, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9 of U.S. Patent No. 10214562 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims 1-4 and 9 teach administering compositions comprising a peptide that consists of the amino acid sequence of VKFNKPFVFLMIEQNTK (SEQ ID NO:1 of reference patent claim 1), which comprises FLMI so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claims 1-4 claim the addition of an epitope tag, a half-life extender, or both, fused to the peptide, meeting the limitations of instant claim 32, so this claim is rejected under this section, and reference patent claims 1 and 9, providing for the composition further comprising a pharmaceutically acceptable carrier, meets and forms the basis for rejection of instant claim 33, and reference patent claim 1 is directed to administering an oral formulation, forming a basis for rejecting instant claim 35 when also considering the basis for rejection of instant claim 26 as set forth above.
Claims 26-28, 32, 33, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 10, 12, 13 of U.S. Patent No. 10899797 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims 1 and 4 teach administering compositions comprising a peptide that consists of the amino acid sequence of VKFNKPFVFLMIEQNTK (SEQ ID NO:1 of reference patent claim 4), which comprises FLMI so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claims 9 and 10 depending from reference patent claim 1 claim the addition of an epitope tag, a half-life extender, or both, fused to the peptide, meeting the limitations of instant claim 32, so this claim is rejected under this section, and reference patent claim 12, also depending from reference patent claim 1, provides for the composition further comprising a pharmaceutically acceptable carrier, meets and forms the basis for rejection of instant claim 33, and reference patent claim 13, also depending from reference patent claim 1, is directed to administering an oral formulation, forming a basis for rejecting instant claim 35 when also considering the basis for rejection of instant claim 26 as set forth above.
Claims 26-28, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 12291581 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claim 1 teaches compositions including comprising a peptide subgenus that consists of the amino acid sequence X1-Z1-F-N-K-P-F-X2-Z2-X3-Z3 (SEQ ID NO: 2), wherein X1 is V or L; X2 is V, L or M; X3 is M, I or V; Z1 is any amino acid; Z2 is a sequence of any two amino acids; and Z3 is a sequence of any five amino acids, such peptides comprising PF so falling within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, peptides of this peptide subgenus also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claim 11, directed to the composition of reference patent claim 1 formulated for oral administration, clearly provides a basis for rejecting instant claim 35 when also considering the basis for rejection of instant claim 26 as set forth above.
Claims 32 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12291581 (reference patent), as applied above to claim 26, and further in view of U.S. Patent No. 9951104 (‘104).
The rejection of claim 26 is set forth above.
Claim 32 is directed to adding an epitope tag and/or half-life extender in a fusion protein also comprising a peptide of instant claim 26, and claim 33 is directed to a pharmaceutical composition that also comprises a pharmaceutically acceptable carrier in addition to a listed amino acid sequence that includes a peptide that comprises PF.
The reference patent claims do not explicitly claim these additional limitations.
The level of ordinary skill in the art of pharmaceutical formulations of therapeutic peptides is high.
The ‘104 teaches peptides very similar to those of the reference patent and the instant claims and teaches that these can be combined in a fusion protein with an epitope tag, a half-life extender, or both, see paras 7-18.
The ‘104 also teaches compositions of such peptides with a pharmaceutical carrier, see paras 18, 39, and claim 4.
One of ordinary skill in the art would have readily understood that by combining the teachings of the ‘104 with the reference claim 1 would lead one of ordinary skill to the combined limitations of instant claims 32 and 33. The rationale is use of known technique to improve similar methods or products in the same way, see MPEP 2143 I C. Reference patent claim 1 claims a peptide upon which the claimed fusion proteins and composition of instant claims 32 and 33 can be seen as improvements. The ‘104 teaches comparable compositions, also used in methods, that has been improved in the same way as the claimed invention by teaching the indicated fusion proteins and pharmaceutical excipients in compositions. One of ordinary skill in the art could have applied the known "improvement" technique, formulating for oral administration, in the same way to the "base" method or product and the results would have been predictable to one of ordinary skill in the art.
Accordingly, claims 32 and 33 would have been obvious and are rejected under this section.
Claims 26-28, 32, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9, 10, 12, 13 of U.S. Patent No. 8975224 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claim 1 teaches administering an oral formulation comprising inter alia a peptide that consists of the amino acid sequence of VKFNKPFVFLMIEQNTK, which comprises FLMI so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claims 4-6 depending from reference patent claim 1 claim the addition of an epitope tag, a half-life extender, or both, fused to the peptide, meeting the limitations of instant claim 32, so this claim is rejected under this section, and in that reference patent claim 1 is directed to an oral formulation instant claim 35 also is rejected.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8975224 (reference patent), as applied above to claim 26, and further in view of U.S. Patent No. 10899797 (‘797’).
The rejection of claim 26 is set forth above.
Claim 33 is directed to a composition comprising one of the listed peptides and a pharmaceutically acceptable carrier, excipient, additive, preservative or combination thereof.
The reference patent claims do not explicitly claim these additional limitations.
The level of ordinary skill in the art of pharmaceutical formulations of therapeutic peptides is high.
The ‘797 teaches administering compositions comprising a peptide that consists of the amino acid sequence of VKFNKPFVFLMIEQNTK (SEQ ID NO:1 of reference patent claim 4), which comprises FLMI so falls within the genus of instant claim 26 as set forth and interpreted, and its claim 12, also depending from reference patent claim 1, provides for the composition further comprising a pharmaceutically acceptable carrier.
One of ordinary skill in the art would have readily understood that by combining the teachings and claims of the ‘797 with the reference patent claim 1 would lead one of ordinary skill to the combined limitations of instant claim 33. The rationale is use of known technique to improve similar methods or products in the same way, see MPEP 2143 I C. Reference patent claim 1 claims a peptide upon which the claimed pharmaceutical composition of instant claim 33 can be seen as improvements. The ‘797 teaches and claims comparable compositions, also used in methods, that has been improved in the same way as the claimed invention by teaching the indicated pharmaceutical excipients in compositions. One of ordinary skill in the art could have applied the known "improvement" technique, to prepare and provide such pharmaceutical composition, in the same way to the "base" method or product and the results would have been predictable to one of ordinary skill in the art.
Accordingly, claim 33 would have been obvious and is rejected under this section.
Claims 26-28, 32, 33, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11020462 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claim 1 teaches administering a pharmaceutical composition comprising a peptide consisting of the amino acid sequence of VKFNKPFVFL[Nle]IEQNTK (SEQ ID NO: 57), which comprises FL so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claim 1 claims the addition of an epitope tag, a half-life extender, or both, fused to the peptide, meeting the limitations of instant claim 32, so this claim is rejected under this section, and given that reference patent claim 6 states wherein the pharmaceutical composition is administered orally, claim 35 also is rejected. Further, in that a pharmaceutical composition is administered in reference patent claim 1, such composition would comprise at least one of the additions of instant claim 33, rendering obvious this claim under this section.
Claims 26-28, 32, 33, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11779630 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claim 1 teaches administering a pharmaceutical composition comprising a peptide consisting of the amino acid sequence of VKFNKPFVFL[Nle]IEQNTK (SEQ ID NO: 35) or a fusion thereof, which comprises FL so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference patent claim 3 claims the fusion comprises an epitope tag, a half-life extender, or both, meeting the limitations of instant claim 32, so this claim is rejected under this section, and given that reference patent claim 1 is directed to a composition and is administered to a subject suffering from a disease or condition, such composition would comprise at least one of the additions of instant claim 33, rendering obvious this claim under this section. In that reference patent claim 5 list oral administration route, claim 35 also is rejected.
Please note that this is a patent issued from the parent application, for which there was no restriction that could provide for a safe harbor from double patenting.
Claims 26-28 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18148942 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 administers a peptide VKFNKPFVFL[Nle]IEQNTK (SEQ ID NO: 35) which comprises FL so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, and reference application claim 10 claims oral administration, so claim 35 also is rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26-28, 32 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 10 of copending Application No. 18726945 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 administers a peptide VKFNKPFVFL[Nle]IEQNTK (SEQ ID NO: 35) which comprises FL so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, reference application claims 5 and 7 provide a basis for rejection of instant claim 32 when also considering the basis of rejection of instant claim 26, and reference application claim 10 claims oral administration, so claim 35 also is rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26-28, 32, 33 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12 of copending Application No. 19097765 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because reference application claim 1 administers an oral formulation of a peptide VKFNKPFVFLMIEQNTK (SEQ ID NO: 1) which comprises FLMI so falls within the genus of instant claim 26 as set forth and interpreted, rendering instant claim 26 rejected under this section, this peptide also meeting the limitations of instant claims 27 and 28 so these also are rejected under this section, reference application claims 2-4 provide a basis for rejection of instant claim 32 when also considering the basis of rejection of instant claim 26, reference application claim 12 adds a pharmaceutically acceptable carrier to the composition of its claim 1, rendering obvious and rejected instant claim 33, and in that reference application claim 1 administered an oral administration, claim 35 also is rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH FISCHER whose telephone number is (571)270-7925, and whose direct facsimile number is (571)270-8925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Monday/Tuesday and on Wednesday-Friday on alternating weeks, but will promptly answer messages upon his return to work.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
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