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 .
Claim Status
Claims 1-18 are pending. Claims 3-8 and 11-17 are withdrawn. Claims 1-2, 9, and 18 are presently considered.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10 and 18 as filed 1/23/2026) and the species of SEQ ID NO: 54 in the reply filed on 1/23/2026 is acknowledged.
The originally elected species is understood to be SEQ ID NO: 54, which has the following sequence:
Ile Ala Leu Ile Leu Glu Pro Xaa Cys Cys Gln Glu Arg Arg Ala
Or
IALILEPXCCQERRA
wherein Xaa or X, at position 8, is Sarcosine, and position 9 is a D-amino acid; wherein related species comprising SEQ ID NO: 54 in a pharmaceutical composition are understood to be obvious variants; but no specific carrier, diluent, or excipient was identified.
The originally elected species is understood to read upon claims 1-2, 9, 10, and 18 (see, e.g., Reply filed 1/23/2026 at 5 at 3rd ¶).
Following extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, examination has proceeded to the subgenus of species comprising the non-elected species of SEQ ID NO: 55. Following extensive search and examination, this subgenus of species has been deemed anticipated and/or obvious in view of the prior art. Accordingly, claims 1-2, 9, 10, and 18 are rejected in view of the non-elected species of SEQ ID NO: 55.
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/23/2026.
Claims 3-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/23/2026.
During the search and examination of the originally elected species, art pertinent to other non-elected species was incidentally discovered. Although examination has not been extended beyond the non-elected species of instant SEQ ID NO: 55 as identified above per MPEP § 803.02, as a courtesy to the Applicant, this incidentally discovered art applicable to instant SEQ ID NOs: 12-24 and 42-53 has been applied below.
Claims 1-2, 9-10, and 18 are presently considered
Denial of Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional 63/108732 (filed 11/02/2020) fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163.
Lack of Express Support
Claims 1-2 are representative of the pending claim scope. Neither claim literally appears in Pro’732, and therefore the claims lack literal support in the Pro’732. More specifically, SEQ ID NOs: 54-55 do not literally appear in Pro’732.
Accordingly, Pro’732 fails to provide literal support for the pending claim scope that is synonymous or equivalent in scope.
Lack of Implicit or Inherent Support
The MPEP states that "[w]hile there is no in haec verba requirment, . . . . claim limitations must be supported in the specification through express, implicit, or inherent disclosure." See MPEP § 2163. In the absence of express support, the relevant issue is whether or not the claimed invention is supported by Pro’231 through implicit or inherent disclosures.
Upon review, zero inherent or implicit support commensurate in scope with the metes and bounds of the instant claims is found in Pro’732, at least because there is no implicit, inherent, or literal support for specifically arriving at the structures of instant SEQ ID NOs: 54-55. According the claim language presently claimed is not supported by the provisional document by synonymous or equivalent language.
Accordingly, Pro’732 fails to provide implicit or inherent support for the pending claim scope that synonymous or equivalent in scope, or otherwise commensurate in scope with the pending claims.
Conclusion
Accordingly, priority to US Provisional 63/108732 (filed 11/02/2020) is denied for claims 1-2 and all of the dependents of those claims; these claims have been accorded a priority date of 11/01/2021, which corresponds to the filing date of PCT/US2021/057504 (filed 11/01/2021).
Information Disclosure Statement
The IDS filed 5/21/2024 and 10/23/2024 are each acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope, and the applicable claim interpretation is set forth below.
SEQ ID NOs: 6-7 and 25-26 are understood to be modified versions of PA-I8Sar further comprising a i+7 staple; SEQ ID NOs:8-11 and 29-31 are understood to be modified versions of PA-I8Sar further comprising a i+4 staple; SEQ ID NOs: 12-24 are understood to represent a D-amino acid scan of PA-I8Sar; SEQ ID NOs: 35-38 are understood to represent PA-C9Sar further comprising a i+7 staple; SEQ ID NOs: 39-41 are understood to represent PA-C9Sar further comprising a i+4 staple; SEQ ID NOs: 42-53 are understood to represent a D-amino acid scan of PA-C9Sar; SEQ ID NOs: 32-35 are PA-I8Sar variants comprising both a D-amino acid and a i+4 staple; and SEQ ID NOs: 27-28 appear to be variants of PA-I8Sar comprising a i+8 or i+3 staple, respectively. SEQ ID NO: 55 is identical to SEQ ID NO: 4 except position 15 of PA-I8Sar is deleted to form a 14-mer.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
The term “about” appears in the claims. However, the term “about” is defined in multiple distinct ways including as “within an acceptable standard deviation”, “±20%”, “±10%”, “±5%”, “±1%”, “within an order of magnitude”, or “preferably within 2-fold” (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12).
“Therapeutically effective amount” is identified as a functionally defined term that may vary depending upon multiple factors (see, e.g., Spec. filed 5/01/2023 at 34 at lines 11-17).
A “variant” is described in the Specification (see, e.g., Spec. filed 5/01/2023 at 21 at line 13 to line 26), and is understood to broadly include any type of modification without regard for functionality, including “fragments of the polypeptides” (i.e., single amino acids), fusion proteins, tagged proteins, etc. At this time, “variants” are optional components not present in the originally elected species, which have not been examined in view of the prior art.
Additional claim interpretations are set forth below.
Claim Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 9-10, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 3 recite the phrase “at least about 95% sequence identity” which conflates qualitative and quantitative language, and is therefore indefinite because it is unknown if 80%, 85%, 90%, 94%, 94.9%, etc. read upon the claim scope or not, since such numbers are “about 95%”, but are not “at least” 95%. For purposes of applying prior art, the phrase “at least about 95%” is interpreted as nested limitations, wherein “about 95%” includes “within an order of magnitude” of 95% (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12), which is 9.5%, and therefore the phrase “at least about 95%” is understood to mean “at least 9.5%”.
Claims 1 and 3 recite the phrase “at least about 95% sequence identity” which recites “about”, which has been defined in multiple, distinct ways on record, which therefore renders the claim scope indefinite. Specifically, “about” is defined in multiple distinct ways including as “within an acceptable standard deviation”, “±20%”, “±10%”, “±5%”, “±1%”, “within an order of magnitude”, or “preferably within 2-fold” (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12). Accordingly, the claim scope materially changes depending upon the selected interpretation because “about 95% sequence identity” could be interpreted, consistent with the specification, to mean
at least 9.5% sequence identity (i.e., within an order of magnitude of 95%);
at least 47.5% sequence identity (i.e., within 2-fold of 95%);
at least 76% sequence identity (i.e., ±20% of 95%);
at least 85.5% sequence identity (i.e., ±10% of 95%);
at least 90.25% sequence identity (i.e., ±5% of 95%); or
at least 94.05% sequence identity (i.e., ±1% of 95%).
This is pertinent because SEQ ID NOs: 6-54 are 15-mers, and 15-mers can only exhibit the following values of sequence identity over the full-length of the sequence: 100% (15/15); 93.33% (14/15); 86.67% (13/15); 80% (12/15); 73.33% (11/15); 66.66% (10/15); 60% (9/15); 53.33% (8/15); 46.67% (7/15); 40% (6/15); 33.33% (5/15); 26.67% (4/15); 20% (3/15); 13.33% (2/15); and 6.67% (1/15). Accordingly, the specific meaning and definition of “about” utilized materially alters the pending claim scope such that the claims may include or exclude sequences sharing 14/15 to 2/15 residues in common with any one of instant SEQ ID NOs: 6-54. Close prior art exists as evidenced by the prior art applied under 35 USC 102 and 103, as set forth below. For purposes of applying prior art, the phrase “at least about 95%” is interpreted as nested limitations, wherein “about 95%” includes “within an order of magnitude” of 95% (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12), which is 9.5%, and therefore the phrase “at least about 95%” is understood to mean “at least 9.5%”. This is reasonable, because it simply reflects the broadest definition of “about” set forth on record in the instant disclosure (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12).
Claims 1 and 3 recite the phrase “at least about 95% sequence identity”, wherein “about” is indefinite (see discussion above), but may include “±1%” (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12). Accordingly, if the indefinite term is removed or otherwise interpreted to mean “±1%”, the phrase would either recite “at least For purposes of applying prior art, the phrase “at least about 95%” is interpreted as nested limitations, wherein “about 95%” includes “within an order of magnitude” of 95% (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12), which is 9.5%, and therefore the phrase “at least about 95%” is understood to mean “at least 9.5%”. This is reasonable, because it simply reflects the broadest definition of “about” set forth on record in the instant disclosure (see, e.g., Spec. filed 5/01/2023 at 13 at line 26 to page 14 at line 12).
Claim 9 recites the term “another D-enantiomeric and/or stapled peptide form of SEQ ID NO:4 and/or SEQ ID NO: 5, and variants thereof, and/or one or more of SEQ ID NO: 2, 3, 4, and/or 5, and variants thereof”, which renders the claim indefinite. The term “another….” Renders the claim scope indefinite for lack of antecedent basis because such limitations are not recited by claim 1.
Claim 9 recites the phrase “another D-enantiomeric and/or stapled peptide form of SEQ ID NO:4 and/or SEQ ID NO: 5, and variants thereof”, and/or one or more of SEQ ID NO: 2, 3, 4, and/or 5, and variants thereof”, which renders the claim scope indefinite because the repeated usage of “and/or” renders the scope ambiguous since it is unclear if each nested “and/or” is intended to be an alternative to everything stated before “and/or” within the claim, or something less than everything stated before the term “and/or”. For purposes of applying prior art, all aspects following “optionally” are understood to be optional, and therefore non-limiting (see, e.g., MPEP § 2111.04(I)).
Claims 10 and 18 each recite and requires a “therapeutically effective amount”, but identifies and admits that this term is a functional limitation that may vary depending upon multiple factors (see, e.g., Spec. filed 5/01/2023 at 34 at lines 11-17). This is problematic because it is prima facie unknown what “amounts” are included or excluded by the pending claim scope. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what amounts do or do not infringe upon the scope of claim 10 or 18. As admitted in the original disclosure, the amount encompassed by this term may vary depending upon multiple unspecified factors (see, e.g., Spec. filed 5/01/2023 at 34 at lines 11-17), which means the interpretation may vary from artisan to artisan. Notably, the amount is therefore unknown, but admittedly variable (see id), and therefore renders the claim indefinite (see, e.g., MPEP § 2173.05(b)). Accordingly, the metes and bounds of claim 10 are indefinite due to the usage of ill-defined, but variable functional limitations.
Claims 9-10, and 18 depend directly or indirectly from an indefinite base claim and fail to address the indefiniteness of the base claim. Accordingly, such claims are rejected as indefinite for the reasons applied to the base claim.
Claims 1, 9-10, and 18 are rejected.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
[Prior Art Rejection 01]
Claims 1-2, 9-10, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US2016/0376322A1.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, US’322 teaches, discloses, and claims SEQ ID NO: 11, also referred to as “PA-I8SAR”, including in pharmaceutical compositions for use in known methods of treatment, wherein the prior art compound has the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’322 at ¶¶[0132], [0190], Tables 2-3, claims 1-2, 5-13; compare US’322 at SEQ ID NO: 11 with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, claims 1-2, 9-10, and 18 are rejected as clearly anticipated by the prior art.
[Prior Art Rejection 02]
Claims 1-2, 9-10, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US10005818B2 (Jun. 26, 2018).
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary references claims SEQ ID NO: 11, pharmaceutical formulations comprising SEQ ID NO: 11, and methods utilizing SEQ ID NO: 11 (see, e.g., US’818 at claims 1-2, 5-13). This is pertinent because SEQ ID NO: 11 of US’818 is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’818 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare US’818 at claims 1-2, 5-13, SEQ ID NO: 11 with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, instant claims 1-2, 9-10, and 18 are clearly anticipated by the prior art.
[Prior Art Rejection 03]
Claims 1-2, 9-10, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by US2019/02096601 (published July 11, 2019; filed Jan. 9, 2018).
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary references discloses and is understood to claim SEQ ID NO: 9, pharmaceutical formulations comprising SEQ ID NO: 9, and methods utilizing SEQ ID NO: 9 (see, e.g., US’660 at SEQ ID NO:9, ¶[0043] and Table 1 disclosing “examples of PIC1 and PIC1 variants”, ¶[0045], claims 1-15). This is pertinent because SEQ ID NO: 9 of US’660 is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’660 at SEQ ID NO: 9), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare US’660 at SEQ ID NO: 9 with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, instant claims 1-2, 9-10, and 18 are clearly anticipated by the prior art.
[Prior Art Rejection 04]
Claims 1-2, 9-10, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being clearly anticipated by WO2016/2103702.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary references discloses and is understood to claim SEQ ID NO: 11, pharmaceutical formulations comprising SEQ ID NO: 11, and methods utilizing SEQ ID NO: 11 (see, e.g., WO’370 at SEQ ID NO:11, ¶¶[0121], Table 2 at pages 28-29 at “PA-I8Sar”, claims 1-28 and 30). This is pertinent because SEQ ID NO: 11 of the primary reference is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., WO’370 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, instant claims 1-2, 9-10, and 18 are clearly anticipated by the prior art.
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.
[Prior Art Rejection 05]
Claim 1-2, 9-10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US20160376322 in view of Simon et al.3
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. The rejection addresses non-elected species of SEQ ID NOs: 12-24 and 42-53.
Regarding instant claim 1-2, 9-10, and 18, US’322 teaches, discloses, and claims pharmaceutical compositions comprising derivatives of Polar Assonant (PA) peptide (see, e.g., US’322 at ¶[0019]), which are disclosed for use in methods of treating and/or preventing hemolytic reactions, hypoxic ischemic encephalopathy, cystic fibrosis and other complement-related diseases and conditions, as well as for anti-microbial applications (see, e.g., US’322 at ¶[0019], claims 1-13). Regarding instant claims 1-2 and instant SEQ ID NOs: 12-24 and 42-53, US’322 explicitly teaches and discloses SEQ ID NO: 11 (“PA-I8Sar”, IALILEP(Sar)CCQERAA) and SEQ ID NO: 12 (“PA-C9Sar”, IALILEPI(Sar)CQERAA) (see, e.g., US’322 at Table 5 at ¶[0190]). These two sequences are among the top three tested compounds at Table 5 that are both soluble and exhibit low hemolysis (see id., noting that only seven species are soluble in water, and from among those seven PA-P7Sar, PA-I8Sar, and PA-C9Sar exhibit the lowest hemolysis).
US’322 differs from the instant claims and instant SEQ ID NOs: 12-24 and 42-53 as follows: SEQ ID NOs: 12-24 differ from the prior art compound of PA-I8Sar by the presence of a single D-amino acid at positions 1-2, 4-7, or 9-15, respectively. SEQ ID NOs: 42-53 differ from the prior art compound of PA-C9Sar by the presence of a single D-amino acid at positions 1-8, 11-13, or 15, respectively. Therefore, the relevant issue is whether or not it would have been obvious and routine to create D-amino acid variants of PA-I8Sar and/or PA-C9Sar in view of the prior art.
Simon explains that a “D-scan” was known and routine in the prior art at least circa 2016 (see, e.g., Simon at title, abs), wherein a “D-scan” is analogous to an alanine scan, but wherein D-amino acids are substituted at each position of a short polypeptide (see, e.g., Simon at title, abs, 12099 at col I-II at § Introduction, 12099-12100 at bridging ¶, 12100 at Fig. 1). The D-scan methodology provides known benefits, including the identification of critical stereocenters required for activity and identification of residues amenable to D-amino acid substitutions without abrogating functionality (see, e.g., Simon at title, abs, 12109 at col II at § Conclusion, 12110 at col I-II). Simon explains that some D-amino acid substitutions may be harmful by abolishing function or impacting folding (see, e.g., Simon at 12110 at col I-II), but that D-amino acid insertions can also desirably stabilize proteins against proteolysis (see, e.g., Simon at 12099 at § Introduction; 12110 at col I-II). Accordingly, performing a “D-scan” by converting each amino acid within a short polypeptide into a D-amino acid, one at a time, is a known method having known benefits, which would be routine to perform in order to identify critical stereocenters and positions amenable to D-amino acid substitutions, wherein D-amino acid substitutions at positions amenable to such substitutions, would predictably increase protease resistance and stability of the peptide.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The claimed sequences of instant SEQ ID NOs: 12-24 and 42-53 are the obvious results of applying and using the known technique and methodology of Simon (i.e., a D-scan) to the known products of PA-I8Sar and PA-C9Sar of US’322, wherein such methodology would predictably yield 14 variants of each prior art peptide having a D-amino acid at a single position, which would desirably and predictably permit an artisan to identify critical stereocenters and positions amenable to D-amino acid substitutions, exactly as taught and suggested by Simon, wherein variants at positions amenable to D-amino acid substitutions would predictably and expectedly exhibit increased protease resistance and enhanced stability (see, e.g., MPEP §§ 2143(I)(B), (C), (D), (F), and (G)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to modify a known polypeptide in a known manner according to a known methodology to obtain a known and expected result.
Accordingly, claims 1-2, 9-10, and 18 are rejected.
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.
[NSDP Rejection 01]
Claims 1-2, 9-10, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-13 of U.S. Patent No. US10005818B2 (Jun. 26, 2018). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims SEQ ID NO: 11, pharmaceutical formulations comprising SEQ ID NO: 11, and methods utilizing SEQ ID NO: 11 (see, e.g., US’818 at claims 1-2, 5-13). This is pertinent because SEQ ID NO: 11 of US’818 is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’818 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare US’818 at claims 1-2, 5-13, SEQ ID NO: 11 with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from US’818, because the two Applications read upon the same embodiments.
[NSDP Rejection 02]
Claims 1-2, 9-10, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 17-19 of U.S. Patent No. 11135272 (Oct. 5, 2021). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims methods of administering “PIC1” to a subject, which necessitates that “PIC1” is in a pharmaceutically acceptable form (see, e.g., US’272 at claims 1-13 and 17-19). The structure of a “PIC1” is not explicitly recited in the claims, but it is reasonably inferred that this term refers to a genus of structures in view of claims 14-16 of US’272. Per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and in US’272 the term is reasonably inferred and understood to encompass SEQ ID NO: 9 (see, e.g., US’272 at SEQ ID NO:9, col. 8 at lines 15-60 and Table 1 disclosing “examples of PIC1 and PIC1 variants”). This is pertinent because SEQ ID NO: 9 of US’272 is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’272 at SEQ ID NO: 9), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare US’272 at SEQ ID NO: 9 with instant SEQ ID NO: 55, showing 100% sequence identity). Even assuming arguendo that SEQ ID NO: 9 did not qualify as a “PIC1” within the scope of the claims of US’272, it is a PIC1 variant, and therefore would be obvious to simply substitute for PIC14. Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from US’272, because the two Applications read upon the same embodiments.
[NSDP Rejection 03]
Claims 1-2, 9-10, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 7 of US Patent 10,933,116 (Mar. 2, 2021). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims methods that require pharmaceutical formulations comprising SEQ ID NO: 11 (see, e.g., US’116 at SEQ ID NO:11, claims 1, 3-4, and 7). This is pertinent because SEQ ID NO: 11 of the primary reference is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’116 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from US’116, because the two Applications read upon the same embodiments.
[NSDP Rejection 04]
Claims 1-2, 9-10, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9 of US Patent 10,947,279 (Mar. 16, 2021). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims pharmaceutical formulations comprising SEQ ID NO: 11 (see, e.g., US’279 at SEQ ID NO:11, claims 1-4 and 9). This is pertinent because SEQ ID NO: 11 of the primary reference is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’279 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from US’279, because the two Applications read upon the same embodiments.
[NSDP Rejection 05]
Claims 1-2, 9-10, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 8 of US Patent 11,814,414 (Nov. 14, 2023; corresponding to US Application 17/169,758; US20210163543A1). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims pharmaceutical formulations comprising SEQ ID NO: 11 (see, e.g., US’414 at SEQ ID NO:11, claims 1-3 and 8). This is pertinent because SEQ ID NO: 11 of the primary reference is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’414 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from US’414, because the two Applications read upon the same embodiments.
[NSDP Rejection 06]
Claims 1-2, 9-10, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 10 of US Patent 12,297,235 (May 13, 2025; corresponding to US Application 18/480,170; US20240067680). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims methods utilizing pharmaceutical formulations comprising SEQ ID NO: 11 (see, e.g., US’235 at SEQ ID NO:11, claims 1-3 and 8). This is pertinent because SEQ ID NO: 11 of the primary reference is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., US’235 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from US’235, because the two Applications read upon the same embodiments.
[Provisional NSDP Rejection 01]
Claim 1-2, 9-10, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/034,718 (reference application corresponding to US20230303623 A1) in view of Simon et al.5
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims pharmaceutical formulations comprising related compounds that are highly similar to the claimed sequences (compare instant claims 1-2, 9-10, and 18 with copending claims 1-13 of App’718).
The scope of the copending claims differ as follows: Both copending claim sets are directed to derivatives and variants of PA-I8Sar (RLS-0088) and PA-C9Sar (RLS-0089) sequences, but the derivatives differ with respect to the exact placement of modifications relative to these base sequences (compare instant Spec. filed 5/01/2023 at Table 1, noting that the PA and RLS numbers are mostly consecutive, but then skip PA-0122 (RLS-0122)6, PA-0134 (RLS-0134)7, PA-0142 (RLS-0142)8, PA-0150 (RLS-0150)9, PA-0152 (RLS-0152)10, PA-0154 (RLS-0154)11, PA-0164 (RLS-0164)12, and PA-0168 (RLS-0168)13, which correspond to SEQ ID NOs: 6-13 as claimed by App’718).
Accordingly, the issue is whether or not the copending claims are patently distinct from one another under an obviousness rationale (see, e.g., MPEP § 804(II)(B)(2)-(3)).
Upon review of the pending claim scope and copending application, App’718 at SEQ ID NO: 12 (i.e., PA-0164, RLS-0164, IALILEPI(Sar)dCQERAA) and SEQ ID NO: 13 (i.e., PA-0168, RLS-0168, IALILEPI(Sar)CQERdAA) each share 100% sequence similarity to instant SEQ ID NOs: 42-53 (compare App’718 at SEQ ID NOs: 12-13 with instant SEQ ID NOs: 42-53, noting that all sequences are PA-C9Sar variants having a single residue substituted with a D-amino acid. Likewise, copending SEQ ID NO: 6 (IAdLILEP(Sar)CCQERAA, PA-0122, RLS-0122) shares 100% similarity to instant SEQ ID NOs: 12-24 (compare instant SEQ ID NOs: 12-24 with App’718 at SEQ ID NO: 6, showing 100% sequence similarity, noting that all sequences are PA-I8Sar variants having a single residue substituted with a D-amino acid).
Accordingly, the relevant issue is whether or not copending claims directed to D-amino acid substitution variants of the same exact base sequence, render other unclaimed D-amino acid substitutions of the same exact base sequence obvious or otherwise patentably indistinct.
Simon pertains D-amino acid substitutions in polypeptides, and Simon explains that a “D-scan” was known and routine in the prior art at least circa 2016 (see, e.g., Simon at title, abs). A “D-scan” is analogous to an alanine scan, but wherein D-amino acids are substituted at each position of a short polypeptide (see, e.g., Simon at title, abs, 12099 at col I-II at § Introduction, 12099-12100 at bridging ¶, 12100 at Fig. 1). The D-scan methodology provides known benefits, including the identification of critical stereocenters required for activity and identification of residues amenable to D-amino acid substitutions without abrogating functionality (see, e.g., Simon at title, abs, 12109 at col II at § Conclusion, 12110 at col I-II). Simon explains that some D-amino acid substitutions may be harmful by abolishing function or impacting folding (see, e.g., Simon at 12110 at col I-II), but that D-amino acid insertions can also desirably and predictably stabilize proteins against proteolysis (see, e.g., Simon at 12099 at § Introduction; 12110 at col I-II). Accordingly, performing a “D-scan” by converting each amino acid within a short polypeptide into a D-amino acid, one at a time, is a known method having known benefits, which would be routine to perform in order to identify critical stereocenters and positions amenable to D-amino acid substitutions, wherein D-amino acid substitutions at positions amenable to such substitutions, would predictably increase protease resistance and stability of the peptide.
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a different D-amino acid substituted variants of the same common base sequences (e.g., PA-I8Sar (RLS-0088) and PA-C9Sar (RLS-0089)). Accordingly, the present claims are directed to obvious variants of the copending claims because an artisan would readily appreciate that other D-amino acid variants of the same exact base sequence (i.e., the ones instantly claimed) could predictably, routinely, and desirably be made via a D-scan methodology exactly as taught and suggested by Simon applied to the D-amino acid variants claimed by the primary reference, wherein the creation of such D-amino acid variants would predictably and expectedly identify critical stereocenters and positions amenable to D-amino acid substitutions, wherein D-amino acid substitutions at positions amenable to such substitutions, would predictably increase protease resistance and stability of the peptide (see, e.g., MPEP §§ 2143(I)(B), (C), (D), (F), (G), 2144.09; see, e.g., MPEP § 804(II)(B)(3)(B)).
Accordingly, instant claims 1-2, 9-10, and 18 are rejected.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[Provisional NSDP Rejection 02]
Claims 1-2, 9-10, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. US18/035,846 (reference application; corresponding to US20230414506 A1). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims pharmaceutical formulations comprising SEQ ID NO: 3 (see, e.g., App’846 at SEQ ID NO:3, claims 1-23). This is pertinent because SEQ ID NO: 3 of the primary reference is PA-I8Sar, which is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., App’846 at SEQ ID NO: 3), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from the claim scope of App’846, because the copending Application recites and requires at least one structure within the pending claim scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[Provisional NSDP Rejection 03]
Claims 1-2, 9-10, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-18 of copending Application No. US18/288,274 (reference application; corresponding to US20240209036 A1). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection. Instant SEQ ID NO: 55 is understood to be a 14-mer having the sequence of IALILEPXCCQERA, wherein X at position 8 is Sarcosine. Additional claim interpretations are provided below.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims pharmaceutical formulations comprising SEQ ID NO: 3 (see, e.g., App’274 at SEQ ID NO:3, claims 2-18). This is pertinent because SEQ ID NO: 3 of the primary reference is PA-I8Sar, which is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., App’274 at SEQ ID NO: 3), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from the claim scope of App’274, because the copending Application recites and requires at least one structure within the pending claim scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
[Provisional NSDP Rejection 04]
Claims 1-2, 9-10, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-13 of copending Application No. US 19/182,023 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been discussed in preceding rejections and in a separate section above, and those discussions are incorporated into the instant rejection.
Regarding instant claim 1-2, 9-10, and 18, the primary reference claims pharmaceutical formulations comprising SEQ ID NO: 11 (see, e.g., App’023 at SEQ ID NO:11, claims, noting that SEQ ID NO: 11 is PA-I8Sar). This is pertinent because SEQ ID NO: 11 of the primary reference is PA-I8Sar, which is understood to have the following structure:
IALILEP(Sar)CCQERAA
(see, e.g., App’023 at SEQ ID NO: 11), which shares 100% sequence identity with instant SEQ ID NO: 55 (compare id. with instant SEQ ID NO: 55, showing 100% sequence identity). Regarding “optional” components recited at instant claims 9-10 and 18, claim scope is not limited by optional components (see, e.g., MPEP § 2111.04(I)).
Accordingly, under an anticipation or obviousness analysis, instant claims 1-2, 9-10, and 18 are not patentably distinct from the claim scope of App’023, because the copending Application recites and requires at least one structure within the pending claim scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8906845 discloses a related sequence, namely PA (see, e.g., US’845 at claims and SEQ ID NO: 9).
US 9422337 discloses a related sequence, namely PA (see, e.g., id. at claims and SEQ ID NO: 9, noting that PA is IALILEPICCQERAA).
US 9914753 discloses a related sequence, namely PA (see, e.g., id. at claims and SEQ ID NO: 9, noting that PA is IALILEPICCQERAA).
US 10414799 discloses a related sequence, namely PA (see, e.g., id. at claims and SEQ ID NO: 9, noting that PA is IALILEPICCQERAA).
US 10844093 discloses a related sequence, namely PA (see, e.g., id. at claims and SEQ ID NO: 9, noting that PA is IALILEPICCQERAA).
US 11020460 discloses and claims related methods and compounds, namely a PIC1 peptide comprising a PEGylated PA protein (see, e.g., US’460 at claims).
US 12257290 B2 discloses and claims related methods and compounds, namely a PIC1 peptide comprising a PEGylated PA protein (see, e.g., US’290 at claims).
US20230272012A1 (corresponding to instant Application 18/034,731) is the PG Publication corresponding to the instant Application.
US20240309047 (corresponding to US App 18/657,556) pertains to related inventions based upon PA peptides (see, e.g., US’373 at title, abs, claims, SEQ ID NO: 9).
US20260028373 (corresponding to US App 19/301,568) pertains to related inventions based upon PA peptides (see, e.g., US’373 at title, abs, claims, SEQ ID NO: 9).
Moiola et al.14 pertains to the general approach for improving peptide-based drugs by introducing a “staple” and creating a “stapled peptide”, which forces a short peptide to adopt an alpha helical structure (see, e.g., Moiola at title, abs, page 5-6 at § 2, page 5 at Scheme 1, page 6 at Fig. 3). Moiola explains that stapled peptides follow a pattern referred to as “i+4” and “i+7” (see, e.g., Moiola at page 6 at Fig. 3, 5-6 at § 2).
Bird et al.15 pertains to the general approach for improving peptide-based drugs by introducing a “staple” and creating a “stapled peptide”, which forces a short peptide to adopt an alpha helical structure, and is useful in therapeutic targeting of short peptides (see, e.g., Bird at title, abs, 2 at § “What can you do with stapled peptides?”). Bird identifies that the non-natural amino acids used to form “staples” were well known, and included R8 and S5, and that such non-natural amino acids formed staples following the positioning patterns of “i+4” and “i+7” (see, e.g., Bird at 3 at § “Strategic Planning”).
Bird et al.16 discusses pitfalls involved with stapled peptides and distinctions involving structural and cellular studies (see, e.g., Bird2014 at title, abs, passim). Bird2014 emphasizes that staples at particular positions may not be successful with respect to binding or functionality (see, e.g., Bird2014 at 831 at col I-II at bridging ¶), and emphasizes that staple location is a variable that is critical to consider and test (see, e.g., Bird2014 at 831 at col II at 1st full ¶, 833 at Fig. 1, Fig. 2 on 834, reproduced below):
PNG
media_image1.png
433
529
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Greyscale
Accordingly, when following known methodologies for creating stapled peptides, it is routine in the art to test different staple types (e.g., “i+4” and “i+7”) and different staple positions to find a fully functional, stapled peptide.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 This is the PG Pub corresponding to subsequently issued US11135272, which was issued 10/05/2021.
2 Corresponds to issued US Patent 10,933,116, issued March 2, 2021.
3 Simon et al. D-Amino Acid Scan of Two Small Proteins, Journal of the American Chemical Society 2016 138 (37), 12099-12111, DOI: 10.1021/jacs.6b03765; hereafter “Simon”.
4 (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”).
5 Simon et al. D-Amino Acid Scan of Two Small Proteins, Journal of the American Chemical Society 2016 138 (37), 12099-12111, DOI: 10.1021/jacs.6b03765; hereafter “Simon”.
6 App’718 SEQ ID NO: 6 (i.e., PA-0122, RLS-0122, IAdLILEP(Sar)CCQERAA)
7 App’718 SEQ ID NO: 7 (i.e., PA-0134, RLS-0134, IAR8ILEP(Sar)CS5QERAA)
8 App’718 SEQ ID NO: 8 (i.e., PA-0142, RLS-0142, IAdLILEP(Sar)CS5QERS5A)
9 App’718 SEQ ID NO: 9 (i.e., PA-0150, RLS-0150, IALILER8I(Sar)CQERS5A)
10 App’718 SEQ ID NO: 10 (i.e., PA-0152, RLS-0152, IS5LILS5PI(Sar)CQERAA)
11 App’718 SEQ ID NO: 11 (i.e., PA-0154, RLS-0154, IALILES5I(Sar)CS5ERAA)
12 App’718 SEQ ID NO: 12 (i.e., PA-0164, RLS-0164, IALILEPI(Sar)dCQERAA)
13 App’718 SEQ ID NO: 13 (i.e., PA-0168, RLS-0168, IALILEPI(Sar)CQERdAA)
14 Moiola et al., Stapled Peptides-A Useful Improvement for Peptide-Based Drugs. Molecules. 2019 Oct 10;24(20):3654. doi: 10.3390/molecules24203654. PMID: 31658723; PMCID: PMC6832507; hereafter “Moiola”.
15 Bird et al., Chemical synthesis of hydrocarbon-stapled peptides for protein interaction research and therapeutic targeting. Curr Protoc Chem Biol. 2011 Sep 1;3(3):99-117, Author manuscript HHS Public Access; doi: 10.1002/9780470559277.ch110042. PMID: 23801563; PMCID: PMC4879976; hereafter “Bird”.
16 Bird et al., Distinct BimBH3 (BimSAHB) stapled peptides for structural and cellular studies. ACS Chem Biol. 2014 Mar 21;9(3):831-7. doi: 10.1021/cb4003305. Epub 2014 Jan 3. PMID: 24358963; PMCID: PMC4131438; hereafter “Bird2014”.
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