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
In view of the reply filed 6/17/2026, claims 1-3, 10, 17-25, and 57-60 are pending; claims 13-15 were canceled; and claims 1-3, 17-18, and 22-24 were amended. Claims 10, 21, 25, and 57-60 remain withdrawn. Claims 1-3, 17-19, and 22-24 are presently considered.
Election/Restrictions
Applicant's election with traverse of Group I (products) and the species of “AnxA1(2-26) with a V to L substitution and a C-terminal amidation and with the sequence SEQ ID NO: 4” in the reply filed on 1/13/2026 is acknowledged. The traversal was fully considered but not found persuasive for reasons of record (see, e.g., Action mailed 3/17/2026 at 2-3), and the requirement was deemed proper and made FINAL (see id).
The originally elected species of “AnxA1(2-26) with a V to L substitution and a C-terminal amidation and with the sequence SEQ ID NO: 4” is understood to be the following 45-mer structure:
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSS-NH2
(SEQ ID NO: 4), which has a Leucine at position 24 (i.e., X3 in SEQ ID NO: 3).
The originally elected species is understood to read upon instant claim 1 wherein X1 is Ala, X2 is Val, X3 is Leu, and X4 is Val; claims 2-3, 17-19, and 23, which each read upon SEQ ID. NO: 4; claims 22-23 because the C-terminal is amidated (-NH2); and claim 24 is presumed to read upon the originally elected species. Accordingly, the originally elected species continues to be understood to read upon instant claims 1-3, 13-15, 17-19, and 23-24.
However, the originally elected species does not read upon instant claims 10, 20-21, 25, or 57-60 for reasons of record (see, e.g., Action mailed 3/17/2026 at 2-4). Accordingly, claims 10, 20-21, and 25 are directed to non-elected species; claims 57-60 are directed to a non-elected invention.
The amended claims have been examined for the originally elected species again, and following extensive search and examination, the originally elected species has again been deemed obvious in view of the prior art as applied below. 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, claims 1-3, 17-19, and 23 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn.
Claims 57-60 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. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/13/2026.
Claims 10, 20-21, and 25 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 1/13/2026.
Claims 1-3, 17-19, and 22-24 are presently considered.
Information Disclosure Statement
The IDS filed 3/18/2026, wherein the fee set forth in 37 CFR 1.17(p) was submitted, is 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).
Amended claim 1 is representative of the pending claim scope, and the applicable claim scope and interpretation is discussed below.
“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)).
Amended claim 1 is understood to encompass some, but not all, sequences consisting of SEQ ID NO: 3, which has the structure
AMVSEFLKQX1WFIENEEQEYX2QTX3KSSKGGPGSAX4SPYPTFNPSS
wherein X1 may be Ala, Leu, Asp, Met, Glu, Ile or Arg; wherein X2 may be Val, Leu, Asp, Met, Glu, Ile, or Lys; wherein X3 may be Val, Gly, Ala, Ser, Thr, Cys, Leu, Ile, Met, Pro, Phe, Tyr, Trp, Asp, Glu, Asn, Gln, His, Lys, or Arg; and wherein X4 may be Val, Gly, Ala, Ser, Thr, Cys, Leu, Ile, Met, Pro, Phe, Tyr, Trp, Asp, Glu, Asn, Gln, His, Lys, or Arg; wherein these definitions are set forth in the Sequence listing at <220>-<223>. This may be rewritten as
AMVSEFLKQ[ALDMEIR]WFIENEEQEY[VLDMEIK]QT[VGASTCLIMPFYWDENQHKR]KSSKGGPGSA[VGASTCLIMPFYWDENQHKR]SPYPTFNPSS
wherein the brackets indicate alternative residues at a single position. However, amended claim 1 limits the subgenus of SEQ ID NO: 3 to only embodiments wherein X1 may be Ala, Leu, Asp, Met, Glu, or Ile; wherein X2 may be Val, Leu, Asp, Met, Glu, or Ile; wherein X3 is Leu; and wherein X4 is Val, which may be rewritten as
AMVSEFLKQ[ALDMEI]WFIENEEQEY[VLDMEI]QT[L]KSSKGGPGSA[V]SPYPTFNPSS
Wherein claim 1 further encompasses “or a variant thereof having 1, 2, or 3 amino acid substitutions at any position other than amino acid residues X1, X2, X3, and X4”.
Amended claim 1 now recites and encompasses any “variant thereof having 1, 2, or 3 amino acid substitutions at any position other than amino acid residues X1, X2, X3, and X4”, wherein a “substitution” may be with any “proteinogenic or non-proteinogenic amino acid” (see, e.g., Spec. filed 2/15/2023 at 7th page at lines 30-35, noting pages are unnumbered), wherein substitutions presumably include branching points (see, e.g., Spec. filed 2/15/2023 at 16th page at lines 8-35, noting pages are unnumbered). The variant amino acids may be substituted with at least 32 different amino acids at three positions selected from among any combination of 41 different positions (see, e.g., Spec. filed 2/15/2023 at 8 at line 30 to page 9 at line 15, noting “22 standard or natural amino acids” and exemplifying at least Abu, Aib, Nle, Dorn, Nal, D-Nal, DArg, DTrp, DPhe and DVal), and therefore the claims read upon at least 349 million linear species of peptides1.
The amended claims raise a definition and usage issue regarding SEQ ID NO: 3. As noted above, SEQ ID NO: 3 is a variable sequence defined in the instant Sequence listing at notes <220>-<223>, to include all sequences satisfying
AMVSEFLKQ[ALDMEIR]WFIENEEQEY[VLDMEIK]QT[VGASTCLIMPFYWDENQHKR]KSSKGGPGSA[VGASTCLIMPFYWDENQHKR]SPYPTFNPSS
Wherein the residues within brackets indicate variation at a single position (see, e.g., instant SEQ ID NO: 3, as filed 2/15/2023, version 1.1, at notes <220>-<223>). However, instant claim 1 defines a different genus of sequences by reference to SEQ ID NO: 3 in combination with explicitly recited additional limitations, such that instant claim 1 includes sequences that are different and distinct from SEQ ID NO: 3 as set forth in the sequence listing, namely claim 1 is limited to sequences of form
AMVSEFLKQ[ALDMEI]WFIENEEQEY[VLDMEI]QT[L]KSSKGGPGSA[V]SPYPTFNPSS
“or a variant thereof having 1, 2, or 3 amino acid substitutions at any position other than amino acid residues X1, X2, X3, and X4”.
Accordingly, although claim 1 refers to SEQ ID NO: 3, it defines a substantially different genus of species that includes “variants” that are not within SEQ ID NO: 3, while simultaneously excluding sequences within SEQ ID NO: 3 (e.g., where X3 is Arg). This is not an issue at claim 1, where SEQ ID NO: 3 is used, by reference, to define the claim scope in combination with express limitations. However, dependent claims 2, 3, and 17 refer directly to SEQ ID NO: 3, which is understood to import the definition and meaning of SEQ ID NO: 3 as actually set forth in the sequence listing. Accordingly, the references at dependent claims 2, 3, and 17 to SEQ ID NO: 3 is understood to refer to all sequences within the scope of SEQ ID NO: 3, which includes all sequences satisfying
AMVSEFLKQ[ALDMEIR]WFIENEEQEY[VLDMEIK]QT[VGASTCLIMPFYWDENQHKR]KSSKGGPGSA[VGASTCLIMPFYWDENQHKR]SPYPTFNPSS
(see, e.g., instant SEQ ID NO: 3, as filed 2/15/2023, version 1.1, at notes <220>-<223>). Therefore, the usage of SEQ ID NO: 3 raises issues under 35 USC 112(d), as noted below.
At claim 3, sequence identity is referenced with respect to a sequence containing variable “X” positions (e.g., SEQ ID NO: 3). For purposes of examination, variable residues are counted as non-identities; this is reasonable because it is consistent with routine sequence alignment calculations, such as BLAST:
PNG
media_image1.png
92
477
media_image1.png
Greyscale
Accordingly, “X” residues constitute mismatches, meaning that SEQ ID NO: 3 can at most share 41/45 residues (~91% sequence identity) with instant SEQ ID NO: 2 or 4. As noted above, SEQ ID NO: 3, as recited at claim 3, is understood to refer to SEQ ID NO: 3 exactly as defined in the sequence listing (see, e.g., instant SEQ ID NO: 3, as filed 2/15/2023, version 1.1, at notes <220>-<223>).
Additional claim interpretations are discussed below.
Withdrawn Claim Rejections
The rejection of claims 1-3, 13-15, 17-19, and 23-24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, has been successfully traversed in part by the cancelation of claims 13-15, and the amendments to claims 1-3, 17-18, and 23-24 as filed 6/17/2026; however, the amendments have necessitated a new or revised rejection, which is set forth below.
The rejection of claims 2-3 and 18 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn in view of the amendments filed 6/17/2026; however, the amendments have necessitated a new or revised rejection, which is set forth below.
The rejection of claims 1-3, 13-15, 17-19, and 23-24 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendments filed 6/17/2026; however, the amendments have necessitated a new or revised rejection, which is set forth below.
The rejection of claims 1-3, 13-15, 17-19, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US9102753 (Aug. 11, 2015) have been successfully traversed in part by the cancellation of claims 13-15; a revised rejection as necessitated by Applicants amendments is set forth below.
The provisional rejection of claims 1-3, 13-15, 17-19, and 23-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 9, 11, 24-25, 28, 36, 39, 48, 56, 58-59, and 62-63 of copending Application No. 18/041,729 (corresponding to US20240041977) was successfully traversed in part by the cancellation of claims 13-15; a revised rejection as necessitated by Applicants amendments is set forth below.
The provisional rejection of claims 1-3, 13-15, 17-19, and 23-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/871,530 (corresponding to US20250345392), was successfully traversed in part by the cancellation of claims 13-15; a revised rejection as necessitated by Applicants amendments is set forth below.
New or Revised Claim Rejections Necessitated by Applicant Amendment
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 3 and 24 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.
Amended claim 3 now recites polypeptides within the scope of amended claim 1 “wherein said variant has at least 95% sequence identity to any one of SEQ ID NO: 2 to SEQ ID NO: 4”. The range of “any one of SEQ ID NO: 2 to SEQ ID NO: 4” includes instant SEQ ID NO: 3, which is a variable sequence defined in the instant Sequence listing at notes <220>-<223>, to include all sequences satisfying
AMVSEFLKQ[ALDMEIR]WFIENEEQEY[VLDMEIK]QT[VGASTCLIMPFYWDENQHKR]KSSKGGPGSA[VGASTCLIMPFYWDENQHKR]SPYPTFNPSS
wherein the residues within brackets correspond to X1, X2, X3, X4, and indicate variation at a single position (see, e.g., instant SEQ ID NO: 3, as filed 2/15/2023, version 1.1, at notes <220>-<223>). This is pertinent because variable positions are routinely counted as non-identities in the prior art, as shown below using BLAST:
PNG
media_image1.png
92
477
media_image1.png
Greyscale
This is pertinent because, since “X” residues constitute mismatches, SEQ ID NO: 3 can at most share 41/45 residues (~91% sequence identity) with other sequences, including instant SEQ ID NOs: 2, 4, or other species within the scope of amended claim 1. Accordingly, the reference to “variants” sharing “at least 95% sequence identity” to instant SEQ ID NO: 3 renders the instant claim scope indefinite, because it is unclear in view of the record and routine usage of sequence identity, what structures Applicant is attempting to claim using this ambiguous language. Accordingly, such language raises a material and substantial concern regarding the claim scope defined by the limitations of amended claim 3.
Amended claim 24 is understood to attempt to claim a narrower genus of compounds within the scope of amended claim 1, by reference to multiple functional limitations (see, e.g., claim 24 at (a)-(i)), but no structure/function relationship commensurate in scope with the recitation of functional limitations has actually been set forth on record permitting artisans to identify which species within the genus defined by instant claim 1 does or does not satisfy any specific functionality recited and required by claim 24. 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, amended claim 24 merely recite a description of a functional result to be achieved by the invention rather than a description of the actual structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). More specifically, amended claim 1 now recites and encompasses any “variant thereof having 1, 2, or 3 amino acid substitutions at any position other than amino acid residues X1, X2, X3, and X4”, wherein a “substitution” may be with any “proteinogenic or non-proteinogenic amino acid” (see, e.g., Spec. filed 2/15/2023 at 7th page at lines 30-35, noting pages are unnumbered), wherein substitutions presumably include branching points (see, e.g., Spec. filed 2/15/2023 at 16th page at lines 8-35, noting pages are unnumbered). Therefore, claim 1 encompasses variant amino acids substituted with at least 32 different amino acids at three positions selected from among any combination of 41 different positions (see, e.g., Spec. filed 2/15/2023 at 8 at line 30 to page 9 at line 15, noting “22 standard or natural amino acids” and exemplifying at least Abu, Aib, Nle, Dorn, Nal, D-Nal, DArg, DTrp, DPhe and DVal), and therefore amended claim 1 reads upon at least 349 million linear species of peptides2. A basic question is simply, “which of these 349+ million species are included or excluded by the amended claim scope set forth at dependent claim 24?” It is unclear if all species fall within the scope of amended, dependent claim 24 (i.e., claim 24 could be non-limiting and merely recites an intended and expected result fully satisfied by all compounds satisfying the limitations of amended claim 1), or perhaps only a few million species satisfy the functional limitations of claim 24, or perhaps only the single species of instant SEQ ID NO: 4 satisfies the limitations of both claim 1 and claim 24. Accordingly, the metes and bounds of amended claim 24 is unknown, and it is unclear what sequences do or do not infringe upon the scope of claim 24. Notably, the courts have stated that
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
Here, because it is unclear what compounds from among the over 349 million within the scope of amended claim 1 do or do not satisfy the functional limitations of amended claim 24, an artisan would be unable to identify infringing from non-infringing compounds, and therefore claim 24 is rejected as indefinite.
Claims 3 and 24 are rejected.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Amended claim 2 depends from amended claim 1, wherein amended claim 1 was amended in the Reply filed 6/17/2026 to exclude SEQ ID NO: 2, which lacks an X3 of Leu, and to exclude numerous species within the scope of SEQ ID NO: 3 (e.g., species of SEQ ID NO: 3 lacking an X3 of Leu and/or an X4 of valine; see, e.g., instant SEQ ID NO: 3, as filed 2/15/2023, version 1.1, at notes <220>-<223>). However, amended claim 2 continues to read upon and recite SEQ ID NO: 2 and species of SEQ ID NO: 3 excluded by the amendments to instant claim 1. Accordingly, claim 2 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to include all the limitations of the claim upon which it depends.
Amended claim 3 depends from amended claim 1, wherein amended claim 1 was amended in the Reply filed 6/17/2026 to exclude SEQ ID NO: 2, which lacks an X3 of Leu. Accordingly, claim 3 reads upon SEQ ID NO: 2, which shares 100% sequence identity to itself, but SEQ ID NO: 2 is excluded from the scope of instant claim 1. Accordingly, amended claim 3 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to include all the limitations of the claim upon which it depends.
Amended claim 17 depends from amended claim 1, wherein amended claim 1 was amended in the Reply filed 6/17/2026 to exclude SEQ ID NO: 2, which lacks an X3 of Leu, and to exclude numerous species within the scope of SEQ ID NO: 3 (e.g., species of SEQ ID NO: 3 lacking an X3 of Leu and/or an X4 of valine; see, e.g., instant SEQ ID NO: 3, as filed 2/15/2023, version 1.1, at notes <220>-<223>). However, amended claim 17 now reads upon and recites SEQ ID NO: 2 and all species of SEQ ID NO: 3. Accordingly, claim 17 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Accordingly, claims 2-3 and 17 are rejected.
Claim Rejections - 35 USC § 112(a), Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Brief Statement of the Issue(s)
Amended claim 24 depends from amended claim 1, but amended claim 24 now attempts to define a genus of unknown structures defined by reference to functional limitations set forth at amended claim 24 (a)-(i). However, the recited “functions” do not correspond to any structure/function relationship of record commensurate in scope with amended claim 1, which reasonably permits artisans to identify what structures are included or excluded by the functional claim limitations set forth at amended claim 24.
Claim Scope
Amended claim 1 is directed to sequences understood to include the following structures:
AMVSEFLKQ[ALDMEI]WFIENEEQEY[VLDMEI]QT[L]KSSKGGPGSA[V]SPYPTFNPSS
“or a variant thereof having 1, 2, or 3 amino acid substitutions at any position other than amino acid residues X1, X2, X3, and X4”.
This is pertinent because a “substitution” may be with any “proteinogenic or non-proteinogenic amino acid” (see, e.g., Spec. filed 2/15/2023 at 7th page at lines 30-35, noting pages are unnumbered), wherein substitutions presumably include branching points (see, e.g., Spec. filed 2/15/2023 at 16th page at lines 8-35, noting pages are unnumbered). The variant amino acids may be substituted with at least 32 different amino acids at three positions selected from among any combination of 41 different positions (see, e.g., Spec. filed 2/15/2023 at 8 at line 30 to page 9 at line 15, noting “22 standard or natural amino acids” and exemplifying at least Abu, Aib, Nle, Dorn, Nal, D-Nal, DArg, DTrp, DPhe and DVal), and therefore amended claim 1 reads upon at least 349 million linear species of peptides3.
However, in the complete absence of any structure/function relationship commensurate in scope with the functions recited at amened claims 24 (a)-(i), it is prima facie unclear which, if any, of these >349 million species are included or excluded by instant claim 24.
Accordingly, it is unclear if amended claim 24 encompasses all species of amended claim 1, >100 million species within the scope of amended claim 1, or potentially just the single sequence of SEQ ID NO: 4. Accordingly, the claim scope reasonably appears to be potentially vast and highly varied, but is unknown in view of the instant record.
Actual Reduction to Practice
Zero species lacking any difference from the following subgenus were reduced to practice on record at all:
AMVSEFLKQAWFIENEEQEYVQT[LV]KSSKGGPGSAVSPYPTFNPSS
The brackets show alternatives at a single position and correspond to instant SEQ ID NO: 2 and 3.
Only the single species of instant SEQ ID NO: 4 reads upon amended claim 1 and was also reduced to practice (i.e., amended claim 1 excludes SEQ ID NO: 2, which lacks an X4 of Leu).
Zero species comprising Abu, Aib, Nle, Dorn, Nal, D-Nal, DArg, DTrp, DPhe and DVal or any other non-proteinogenic amino acid were reduced to practice.
Zero species comprising any non-conservative substitutions were reduced to practice.
Accordingly, the only species of record actually tested and reduced to practice is the single species of SEQ ID NO: 4. Zero additional variations within the scope of amended claim 1 were actually tested and verified as capable of achieving any functionality enumerated at amended claim 24 (a)-(i).
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In this case, the claims encompasses >>349 million species of polypeptides, but only one, single species was reduced to practice reading upon amended claim 1. Zero additional species were actually tested, reduced to practice, or shown to have any functionality.
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of two species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of one, single species within a vast, and highly varied genus, does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Identifying characteristics of the genus
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Upon review, the functional limitations recited at amended claim 24 (a)-(i) appear to be utilized only as a vague attempt to capture unknown and undisclosed functional structures, sufficient to achieve some functional result that Applicant hopes and desires that the disclosed invention is able to achieve. However, the disclosure but does not meaningfully disclose any unambiguous structure/function relationship permitting an artisan to identify, a priori, which exact structures within the scope of amended claim 1 are actually capable of achieving any particular functionality enumerated at amended claim 24. Accordingly, no evidence Applicant “possessed” a potentially vast and highly varied genus of “functional” structures commensurate in scope with amended claim 24 has been found in the original disclosure.
Accordingly, basic identifying characteristics pertinent to the claimed genus and subgenera are left unanswered, including “which compounds within the scope of amended claim 1 can actually satisfy the functional limitations of amended claim 24?” Rather than clearly providing a structure/function relationship or clear definition permitting artisans to identify such compounds, a priori, the disclosure instead leaves the work and actual discovery of functional species to future researchers, wherein future researchers would be burdened to make, test, and scree hundreds of millions of potential sequences to simply identify the metes and bounds of amended claim 24. Accordingly, an artisan would be unaware, prior to making and potentially infringing upon the instant claims, whether or not a particular sequence did or did not satisfy the functional limitations of the pending claims.
Predictability in the Art
Although the level of skill in the art is high, the predictability in the art is low due to the complexity of biological systems, biochemistry, and protein function prediction. Specifically, an artisan would not be able to predict or identify, a priori, and in the absence of any guidance or consensus structures exactly what compounds within the scope of amended claim 1 would be included or excluded by the “functional” limitations of amended claim 24(a)-(i), or other claims.
Accordingly, in the absence of sufficient structure/function teachings identifying particular compounds capable of the functionality required by the pending claims, as required to practice the full scope of the claims, an artisan would not reasonably conclude that Applicant possessed the full scope of the broad and highly varied claim scope.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). In addition, the Courts have stated
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is pertinent because, in the instant case, Applicants have claimed a broad and highly varied genus comprising an unknown number of “functional” species within the scope of amended claim 1, which are defined by reference to functional limitations set forth in amended claim 24; however, the originally filed disclosure has failed to identify any common structure/function relationship sufficient to permit an artisan to identify what structures, from among potentially hundreds of millions, are actually included or excluded by the claim scope. This also means that it is prima facie unclear what structures are infringe or do not infringe upon the pending claim scope.
In conclusion, for the reasons discussed above, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claim 24 is rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-3, 17-19, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US9102753 (Aug. 11, 2015).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
US’753 discloses, claims, and pertains to polypeptides having homology to regions of the N-terminal 50 residues of human Annexin 1, which are identified and taught for use as anti-inflammatory agents, which may be amidated at the C-terminus (see, e.g., US’753 at title, abs, claims 1-4). Regarding instant claims 1-3, 13-15, 17-19, 23-24, and instant SEQ ID NO: 4, US’753 teaches and discloses SEQ ID NO: 7 (see, e.g., US’753 at claims 1-4 and SEQ ID NO: 7), which shares 100% sequence identity with instant SEQ ID NO: 4 from positions 1 to 45:
PNG
media_image2.png
106
583
media_image2.png
Greyscale
Regarding instant claims 1-3, 13-15, 17-19, 23, SEQ ID NO: 4, a C-terminal amidation, and a Leucine at residue 24, US’753 explicitly teaches that the disclosed polypeptides, including SEQ ID NO: 7, may desirably include an amidated C-terminus (see, e.g., US’753 at abs, col. 5 at lines 44-51, col. 12 at lines 4-16, col. 12 at lines 28-36, col. 13 at lines 1-5), and US’753 explicitly teaches that a Leucine at position 24 improves stability (see, e.g., US’753 at col. 12 at lines 16-27, noting that “Better stability was observed for polypeptides with Leucine substitution at position 24”, col. 5 at lines 44-51). Regarding instant claim 24, US’753 explicitly teaches that SEQ ID NO: 7 acts through the FPR2 receptor (see, e.g., US’753 at col. 10 at lines 42-55).
US’753 differs from the instant claim scope as follows: The pending claim scope and originally elected species differs from prior art SEQ ID NO: 7, because the instant claims are limited to 45-mers that are two amino acids shorter than the prior art sequence of SEQ ID NO: 7 (compare instant SEQ ID NO: 4 with US’753 at SEQ ID NO: 7, noting that the sequences are identical at positions 1-45, but wherein instant SEQ ID NO: 4 “consists of” positions 1-45, and lacks the “Asp Val” dipeptide located at positions 46-47 of prior art sequence SEQ ID NO: 7. Accordingly, the relevant issue is whether or not 45-mer truncation variants of SEQ ID NO: 7 would be obvious to one of ordinary skill in the prior art.
Regarding guidance to shorter sequences, reasonable expectation of success, and predictability, US’753 expressly teaches and discloses the subgenus of polypeptides having the following structure:
[T]here is provided a polypeptide having from 37 to 51 amino acid residues and including within its molecular structure a region of homology that is at least 90 percent identical to SEQ ID NO: 2, wherein the homology region of the polypeptide has at least one of the following characteristics …. (c) the residue of the polypeptide corresponding to residue 15 of SEQ ID NO: 2 is not valine or (d) the residue of the polypeptide corresponding to residue 26 of SEQ ID NO: 2 is not valine.
(see, e.g., US’753 at col. 3 at lines 19-31; see also US;753 at col. 17 at lines 14-59). This is pertinent because SEQ ID NO: 2 of US’753 is
XWFIENEEQEYXQTXKSSKGGPGSAXSPYPTFNPSSDV
wherein each X can be any natural amino acid (see, e.g., US’733 at SEQ ID NO: 2). Critically, SEQ ID NO: 7 of US’733 has a corresponding residue 15 that is “not value”, but is instead leucine (see, e.g., US’733 at SEQ ID NO: 7, noting that position 15 of SEQ ID NO: 2 is position 24 of SEQ ID NO: 7). This is pertinent because an artisan would readily appreciate because SEQ ID NO: 2 is 38 amino acids in length, that any sequence sharing at least 35/38 residues with SEQ ID NO: 2 would necessarily retain at least 92.1% sequence identity with it. Accordingly, an artisan would readily appreciate that variants of SEQ ID NO: 7 having 37 to 47 amino acids in length, and retaining at least 35/38 residues in common with SEQ ID NO: 2, would be predicted and expected to act as anti-inflammatory polypeptides exactly as taught, disclosed, and suggested by the prior art. For example, in view of this guidance (see, e.g., US’753 at col. 3 at lines 19-31) and SEQ ID NO: 7, an artisan would at once envisage N- and C-terminal truncation variants satisfying the recited limitations:
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSD (46-mer, 37/38);
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSS (45-mer, 36/38);
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPS (44-mer, 35/38)
MVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (46-mer, 38/38);
VSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (45-mer, 38/38);
SEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (44-mer, 38/38);
EFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (43-mer, 38/38);
FLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (42-mer, 38/38);
LKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (41-mer, 38/38);
KQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (40-mer, 38/38);
QAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (39-mer, 38/38);
AWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (38-mer, 38/38);
WFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSDV (37-mer, 37/38);
The underlined portion corresponds to SEQ ID NO: 2 of US’753, and the fraction (“37/38”) shows how many residues of SEQ ID ON: 2 of US’753 are present. This is pertinent because the 45-mer species, truncated from the C-terminal, is identical to the originally elected species, and shares 36/38 (94.74% sequence identity) residues in common with SEQ ID NO: 2 of US’753. Accordingly, the predicted and expected results in view of the prior art, would be that all such truncation variants ranging from 37-47 amino acids in length, sharing 90% or more sequence identity with SEQ ID NO: 2 of US’753, and having a Leu as required by the disclosure, would predictably and expectedly act as anti-inflammatory peptides (see, e.g., US’753 at col. 1 at lines 1-20 and 37-56, col. 2 at lines 1-28, col. 3 at lines 54-67, col. 7 at lines 47-55).
An artisan would truncate SEQ ID NO: 7 from the C-terminus: US’753 experimental tests SEQ ID NO: 7 (a.k.a., UGP025 and “Leu25-ANXA1(2-48)-NH2), which is shown to exhibit superior PR3 resistance and HNE resistance relative to both UGP022 and UGP026 (see, e.g., US’753 at Figs. 8-9). This is pertinent because relative to UGP022 and UGP026, SEQ ID NO: 7 is a C-terminal truncation variant (i.e., both UGP022 and UGP026 are 49-mers), and relative to UGP0224 SEQ ID NO: 7 also has a Leu24 substitution (see, e.g., US’753 at SEQ ID NOs: 5, 7-9, and Figs. 8-9; see also US’753 at col. 9 at lines 8-27, noting that “A 47-residue polypeptide outperformed an otherwise identical 49-residue polypeptide”). Accordingly, an artisan would be directed to test additional C-terminal truncation variants of SEQ ID NO: 7, that maintained at least 35/38 residues (i.e., over 90% identity) in common with SEQ ID NO: 2 (see, e.g., US’753 at col. 3 at lines 19-31; see also US;753 at col. 17 at lines 14-59), with the reasonable expectation that such variants would exhibit superior PR3 and HNE resistance. The only variants of SEQ ID NO: 7 satisfying such limitations are
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSSD (46-mer, 37/38);
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSS (45-mer, 36/38);
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPS (44-mer, 35/38)
Accordingly, an artisan would readily predict and expect that each of these variants would exhibit anti-inflammatory properties exactly as taught, disclosed, and suggested by the prior art, and would reasonably expect that such C-terminal truncation variants of SEQ ID NO: 7 would also exhibit superior PR3 and HNE resistance.
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 claims are obvious as directed to predictable length variants of SEQ ID NO: 7 of US’753, wherein the variations amount to a C-terminal truncation following with the subgenus of Annexin A1 polypeptides taught by the prior art for use in anti-inflammatory applications, wherein it was well-within the ordinary skill in the art to make and use such polypeptides, and such variants would have yielded predictable and expected results, namely polypeptides having anti-inflammatory properties and also predictably exhibiting superior PR3 and HNE resistance, exactly as taught, disclosed, and suggested by the prior art (see, e.g., MPEP §§ 2143(I)(A), (F)). In addition, or alternatively, in view of the teachings of US’753, artisan would have readily appreciated in view of US’753 that C-terminal truncation variants of SEQ ID NO: 7 (e.g., 46-mer with 37/38 to SEQ ID NO: 2; a 45-mer with 36/38 identity to SEQ ID NO: 2; and a 44-mer sharing 35/38) were obvious in view of the disclosure of SEQ ID NO: 7, the guidance regarding sequence identity to SEQ ID NO: 2 of US’753, and the length limitations set forth by US’753, wherein such C-terminal truncation variants would be readily expected and predicted to have the utility disclosed by the prior art (i.e., anti-inflammatory therapeutic applications) and would be desirably and reasonably expected to exhibit superior PR3 and HNE resistance (see, e.g., MPEP §§ 2144.08(II), 2144.09).
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. The closest existing prior art relative to the elected species is SEQ ID NO: 7 of US’753, and zero evidence of any unexpected results relative to the closest prior art has been placed on record. However, the claimed genus is not limited to SEQ ID NO: 7, and multiple additional, close prior art sequences exist (see, e.g., MPEP §§ 716.02(d), 716.02(e)(II)). Furthermore, evidence showing expected results weighs in favor of a determination of obviousness (see, e.g., MPEP §§ 716.02(c)(II)).
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 make and use a polypeptide, or variants thereof, exactly as taught and suggested by the prior art, wherein such polypeptides would be reasonably expected and predicted to have the exact applications and properties taught and disclosed by the prior art.
Accordingly, claims 1-3, 17-19, and 23-24 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.
Claims 1-3, 17-19, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 9, 11, 24-25, 28, 36, 39, 56, 58-59, and 62-63 of copending Application No. 18/041,729 (corresponding to US20240041977). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
The instant claims are directed to, and encompass at least the originally elected species of instant SEQ ID NO: 4, which has the sequence of
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSS-NH2
However, the copending claims of App’729 (claim set filed 12/09/2025) recite compositions comprising a polypeptide consisting of SEQ ID NO: 9, which shares 100% sequence identity to instant SEQ ID NO: 4 (compare instant SEQ ID NO: 4 with App’729 at SEQ ID NO: 9, showing 100% identity). Regarding the amidated C-terminus, in view of claims 48, 56, and 62-63, an artisan would readily appreciate that all disclosed sequences could be amidated, and would at once envisage SEQ ID NO: 9 having an amidated C-terminus.
Accordingly, although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 17-19, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/871,530 (corresponding to US20250345392). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Regarding the instant claims, the instant claims are directed to, and encompass at least the originally elected species of instant SEQ ID NO: 4, which has the sequence of
AMVSEFLKQAWFIENEEQEYVQTLKSSKGGPGSAVSPYPTFNPSS-NH2
However, the copending claims of App’530 (claim set filed 12/04/2024) recites compositions comprising a polypeptide consisting of SEQ ID NO: 7, which shares 100% sequence identity to instant SEQ ID NO: 4 (compare instant SEQ ID NO: 4 with App’530 at SEQ ID NO: 7, claim 4, showing 100% identity). Regarding the amidated C-terminus, in view of claim 5 of App’530, an artisan would readily appreciate that all disclosed sequences could be optionally amidated, and would at once envisage SEQ ID NO: 7 having an amidated C-terminus.
Accordingly, although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 6/17/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 112(b)
It is the Examiner’s understanding that Applicant addressed the rejections under 35 USC 112(b) at pages 6-7 of the Reply filed 6/17/2026. The arguments are substantially rendered moot in view of the revised rejections. Remaining applicable arguments have been fully considered but not found persuasive. The revised rejections include a rejection of amended claim 24, which presumably satisfies 35 USC 112(d) by further narrowing the scope of structures encompassed by instant claim 1. However, amended claim 1 reads upon hundreds of millions of structures, but it remains unknown if claim 24 reads upon only the single sequence of SEQ ID NO: 4, or if it might read upon millions of other structures. No structure/function relationship is identified by the Applicant, and therefore it remains unclear what structures do or do not infringe upon the scope of instant claim 24. Therefore, the scope of claim 24 remains rejected as indefinite, because it is not simply “broad”, but it is indefinite since it is unclear if it reads upon only SEQ ID NO: 4, a dozen sequences, ten million sequences, or even if it has the same identical scope as instant claim 1.
Rejections under 35 USC 112(d)
It is the Examiner’s understanding that Applicant acknowledged the rejections under 35 USC 112(d) at page 8 of the Reply filed 6/17/2026, but Applicant offers no explanation of how the amendments filed 6/17/2026 meaningfully limit the scope of claims 2-3 and 17 to subject matter within the scope of amended claim 1, as required by 35 USC 112(d). Notably, amended claim 1 explicitly excludes SEQ ID NO: 2 and portions of SEQ ID NO: 3, but dependent claims continue reading upon such subject matter.
Accordingly, the rejections under 35 USC §112(d) have been maintained as revised above.
Rejections under 35 USC 112(a)
It is the Examiner’s understanding that Applicant addresses the previous rejection under 35 USC 112(a) at pages 8-9 of the Reply filed 6/17/2026. The arguments have been substantially rendered moot in view of the revised rejection above, which was necessitated by Applicant’s amendments. Remaining applicable arguments are considered below.
First, Applicant cites case law pertaining to the fact that nucleic acid sequences encoding a disclosed peptide are presumed to be known by artisans in view of the wide-spread knowledge of the genetic code (see, e.g., Reply filed 6/17/2026 at 8-9 at bridging ¶). No nucleic acid sequences are at issue and therefore such references do not appear germane to the rejections at issue.
Second, it is the Examiner’s understanding that Applicant’s response to the issue of “what sequences are capable of actually achieving the functionality recited in amended claim 24?” is that “one of ordinary skill in the art can readily envision the entire claimed genus and, therefore, would readily accept Applicant’s possession thereof” (see, e.g., Reply filed 6/17/2026 at 8-9 at bridging ¶). This is understood to be a general assertion that “obviousness” is sufficient to establish possession for purposes of the written description requirement. This is not persuasive because obviousness is not the test for written description:
[A]n applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention" (see, e.g., Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398, emphasis added).
Therefore, even assuming arguendo that the originally-filed disclosure were sufficient to render the instant claim scope obvious, “a description which renders obvious a claimed invention is not sufficient to satisfy the written description requirement of that invention” (see, Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1567 (Fed. Cir. 1997)) because “[o]ne shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious” (Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1571-72 (Fed. Cir. 1997) at 1572).
Third, it is the Examiner’s understanding that Applicant is alleging that an artisan would “envision the entire claimed genus” or “visualize or recognize the members of the genus” based upon structure alone (see, e.g., Reply filed 6/17/2026 at 8-9 at bridging ¶ to 9 at 1st full ¶). This is not persuasive because claim 24 is not limited by structure alone, but rather upon a structure/function relationship that is not disclosed on record or identified as existing in the prior art. Here, amended claim 24 continues to include functional limitations, which presumably further limit the scope of amended claim 1 (i.e., >349 million sequences) to an unknown, but smaller number of functional sequences. Accordingly, the scope of claim 24 may include only the single species of instant SEQ ID NO: 4, or perhaps a dozen sequences, or a million sequences, or a hundred million, or even all >349 million structures within the scope of amended claim 1, but it is unknown in view of the record what structures actually satisfy the claimed limitations set forth at amended claim 23. The Applicant fails to identify any structure/function relationship commensurate in scope with amended claim 24 that reasonably permits an artisan to distinguish which structures within claim 1 are included or excluded by the limitations set forth at claim 24. Accordingly, such arguments are not persuasive because in the absence of guidance pertaining to the functional limitations, guidance to structures alone do not permit artisans to distinguish the genus of claim 1 from claim 24.
Accordingly, the rejection is maintained as revised above. Examiner suggests cancelling claim 24 if the claim merely recites hoped-for and expected results that Applicant wants the structures to achieve, but has not actually shown exist commensurate in scope with the >349 million linear and branched compounds within claim 1.
Rejections under 35 USC 103
It is the Examiner’s understanding that Applicant addresses the previous rejection under 35 USC 103 at pages 9-11 of the Reply filed 6/17/2026. The arguments have been substantially rendered moot in view of the revised rejection above, which was necessitated by Applicant’s amendments. Remaining applicable arguments are considered below.
Allegations suggesting improper or impermissible hindsight: It is the Examiner’s understanding that Applicant is suggesting that the Examiner’s position fails to establish a prima facie case of obviousness because the prior art does not lead an artisan to the instant invention (see, e.g., Reply filed 6/17/2026 at 9 at § Remarks to the rejections under 35 USC 103). If Applicant means to suggest that the Examiner arrived at the instantly claimed invention via the use of improper hindsight, this is not persuasive because any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, Applicant fails to identify even a single aspect of the claimed invention that was not explicitly taught, disclosed, or suggested by the prior art relied upon by the Examiner, and merely performs anything other than the predicted, expected, and disclosed art-recognized function.
Allegations regarding “obvious to try” rationales: It is the Examiner’s understanding that (i) Applicant first alleges that the Examiner relied upon an “obvious to try” rationale to establish obviousness (see, e.g., Reply filed 6/17/2026 at 9 at § “Remarks to the rejections under 35 USC § 103” to page 10 at 2nd full ¶), and then (ii) subsequently alleges that the alleged “obvious to try” rationale was made improperly (see id). This line of reasoning is not persuasive because an “obvious to try” (i.e., MPEP § 2143(I)(E)) was not made on record. The Examiner explicitly set forth and identified that the rationale supporting a determination of obviousness was based upon the rationales set forth at MPEP §§ 2143(I)(A), 2143(I)(F), 2144.08(II), and 2144.09. Accordingly, arguments attempting to rebut a rationale that was not presented in the rejection and was not relied upon by the Examined is not persuasive because such arguments fail to address, acknowledge or dispute any of the rationales supporting a determination of obviousness that the Examiner expressly relied. Because the rationales actually relied upon by the Examiner to support obviousness (and accompanying facts, findings, analysis, evidence, and citations) were not actually addressed, the Examiner’s rationale is not clearly disputed. Accordingly, the claimed invention remains obvious for reasons of record per the rationales explained at MPEP §§ 2143(I)(A), 2143(I)(F), 2144.08(II), and 2144.09.
Expected results support a determination of obviousness: Examiner notes that the claimed invention is a truncation variant of a known 47-mer anti-inflammatory peptide, differing by the truncation of 2-amino acids from the C-terminus, wherein the prior art explicitly directed artisans to truncation variants ranging from 37 to 51 mers (see, e.g., US’753 at col. 3 at lines 19-31; see also US;753 at col. 17 at lines 14-59; see, e.g., MPEP § 2144.05(I), noting that where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; here 45 is within the range 37 to 51), wherein all such compounds would have been predicted and expected to have the same utility presently disclosed (i.e., such peptides have anti-inflammatory effects and applications). Critically, such evidence showing expected results weighs in favor of a determination of obviousness (see, e.g., MPEP §§ 716.02(c)(II)). Notably, a truncation variant of a known peptide, within the length range explicitly identified by the prior art, was a predictable variation of the prior art sequence with predicted and expected activity identical to that disclosed by the prior art, and the Court has stated that
“If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 415 (2007), at 417.
Notably, 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)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), including truncation variants fairly taught and rendered obvious to artisans, even if not reduced to practice.
Applicant arguments unsupported by objective evidence: It is the Examiner’s understanding that Applicant speculates what a person of ordinary skill in the art would do, including concluding that “there is no benefit in reducing the sequence length further” (see, e.g., Reply filed 6/17/2026 at 10 at final ¶) despite explicit guidance to the contrary (see, e.g., US’753 at col. 3 at lines 19-31; see also US;753 at col. 17 at lines 14-59). If Applicant means to suggest the existence of skepticism of experts, such evidence should be filed per MPEP § 716.05 as evidence is required to establish skepticism of experts. No evidence commensurate in scope with MPEP § 716.05 has been filed at this time. If Applicant is attempting to allege that the prior art is not enabling or inoperable Applicant is directed to MPEP § 2121(I), which notes that the prior art is presumed fully enabled for all that it discloses, and the burden is on the Applicant to rebut the presumption of operability (see, e.g., MPEP § 2121(I); MPEP § 716.07). No evidence of inoperability commensurate in scope with the requirements of MPEP § 716.07 have been placed on record at this time. In the absence of any evidence commensurate in scope with MPEP § 716.05 or MPEP § 716.07, such arguments appear to be arguments of counsel, unsupported by objective evidence, which appears to amount to a blanket dismissal of the teachings of the prior art. However, 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)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and no objective evidence rebutting this presumption has been placed on record to date. Accordingly, the Examiner’s position is that 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)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)). This includes all truncation variants of known and disclosed sequences, wherein the truncation variants would be expected and predicted to have the same utility and functionality as SEQ ID NO: 7 of US’753 (see, e.g., US’753 at claims 1-4 and SEQ ID NO: 7; see also id. at abs, col. 5 at lines 44-51, col. 12 at lines 4-16, col. 12 at lines 28-36, col. 13 at lines 1-5). Accordingly, the Applicant has not satisfied their burden to establish skepticism of experts or otherwise to rebut the presumption of operability of the prior art at this time (see, e.g., MPEP § 2121(I); MPEP § 716.07).
Allegations of unexpected results: It is the Examiner’s understanding that Applicant repeatedly alleges the existence of unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02, wherein such results are sufficient to rebut prima facie obviousness (see, e.g., Reply filed 6/17/2026 at 11 at 1st full ¶). However, to establish such unexpected results, the allegations must be timely and supported by objective evidence (see, e.g., 37 C.F.R. 1.132; see MPEP §§ 716.01, 716.01(a), 716.01(c)); to be of probative value the proffered evidence must be related to the claimed invention (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"); the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP §§ 716.01(d), 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)). Here, the proffered evidence is Example 3 (see, e.g., Reply filed 6/17/2026 at 11 at 1st full ¶). Example 3 is insufficient to establish unexpected results sufficient to rebut prima facie obviousness for multiple reasons: First, Example 3 is limited to instant SEQ ID NO: 4 which is not reasonably commensurate in scope with the >349 million sequences claimed, and therefore such data does not satisfy MPEP 716.02(d). Second, the practical and statistical significance of Example 3 is unknown because SEQ ID NO: 4 and the control sequence were tested at different concentrations, and potentially tested at different formulations (see, e.g., Spec. filed 2/15/2023 at Example 3 on 69th page at lines 15-20, noting that it is unclear if the control dosage was in 5% glucose and 1 mM acetic acid), and no actual statistical difference was shown to exist (see, e.g., Spec. filed 2/15/2023 at Example 3), and therefore the alleged differences in time may be well-within the ordinary experimental variation for such experiments. Accordingly, Example 3 does not satisfy the requirements of MPEP § 716.02(b)(I) or § 716.02(b)(II). Third, the claimed invention appears to actually yield the exact results expected and predicted by the prior art, namely that such peptides may act as anti-inflammatory agents (see, e.g., US’753 at title, abs, claims 1-4). Accordingly, data confirming the expected and predicted results (see, e.g., Spec. filed 2/15/2023 at Example 1) confirms the expected result (i.e., anti-inflammatory activity), which weighs in favor of obviousness (see, e.g., MPEP § 716.02(c)(II)). Fourth, the half-life shown at Example 3 is made in the absence of any comparison of activity between the closest prior art of record and instant SEQ ID NO: 4 (see, e.g., Spec. filed 2/15/2023 at Examples 1 and 3, noting that Example 1 fails to test using the same control as Example 3). This raises concerns regarding nexus and practical significance of half-life, since a longer half-life at the cost of substantial activity is relevant to a proper weighing and considering of the evidence (see, e.g., MPEP § 716.02(b)(I), § 716.02(b)(II), and § 716.02(c)(I)). Fifth, Example 3 is directed to a narrow, unclaimed method of treating 5-6 month old beagle dogs by administering 2, 6, or 10 mg/kg of SEQ ID NO: 4 (presumably non-elected non-amidated species) in “5% glucose; 1.0 mM acetic acid” via intravenous injection through the cephalic vein given over 5 minutes at 5 mL/Kg volume, for “a minimum of two weeks” (see, e.g., Spec. filed 2/15/2023 at Example 3). This raises substantial concerns because the pending claims are directed to products, not methods, and the claimed products are not limited to methods of treating beagles by intravenous injection of 2-10 mg/kg of SEQ ID NO: 4 in “5% glucose; 1.0 mM acetic acid” for a minimum of two weeks at 5 mL/Kg volume. Critically, to be of probative value the proffered evidence must be related to the claimed invention (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"). Here, given the complexities involved with formulations, timing, dosage, organism, purity of compounds, and administration issues, the alleged difference in the unclaimed difference in half-life cannot be reasonably said to result from something that is both “claimed and novel in the claims”, and Applicant fails to explain the relevance of such limited evidence regarding an unclaimed method compared to the claimed invention (see, e.g., MPEP § 716.02(b)(II), noting that Applicant has the burden to explain all proffered data). In sum, the proffered data has been fully considered, but is insufficient to establish unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02 for at least the reasons discussed above.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive for the reasons discussed above, and therefore the rejection is maintained as revised above. All revisions were necessitated by Applicant amendment.
Non-Statutory Double Patenting
It is the Examiner’s understanding that Applicant addresses the previous provisional NSDP rejections at pages 11-12 of the Reply filed 6/17/2026. The arguments appear conclusory in nature, merely alleging that “Applicant requests reconsideration of the reject in in view of the current amendments to claim 1” (see, e.g., Reply filed 6/17/2026 at 11-12). Such arguments are conclusory in nature because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the cited references. Further, the rejections explicitly show that the copending applications explicitly claim instant SEQ ID NO: 4, and Applicant fails to show or explain how the amendments avoid such references or objections. Accordingly, such arguments are not persuasive.
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive for the reasons discussed above, and therefore the rejection is maintained as revised above. All revisions were necessitated by Applicant amendment.
Conclusion
Accordingly, all arguments raised by the Applicant have been fully considered but not found persuasive for the reasons discussed above, and therefore the rejection is maintained as revised above. All revisions were necessitated by Applicant amendment.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new or revised ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 There are 10,660 combinations for picking three positions out of 41 amino acids, (41!/3!), and at these positions the amino acids may be selected from at least 32 different possibilities (32^3), and (41!/3!)*(32^3) is 349,306,880.
2 There are 10,660 combinations for picking three positions out of 41 amino acids, (41!/3!), and at these positions the amino acids may be selected from at least 32 different possibilities (32^3), and (41!/3!)*(32^3) is 349,306,880.
3 There are 10,660 combinations for picking three positions out of 41 amino acids, (41!/3!), and at these positions the amino acids may be selected from at least 32 different possibilities (32^3), and (41!/3!)*(32^3) is 349,306,880.
4 (a.k.a., SEQ ID NO: 5 of US’753, “ANXA1(2-50)-NH2).
Prosecution Insights