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 claim set filed January 13, 2026, claims 1-3, 10, 13-15, 17-25, and 57-60 are pending and claims 1-2, 17-20, 23, and 25 were amended in that reply. Claims 10, 20-21, 25, and 57-60 are withdrawn. Claims 1-3, 13-15, 17-19, and 23-24 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 is on the grounds that amended claim 25, as amended in the Reply filed 1/13/2026, now excludes the species of US 9,102,753, and that the species of US’753 are excluded from the amended claim scopes since they are “of a different length” (see, e.g., Reply filed 1/13/2026 at 8 at 1st full ¶). This is not found persuasive because the difference in length was also addressed under a lack of inventive step rationale (see, e.g., Requirement mailed 10/29/2025 at 6-7 at bridging ¶), which was not acknowledged or disputed by the Applicant. Accordingly, even assuming arguendo that Applicant’s arguments pertaining to subsequently filed amendments were deemed persuasive, the lack of unity due to lack of inventive step rationale would be maintained.
The requirement is still deemed proper and is therefore made FINAL.
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, 13-15, 17-19, and 23, which each read upon SEQ IDNO: 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 is understood to read upon instant claims 1-3, 13-15, 17-19, and 23-24.
However, the originally elected species is not understood to read upon claim 10 because the originally elected species lacks any substitutions at positions other than X1, X2, X3, and X4; claim 20 because zero post-translational modifications were identified and no recombinant production is required exposing the claimed product to post-translational machinery is required (i.e., the species was not identified using product-by-process limitations that would result in post-translational modifications); claim 21 because no N-terminal modification was identified as present; and claim 25 because the originally elected species lacks any branched amino acid probe. Accordingly, claims 10, 20-21, and 25 are directed to non-elected species.
Following extensive search and examination, the originally elected species has 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, 13-15, 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, 13-15, 17-19, and 23-24 are presently considered.
Information Disclosure Statement
The IDS filed 5/12/2023 and 1/13/2026 are each acknowledged and presently considered.
Applicant should note that some documents disclosed on the IDS form submitted on 5/12/2023 were not considered since they did not conform to 37 CFR 1.98(b) by providing a proper date, as 37 CFR 1.98(b) requires that each publication must be identified by publisher, author (if any), title, relevant pages of the publication, and date and place of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. See MPEP 609.04(a). Here, the earliest priority claim is to EP20192142.6, filed Augugst 21, 2020, and therefore all publications filed 2019 or later must include both the month and year of publication.
References that were not considered have been indicated by strike-though on the attached IDS forms. Although not considered, these documents have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 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)).
Claim 1 is understood to encompass 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. This may be rewritten as
AMVSEFLKQ[ALDMEIR]WFIENEEQEY[VLDMEIK]QT[VGASTCLIMPFYWDENQHKR]KSSKGGPGSA[VGASTCLIMPFYWDENQHKR]SPYPTFNPSS
wherein the brackets indicate alternative residues at a single position.
Claim 1 further recites and encompasses “a functional variant thereof having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”, but the structure/function relationship of what does or does not constitute a “functional variant” is not actually taught or disclosed on record, and the specification fails to identify any means of identifying a “functional variant” from a non-functional variant, a priori.
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
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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.
Additional claim interpretations are discussed 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 1-3, 13-15, 17-19, and 23-24 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.
Claims 1-3, 18, and 24 refer to a “functional variant” which renders the claim scope indefinite; claim 1 is representative of the issue and is discussed herein, but the issue applies to each of claims 1-3, 18, and 24. Claim 1 recites and attempts to claim any “functional variant” of SEQ ID NO: 3 “having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”, but fails to provide a structure/function relationship that meaningfully identifies which such sequences do or do not constitute a “functional variant” as claimed. 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 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). This is pertinent because SEQ ID NO: 3 is a 45-mer with four variable residues, and therefore the claim scope encompasses up to five amino acid substitutions at 41 positions relative to SEQ ID NO: 3, wherein the five amino acids may be substituted with at least 32 different amino acids (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). Accordingly, the placement of the five substitutions at 41 positions means there are 749,398 different combinations (e.g., C(n,k) is C(41,5)), and each of the five substitutions may be selected from at least 32 possibilities (e.g., 325 or 33,554,432 possibilities for those five), which means there are over 25 trillion1 subgenera of sequences that satisfy the structural limitations (i.e., “having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”). However, in the complete absence of any structure/function relationship, it is prima facie unclear which, if any, of these 25 trillion subgenera do or do not constitute “functional variants” as required by instant claim 1, and therefore the metes and bounds of the claim scope are uncertain. This is pertinent 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 compounds do or do not infringe upon the scope of claim 1 because of the functional language, and zero guidance is provided on record permitting an artisan to identify and distinguish infringing from non-infringing compounds among the over 25 trillion subgenera of structures that may read upon the claim. 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).
Accordingly, because it is unclear what compounds from among the over 25 trillion subgenera constitute “functional variants” or not, an artisan would be unable to identify infringing from non-infringing compounds, and therefore claim 1 is rejected as indefinite.
Claim 13 refers to “the valine residue at position 24 of any one of SEQ ID NO: 2 to SEQ ID NO: 4”, which renders the claim scope indefinite for lack of antecedent basis because SEQ ID NO: 3 does not have a valine residue at position 24, rather it has a variable residue (a.k.a., X3).
Claim 14 refers to “the valine residue at position 24 of any one of SEQ ID NO: 2 to SEQ ID NO: 4”, which renders the claim scope indefinite for lack of antecedent basis because SEQ ID NO: 3 does not have a valine residue at position 24, rather it has a variable residue (a.k.a., X3).
Claim 15 refers to “the valine residue at position 24 of any one of SEQ ID NO: 2 to SEQ ID NO: 4”, which renders the claim scope indefinite for lack of antecedent basis because SEQ ID NO: 3 does not have a valine residue at position 24, rather it has a variable residue (a.k.a., X3).
Claim 22 recites an active method step within a product claim (i.e., the “residue is amidated”). Per MPEP § 2173.05(p)(II), product claims comprising a process limitation involving the usage of the product render the claim scope indefinite because it is unclear if infringement occurs before, during, or after the completion of the method step. Accordingly, claim 22 is rejected as indefinite. Applicant may overcome this rejection by redrafting the claim to avoid active language; for example, “The polypeptide . . . of claim 1, having a -NH2 moiety at the C-terminus” or “The polypeptide . . . of claim 1, wherein the peptide is SEQ ID NO: 4 amidated at the C-terminus” (wherein “amidated at the C-terminus” is in a noun phrase).
Claim 24 appears to recite active method steps within a product claim, or otherwise recites functional limitations. This rejection covers the interpretation wherein the recitations at claims 24 are understood to include active method steps. Per MPEP § 2173.05(p)(II), product claims comprising a process limitation involving the usage of the product render the claim scope indefinite because it is unclear if infringement occurs before, during, or after the completion of the method step. Here, claim 24 does not literally state that the products are “capable of” performing the listed functions, but instead explicitly uses active language (“The polypeptide. . . binds to…”, “activates and/or stimulates”, “binds”, “activates”, “induces”, etc.). Accordingly, claim 24 is reasonably interpreted as reciting active method steps, and is therefore rejected as indefinite (see, e.g., MPEP § 2173.05(p)(II)). An alternative interpretation, wherein each of claim 24(a)-(i) are considered functional limitations is considered below. For purposes of applying prior art, the originally elected species of SEQ ID NO: 4 is reasonably inferred to satisfy the limitations of claim 24.
Claim 24 appears to recite active method steps within a product claim, or otherwise recites functional limitations. This rejection covers the interpretation wherein the recitations at claims 24 are understood to be functional limitations that some (but not all2) species within claim 1 are “capable of” performing. If each of claims 24(a)-(i) are considered functional limitations, then the claim is indefinite because no structure/function relationship permitting an artisan to identify which species (>> trillions) of claim 1 do or do not satisfy each functional limitation, commensurate in scope with the instant claims. 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 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). In the absence of any structure/ function relationship, it is unclear which, if any, of these 25 trillion subgenera within the scope of instant claim 1 do or do not satisfy the limitations of claim 24(a), 24(b), 24(c) . . . . or 24(i), and therefore the metes and bounds of claim 24 are uncertain. This is pertinent 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 compounds do or do not infringe upon the scope of claim 24 because of the functional language, and zero guidance is provided on record permitting an artisan to identify and distinguish infringing from non-infringing compounds among the over 25 trillion subgenera of structures that may read upon the claim. 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).
Accordingly, because it is unclear what compounds from among the over 25 trillion subgenera of claim 1 do or do not satisfy the functional limitations of claim 24, an artisan would be unable to identify infringing from non-infringing compounds, and therefore claim 24 is rejected as indefinite.
Claims 2-3, 13-15, 17-19, and 23-24 depend directly or indirectly from an indefinite base claim and fail to clarify the indefiniteness of that claim; accordingly these claims are rejected as depending upon an indefinite claim.
Claims 1-3, 13-15, 17-19, and 23-24 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 18 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.
Claim 2 depends from instant claim 1, which limits the claim scope to species consisting of SEQ ID NO: 3 or any “functional variant thereof having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”, wherein SEQ ID NO: 3 has X1, X2, X3 and X4 as defined at claim 1. Accordingly, claim 1 is limited to species consisting of SEQ ID NO: 3 wherein X1 must be Ala, Leu, Asp, Met, Glu, Ile or Arg; however, claim 2 more broadly encompasses any “functional variant” of SEQ ID NO: 2 or 4 “having one, two, three, four or five amino acid substitutions”, wherein SEQ ID NOs: 2 and 4 lack variable residues, and therefore claim 2 ostensibly encompasses species that may have any substitutions at any position within SEQ ID NO:2 or 4, including species such as
AMVSEFLKQKWFIENEEQEYRQTVKSSKGGPGSAVSPYPTFNPSS
which are excluded from the scope of 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.
Claim 3 depends from claim 1, which limits the claim scope to species of 45-mers consisting of SEQ ID NO: 3 or any “functional variant thereof having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”, wherein SEQ ID NO: 3 has X1, X2, X3 and X4 as defined at claim 1. Notably, SEQ ID NO: 3 has four variable residues (i.e., X1, X2, X3 and X4) and permits up to five additional amino acid substitutions, and because 4+5 is 9, this means that claim 1 is limited to species required to share a minimum of 36/45 residues in common with SEQ ID NO: 3. This is pertinent because 36/45 would correspond to a minimum requirement of 80% sequence identity. Accordingly, claim 3 is broader in scope than claim 1. This issue is exemplified by noting that the following sequence
VVLVVVLKQX1WFIENEEQEYX2QTX3KSSKGGPGSAX4SPYPTFNPSS
which is excluded from the scope of instant claim 1 for having six substitutions relative to SEQ ID NO: 3, but is within the scope of claim 3 because it shares 35/45 residues (77% sequence identity) relative to any of instant SEQ ID NOs: 2-4. Accordingly, 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.
Claim 18 depends from instant claim 1, which limits the claim scope to species consisting of SEQ ID NO: 3 or any “functional variant thereof having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”, wherein SEQ ID NO: 3 has X1, X2, X3 and X4 as defined at claim 1. Accordingly, claim 1 is limited to species consisting of SEQ ID NO: 3 wherein X1 must be Ala, Leu, Asp, Met, Glu, Ile or Arg; however, claim 18 more broadly encompasses any “functional variant” of SEQ ID NO: 4 “having 1, 2, 3, 4, or 5 amino acid substitutions”, wherein SEQ ID NO: 4 lacks variable residues, and therefore claim 18 literally encompasses species of SEQ ID NO: 4 having up to five substitutions, including species such as
AMVSEFLKQKWFIENEEQEYRQTVKSSKGGPGSAVSPYPTFNPSS
which are excluded from the scope of instant claim 1. Accordingly, claim 18 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 18 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.
Claims 1-3, 13-15, 17-19, and 23-24 are 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)
Instant claims 1-3, 18, and 24 refer to “functional variants” or otherwise recite functional limitations (e.g., instant claim 24). However, the required “function” does not correspond to a structure/function relationship of record permitting artisans to identify what structures are “functional” and included by the claim scope, or non-functional and excluded from the claim scope.
Claim Scope
Claim 1 is representative of the pending claim scope. Claim 1 recites and attempts to claim any “functional variant” of SEQ ID NO: 3 “having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”, but fails to provide a structure/function relationship that meaningfully identifies which such sequences do or do not constitute a “functional variant” as claimed. Because SEQ ID NO: 3 is a 45-mer with four variable residues, claim 1 permits up to five additional amino acid substitutions at the remaining 41 positions relative to SEQ ID NO: 3, wherein the five amino acids substitutions may be made with one of at least 32 different amino acids (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); wherein the placement of the five substitutions within 41 possible positions means there are 749,398 different combinations (e.g., C(n,k) is C(41,5)); wherein each of the five substitutions may be selected from at least 32 possibilities (e.g., 325 or 33,554,432 possibilities for those five); this means there are over 25 trillion3 subgenera of sequences that satisfy the structural limitations (i.e., “having 1, 2, 3, 4 or 5 amino acid substitutions at any position other than X1, X2, X3 and X4”) at claim 1 (this does not include the variability of positions X1, X2, X3 and X4). Accordingly, the claim scope is ostensibly vast and highly varied, potentially encompassing over 25 trillion subgenera of SEQ ID NO: 3.
However, in the complete absence of any structure/function relationship, it is prima facie unclear which, if any, of these 25 trillion subgenera do or do not constitute “functional variants” as required by instant claim 1 or claim 24, and therefore the metes and bounds of the claim scope are uncertain.
Accordingly, it is unclear if the claim scope encompass trillions of species or perhaps only encompasses SEQ ID NOs: 2 and 4 in view of the functional limitations set forth in the claim(s). Accordingly, the claim scope reasonably appears to be vast and highly varied.
Actual Reduction to Practice
Only SEQ ID NO: 2 and 4, which differ only at a single position (i.e., position 24 is a Leu in SEQ ID NO: 4, but Valine in SEQ ID NO: 2) were reduced to practice. These sequences share 44/45 residues in common (i.e., 97.78% sequence identity) and differ only by a conservative substitution at position 24.
Zero species lacking differing from the following subgenus were reduced to practice:
AMVSEFLKQAWFIENEEQEYVQT[LV]KSSKGGPGSAVSPYPTFNPSS
The brackets show alternatives at a single position.
Zero species differing from SEQ ID NO: 4 at positions 1-23 or 25-45 were reduced to practice.
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.
Accordingly, the only species of record actually tested and reduced to practice are the highly similar sequences of SEQ ID NOs: 2 and 4. Zero additional variations were actually tested and verified as “functional”.
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 >>25 trillion species of polypeptides, but only reduces two nearly identical species of compounds sharing over 97.7% sequence identity. Zero species showing that functionality is preserved upon varying positions 1-23 or positions 25-45 relative to SEQ ID NO: 4 were actually tested and reduced to practice.
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 two “functional” species within a substantially narrower subgenus than the genus actually claimed, 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 in the instant claims appear to be only utilized as a vague attempt to capture unknown and undisclosed 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 an unambiguous structure/function relationship permitting an artisan to identify, a priori, which exact structures do or do not satisfy the functional limitations at issue. Accordingly, no evidence Applicant “possessed” such “functional” structures commensurate with the claims has been found in the original disclosure.
Accordingly, basic identifying characteristics pertinent to the claimed genus and subgenera are left unanswered, including “which compounds can actually satisfy the functional limitations of the pending claims?” Rather, the disclosure does not provide a description of such “functional” embodiments permitting an artisan to identify sequences falling within the claim scope a priori, but instead leaves the discovery of which species, among trillions, are actually functional to future researchers. 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 would be included or excluded by the “functional” limitations of claim 1, 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 defined by reference to functional limitations; 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 trillions, 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.
Claims 1-3, 13-15, 17-19, and 23-24 are 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, 13-15, 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:
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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, 13-15, 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, 13-15, 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, 48, 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, 13-15, 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.
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 The possibilities at the five positions multiplied by the number of placement combinations for the five.
2 If All species within the scope of claim 1 satisfies claim 24, then claim 24 would be rejected under 35 USC § 112(d) for failing to further limit the scope of the claim 1. So this rejection assumes claim 24 further limits the scope of claim 1.
3 The possibilities at the five positions multiplied by the number of placement combinations.
4 (a.k.a., SEQ ID NO: 5 of US’753, “ANXA1(2-50)-NH2).