DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-17 are pending. Claim 17 was added and claim 1 was amended in the Reply filed 7/23/2026. Claim 17 is withdrawn. Claims 1-16 are presently considered.
Election/Restrictions
Applicant's election with traverse of the species of Example 6-1 and 6-2 (Peptide Complex No. 49, comprising two copies of SEQ ID NO: 34 linked via SEQ ID NO: 37) in the reply filed on 7/23/2026 is acknowledged. The traversal is on the ground(s) that US 10,781,457 (i) discloses only a fragment of a naturally occurring plant enzyme, (ii) does not disclose a cyclic peptide, (iii) does not disclose N-methylated or other non-natural amino acids, (iv) does not disclose c-Met binding/agonist activity, and (v) that SEQ ID NO: 1 comprises Cys rather than N-methylated cysteine (see, e.g., Reply filed 7/23/2026 at 7-8). This traversal is not found persuasive because (I) claim 1 does not actually exclude naturally occurring plant enzyme fragments, (II) claim 1 does not actually recite or require a cyclic structure, (III) claim 1 does not actually require non-natural amino acids to be present (e.g., any three amino acids of SEQ ID NO: 1 may be deleted or substituted per lines 4-6 of claim 1), (IV) claim 1 does not actually require a functional limitation requiring C-Met binding/agonist activity (i.e., it is presumed line 2 of claim 1 is fully satisfied by all structures that satisfy the positively recited structural limitations set forth at lines 3-14 of instant claim 1; see MPEP § 2111.04(I)), and (V) claim 1 does not require the presence of a N-methylated cysteine (e.g., three amino acids may be deleted or substituted per lines 4-6 of claim 1, and MeC may therefore be deleted/substituted by Cys; alternatively, SEQ ID NO: 1 does not match the sequence at instant claim 1 as the sequence listing shows Cys at position 15, not MeC). If Applicant wishes to limit the claim scope to require such limitations, Applicant should so amend instant claim 1. A rejection further identifying and explaining how US 10,781,457 satisfies the limitations of amended claim 1 is set forth below, and those explanations are incorporated herein. Accordingly, the traversal is not persuasive as it does not identify how the pending claims exclude the prior art embodiment disclosed by US’457.
The requirement is still deemed proper and is therefore made FINAL.
The originally elected species of “protein complex” is understood to be the species of Example 6-1 and 6-2 (Peptide Complex No. 49, which is described by the Applicant as comprising two copies of SEQ ID NO: 34 linked via SEQ ID NO: 371) (see, e.g., Reply filed 7/23/2026 at 6-7). This description is problematic because the sequence listing for SEQ ID NO: 34 does not actually match the structure actually shown and referred to as SEQ ID NO: 34 in the originally filed disclosure (see, e.g., SEQ ID NO: 34, see also Spec. filed 9/21/2023 at Table 1-2 at ¶[0063]), because the specification at Example 6-1 refers to a 17-mer peptide having an exocyclic Gly-Lys unit as “SEQ ID NO: 34” (see, e.g., Spec. filed 9/21/2023 at [0077])2, but the sequence listing identifies SEQ ID NO:343 as a 15-mer. This distinction alters the technical meaning and scope of the claims and references specifically to SEQ ID NO: 1, 34, and “peptide A", but does not impact the structure of the originally elected species, which is:
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4
The originally elected species is understood to read upon instant claims 1-16, but not instant claim 17, because claim 17 requires “one, two, or three of the amino acid at position 2, …position 3, and . . . position 8 of SEQ ID NO: 34” to be substituted, which excludes the non-substituted sequence of instant SEQ ID NO: 34 present in the originally filed disclosure. Accordingly, the elected species is currently understood to read upon instant claims 1-16, but not instant claim 17.
Following extensive search and examination, the originally elected species5 has been deemed free of the prior art. Per MPEP § 803.02(III)
If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping.
Claim 1 has been rejected below as directed to an improper Markush grouping, but as a courtesy to the Applicant examination has been extended to the non-elected subgenus of compounds comprising the 17-mer polypeptide substructure shown at ¶[0077] of the Specification filed 9/21/2023 and corresponding to CAS Registry Number: 2842398-67-6:
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(i.e., meF-T-A-V-S-meF-D-E-D-X-P-R-W-S-meC-G-K , wherein X is Ahp). The subgenus defined by comprising this substructure has been deemed free of the prior art. Examination was then extended to the species disclosed by US 10,781,457, which is discussed below. Following extensive search and examination, the non-elected species was deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III), claims directed to other nonelected species have been withdrawn.
Claim 17 is 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 7/23/2026.
Claims 1-16 are presently considered as discussed below.
Priority
The priority claim to PCT/JP2022/013001 (filed 3/22/2022) is acknowledged.
Examiner notes that no certified translation of the Foreign Application JP2021-047949 (filed 3/22/2021) has been placed on record. If applicant wants the application to be accorded benefit of the non-English language application, a certified translation is required (see 35 U.S.C. 119(b)(3), 37 CFR 1.55(g)(1)-(4)). Applicant is advised that any showing of priority that relies on a non-English language application is prima facie insufficient if no certified translation of the application is on file. See 37 CFR 41.154(b).
Information Disclosure Statement
The IDS filed 9/21/2023 and 9/13/2024 are each acknowledged.
Applicant should note that one or more documents disclosed on the IDS form submitted on 9/13/2012 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).
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).
Drawings
The drawings are objected to under 37 CFR 1.83(a) because Figures 5(1) and 5(2) contains illegible text. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The instant disclosure is objected to because the structures shown at ¶¶[0068], [0071], [0077], [0080], [0083], and [0086] of the Specification filed 9/21/2023 are illegible in whole or part.
The instant disclosure is objected to for not complying with 37 C.F.R. 1.821 as detailed in MPEP §§ 2421–2424. Specifically, the instant application does not comply with 37 C.F.R. 1.821(b)-(e). The instant disclosure contains references or disclosures of amino acid sequences that should be accompanied by a sequence listing and identified using "SEQ ID NOs” as prescribed (see, MPEP §§ 2421–2424). Specifically,
(A) the instant application discloses sequence that does not correspond to a SEQ ID NO of record at page 22 at line 1 of the Specification filed 9/21/2023, and
(B) the instant application incorrectly labels a 17-mer cyclic structure as the 15-mer of SEQ ID NO: 34 (see, e.g., Spec. filed 9/21/2023 at [0077])6, which should be corrected by providing a proper 17-mer sequence identifier.
Appropriate correction is required.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1 comprises superfluous, non-limiting language, namely “a residue that is structurally distinct from underivatized cysteine (Cys)”. The terms are presumed different without such language (see, e.g., Nystrom v. TREX Co., Inc., 424 F. 3d 1136, 1143 (Fed. Cir. 2005), explaining that "When different words or phrases are used . . . . a difference in meaning is presumed"). Unnecessary language should be removed to reduce confusion and enhance claim clarity.
Claim 11 comprises grammatical issues and superfluous, non-limiting language, namely claim 11 recites “the linker is consisting of a sequence represented by any of SEQ ID NOs: 35 to 41 or a sequence with substitution, deletion, addition, or insertion of one to three amino acids in the sequence represented by any of SEQ ID NOs: 35 to 41”, which is presumably equivalent to “the linker consists of any of SEQ ID NOs: 35 to 41 or a sequence with substitution, deletion, addition, or insertion of one to three amino acids relative to any of SEQ ID NOs: 35 to 41”. Unnecessary language should be removed to reduce confusion and enhance claim clarity.
Appropriate correction is required.
Claim Objection Warning
Applicant is advised that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Here, the only difference is the preamble at claim 15 refers to “A culture medium additive”, which does not alter the structure of the claimed chemical compound relative to claim 1, but appears to amount to renaming the same compound using a second term based upon an intended use.
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 presently recites:
1 (Currently Amended). A peptide complex comprising:
a peptide A that binds to a c-Met protein, wherein
the peptide A is a peptide consisting of an amino acid sequence represented by X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC (SEQ ID NO: 1) or an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 1, wherein
X1 is an amino acid that is optionally N-alkylated,
X2 is any amino acid,
X3 is any amino acid,
X4 is a hydrophobic amino acid that is optionally N-alkylated,
X5 is any amino acid,
X6 is an amino acid having an alkyl chain in the side chain that is optionally substituted, or S, and
X7 is any amino acid, and
wherein MeC represents N-methyleysteine, a residue that is structurally distinct from underivatized cysteine (Cys).
Accordingly, the claims are directed to products, namely a “peptide complex”. Applicable claim interpretations are discussed below.
A “peptide complex” is a structure “in which the peptides are bound by a linker and designed to have a dimer structure, functions as a c-Met protein agonist” (see, e.g., Spec. filed 9/21/2023 at ¶[0007]).
In the preamble phrase “A peptide complex comprising”, “comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
Regarding “consisting of” in the phrase “the peptide A is a peptide consisting of …”, the term “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)). This is pertinent because the phrase “peptide A is a peptide consisting of..” limits the structure of peptide A to X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC, “or”
….an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 1,…
Accordingly, peptide A consists of a peptide that may vary in length from 12 to 187. This “consisting of” language is therefore relevant because it limits the how a “cyclic peptide” may be formed from a “peptide A” sequence, since not all peptide A “consisting of” such structures can form a cyclic peptide.
The “wherein” clause at claim 1 reciting
wherein
X1 is an amino acid that is optionally N-alkylated,
X2 is any amino acid,
X3 is any amino acid,
X4 is a hydrophobic amino acid that is optionally N-alkylated,
X5 is any amino acid,
X6 is an amino acid having an alkyl chain in the side chain that is optionally substituted, or S, and
X7 is any amino acid, and
wherein MeC represents N-methyleysteine, a residue that is structurally distinct from underivatized cysteine (Cys).
Is understood to define and describe X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC, but is not reasonably inferred to limit the scope of
….an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 1,…
Accordingly, the claim subgenus of structures having “one to three” substitutions, deletions, additions, or insertions relative to instant claim 1 are not required to have, for example, a V at position 4, a MeC at position 15, etc.
At claims 1, 2, and 3, the term “optionally” indicates optional structures, which are non-limiting per MPEP § 2111.04(I), which explains that claim scope is not limited by claim language that suggests or makes optional but does nor limit a claim to a particular structure.
At claim 7, the term “cyclic peptide” is interpreted consistent with the disclosure see, e.g., Spec. filed 9/21/2023 at ¶[0036]), which identifies that a cyclic peptide refers to a peptide “in which two amino acids in a peptide are bound to form a ring in whole or in part” and wherein “the cyclic peptide encompasses …. Cyclic structure formed by lactam ring formation or macrocyclization reaction, and those having a lasso peptide-like structure” (see id; see also id. at ¶[0038]).
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 1-16 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.
Claim 1 is rejected as indefinite because claim 1 incorporates SEQ ID NO: 1 into the claim and also recites the sequence X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC, but these structures are not identical because the sequence listing (version 2.1 filed 4/16/2024) for SEQ ID NO: 1 identifies that SEQ ID NO: 1 consists of XXXVSXDXDXPRWXC, wherein each X may be “any naturally occurring amino acid”. Therefore, SEQ ID NO: 1 lacks a MeC at position 15, but instead has a Cys residue at position 15. Accordingly, because the structures referenced are inconsistent, it is unclear what the claimed structure may actually be, and therefore claim 1 is rejected as indefinite. For purposes of applying prior art, unless otherwise stated, the explicit structure identified in the claim (e.g., X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC) is presumed to be the correct structure.
Claim 1 is rejected as indefinite because claim 1 incorporates SEQ ID NO: 1 into the claim and also recites the sequence X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC, but these structures are not identical because the sequence listing (version 2.1 filed 4/16/2024) for SEQ ID NO: 1 identifies that SEQ ID NO: 1 consists of XXXVSXDXDXPRWXC, wherein each X may be “any naturally occurring amino acid”. However, instant claim 1 recites that X1, X2, X3, X5, and X7 may be “any amino acid”; that X4 is any “hydrophobic amino acid”; and that X6 is any “amino acid having an alkyl chain”. The issue is the difference between “naturally occurring” and “any amino acid”, because while the sequence listing requires “naturally occurring amino acids” (see instant SEQ ID NO: 1 in sequence listing version 2.1 filed 4/16/2024), the specification defines that “’amino acid’ herein includes not only a natural amino acid but also a non-natural amino acid . . . such as D-type amino acid…β-amino acid, γ-amino acid, amino acid variants, and amino acid derivatives” (see, e.g., Spec. filed 9/21/2023 at ¶[0032]). Accordingly, the incorporated limitations of SEQ ID NO: 1 ostensibly limit the claim scope and positions X1, X2, X3, X4, X5, X6, and X7 to “naturally occurring amino acids”, but claim 1 subsequently attempts to more broadly encompass all possible amino acids in the body of claim 1, which renders the claim scope indefinite, because it is unclear if non-natural amino acids are excluded or not (see, e.g., Nystrom v. TREX Co., Inc., 424 F. 3d 1136, 1143 (Fed. Cir. 2005), explaining that "When different words or phrases are used . . . a difference in meaning is presumed"). For purposes of applying prior art, unless otherwise stated, the explicit structure identified in the claim (e.g., X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC) is presumed to be the correct structure, and the positions are given the broadest definition of record, which includes non-natural amino acids.
Claims 1 and 2 recite that “X4 is a hydrophobic amino acid”, and claim 2 recites “hydrophilic amino acid”, and although “hydrophobic” and “hydrophilic” amino acids are exemplified, the terms are not defined, and the exemplified groups are not identified as mutually exclusive or otherwise exhaustive (see, e.g., Spec. filed 9/21/2023 at ¶[0031]). Accordingly, it is therefore prima facie unclear if non-exemplified amino acids may be considered “hydrophobic” or “hydrophilic”; this is further complicated because the specification identifies that amino acids can be classified because of properties it exhibits (see, e.g., Spec. filed 9/21/2023 at ¶[0032] on 18 discussing classification as a basic amino acid “because it exhibits basic properties”), but the disclosure even identifies that although “hydrophobic amino acids” include “aliphatic amino acids” (see, e.g., Spec. filed 9/21/2023 at ¶[0031]), that “the role played by a particular amino-acid residue” depends, such that “[t]he long aliphatic moiety of the arginine side chain can constitute a structurally and functionally important feature” (see, e.g., Spec. filed 9/21/2023 at ¶[0030]). Accordingly, “arginine” presumably may constitute an aliphatic amino acid, and therefore be deemed a “hydrophobic amino acid” if the aliphatic chain provides an important structural or functional feature (see id). However, although the aliphatic portion of arginine is referenced as potentially important, and aliphatic residues are identified as “hydrophobic” (see id. at ¶¶[0030]-[0031]), arginine is also identified as hydrophilic and the specification is silent regarding whether or not it should be included as hydrophobic due to the aliphatic chain (see, e.g., Spec. filed 9/21/2023 at ¶[0031]). Accordingly, in view of the originally filed disclosure, it is unclear if the usage of “hydrophobic” and “hydrophilic” should be viewed as mutually exclusive sets of amino acids, or as general categories that are relative and fact-dependent but not absolute. The prior art does not provide clarity in this matter because hydrophobic and hydrophilic are relative terms rather than absolute classifications. For example:
Serine has been identified in the prior art as both hydrophobic (see, e.g., US2014/0286865A1 at ¶[0067]; see also US 5,670,483 at claims 1 and 7, identifying serine as hydrophobic) and hydrophilic (see, e.g., Livingstone et al.8, at Figure 1);
Glutamine has been identified as hydrophobic (see, e.g., US’865A1 at ¶[0067]) and hydrophilic (see, e.g., Livingstone at Figure 1);
Threonine has been identified as hydrophobic (see, e.g., Livingstone at Figure 1) but also hydrophilic (see, e.g., Taylor at 86 at § 5.2.2.2)9;
Tyrosine has been identified as both hydrophobic (see, e.g., Livingstone at Figure 1) and hydrophilic (see, e.g., Taylor at 87 at § 5.2.2.3);
These examples are not exhaustive but illustrate the basic relative nature of such terms. Notably, if tyrosine is deemed hydrophilic as taught by the prior art (see, e.g., Taylor at 87 at § 5.2.2.3), then all amino acids with a hydrophilicity value greater than tyrosine are presumably also hydrophilic, which would include amino acids such as cysteine and valine (see, e.g., US 4,554,101 at col 2 at lines 1-20, providing a table of comparative hydrophilicity values reproduced below):
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However, if lysine is considered hydrophobic as taught by the prior art (see, e.g., Livingstone at Figure 1), then all amino acids with a hydrophilicity value less than lysine are presumably also hydrophobic, which would include amino acids such as serine, asparagine, and glutamine (see, e.g., US’101 at col 2 at lines 1-20). Accordingly, hydrophobic and hydrophilic are relative terms because any particular amino acid is more or less hydrophilic than another amino acid, while simultaneously more or less hydrophobic than another natural or non-natural amino acid. Accordingly, the use of a relative term in the absence of a clear definition informing artisans of clear metes and bounds of the claim scope, renders the claim scope indefinite. For purposes of applying prior art, positions are understood to correspond to any amino acid exemplified at SEQ ID NOs: 2 to 34.
Claim 4 depends from instant claim 1, and is claim 4 appears to recite and required that the “peptide complex” comprises three separate and distinct components, namely “a first peptide”, “a second peptide”, and a “linker connecting the first and second peptide”; although there is a general presumption that separately listed components require separate and distinct structures10, this is not a per se rule, and claim 4 recites the ambiguous language “at least one of the first peptide or the second peptide is the peptide A”, which utilizes “the”, which is the definite article referring to a specific “peptide A”, and wherein “at least one” implies that that (i) the first peptide, (ii) the second peptide, or (iii) both the first and second peptide “is the peptide A”. Critically, “the” only “peptide A” incorporated at claim 4 is the singular “peptide A” defined by claim 1, and claim 1 is not limited to three separate and distinct peptide structures. Therefore, the specific language of claim 4 renders the claim scope indefinite because it is unclear is attempting to define a “peptide complex” having two separate copies of a “peptide A” as defined by claim 1 (e.g. a dimer or fusion peptide), or if claim 4 is attempting to arbitrarily define a single “peptide A” as both the first and second peptides (e.g., a 15-mer “peptide A” may be arbitrarily considered three linked peptides of 5 amino acid residues each). For purposes of applying prior art, claim 4 is assumed to include homodimeric and heterodimeric structures, comprising two copies of “peptide A”, wherein the two copies may be the same or different. Examiner suggests a clarifying amendment, such as:
Claim 4. A dimer comprising a first peptide A, a second peptide A, and a linker, wherein the first peptide A and second peptide A are connected via the linker;
wherein the first peptide A and second peptide A may be the same or different, and wherein a peptide A consists of X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-C (SEQ ID NO: 1), wherein
X1 is any amino acid,
X2 is any amino acid,
X3 is any amino acid,
X4 is a F that is optionally methylated or L that is optionally methylated,
X5 is any amino acid,
X6 is an amino acid having an alkyl chain in the side chain that is optionally substituted, or S, and
X7 is any amino acid, and
wherein the Cys at position 15 of SEQ ID NO: 1 is N-methylated.
Applicant is advised that this suggested language may contain problems and/or raise additional issues during prosecution, and therefore should be carefully reviewed by Applicant prior to adopting. However, the Examiner’s proposed language is intended to clearly claim homodimers and heterodimers, and would include the originally elected species.
Claims 5 and 8 depend directly or indirectly from claim 4, wherein claim 5 recites that the “first peptide and the second peptide are identical to or different from each other, and are each the peptide A” and claim 8 states “the first peptide and the second peptide are the same peptide A”, and therefore each claim utilizes “the peptide A” or “the same peptide A”, and “the” is the definite article referring to a specific “peptide A”. Accordingly, claims 5 and 8 each raise indefiniteness issues like claim 4, which was addressed in the preceding paragraph, and those discussions are incorporated into the instant discussion regarding claims 5 and 8. Specifically, the recitation that each of the first peptide and second peptide “are each the peptide A” or “the same peptide A”, using the definite article “the”, creates substantial and material confusion regarding whether or not the “first peptide” and “second peptide” are arbitrarily used as descriptors fully satisfied by a single copy of “peptide A” (e.g., a 15-mer “peptide A” may be arbitrarily considered three linked peptides of 5 amino acid residues each, wherein the first peptide and second peptide are “different”; or a 15-mer “peptide A” may arbitrarily be considered three linked peptides, of lengths 2, 11, and 2, respectively, wherein the first and second peptides are identical, and wherein the 11-mer is a linker connecting the first and second peptides). For purposes of applying prior art, claim 4 is assumed to include homodimeric and heterodimeric structures, comprising two separate and distinct copies of “peptide A”, wherein the two copies may be the same or different. Suggested clarifying amendments have been set forth above regarding claim 4. Such amendment to claim 4 would presumably permit the cancellation of claims 5 and 8.
Claim 5 depends from claim 4 and claim 5 recites “the peptide A”; however, if claim 4 is interpreted to read upon the originally elected species and generally to encompass dimeric structures comprising two copies of “peptide A” (e.g., a first peptide A and a second peptide A), then the subsequent reference at claim 5 lacks antecedent basis because it is unclear if the reference pertains to the first or second instance of “peptide A”. Accordingly, claim 5 is rejected as indefinite because there is insufficient antecedent basis for this limitation in the claim.
Claim 6 depends from claim 5, which depends from claim 4, but claim 6 recites “the peptide A”; however, if claim 4 is interpreted to read upon the originally elected species and generally to encompass dimeric structures comprising two copies of “peptide A” (e.g., a first peptide A and a second peptide A), then the subsequent reference at claim 6 to “the peptide A” lacks antecedent basis. Accordingly, claim 6 is rejected as indefinite because there is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites and refers to the 15-mer peptide of MeF-T-A-V-S-MeF-D-E-D-Ahp-P-R-W-S-MeC as “SEQ ID NO: 34”; although this structure matches the sequence listing for SEQ ID NO: 34 (see, e.g., sequence listing version 2.1 as filed 4/16/2024; see also Spec. filed 9/21/2023 at Table 1-2 at ¶[0063]), this structure does not match “SEQ ID NO: 34” as identified in the originally filed disclosure at Example 6-1, which is reasonably understood to identify instant SEQ ID NO: 34 as a 17-mer peptide having exocyclic Gly-Lys unit (see, e.g., Spec. filed 9/21/2023 at [0077])-[0079]11:
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Greyscale
It is reasonable to infer that this 17-mer is the synthesized peptide of Example 6-1, referenced as SEQ ID NO: 34, because it is subsequently utilized to make the “peptide complex No. 49” (i.e., the originally elected species) at Example 6-2. However, the 17-mer structure does not match the sequence listing for instant SEQ ID NO: 34; furthermore, this 17-mer does not appear to be separately listed in the sequence listing at all. Accordingly, the reference to SEQ ID NO: 34 at claim 6 raises substantial and material concerns, namely whether or not “SEQ ID NO: 34” is a 15-mer per the sequence listing or a 17-mer per the disclosure. Accordingly, in view of the sequence listing and references in the originally filed disclosure, the scope of claim 6 is ambiguous. For purposes of applying prior art, claim 6 is understood to comprise MeF-T-A-V-S-MeF-D-E-D-Ahp-P-R-W-S-MeC, but not to exclude a 17-mer.
Claim 1 and claim 6 recite a peptide “that binds to a c-Met protein”, which is interpreted as a functional language for purposes of the instant rejection. The recitation of the functional limitation renders the claim scope indefinite, because the functional limitations do not correspond to a single structure/function relationship of record. Specifically, claim 1 recites and requires
1. A peptide complex comprising:
a peptide A that binds to a c-Met protein, wherein
the peptide A is …. an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 1…
and claim 6 recites
6. The peptide complex ….. wherein the peptide A is a peptide consisting of [SEQ ID NO: 34] or an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 34, and is a peptide that binds to the c-Met protein.
Therefore, claims 1 and 6 do not encompass all possible variants differing by one to three substitutions, deletions, additions, or insertions, but rather only attempts to encompass the specific variants that are functional and “bind” to some extent “to a[n]” unspecified “c-Met protein”. This is problematic because such language ostensibly reads upon numerous structures (e.g., SEQ ID NO: 1 at claim 1 is a 15-mer that already has seven variable positions, so three more would yield 10/15 positions variable, wherein hundreds of amino acids exist and occur naturally12). Accordingly, the claim scope potentially encompasses trillions of structures, or perhaps less than forty such structures “bind[] to a c-Met protein” as required by the functional limitation. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). Here, the originally filed disclosure provides zero structure/function relationships commensurate in scope with the pending claim scope. For example, although ostensibly the claim scope reads upon insertion, deletion, addition, and substitution variants ranging in length from 12 amino acids to 18 amino acids:
Zero functional non-15-mer length variants (e.g. 12-mers, 13-mers, 14-mers, 16-mers, 17-mers, or 18-mers) other than 15-mers were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional 15-mer variants lacking valine at position 4, serine at position 5, aspartic acid at position 7, aspartic acid at position 9, proline at position 11, tryptophan at position 13, or MeC at position 15 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking MeF, MeA, F, or A at position 1 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking V, T, W, E, or Q at position 2 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking Y, D, A, or R at position 3 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking MeF or L at position 6 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking D, V, P, S, or E at position 8 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking Ahp, Nle, Hty, S, or R at position 10 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking R or S at position 12 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking S, Abu, A, D, H, Q, V at position 14 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants comprising any D-amino acids were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking at least two methylated positions selected from position 1, position 6, and position 15 of SEQ ID NO: 1, were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
It is unclear if any non-cyclic functional variants were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36, ¶¶[0002], [0024], [0034]) and examples);
Zero functional “Peptide Complexes” comprising a Linker of SEQ ID NO: 39 or 40 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36).
Accordingly, although the claim scope ostensibly reads upon >>trillions of potential structures, wherein any position may be “substituted” or “deleted”, and relative positioning may be altered by “insertion” or “addition”, the actual functional sequences taught, disclosed, and reduced to practice fail to literally, inherently, or implicitly provide a unambiguous structure/function relationship permitting an artisan to meaningfully identify and distinguish infringing embodiments capable of “bind[ing] to a c-Met protein” from non-infringing embodiments that lack the capability to “bind[] to a c-Met protein”. This is pertinent because MPEP § 2173 identifies that the primary purpose of the requirement of 35 USC 112(b) 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 claims. Rather, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). 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 do or do not satisfy the functional limitations of claims 1 and 6, and close prior art exists (see rejections below), an artisan would be unable to identify infringing from non-infringing compounds, without actually making and testing each possible compound, and therefore claims 1 and 6 are rejected as indefinite.
Claim 7 depends from claim 6, which ultimately depends from claim 4, but claim 7 recites “the peptide A”; however, if claim 4 is interpreted to read upon the originally elected species and generally to encompass dimeric structures comprising two copies of “peptide A” (e.g., a first peptide A and a second peptide A), then the subsequent reference at claim 7 to “the peptide A” lacks antecedent basis as it is unclear which “peptide A” is being referenced and further limited. Accordingly, claim 7 is rejected as indefinite because there is insufficient antecedent basis for this limitation in the claim.
Claim 8 depends directly or indirectly from claims 7, 6, and claim 4, but claim 8 recites “the same peptide A”; however, if claim 4 is interpreted to read upon the originally elected species and generally to encompass dimeric structures comprising two copies of “peptide A” (e.g., a first peptide A and a second peptide A), then the subsequent reference at claim 8 to “the same peptide A” lacks antecedent basis as it is unclear which “peptide A” is being referenced and further limited. Accordingly, claim 8 is rejected as indefinite because there is insufficient antecedent basis for this limitation in the claim.
Claim 9 depends directly or indirectly from claims 8, 7, 6, and claim 4, but claim 9 recites “the peptide A”; however, if claim 4 is interpreted to read upon the originally elected species and generally to encompass dimeric structures comprising two copies of “peptide A” (e.g., a first peptide A and a second peptide A), then the subsequent reference at claim 9 to “the same peptide A” lacks antecedent basis as it is unclear which “peptide A” is being referenced and further limited. Accordingly, claim 9 is rejected as indefinite because there is insufficient antecedent basis for this limitation in the claim.
Claim 11 depends from claim 10, wherein claim 10 requires that “the linker is a PEG linker”, but wherein claim 11 subsequently recites that the linker consists of SEQ ID NOs: 35 to 41, or a variant of SEQ ID NOs: 35-41, wherein the variant has one to three differences relative to one of SEQ ID NOs: 35-41, wherein the differences are selected from a substitution, deletion, addition, or insertion of “one to three amino acids”. The indefiniteness arises because PEG moieties within SEQ ID NOs: 35-41 are treated as amino acid “X” residues (see sequence listing version 2.1 filed 4/16/2024 at SEQ ID NOs: 35-41; see also Spec. filed 9/21/2023 at ¶[0042]). This raises a material concern over the Applicant’s usage and implied definition of the term “amino acid” and “PEG”, and the implication as it pertains to the scope of the pending claims. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Here, the term “amino acid” and “PEG” in claim 11 are used by the claim and sequence listing to refer to overlapping categories of chemical structures (i.e., PEG is treated as an amino acid residue “X”), while the accepted meaning is that these terms refer to chemically distinct categories of chemical structures (i.e., PEG is not an art-recognized an amino acid). The terms render the claim scope indefinite because the specification does not clearly redefine the terms, the specification describes PEG-based, amino acid based, and PEG-amino acid based linkers (see, e.g., Spec. filed 9/21/2023 at ¶¶[0041]-[0042]). Accordingly, it is unclear, for example, if a variant of SEQ ID NO: 37 (“GKXKG”, wherein “X” is “OCOPEG13OCO”), having a single substitution relative to SEQ ID NO: 37 at position 3, wherein the “X” is substituted with alanine to form the linker “GKAKG” is a “PEG linker” as required by claim 10, or otherwise falls within the scope of claim 11 as having a single “amino acid” substitution relative to instant SEQ ID NO: 37 (i.e., since PEG is treated as an amino acid, it is unclear if claimed substitutions of amino acids apply or not to the PEG moieties). Accordingly, by treating and referring to PEG moieties as “X” amino acids, it is unclear if such moieties can be wholly substituted and still fall within the scope of claims 10-11. Therefore, claim 11 is rejected as indefinite.
Claim 12 is rendered indefinite in view of the preamble, which recites “A c-Met protein agonist”, which for purposes of the instant rejection is understood to be a functional limitation limiting the scope of embodiments recited at claim 11 to a narrower genus of embodiments that specifically “bind to a c-Met protein” (see claims 1 and 6) and also further specifically function as a “c-Met agonist”. This interpretation is reasonable, because otherwise claim 12 would not meaningfully further limit the scope of claim 11 and would be reasonably objected to as a substantial duplicate of claim 11 (see, e.g., MPEP § 608.01(m) and Form Paragraph 7.05.05 and 7.05.06). Accordingly, claim 12 is reasonably inferred to further limit the scope of claim 11 by using a functional limitation, namely claim 12 requires that the claimed compound do more than merely “bind to a c-Met protein”, but more specifically must function more specifically as a “c-Met agonist”. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims raise substantial concerns of indefiniteness per MPEP § 2173.05(g). Upon inspection, the originally filed disclosure appears to provides zero structure/function relationships commensurate in scope with the pending claim scope. Critically, “agonist” activity is discussed primarily at a high/generic level as a desired outcome (see, e.g., Spec. filed 9/21/2023 at ¶¶[0002], [0004], [0007], [0010]-[0014], [0019], [0020]-[0021], [0044]), and although the specification discusses potential uses for compounds with the hoped-for and desired “agonist” activity (see, e.g., Spec. filed 9/21/2023 at ¶[0021], [0045]), rather than disclosing a clear structure/function relationship commensurate in scope with the pending claims, the specification instead discloses screening assays capable of checking to see if a compound shows c-Met agonist activity (see, e.g., Spec. filed 9/21/2023 at ¶[0020], [0061], [0074]-[0075]). This is relevant because possession of a screening assay is not equivalent to possession of a consensus motif necessary and sufficient to achieve a functional outcome, and disclosure of a screening assay fails to meaningfully permit an artisan to distinguish infringing from non-infringing embodiments without first making (i.e., infringing) and testing each embodiment. The specific teachings (or lack thereof) of the instant disclosure has been set forth above with respect to claims 1 and 6, and that discussion is incorporated herein but not repeated. In addition, it is noted that
Zero functional “Peptide Complexes” comprising a linker of SEQ ID NO: 39 or 40 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36).
It is unclear if any non-cyclic functional variants were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36, ¶¶[0002], [0024], [0034]) and examples);
Accordingly, it is unclear what structures infringe or do not infringe upon the functional language of claim 12, because such functional language fails to correspond to an unambiguous structure/function relationship of record. Furthermore, it is unclear how the scope of claim 12 materially differs from the scope of claim 11. This is pertinent because MPEP § 2173 identifies that the primary purpose of the requirement of 35 USC 112(b) 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 claims. Rather, claim 12 merely recites a description of functions or results to be achieved by the invention rather than a description of the structures capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). 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 do or do not satisfy the functional limitation of claim 12, and close prior art exists (see rejections below), an artisan would be unable to identify infringing from non-infringing compounds, without actually making and testing each possible compound (i.e., infringing), and therefore the claim 12 is rejected as indefinite.
Claim 14 is rejected as indefinite because it recites a product and steps of using the product within a single claim (see, e.g., MPEP § 2173.05(p)(II), noting that when a product and process steps using the product are in a single claim, it is unclear if infringement occurs before, during, or after the completion of the process step). Here, claim 14 is directed to a product, and claims an active method step in the same claim (i.e., “the pharmaceutical composition is used to treat or prevent…”), and therefore claim 14 is rejected as indefinite. In addition, Examiner notes that if such language is altered (e.g., “the pharmaceutical composition is capable of being used to treat or prevent), it may raise an objection as a substantial duplicate of claim 13 if no clear structural difference exists (see, e.g., MPEP § 608.01(m) and Form Paragraph 7.05.05 and 7.05.06). Accordingly, claim 14 is rejected as indefinite.
Claim 16 is rejected as indefinite because it recites a product and steps of using the product within a single claim (see, e.g., MPEP § 2173.05(p)(II), noting that when a product and process steps using the product are in a single claim, it is unclear if infringement occurs before, during, or after the completion of the process step). Here, claim 16 is directed to a product, and claims an active method step in the same claim (i.e., “the culture medium additive is used to culture cells…”), and therefore claim 16 is rejected as indefinite. In addition, Examiner notes that if such language is altered (e.g., “the culture medium additive is capable of being used to culture cells…), it may raise an objection as a substantial duplicate of claim 15 and claim 1 if no clear structural difference exists, as an intended use does not limit the product actually being claimed (see, e.g., MPEP § 608.01(m) and Form Paragraph 7.05.05 and 7.05.06). Accordingly, claim 16 is rejected as indefinite.
Claims 2-16 depend directly or indirectly from an indefinite base claim, but fail to rectify the indefiniteness of the base claim. Accordingly, claims 2-16 are rejected as indefinite for the reasons applied to the claims upon which they depend.
Accordingly, claims 1-16 are rejected as indefinite.
Improper Markush Rejection
Claim 1 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations.
First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use.
Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
First, no “single structural similarity” is claimed or identifiable at claim 1. The interpretations and indefiniteness of claim 1 has been discussed above under 35 USC 112(b), and those discussions are incorporated herein. For purposes of the instant rejection, it is noted that claim 1 recites genus of highly variable structures that include variants of SEQ ID NO: 1 (e.g., XXXVSXDXDXPRWXC, wherein each X may be “any naturally occurring amino acid” per sequence listing version 2.1 filed 4/16/2024)
1. A peptide complex comprising:
a peptide A that binds to a c-Met protein, wherein
the peptide A is …. an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 1…
This is problematic because only 8 residues from among 15 are defined in SEQ ID NO: 1, and the claim scope means that any three of those residues may be deleted or substituted, and therefore none of those 8 residues are necessary or required to define a single, shared structural motif responsible for a common activity and that is shared among all species within the scope of instant claim 1. This issue is further complicated by the indefiniteness issues discussed above under 35 USC 112(b), because it is unclear if the variants encompassed by instant claim 1 even share the structural limitations of instant SEQ ID NO: 1 as set forth in the sequence listing. Even assuming arguendo that the claim scope was X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC as recited at claim 1, the assumed claim scope is even broader in scope because each X is not limited to “naturally occurring amino acids”) and would still suffer from the same issue since only positions 4, 5, 7, 9, 11, 12, 13, and 15 are defined at all, but none of these positions are “required” to be present in all species because all positions may be substituted. Furthermore, no relative positioning between positions is required, because any position may be deleted or moved by addition or insertion (e.g., the relative positions of X1 and X3 as positions 1 and 3 of SEQ ID NO: 1 need not be preserved since intervening amino acids may be added). In sum, no single, shared structural motif responsible for a common activity exists among all species within the scope of instant claim 1.
Second, no “common use” shared by all species encompassed by instant claim 1 (e.g., instant claim 1 includes species lacking Cys or MeC at position 15, species having 12 amino acids, species having 18 amino acids, species having D-amino acids, etc., etc., which have no identified shared function or use). Although claim 1 ostensibly recites a functional limitation at claim 1 requiring that the “peptide A” be able “bind[] to a c-Met protein”, this function is not credibly shared by all species encompassed by instant claim 1 in view of the originally filed disclosure and Applicant response to the Restriction requirement (see, e.g., Reply filed 7/23/2026 at 8, alleging unclaimed and unshared structural limitations ranging from “cyclic” structures, and MeC at position 15). The specification fails to credibly establish any shared “common use” among all species, but instead appears to use the recitation that the “peptide A” be able “bind[] to a c-Met protein” as an indefinite functional limitation corresponding to an unknown structure/function relationship corresponding to an unknown subgenus of structures capable of achieving a desired and hoped for result (see discussion of claim 1 under 35 USC § 112(a) regarding functional language above, incorporated herein). Accordingly, as actually drafted, the vast genus of instant claim 1 includes trillions of species that lack any known or credible “common use”.
Therefore, claim 1 is rejected as reciting an improper Markush grouping, wherein the improper Markush grouping attempts to encompass species lacking any common structural similarity (e.g., consensus motifs), and also lacking any identifiably “common use”.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1-16 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)
The pending claims are vast and highly varied, and potentially encompass trillions of highly varied structures or perhaps only a few dozen, wherein the structures are ostensibly limited by functional limitations that do not correspond to any structure/function relationship of record or otherwise known in the prior art, commensurate in scope with the instant claims.
Claim Scope
The pending claims are vast and highly varied, and potentially encompass trillions of highly varied structures or perhaps only a few dozen. Claim 1 is representative of the pending claims scope and recites products, namely peptides, that are functionally capable of “bind[ing] to a c-Met protein”, and claim 12 further attempts to functionally limit such structures to compounds that function specifically as a “c-Met protein agonist”.
The applicable claim interpretation has been set forth in a separate section above, and applicable claim interpretations appear in the rejections under 35 USC 112(b), and those discussions are incorporated into the instant rejection. How those discussions and facts apply under 35 USC 112(a) in the present rejection is discussed below.
It is unclear if the claim scope encompasses trillions of species or perhaps only a few 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
The originally filed disclosure appears to reduce to practice highly similar peptide variants as shown at Tables 1-3 and discussed in the Examples of record (see, e.g., Spec. filed 9/21/2023 at Table 1-1, 1-2, 2, 3, and 4 at pages 33-38; see also id. at Examples at ¶¶[0067]-[0089]).
In view of the indefinite claim scope, it is currently unclear exactly how many species of record are included or excluded from the pending claim scope; however, even assuming arguendo that all species explicitly discussed on record read upon the instant claims, the exemplified embodiments are not commensurate in scope with the instant claims. More specifically, although ostensibly the claim scope reads upon insertion, deletion, addition, and substitution variants ranging in length from 12 amino acids to 18 amino acids:
Zero function 15-mer length variants (e.g. 12-mers, 13-mers, 14-mers, 16-mers, 17-mers, or 18-mers) other than 15-mers were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional 15-mer variants lacking valine at position 4, serine at position 5, aspartic acid at position 7, aspartic acid at position 9, proline at position 11, tryptophan at position 13, or MeC at position 15 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking MeF, MeA, F, or A at position 1 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking V, T, W, E, or Q at position 2 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking Y, D, A, or R at position 3 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking MeF or L at position 6 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking D, V, P, S, or E at position 8 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking Ahp, Nle, Hty, S, or R at position 10 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking R or S at position 12 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking S, Abu, A, D, H, Q, V at position 14 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants comprising any D-amino acids were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
Zero functional variants lacking at least two methylated positions selected from position 1, position 6, and position 15 of SEQ ID NO: 1, were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36);
In addition, it is further noted that
It is unclear if any non-cyclic functional variants were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36, ¶¶[0002], [0024], [0034]) and examples);
Zero functional “Peptide Complexes” comprising a Linker of SEQ ID NO: 39 or 40 were tested, reduced to practice, or otherwise identified as functional (see, e.g., Spec. filed 9/21/2023 at Tables 1-3 at pages 33-36).
Accordingly, even considered in the light most favorable to the Applicant, the disclosed species of record are limited to highly similar 15-mer peptides with invariant positions and limited variability.
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 ostensibly encompass an essentially infinite number of products, but at best reduces to practice a limited number of highly similar structures, wherein length is invariant and particular positions are invariant or limited to very few amino acids. As noted above, even considered in the light most favorable to the Applicant, the disclosure provides zero functional length variants of 12-14 or 16-18 amino acids in length; zero functional variants species lacking valine at position 4; zero functional variants species lacking serine at position 5, zero functional variants species lacking aspartic acid at position 7; zero functional variants species lacking aspartic acid at position 9; zero functional variants species lacking proline at position 11; zero functional variants species lacking tryptophan at position 13; zero functional variants species lacking MeC at position 15; zero functional variants species lacking either MeF, MeA, F, or A at position 1; zero functional variants species lacking V, T, W, E, or Q at position 2; zero functional variants species lacking Y, D, A, or R at position 3; zero functional variants species lacking lacking MeF or L at position 6; zero functional variants species lacking D, V, P, S, or E at position 8; zero functional variants species lacking Ahp, Nle, Hty, S, or R at position 10; zero functional variants species lacking R or S at position 12; zero functional variants species lacking S, Abu, A, D, H, Q, V at position 14; zero functional variants comprising any D-amino acids; zero functional variants species lacking at least two methylated positions selected from position 1, position 6, and position 15 of SEQ ID NO: 1; and zero functional variants comprising a Linker of SEQ ID NO: 39 or 40 were tested, reduced to practice, or otherwise shown to be functional on record. Furthermore, it appears that zero non-cyclic functional variants were tested, reduced to practice, or otherwise shown to be functional on record.
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 zero functional length variants of 12-14 or 16-18 amino acids in length; zero functional variants species lacking valine at position 4; zero functional variants species lacking serine at position 5, zero functional variants species lacking aspartic acid at position 7; zero functional variants species lacking aspartic acid at position 9; zero functional variants species lacking proline at position 11; zero functional variants species lacking tryptophan at position 13; zero functional variants species lacking MeC at position 15; zero functional variants species lacking either MeF, MeA, F, or A at position 1; zero functional variants species lacking V, T, W, E, or Q at position 2; zero functional variants species lacking Y, D, A, or R at position 3; zero functional variants species lacking lacking MeF or L at position 6; zero functional variants species lacking D, V, P, S, or E at position 8; zero functional variants species lacking Ahp, Nle, Hty, S, or R at position 10; zero functional variants species lacking R or S at position 12; zero functional variants species lacking S, Abu, A, D, H, Q, V at position 14; zero functional variants comprising any D-amino acids; zero functional variants species lacking at least two methylated positions selected from position 1, position 6, and position 15 of SEQ ID NO: 1; zero functional variants comprising a Linker of SEQ ID NO: 39 or 40; and zero non-cyclic functional variants 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.
Here, no clear structure/function relationship is disclosed on record commensurate in scope with the pending claims, and no required consensus structure sufficient to achieve the functional limitations is actually provided. Rather, the originally filed disclosure is understood to discuss functional limitations primarily at a high level as a desired outcome (see, e.g., Spec. filed 9/21/2023 at ¶¶[0002], [0004], [0007], [0010]-[0014], [0019], [0020]-[0021], [0044]). Although the specification discusses potential uses for compounds capable of achieving the hoped-for and desired functional activities (see, e.g., Spec. filed 9/21/2023 at ¶[0021], [0045]), the specification does not provide a clear structure/function relationship permitting an artisan to identify, a priori, structures capable of “bind[ing] to a c-Met protein” or otherwise compounds that function specifically as a “c-Met protein agonist”.
At best, rather than disclosing a clear structure/function relationship commensurate in scope with the pending claims, the specification instead discloses screening assays capable of checking to see if a compound, once it is already made, is capable of “bind[ing] to a c-Met protein” (see, e.g., Spec. filed 9/21/2023 at ¶[0019]) or otherwise if the compound shows c-Met agonist activity (see, e.g., Spec. filed 9/21/2023 at ¶¶[0020], [0061], [0074]-[0075]). However, such disclosures are not equivalent to a structure/function relationship, because such disclosures merely evidence that the Applicant had possession of an unclaimed screening assay, but does not support a conclusion that Applicant had possession of a structure/function relationship commensurate in scope with the pending claims sufficient to permit an artisan to identify, a priori, structures included or excluded by the functional language set forth in the pending claims. Accordingly, possession of a screening method is not equivalent to possession of a functionally defined genus of structures identifiable a priori by a commonly shared structural motif responsible and sufficient to achieve the desired functional capability13.
Accordingly, the functional limitation of the pending claims is 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, basic identifying characteristics pertinent to the claimed genus are left unanswered, including “which compounds can actually bind to a c-Met protein?”, and “which compounds can actually function as a c-Met protein agonist?”.
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, molecular biophysics, and structure/function activity relationships for linear, branched, and cyclic protein structures within the scope of the instant claims. 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 capable of “bind[ing] to a c-Met protein” or functioning as a “c-Met protein agonist”.
Accordingly, in the absence of sufficient structure/function teachings identifying particular compounds capable of achieving the claimed functional limitations, 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 species defined by reference to one or more 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 are 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.
Accordingly, claims 1-16 are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, and 15-16 are rejected under 35 U.S.C. 102(b) as being clearly anticipated by US 10781457 (cited in Requirement mailed 3/26/2026).
Claim Interpretation: The pending claims have been rejected as indefinite for reasons discussed above. For purposes of the instant rejection, the reference to SEQ ID NO: 1 as it is listed in the sequence listing filed 4/16/2024 is controlling, and SEQ ID NO: 1 is defined as XXXVSXDXDXPRWXC, wherein each X “can be any naturally occurring amino acid”. Accordingly, instant claim 1 is deemed fully satisfied by any peptide comprising “an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acid in the amino acid sequence represented by SEQ ID NO: 1”
Regarding the structure recited at instant claim 1, US’457 discloses SEQ ID NO: 85 which is
MLRGTVSMAKRTPLFSILTHRPFLSSFSLKHTFNRATLPFTTTTINNTLSQTPTSQNNTESTTHPIKLSTKARRKAAQESPVGILQKKLNNCSKTSDVLQALNLYDEARKAHVPLNLDHYNKLLYLCTVQNGDGSFFHLGLQRGFEIFEQMLRDNVEPNEATFTNAARLAAAKEDPEMAFELLKQMKRVGIAPKLRSYGPALYGFCARGDAMKAYEVDDDMIESGVMAEEDELCALLEVSVEVKNEDKVYEILHRLRAVVRQVSESTLKVIEDWFESEYAMKIGKREWDDEEIREGFVRGGGGWHGQGWLGSGEWKVVKTNVDEDGMCLSCSEKLVSIDIDPKETENFAASLSKLAHEKQPKANFNHFQKWLEKNGPFDAVVDGANVGLANIAEFSFKQLDYVVRQLRQLSPSKRLPLIILHVNRVTGGPAQNPNNKRLIENWKKNGVLYATPHGSNDDWYWLYAAVSCKCLLLTNDEMRDHLFQLLGSSFFPRWKEKHQVRVSVSTRGASLVLPPRYSLVIQESANGSWHVPTVVSDEPDIPRKWLCVTRSRKKLIT
(see, e.g., US’457 at SEQ ID NO: 85). This sequence comprises, at the underlined portion, the fragment PTVVSDEPDIPRK WLC, and therefore satisfies the structural requirements of instant claim 1 with respect to instant SEQ ID NO: 1 as follows.
Position 1 is X1, which is P;
Position 2 is X2, which is T;
Position 3 is X3, which is V;
Position 4 is V;
Position 5 is S;
Position 6 is X4, which is D, and substituted for a hydrophobic amino acid;
Position 7 is a E, which is a substituted for D;
Position 8 is X5, which is P;
Position 9 is D;
Position 10 is X6, which is I, which contains a branched alkyl chain;
Position 11 is P;
Position 12 is R;
Between position 12 and 13, relative to instant SEQ ID NO: 1, is an inserted K residue;
Position 13 is W;
Position 14 is X7, which is L; and
Position 15 is Cys (note that position 15 of SEQ ID NO: 1 as filed is Cys not MeC).
(compare with instant SEQ ID NO: 12 with US'457 at SEQ ID NO: 85). Accordingly, US’457 teaches and discloses a polypeptide comprising a “peptide A consisting of . . . . an amino acid sequence with substitution, deletion, addition, or insertion of … three amino acids in the amino acid sequence represented by SEQ ID NO: 1”. Regarding the recitation at instant claim 1 that “peptide A binds to a c-Met protein”, for purposes of the instant rejection, the phrase at claim 1 that the peptide “binds to a c-Met protein” is interpreted as a recitation of intended and expected results fully satisfied by all species of peptides that satisfy the explicitly recited limitations set forth in the body of claim 1 (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not limit a claim to a particular structure). This is reasonable because the phrase “binds to a c-Met protein” does not correspond to any structure/function relationship of record, and therefore the phrase is reasonably interpreted as a recitation of intended and expected results fully satisfied by any and all species satisfying the structural limitations set forth at lines 3-14 of claim 1). If applicant disagrees, Applicant should identify a structural limitation recited at claim 1 that is not fully satisfied by the prior art sequence, or otherwise identify that the phrase “binds to a c-Met protein” is a functional limitation that corresponds to an unambiguous structure/function relationship of record. Regarding instant claim 4, SEQ ID NO: 85 is deemed to satisfy instant claim 4 as follows: The “first peptide” is
MLRGTVSMAKRTPLFSILTHRPFLSSFSLKHTFNRATLPFTTTTINNTLSQTPTSQNNTESTTHPIKLSTKARRKAAQESPVGILQKKLNNCSKTSDVLQALNLYDEARKAHVPLNLDHYNKLLYLCTVQNGDGSFFHLGLQRGFEIFEQMLRDNVEPNEATFTNAARLAAAKEDPEMAFELLKQMKRVGIAPKLRSYGPALYGFCARGDAMKAYEVDDDMIESGVMAEEDELCALLEVSVEVKNEDKVYEILHRLRAVVRQVSESTLKVIEDWFESEYAMKIGKREWDDEEIREGFVRGGGGWHGQGWLGSGEWKVVKTNVDEDGMCLSCSEKLVSIDIDPKETENFAASLSKLAHEKQPKANFNHFQKWLEKNGPFDAVVDGANVGLANIAEFSFKQLDYVVRQLRQLSPSKRLPLIILHVNRVTGGPAQNPNNKRLIENWKKNGVLYATPHGSNDDWYWLYAAVSCKCLLLTNDEMRDHLFQLLGSSFFPRWKEKHQVRVSVSTRGASLVLPPRYSLVIQESAN;
“GSWHV” is deemed the linker; and PTVVSDEPDIPRKWLC is deemed the “second peptide”; and the remaining portion of SEQ ID NO: 85 of US’457 is deemed a trailer sequence (trailer sequences are not excluded from the pending claim scope). Regarding instant claim 15, claim 15 depends from instant claim 1, and does not recite any structural differences, and the preamble does not correspond to any structural differences of record. Accordingly, claim 15 is rejected for the reasons set forth above for claim 1. Regarding instant claim 16, has been rejected under 35 USC 112(b), above, and for purposes of the instant rejection the claim is reasonably inferred to be directed to a product of claim 1 that is “capable of being used to culture cells”. Here, US’457 identifies that SEQ ID NO: 85 is a PRORP enzyme that occurs in alfalfa plants and is understood to aid alfalfa plants to resist viruses (see, e.g., US’457 at col. 1 at lines 1-50, col. 2 at lines 1-10, col. 4 at lines 6-35); and therefore an artisan would readily infer that such proteins were capable of being used to culture cells, and specifically alfalfa plant cells.
Accordingly, claims 1, 4, and 15-16 are anticipated by the prior art.
Claims 1, 4, and 15-16 are rejected under 35 U.S.C. 102(b) as being clearly anticipated by US 10167482.
Claim Interpretation: The pending claims have been rejected as indefinite for reasons discussed above. For purposes of the instant rejection, the claim scope is understood to include any sequence of form X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC, or an amino acid sequence with substitution, deletion, addition, or insertion of one to three amino acids in the amino acid sequence represented by SEQ ID NO: 1, wherein X1 is any amino acid, X2 is any amino acid, X3 is any amino acid, X4 is a hydrophobic amino acid, X5 is any amino acid, X6 is an amino acid having an alkyl chain in the side chain or S, and X7 is any amino acid.
Regarding instant claim 1, US’482 discloses SEQ ID NO: 33707, which consists of
MSRVLSRRDIADRIAKGQTIVIYEDSVLNLDKWIKFHPGGDKSIYHMIGRDATDEMNAYHDDQTITKFKIWKIGRIDYPWENMLPPIQGGRFSKIDERDDIGDYDINLTSKWRSVDESNQYTKIPKNDRLASEAEVKIYPKIPQGVVPSLDLKEAYEKKIVVDPAIVSENYDNERVYEDLTNFPSLDVKNQEWIASEYRKLHGEITAAGLYQCNYVRYLREFLRIGTLFGISFYLLSLKWFAISAICLGFAWQQLVFIAHDAGHISITHNYQVDNIIGMTVASWIGGLSLGWWKRNHDVHHLVTNDPVHDPDIQHLPFFAVSTRLFHNVYSTYYDKFLWFDKFAQKVVPIQHYLYYPILCFGRFNLYRLSWMHVLLGQGPRRGKAAWFRYYELAELSFFNYWFFYLIIYKQMPTNAERFKYVMISHIATMIVHVQITLSHFAMSTSDLGVTESFPMRQLRTSMDVDCPRWLDFFHGGLQFQVIHHLFPRLPRHNLKDAQSLVIKFCDKVGIKYSIYGFAAGNDVVISHLQQIAQQAHTMLECAKTMKKEATDTEFHTNKHVLAANVNEKRKQE
(see, e.g., SEQ ID NO: 33707 of US’482), which comprises a “peptide A” consisting of the sequence QLRTSMDVDCPRWLD (underlined above). This sequence satisfies the structural limitations of instant claim 1, wherein
Position 1 is X1, which is Q;
Position 2 is X2, which is L;
Position 3 is X3, which is R;
Position 4 is T, which is substituted in place of “V”;
Position 5 is S;
Position 6 is X4, which is M, which is a hydrophobic amino acid;
Position 7 is D;
Position 8 is X5, which is V;
Position 9 is D;
Position 10 is X6, which is C, which either constitutes an “amino acid having an alkyl chain in the side chain that is optionally substituted” (see, e.g., Spec. filed 9/21/2023 at ¶[0028]; note that Cys is classifiable as a methyl group (i.e., a 1-carbon alkyl chain) that is substituted with a thiol), or is a substitution for such an amino acid.
Position 11 is P;
Position 12 is R;
Position 13 is W;
Position 14 is X7, which is L; and
Position 15 is D; which is a substitution for MeC.
Accordingly, QLRTSMDVDCPRWLD satisfies the requirements for a “peptide A” having either two or three differences relative to X1-X2-X3-V-S-X4-D-X5-D-X6-P-R-W-X7-MeC (compare instant claim 1 with US’482 at SEQ ID NO: 3370714). Regarding the recitation at instant claim 1 that “peptide A binds to a c-Met protein”, for purposes of the instant rejection, the phrase at claim 1 that the peptide “binds to a c-Met protein” is interpreted as a recitation of intended and expected results fully satisfied by all species of peptides that satisfy the explicitly recited limitations set forth in the body of claim 1 (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not limit a claim to a particular structure). This is reasonable because the phrase “binds to a c-Met protein” does not correspond to any structure/function relationship of record, and therefore the phrase is reasonably interpreted as a recitation of intended and expected results fully satisfied by any and all species satisfying the structural limitations set forth at lines 3-14 of claim 1). If applicant disagrees, Applicant should identify a structural limitation recited at claim 1 that is not fully satisfied by the prior art sequence, or otherwise identify that the phrase “binds to a c-Met protein” is a functional limitation that corresponds to an unambiguous structure/function relationship of record. Regarding instant claim 4, the prior art of SEQ ID NO: 33707 is understood to satisfy instant claim 4 wherein the amino acid sequence prior to the fragment QLRTSMDVDCPRWLD is arbitrarily deemed to comprise two proteins, one of which is a “first peptide”, and the other is a linker that connects the “first peptide” to the fragment QLRTSMDVDCPRWLD, wherein everything present C-terminal to the fragment is deemed a C-terminal trailer sequence, which is not excluded from the instant claim scope. Regarding instant claim 15, claim 15 depends from instant claim 1, and does not recite any structural differences, and the preamble does not correspond to any structural differences of record. Accordingly, claim 15 is rejected for the reasons set forth above for claim 1. Regarding instant claim 16, has been rejected under 35 USC 112(b), above, and for purposes of the instant rejection the claim is reasonably inferred to be directed to a product of claim 1 that is “capable of being used to culture cells”. Here, US’482 identifies that SEQ ID NO: 33707 is a homologous sequence (see, e.g., US’482 at col. 4 at lines 1-10), and such sequences are identified as “trait-improving proteins” for plants (see, e.g., US’482 at col. 27 at lines 35-63), which are understood to be usable to create plants with multiple desired traits (see, e.g., US’482 at col. 27-28 at bridging ¶). Accordingly, an artisan would readily infer that SEQ ID NO: 33707 was fully capable of being used in plant cultures.
Accordingly, claims 1, 4, and 15-16 are anticipated by the prior art.
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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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 SEQ ID NO: 37 is understood in view of the sequence listing to be GKXKG, wherein wherein X is “-O-C(O)-PEG13-(O)C-O-”.
2 The structure shown at [0077] of the Spec. filed 9/21/2023 is understood to CAS Registry Number: 2842398-67-6
3 SEQ ID NO: 34 is identified in the sequence listing as FTAVSFDEDXPRWSC, wherein positions 1, 6, and 15 are methylated, and wherein X is Ahp (i.e., (S)-2-aminoheptanoic acid).
4 The originally elected species is understood to correspond to CAS Registry Number 2842423-56-5.
5 The originally elected species is understood to correspond to CAS Registry Number 2842423-56-5.
6 The structure shown at [0077] of the Spec. filed 9/21/2023 is understood to CAS Registry Number: 2842398-67-6
7 Therefore the claim scope is narrower than the description at ¶[0039] of the Spec. filed 9/21/2023.
8 Livingstone et al., Protein sequence alignments, CABIOS, vol. 9(6):745-756 (1993); hereafter “Livingstone”
9 See, e.g.,William R. Taylor, 5 - The properties of Amino Acids in Sequences, In Biological Techniques Series, Genetic Databases, Academic Press, 1997, Pages 81-103, ISSN 08924473; hereafter “Taylor”.
10 See, e.g., Becton, Dickinson & Co. v. Tyco Healthcare Group, LP, Nos. 09-1053, -1111 (Fed. Cir. July 29, 2010); see also Gaus v. Conair Corp., 363 F.3d 1284, 1288 (Fed. Cir. 2004); Magnolia Medical Technologies, Inc. v. Kurin, Inc., Case No. 24-2001 (Fed. Cir. Mar. 6, 2026).
11 The structure shown at [0077] of the Spec. filed 9/21/2023 is understood to CAS Registry Number: 2842398-67-6
12 See, e.g., US2008/0139481 A1 at title, abs, at claims, disclosing subgenera of non-natural amino acids; see, e.g., US 6,858,396 B2 at title, abs, claims, disclosing thousands of amino acids; see, e.g., Wagner et al., New Naturally Occurring Amino Acids, Anew. Chem. Int. Ed. Engl. 22:816-828 (1983), noting the existence of over 500 natural amino acids).
13 See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").
14 Also known as GenBank: QBD40391.1, see search notes.
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