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 9-16 are pending and presently examined.
Election/Restrictions
The claims are directed to the 9-mer peptides of SEQ ID NOs: 1-8 (claims 9-10), nucleic acids encoding such polypeptides (claim 11), and claims 12-16 are directed to indefinite methods lacking any steps and failing to recite any specific materials within the scope of claims 9-11 (claims 12-16). Accordingly, an election/restriction requirement has not been set forth on record at this time. However, Applicant is directed to MPEP §§ 818, 818.02(a), 819, and 821.
Following extensive search and examination, polypeptides consisting of instant SEQ ID NOs: 1-4, 6, and 8-9 have been deemed free of the prior art. The closest prior art of record is discussed below as applied to instant SEQ ID NOs: 5 and 7. No claims are directed to these species. No claims are presently allowed.
Claims 9-16 are presently examined.
Priority
The priority document of PCT/CN2022/107650 (filed 7/25/2022) is acknowledged.
Examiner notes that no certified translation of the Foreign Application CN202210175874.5 (filed 2/24/2022) 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 6/06/2023 is acknowledged and presently considered.
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1, as filed 12/21/2025, is representative of the pending claim scope. Applicable claim interpretations are set forth below.
Claim 1 is reasonably inferred to be limited to 9-mer polypeptides within the genus defined by SEQ ID NO: 9 (X1TX2YX3RTGR, wherein X1 is Gly or Arg, X2 is Arg or Cys, and X3 is Lys or Cys).
At claim one, the term “9-peptide” is undefined on record, but is reasonably understood to mean and refer to a “9-mer peptide” or “nonapeptide”.
At claim 1, the phrase “characterized in that, the polypeptide is a 9-peptide, with an amino acid sequence as follows” is ambiguous regarding whether or not it implies closed or open-ended language (e.g., “consisting of” versus “comprising”):
Weighing in favor of an open-ended interpretation: “Characterized by” is expressly identified as equivalent to “comprising” (see, e.g., MPEP § 2111.03(I), noting that the translational term “comprising” is synonymous with “characterized by”, and is open-ended language). In addition, claim 1 is directed to any “derivative”, but the term “derivative” is exemplified but not defined (see, e.g., Spec. filed 6/06/2023 at p. 10 at lines 19-21, noting the “derivative can be a linker”).
Weighing in favor of a closed interpretation: “is a 9-peptide”, wherein “9-peptide” is interpreted to mean “nonapeptide” or “9-mer”, would limit the scope of the claims to nonapeptides having the sequence shown within the formula of instant SEQ ID NO: 9, because SEQ ID NO:9 is a nonapeptide with specific definitions for each moiety per the “Features” and “Variants” noted in the sequence listing. However, SEQ ID NO: 9 would ostensibly limit the meaning of “derivative” since positions 1 and 9 of SEQ ID NO: 9 do not identify additional modifications at the N- or C-termini.
Accordingly, following consideration of the record and claims as a whole, in view of MPEP § 2111.03(I) and the unspecified breadth of “derivative thereof”, claim 1 has been given the broadest reasonable interpretation, wherein “characterized in that….” is understood to be synonymous with “Characterized by” and therefore equivalent to “comprising” language. If this is incorrect, Applicant should clearly amend claim 1 to utilize closed language by deleting “characterized in that” and “derivative”, and instead using “consisting of” (see, e.g., MPEP § 2111.03(I)-(II)).
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Consisting of” excludes any elements, step, or ingredient not specified (see, e.g., MPEP § 2111.03(II)). When the phrase "consists of" appears in a clause of the body of a claim, rather than immediately following the preamble, the "consisting of" phrase limits only the element set forth in that clause; other elements are not excluded from the claim as a whole (see, e.g., MPEP § 2111.03(II)).
Claim 10 is indefinite as discussed below. For purposes of applying prior art, claim 10 is understood to recite and refer to eight polypeptide sequences, namely instant SEQ ID NOs: 1-8. SEQ ID NO:1 is RTRYKRTGR; SEQ ID NO:2 is GTCYKRTGR; SEQ ID NO:3 is RTRYCRTGR; SEQ ID NO:4 is RTCYKRTGR; SEQ ID NO:5 GTCYCRTGR; SEQ ID NO:6 is GTRYKRTGR; SEQ ID NO:7 is RTCYCRTGR; and SEQ ID NO:8 is GTRYCRTGR. Claim 10 is understood to limit the scope of SEQ ID NO: 9 only, but does not limit the claim scope to only the eight polypeptides enumerated (i.e., claim 10 is understood to be open-ended, “comprising” language rather than “consisting of language”). If this is incorrect, Applicant should clearly utilize a “consisting of” transitional phrase (see, e.g., MPEP § 2111.03(II)).
Claim 11(B1) is understood to be a claim attempting to capture at least any polynucleotide encoding any polypeptide comprising instant SEQ ID NO: 9.
Claim 11(B2) is indefinite and has been rejected under 35 USC §112(b), below.
Claims 12-16 are indefinite and understood to be directed to non-statutory subject matter, as set forth in the rejections below.
Additional claim interpretations are set forth below.
Claim Objections
Claims 9-10 and 14 are objected to because of the following informalities:
Claim 9 is objected to because it contains redundant and superfluous language that fails to meaningfully limit the pending claim scope. Specifically, the phrase
…characterized in that, the polypeptide is a 9-peptide, with an amino acid sequence as follows: X1TX2YX3RTGR (SEQ ID NO: 9); wherein, T represents Threonine, Y represents tyrosine, R represents arginine, and G represents glycine; X1 is any one of glycine and arginine; X2 is any one of arginine or cysteine; X3 is one of lysine or cysteine.
could be simplified by removing unnecessary and redundant terminology as follows:
…that consists of X1TX2YX3RTGR (SEQ ID NO: 9); whereinX1 is or arginine; X2 is or cysteine; X3 isor cysteine.
Such amendments remove superfluous language while still capturing the same subject matter, namely a genus defining eight nonapeptides, as explicitly claimed at instant claim 2. Redundant and superfluous language should be removed to enhance claim clarity and to minimize potential confusion. Examiner suggests the following amendments:
Claim 10 recites “sequence 3, sequence 1, sequence 2, sequence 4, sequence 5, sequence 6, sequence 7, and sequence 8”. The reference to a numbered sequence is understood to be an improper attempt to reference a sequence identifier (see, e.g., MPEP 2422.01(V), 37CFR 1.823(a)(5), noting that “SEQ ID NO: is preferred” by noting that “SEQ NO.” or “Seq. Id. No.” are acceptable). This objection may be overcome by amending claim 10 to delete this phrase and replace it with, for example, “SEQ ID NOs: 1-8”.
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. 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).
Appropriate correction is required.
Objection to Specification
Sequence Listing: 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 claims and/or disclosure contain 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, the instant application, as filed 6/06/2023 discloses sequences at page 10 at lines 1-20, page 17 at lines 20-25, page 18 at lines 1-15 because sequences are disclosed that do not recite a “SEQ ID NO:”.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show details as described in the specification. Specifically, Figures 1, 6-7, and 8a are illegible in whole or part. 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.
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 9-16 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 9 recites a “9-peptide”, which is undefined on record, not a term of art having a unique meaning, and the term is not defined in the pending claims. Accordingly, the usage of this term renders the claim scope indefinite. For purposes of applying prior art, the term is reasonably understood to mean a “9-mer peptide” or “nonapeptide”.
Claim 10 recites “sequence 1”, “sequence 2”, “sequence 3”, “sequence 4”, “sequence 5”, “sequence 6”, ““sequence 7”, and “sequence 8”, which render the claim scope indefinite for lack of antecedent basis. There is insufficient antecedent basis for these limitations in the claim. For purposes of applying prior art, the recitations are reasonably inferred to mean “SEQ ID NO: 1”, “SEQ ID NO: 2”, “SEQ ID NO: 3”, “SEQ ID NO: 4”, “SEQ ID NO: 5”, “SEQ ID NO: 6”, “SEQ ID NO: 7”, and “SEQ ID NO: 8”.
Claim 11 recites (B1) and (B2), which renders the claim scope indefinite. Claim B2 confusingly appears to recite a distinct limitation relative to B1 since it is separately recited (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"). However, B1 recites and refers to “the polypeptide”, which is presumed to be different from those enumerated at claim 9, and therefore lacks antecedent basis. There is insufficient antecedent basis for these limitations in the claim. For purposes of applying prior art, claim 11(B1) has been examined and rejected.
Claim 12 recites the term “medicament” multiple times with different qualifying statements (i.e., “for preventing…”, “for inhibiting…”, etc.). It is unclear in context if each usage of “medicament” refers to the same genus of compounds at each instance, or if each instance refers to a materially different genera of compounds. Accordingly, there is insufficient antecedent basis for this limitation in the claim. For purposes of examination in view of the prior art, further examination of claim 12 in view of the prior art is precluded.
At claim 12, the term “animal obesity inhibitor” is not defined on record, does not correspond to any structure/function relationship of record, does not correspond to an art-recognized genus of compounds, and claim 12 fails to provide a definition of this term. Per MPEP § 2173, “The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent”. Here, the usage of an Applicant-derived term in the absence of any meaningful definition of the metes and bounds of the term, renders the claim scope indefinite because it is unclear when infringement does or does not occur since it is unclear if the “inhibitor” is a peptide, protein, carbohydrate, lipid, nucleic acid, small molecule, hydrogel, water, etc. At best, the phrase “animal obesity inhibitor” is reasonably inferred to be a functionally defined term, wherein the phrase defines a compound “by what it does rather than by what it is” (see, e.g., MPEP § 2173.05(g), noting that the compounds encompassed by the phrase “animal obesity inhibitor” presumably inhibits “animal obesity”, and therefore encompasses any compound capable of inhibiting “animal obesity”). As explained at MPEP § 2173.05(g)
Notwithstanding the permissible instances, the 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. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008)
Here, it is unclear what structures do or do not achieve the function of inhibiting animal obesity, and no structure/function relationship has been placed on record. Accordingly, an artisan would not be reasonably informed of the metes and bounds of the functionally defined genus as necessary to identify and distinguish infringing and non-infringing substances. Notably,
“[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).
Accordingly, claim 12 is rejected as indefinite. For purposes of examination in view of the prior art, further examination of claim 12 in view of the prior art is precluded.
Claim 12 is rejected as directed to a “use” claim as explained below. Per MPEP § 2173.05(q):
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Here, claim 12 appears to be a list of multiple preambles for multiple methods, but each method lacks any active method steps. Accordingly, such a claim “merely recites a use without any active, positive steps delimiting how this use is actually practiced” and is therefore indefinite.
Claims 13-16 refer to methods of claim 12, which lack any active method steps, and simply recite and require that such methods “use[] the polypeptide or the medicinal salt or derivative thereof”, without specification or clarification of the specific “use” claimed. Accordingly, claims 13-16 are each rejected as directed to a “use” claim as explained below. Per MPEP § 2173.05(q):
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Here, claims 13-16, like the preambles at issue only differ from Ex parte Erlich because instant claims 13-16 refer to “the polypeptide or the medicinal salt or derivative thereof” rather than “monoclonal antibodies”; however, like Ex parte Erlich, the instant claims merely recite and require “use” of such substances, in the absence of “any active, positive steps delimiting how this use is actually performed” (see id). Accordingly, claims 13-16 are rejected as indefinite because each claim “merely recites a use without any active, positive steps delimiting how this use is actually practiced” and is therefore indefinite.
Claims 13-14 refer to “the polypeptide of the medicinal salt or derivative thereof”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination in view of the prior art, further examination of claims 12-14 in view of the prior art is precluded.
Claim 15 recites the limitation "the nucleic acid" at line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination in view of the prior art, further examination of claims 12-15 in view of the prior art is precluded.
Claim 15 recites the limitation "B1" at line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination in view of the prior art, further examination of claims 12-15 in view of the prior art is precluded.
Claim 16 recites the limitation "the nucleic acid" at line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination in view of the prior art, further examination of claims 12-16 in view of the prior art is precluded.
Claim 16 recites the limitation "B2" at line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination in view of the prior art, further examination of claims 12-16 in view of the prior art is precluded.
Accordingly, claims 9-16 are rejected. Further examination of claims 12-16 in view of the prior art is precluded.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter as explained below
Claim 12 is rejected as directed to a “use” claim as explained below. Per MPEP § 2173.05(q):
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Here, claim 12 appears to be a list of multiple preambles for multiple methods, but each method lacks any active method steps. Accordingly, such a claim “merely recites a use without any active, positive steps delimiting how this use is actually practiced” and is therefore indefinite.
Claims 13-16 refer to methods of claim 12, which lack any active method steps, and simply recite and require that such methods “use[] the polypeptide or the medicinal salt or derivative thereof”, without specification or clarification of the specific “use” claimed. Accordingly, claims 13-16 are each rejected as directed to a “use” claim as explained below. Per MPEP § 2173.05(q):
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Here, claims 13-16, like the preambles at issue only differ from Ex parte Erlich because instant claims 13-16 refer to “the polypeptide or the medicinal salt or derivative thereof” rather than “monoclonal antibodies”; however, like Ex parte Erlich, the instant claims merely recite and require “use” of such substances, in the absence of “any active, positive steps delimiting how this use is actually performed” (see id). Accordingly, claims 13-16 are rejected as indefinite because each claim “merely recites a use without any active, positive steps delimiting how this use is actually practiced” and is therefore indefinite.
This analysis provided above is pertinent to the instant rejection under 35 USC 101 as follows: Per MPEP § 2173.05(q)(I), a “use” claim may be rejected under 35 USC 101 and/or 112(b) because "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). Accordingly, claims 12-16 are rejected under both 35 USC 101 and 112(b).
Accordingly, claims 12-16 are rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring products without significantly more.
The claims recite SEQ ID NO: 9 and SEQ ID NO: 7, and polynucleotides encoding such polypeptides; however, Tanabe et al.1 evidences such sequences naturally occur. Specifically, Tanabe teaches and discloses a naturally occurring α-defensin peptide referred to as “RED-4”, isolated from Rhesus Macaque small intestine, having the N-termini of RTCYCRTGR (see, e.g., Tanabe at title, abs). Accordingly, the naturally occurring protein comprises instant SEQ ID NO: 7 (compare instant SEQ ID NO: 7 with Tanabe at abs, Fig. 2 on 1473, showing RTCYCRTGR, showing 100% sequence identity). Regarding instant claim 11, Tanabe identifies that the proteins were encoded by mRNAs (cDNAs) derived from naturally occurring sequences within Rhesus Macaque small intestine that localized exclusively to small intestinal Paneth cells (see, e.g., Tanabe at title, abs, 1470 at col II at § “Materials and Methods” to page 1471 at col I, Fig. 1 on 1472, Fig. 2 on 1473). In addition, Examiner notes that instant SEQ ID NO: 7 (and therefore polynucleotides encoding it) naturally occur as evidenced by Genbank AAW78346.12 (compare instant claims with AAW78346, showing 100% sequence identity with instant SEQ ID NO: 7) and Genbank AAW51368.13 (compare instant claims with AAW78346, showing 100% sequence identity with instant SEQ ID NO: 7)
This judicial exception is not integrated into a practical application because claims 9-11 do not include any additional elements that are sufficient o significantly more than the judicial exception.
Even assuming arguendo that the indefinite preamble of claim 9 is intended to limit the scope of the claims to embodiments “consisting of” sequences of SEQ ID NO: 9 (i.e., instant SEQ ID NOs: 1-8), rather than “comprising” (see indefiniteness rejections and claim interpretation section, above), this would not be sufficient to distinguish the claimed invention over the prior art because the Court has clarified that fragmentation does not constitute a feature that renders structures “markedly different” from what exists in nature. Specifically, the Court in Myriad determined that even though fragmentation or truncation structurally changes a nucleic acid from its natural state, the resultant difference (e.g., “broken” bonds) is not significant enough to render the isolated polynucleotide markedly different, because the sequence of the nucleic acid has not been altered. See, e.g., Myriad, 133 S. Ct. at 2116-18. Similarly, here, the fragmentation of a naturally occurring polypeptide to obtain the truncated sequence consisting of SEQ ID NO: 7 is not significant enough to render the isolated peptide markedly different, because the sequence of the peptide has not been altered and the domain would continue performing the functionality attributable to that structure (see also MPEP § 2112.01(II), noting that “A chemical composition and its properties are inseparable”).
Therefore, claims 9-11 do not appear to recite additional elements that amount to significantly more than the judicial exception of the naturally occurring polypeptides and polynucleotides encoding those polypeptides, as found in nature.
Summary
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 9-11 do not qualify as eligible subject matter.
“To be patent eligible, a claim that is directed to a judicial exception must include additional features to ensure that the claim describes a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception” (79 FR 74624 col I).
Claim Rejections - 35 USC § 112(a), Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for polynucleotides encoding polypeptides of SEQ ID NOs: 1-9, does not reasonably provide enablement for polypeptides encoding specific “medicinal salts” of such polypeptides. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The applicable legal standards for enablement are discussed at MPEP § 2164 and the specific legal standards relevant to determinations regarding the scope of enablement are set forth at MPEP § 2164.08. MPEP § 2164 identifies the following relevant factors for determining “undue” experimentation: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.” The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
Claim 11 shows the breadth of the claims and nature of the invention. Specifically, claim 11 is directed to at least “a nucleic acid molecule encoding the polypeptide …. according to claim 9”. Accordingly, claim 11 encompasses numerous polynucleotides including any and all relevant to recombinant expression systems. However, claim 11 also recites and attempts to claim any “nucleic acid molecule encoding the polypeptide or a medicinal salt thereof according to claim 9” (emphasis added). It is prima facie unknown how a polynucleotide can encode a specific medicinal salt.
Regarding the state of the prior art; the level of one of ordinary skill; the level of predictability in the art; the amount of direction provided by the inventor; the existence of working examples; and the quantity of experimentation needed to make or use the invention: It is prima facie unknown how a polynucleotide can encode a specific medicinal salt. Zero examples of any polynucleotides encoding for a medicinal salt has been shown on record or is otherwise known in the prior art. One of ordinary skill in the art would readily appreciate that amino acids are encoded by codons (triplets of nucleotides), but would not be aware of any codon or other sequence capable of encoding a specific medicinal salt at the level of nucleic acids. Accordingly, the quantity of experimentation required to make and use the invention is substantial and undue, because encoding specific medicinal salts into a nucleic acid would be reasonably and readily viewed as impossible at the time of the invention. Zero evidence to the contrary has been placed on record.
Conclusion: Therefore, in view of the lack of guidance and working examples, high degree of unpredictability (presumably impossible), and Applicant’s failure to address and explain how a polynucleotide sequence could encode a medicinal salt, an artisan would be unduly burdened with experimentation in order to practice the full scope of the instantly claimed invention.
Accordingly, claim is 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 9-11 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Tanabe et al.4
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and rejections above, and those interpretations are incorporated into the instant rejection. For purposes of the instant rejection, indefinite claims 9-11 are understood to read upon any polypeptide “comprising” SEQ ID NO: 9, including full-length polypeptides (see claim interpretation section, above, and see rejections under 35 USC §112(b)). Additional claim interpretations are set forth below.
Regarding instant claims 9-10, Tanabe teaches and discloses a naturally occurring α-defensin peptide referred to as “RED-4”, isolated from Rhesus Macaque small intestine, having the N-termini of RTCYCRTGR (see, e.g., Tanabe at title, abs). Accordingly, the naturally occurring protein comprises instant SEQ ID NO: 7 (compare instant SEQ ID NO: 7 with Tanabe at abs, Fig. 2 on 1473, showing RTCYCRTGR, showing 100% sequence identity). Regarding instant claim 11, Tanabe identifies that the proteins were encoded by mRNAs (cDNAs) derived from naturally occurring sequences within Rhesus Macaque small intestine that localized exclusively to small intestinal Paneth cells (see, e.g., Tanabe at title, abs, 1470 at col II at § “Materials and Methods” to page 1471 at col I, Fig. 1 on 1472, Fig. 2 on 1473). In sum, peptides comprising instant SEQ ID NO: 7 occur naturally, and polynucleotides encoding such peptides occur naturally.
Accordingly, claims 9-11 are rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020/229349A1 (November 19, 2020).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and rejections above, and those interpretations are incorporated into the instant rejection. The instant rejection is applicable wherein the preamble of claims 9-10 is interpreted as either “consisting of” or “comprising” language. Additional claim interpretations are set forth below.
WO’349 pertains to defensin fragments derived from HD-5 (see, e.g., WO’349 at title, abs, claims), which are understood to have known predicted and expected results and applications, based upon antimicrobial activity (see, e.g., WO’349 at ¶¶[0014]-[0016], [0031], [0035]-[0040], claims 1-5). Regarding instant claims 9-10, WO’349 teaches and discloses a narrow genus of nonapeptides having the formula of A1-B1-X1-C1-X2-Z1-B2-A2-Z2 (see, e.g., WO’349 at ¶[0011], claims 1 and 4), wherein each of X1 and X2 are cysteine, and each of Z1 and Z2 are arginine (see id), which yields A1-B1-Cys-C1-Cys-Arg-B2-A2-Arg (see id). WO’349 provides additional guidance in the way of preferred residues, namely wherein A1 and A2 are “preferably alanine or glycine”, wherein B1 and B2 are “preferably selected from serine, threonine, or tyrosine”, and wherein C1 is “preferably tyrosine” (see id.). Accordingly, such additional guidance would lead an artisan to the preferred genus of 36 nonapeptides represented by the formula:
[AG][STY]CYCR[STY][AG]R
Wherein residues within brackets “[]” represent alternatives at a single position. WO’349 identifies additional derivatives and pharmaceutical formulations of these sequences (see, e.g., WO’349 at ¶¶[0018]-[0023], [0031], [0044]-[0047], claims 5, 8-9, 11-13). Regarding instant claim 11, WO’349 identifies polynucleotides encoding such peptides are routinely utilized to synthesize such peptides (see, e.g., WO’349 at ¶¶[0024]-[0030], discussing recombinant expression systems). Therefore, an artisan would at once envisage such polynucleotides in view of the disclosure of the peptide sequences and guidance to make such peptides using recombinant methods.
WO’349 differs from the instant claims as follows: Although WO’349 discloses a narrow genus of 36 species of nonapeptides, including instant SEQ ID NO:5 (i.e., GTCYCRTGR), WO’349 does not explicitly reduce to practice and exemplify this embodiment.
However, WO’349 explicitly directs artisans to a narrow genus of preferred nonapeptides, including the 36 species within the scope of [AG][STY]CYCR[STY][AG]R, which includes instant SEQ ID NO: 5 (i.e., GTCYCRTGR). WO’349 explicitly directs artisans to such species, wherein such species have explicitly disclosed and predicted results, activity, and applications (see, e.g., WO’349 at ¶¶[0014]-[0016], [0031], [0035]-[0040], claims 1-5).
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 invention is the simple substitution of permissible amino acids at one position for another permissible amino acid at that position, exactly as taught by the prior art, to obtain predictable results, namely an antimicrobial nonapeptide having the sequence of GTCYCRTGR, which would be predicted and expected to have the utility and functionality disclosed, and be applicable for use in the methods disclosed by WO’349 (see, e.g., MPEP §§ 2143(I)(B), (D), (E), (F), and (G)).
Furthermore, 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. Accordingly, the prior art sequence of GTCYCRTGR appears to do no more than identified by the prior art.
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 all 36 nonapeptides identified as “preferred” by WO’349, and to test them using routine assays in the art.
Accordingly, claims 9-11 are rejected.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020144166 (July 16, 2020) in view of Tanabe et al.5
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section and rejections above, and those interpretations are incorporated into the instant rejection. The instant rejection is applicable wherein the preamble of claims 9-10 is interpreted as either “consisting of” or “comprising” language. Additional claim interpretations are set forth below.
WO’166 pertains to alpha-defensin fragments (see, e.g., WO’166 at title, abs, claims), including fragments comprising positions 1-9 of a defensin (see id), and to fragments of alpha-defensins expressed by Paneth cells of the small intestine (see, e.g., WO’166 at 6 at lines 1-3). Regarding instant claims 9-10, WO’166 directs artisans to utilize fragments of alpha-defensins having 9 amino acids (see, e.g., WO’166 at 4 at lines 20-25, pages 4-5 at bridging ¶), discloses the advantages of using such short fragments of naturally occurring alpha-defensin fragments (see, e.g., WO’166 at pages 4-5 at bridging ¶), the predicted and expected results of using such fragments (see, e.g., WO’166 at 5 a lines 4-12, p. 13 at lines 4-30, noting antimicrobial activities), and obvious derivatives of such compounds (see, e.g., WO’166 at pages 8 at lines 10 to page 10 at line 8). Regarding nonapeptides, WO’166 explicitly directs artisans to utilize positions 1-9 of an alpha-defensin protein to generate a nonapeptide fragment (see, e.g., WO’166 at p. 12 at line 6). Furthermore, nonapeptides from positions 1-9 of the tested α-defensin peptides expressed by Paneth cells showed the best activity relative to other tested fragments (see, e.g., WO’166 at 34 at lines 1-10), which would reasonably direct artisans to utilize nonapeptides consisting or comprising positions 1-9 of α-defensin peptides expressed by Paneth cells. Regarding instant claim 11, WO’166 directs artisans to make such polypeptides by using recombinant expression systems, which necessitate the use of polynucleotides that encode such peptides (see, e.g., WO’166 at page 10 at line 33 to page 11 at line 35).
WO’166 differs from the instant claim scope as follows: WO’166 teaches and discloses nonapeptides comprising positions 1-9 of an alpha-defensin expressed by Paneth cells of the small intestine, including ATCYCRTGR (SEQ ID NO: 1 of WO’166), but WO’166 does not teach or disclose RTCYCRTGR (i.e., instant SEQ ID NO: 7).
Tanabe teaches and discloses a naturally occurring α-defensin peptide referred to as “RED-4”, which is an alpha-defensin expressed by Paneth cells of the small intestine of Rhesus Macaque, wherein “RED-4” has, at positions 1-9, an N-terminal sequence of RTCYCRTGR (see, e.g., Tanabe at title, abs, 1470 at col II at § “Materials and Methods” to page 1471 at col I, Fig. 1 on 1472, Fig. 2 on 1473). This N-terminal sequence shares 100% sequence identity with instant SEQ ID NO: 7 (compare instant SEQ ID NO: 7 with Tanabe at abs, Fig. 2 on 1473, showing RTCYCRTGR, showing 100% sequence identity).
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):
First, the invention is the simple substitution of the alpha-defensin expressed by Paneth cells of the small intestines (i.e., “RED-4”) disclosed by Tanabe in place of the alpha-defensin expressed by Paneth cells of the small intestines disclosed by WO’166 in the method of forming nonapeptide fragments comprising positions 1-9 of an alpha defensin as disclosed by WO’166, which would yield the nonapeptide of RTCYCRTGR from RED-4, which would be predicted and expected to have antimicrobial activities and applications as disclosed by WO’166 and advantageously be cheaper to product as taught by WO’166 (see, e.g., MPEP §§ 2143(I)(B), and (G)).
In addition, or alternatively, the claimed invention is the obvious application of the technique of forming a nonapeptide fragment comprising positions 1-9 of an alpha-defensin expressed by Paneth cells of the small intestines, to the alpha-defensin of RED-4 as taught and disclosed by Tanabe, wherein such nonapeptide fragment would be predicted and expected to have the antimicrobial activities and applications taught and disclosed by WO’166 for such peptides (see, e.g., MPEP §§ 2143(I)(C), (D), (F), and (G)).
Furthermore, no evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to make and use nonapeptide fragments comprising positions 1-9 of known alpha defensin proteins taught and disclosed in the prior art.
Accordingly, claims 9-11 are rejected.
Allowable Subject Matter
Following extensive search and examination, polypeptides consisting of instant SEQ ID NOs: 1-4, 6, and 8-9 have been deemed free of the prior art. The closest prior art of record is WO2020144166 (July 16, 2020), Tanabe et al.6, and/or WO2020/229349A1 as discussed above.
Applicant is advised that the instant Application could be placed in form for allowance by canceling claims 9-16 and adding claims such as those shown below:
Claim 17. A polypeptide consisting of a sequence selected from the group consisting of SEQ ID NOs: 1-4, 6, and 8-9.
Claim 18. A pharmaceutical formulation comprising (i) a polypeptide consisting of a sequence selected from the group consisting of SEQ ID NOs: 1-4, 6, and 8-9, and (ii) a pharmaceutically acceptable excipient.
Claim 19. A polynucleotide sequence encoding a polypeptide sequence selected from the group consisting of SEQ ID NOs: 1-4, 6, and 8-9.
If Applicant would like to discuss alternative claims, Applicant is invited to arrange an interview by filing an Interview Request (AIR).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20250368685 (priority to Jan. 7, 2019) is directed to peptides consisting of 9 amino acids that comprise the sequence of CRTGR (see, e.g., US’585 at claims 23-24, 26-30, 37).
US20220213156 (priority to 5/10/2019) is directed to methods of treating infections by administering compounds of form [AG][STY]CYCR[STY][AG]R (see, e.g., US’156 at claims).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 Tanabe et al., Paneth Cell α-Defensins from Rhesus Macaque Small Intestine. Infect Immun 72 (2004):
https://doi.org/10.1128/iai.72.3.1470-1478.2004; hereafter “Tanabe”.
2 Genbank AAW78346.1, defensin alpha 2 [Papio anubis] (Feb 3, 2005), attached as 1 page pdf; also available at https://www.ncbi.nlm.nih.gov/protein/AAW78346 (last visited 2/17/2026); hereafter “AAW78346”; a.k.a. CAS 827246-77-5.
3 GenBank: AAW51368.1, alpha-defensin 4 precursor [Macaca mulatta] (Dec. 21, 2016), attached as 2 page pdf; also available at https://www.ncbi.nlm.nih.gov/protein/AAW51368.1 (last visited 2/17/2026).
4 Tanabe et al., Paneth Cell α-Defensins from Rhesus Macaque Small Intestine. Infect Immun 72 (2004):
https://doi.org/10.1128/iai.72.3.1470-1478.2004; hereafter “Tanabe”.
5 Tanabe et al., Paneth Cell α-Defensins from Rhesus Macaque Small Intestine. Infect Immun 72 (2004):
https://doi.org/10.1128/iai.72.3.1470-1478.2004; hereafter “Tanabe”.
6 Tanabe et al., Paneth Cell α-Defensins from Rhesus Macaque Small Intestine. Infect Immun 72 (2004):
https://doi.org/10.1128/iai.72.3.1470-1478.2004; hereafter “Tanabe”.