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 .
DETAILED ACTION
Response to Election/Restriction filed on December 1, 2025 is acknowledged. Claims 12, 15-18, 20 were canceled, claim 1 was amended and claims 1-11, 13-14, 19, 21-28 are pending in the instant application.
Election/Restrictions
Applicant elected with traverse Group I (claims 1-14, 28) and with traverse the peptide of SEQ ID NO. Applicant argues that the Giuliani reference included does not reference SEQ ID NOs:2316, 2318 or 2320. However, the correct reference is Giuliani (WO9957280) which just lists the amino acid sequences of Neisseria meningitidis genus that do not bind fibrils of Huntingtin exon 1. Applicants arguments have been fully considered but not found persuasive. First, the examiner would like to point out that Giuliani provided (WO0137863, previously attached) does have more than 2000 sequences in the document including SEQ ID Nos:2316, 2318, 2320 (See page 6). The reference listed “WO0137863” is the same as the reference previously provided. Nevertheless, regarding the limitation of “selectively binds to unbundled fibrils of Huntingtin exon 1”, while Giuliani may not explicitly state this specific binding preference, the property is inherent to the peptide sequence (see MPEP2112).
The restriction is deemed proper and is made FINAL in this office action. Claims 3-5, 10, 19, 21-22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species/invention, there being no allowable generic or linking claim.
*Please note that SEQ ID NO:1 was searched and found free of the prior art. The search was extended to other species including SEQ ID NO:9, a HD1 (SEQ ID NO:1) derivative, and art was found. Furthermore, even though naturally occurring sequences could fall within the scope of SEQ ID Nos:9-12, there is no evidence or reasoning that these sequences would have the property of binding unbundled fibrils of Huntington exon I.
Claims 1-2, 6-9, 11, 13-14, 28 are examined on the merits of this office action.
Specification Objection
The specification is objected to because the application was filed under WIPO standard ST.26 and SEQ ID NO: 9-11 do not meet the criteria for mandatory inclusion criteria for a sequence listing under MPEP 2412.05. As a result, the sequence listing contains only a placeholder identification such at “000” and no corresponding sequence data in the sequence listing for those SEQ ID Nos. When Applicant intentionally skips a sequence, reference to that SEQ ID NO should be deleted from the disclosure and claims. However, in the instant case, the SEQ ID Nos are in the disclosure and claims. To overcome this objection, Applicants should delete the SEQ ID No from the disclosure. Furthermore, Applicants indicate “000” for SEQ ID NO:12, however, SEQ ID NO:12 has four or more defined amino acids and thus is required to have a sequence listing under ST. 26. Applicants must file a proper sequence listing for SEQ ID NO:12.
Drawings
The drawings are objected to because according to 37 CFR 1.821(b) the sequence information so conveyed must still be included in a "Sequence Listing” and the sequence identifier (“SEQ ID NO:X”) must be used, either in the drawing or in the “Brief Description” of the Drawings. Figures 12-14 comprises sequences without sequence identifiers. There are no sequence identifiers listed in Figure 12-14 or the description of Figures 12-14. 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 Objections
Claim 1 is objected to for the following informality: the limitation of “Huntintin” should be replaced with -Huntingtin-.
Claim 13 is objected to for the following informality: the sequence of MMNGMSQ in line 10 should be removed from the claim (for consistency) given that the claim throughout recites the SEQ ID NO alone without the sequences.
Claim Rejections - 35 USC § 112, First Paragraph
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 1-2, 6-9, 11, 13-14, 28 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
Scope of the claims
Claims 1-2, 6-9, 11, 13-14, 28 are directed to a peptide agent comprising one or more peptides defined by SEQ ID Nos:1-8 (defined amino acid sequences) or SEQ ID Nos:9-12 (which are variable sequences with many potential sequences encompassed SEQ ID Nos:9-12). SEQ ID NO:9 encompasses peptides having multiple variable amino acid positions, thereby defining a genus of structurally distinct peptide sequences. Claim 2 further recites that the one or more peptides comprise one or more conservative amino acid substitutions.
Please note that regarding claim 13, Figure 17 depicts peptide constructs and explicit amino acid sequences (e.g., HD8–Q–HD8; HD1–SP4–HD1) that do not consistently correspond to the peptide sequences recited in claim 13 or to the sequences as set forth in the sequence listing. Certain constructs shown in Figure 17 appear to include spacer sequences or residue arrangements that are not clearly identified by a corresponding SEQ ID NO in the claims or the sequence listing.
Where the specification, figures, and sequence listing describe differing peptide structures without clear reconciliation, the scope of the claimed peptide constructs cannot be determined with reasonable certainty. Claim 13 fails to clearly define the structure of the recited peptide constructs and is inconsistent with the sequences depicted in the specification and sequence listing.
Therefore, to meet the written description requirement of 35 U.S.C. § 112, first paragraph, the specification must disclose a representative number of species that meet both the structural and functional limitations of the genus or the specification and/or the prior art must identify the structural elements that correlate to the claimed function in a manner that demonstrates to one of ordinary skill in the art that Applicant was in possession of the claimed genus at the time the application was filed.
Accordingly, the scope of the claims encompasses all peptides falling within SEQ ID Nos1-12, including SEQ IDNO:9 which is the most broad, in addition to additional conservative substitutions that satisfy the selective binding function, including peptides not expressly exemplified in the specification. Furthermore, there is some confusion regarding the term “peptide agent” and what it actually encompasses (see below rejection).
Actual Reduction to Practice
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The specification demonstrates actual reduction to practice for specific peptide species, including HD1-HD8 (SEQ ID NOS:1-8) and certain individual substituted variants thereof (see claims 3-5). These peptides were identified, synthesized, and experimentally evaluated for binding to unbundled Huntington exon-1 fibrils using biochemical, biophysical, and cell based assays. However, the specification does not demonstrate actual reduction to practice for the full scope of peptides encompassed by SEQ ID Nos:9-12, including one or more conservative substitutions thereof (at multiple positions). Reduction to practice of a limited number of species does not establish possession of the entire claimed genus. The specification includes alanine scanning analyses of HD1 and HD8 (e.g. figures 12-13), which demonstrates that substitution of individual residues with alanine can substantially reduce or abolish binding to unbundled Huntingtin exon-1 fibrils. These results confirm that the claimed selective binding function is highly dependent on precise amino acid identity and position. However, the alanine scanning data do not establish a general structure function relationship applicable across the full scope of peptides encompassed by SEQ IDNOs:9-12 and variants thereof. Rather, the data show the unpredictability of binding outcome upon sequence modification and fail to identify common structural features or substitution rules that would enable a person of ordinary skill in the art to recognize which peptides within the claimed genus (which is inclusive to further variants due to claim 2) would have the selective binding.
Therefore, the instant specification has failed to meet the written description requirement by actual reduction to practice of a representative number of species alone.
Sufficient relevant identifying characteristic
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination thereof.
While the specification discloses certain conservative substitutions for specific peptides (e.g. SEQ ID NO1 and 8 variants), it does not provide objective structural criteria defining which conservative substitutions within SEQ ID Nos:9-12 preserves selective binding. The disclosure does not identify which amino acid positions tolerate substitution across the full genus, nor does it define limits on the number or combination of conservative substitutions that maintain the claimed binding function. The term “conservative amino acid substitution” as recited in claim 2, is itself structurally broad and encompasses numerous amino acid replacements with differing physicochemical properties. The specification does not describe sufficient characteristics to distinguish peptides within SEQ ID Nos:1-12 that selectively bind unbounded fibrils from those that do not.
Physical/Chemical Properties
The specification describes physical and chemical properties (peptide length, synthesis, labeling and multimerization) for specific exemplified peptides and selected variants. However, the specification does not establish that peptides across the full scope of SEQ ID Nos:1-12 with conservative substitutions share common physical or chemical properties that correlate with selective binding to unbundled Huntington exon-1 fibrils.
The specification further illustrates the lack of sufficient identifying characteristics for the claimed genus through comparison with the previously reported peptide QBP1. As described in paragraphs [0139]–[0140] and FIG. 7, QBP1 binds unbundled Huntingtin fibrils above background levels, yet exhibits greater than ten-fold lower binding relative to HD1 and HD8. Thus, the specification acknowledges the existence of peptides that bind unbundled Huntingtin fibrils, but do not exhibit the degree of selective binding demonstrated by HD1 and HD8.
The claims, however, encompass peptides defined by SEQ ID NO:9 that selectively bind unbundled Huntingtin exon-1 fibrils, without providing structural criteria distinguishing peptides that exhibit HD1/HD8-like selectivity from peptides that behave more like QBP1. The disclosure does not identify common structural features, sequence motifs, or substitution patterns within SEQ ID NO:9 that correlate with the claimed selective binding, nor does it provide guidance sufficient to allow a person of ordinary skill in the art to recognize which peptides within the claimed scope would satisfy the functional limitation.
Functional characteristics when coupled with a known or disclosed correlation between function and structure:
The specification demonstrates that certain specific peptides selectively bind unbundled Huntingtin exon-1 fibrils. The disclosure further shows that some substitutions diminish or abolish binding, indicating that binding is highly sequence-dependent. However, the specification does not disclose a predictive structure–function relationship that would allow a person of ordinary skill in the art to determine which peptides within SEQ ID Nos:1-12, including those comprising one or more conservative amino acid substitutions as recited in claim 2, will retain the claimed selective binding. Functional language alone does not establish written description of a structurally diverse genus absent disclosure of common structural features correlating structure with function.
The comparison to QBP1 further demonstrates that binding to unbundled Huntingtin fibrils alone is insufficient to define the claimed genus. The specification expressly distinguishes HD1 and HD8 from QBP1 based on the magnitude of binding and selectivity, indicating that selective binding is a quantitative and sequence-dependent property. However, the specification does not disclose a predictive structure–function relationship explaining why certain peptide sequences exhibit HD1/HD8-like selectivity while other peptides, including known binders such as QBP1, do not.
In the absence of such disclosed correlation, the specification fails to demonstrate possession of peptides within SEQ ID NO:9 that exhibit the claimed selective binding across the full scope of the genus. Functional characterization of a limited number of peptides does not establish written description for a structurally diverse class where binding behavior varies significantly among members.
Method of Making
The specification discloses general methods for synthesizing, modifying, and testing peptides. While these methods enable the making and evaluation of peptides, the ability to synthesize and screen peptides does not demonstrate possession of the full scope of the claimed genus.
Conclusion
The specification demonstrates possession of specific peptide species and certain individual conservative substitutions thereof. However, the claims encompass a broad genus of peptides defined by SEQ ID Nos:9-12 and further expanded by conservative amino acid substitutions, without sufficient disclosure of representative species or common structural features correlating structure with the claimed selective binding function across the full scope.
Accordingly, the specification does not reasonably convey to a person of ordinary skill in the art that the inventors were in possession of the full scope of the claimed invention at the time of filing, and Claims 1-2, 6-9, 11, 13-14, 28 therefore fail to satisfy the written description requirement of 35 U.S.C. §112(a).
Claim Rejections - 35 USC § 112
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 1-2, 6-9, 11, 13-14, 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-2, 6-9, 11, 13-14, 28 are indefinite because the application was filed under WIPO standard ST.26 and SEQ ID NO: 9-11 do not meet the criteria for mandatory inclusion criteria for a sequence listing under MPEP 2412.05. As a result, the sequence listing contains only a placeholder identification such at “000” and no corresponding sequence data in the sequence listing for those SEQ ID Nos. When Applicant intentionally skips a sequence, reference to that SEQ ID NO should be deleted from the disclosure and claims. However, in the instant case, the SEQ ID Nos are in the disclosure and claims. To overcome this rejection, Applicants should delete the SEQ ID Nos from the disclosure and claims. Please note that the claim will require the complete sequence formula. Please also note that SEQ ID NO:12 has four or more amino acids and thus, requires a sequence listing under ST26 and “000” is no acceptable.
Furthermore, there is some confusion regarding the term “peptide agent” and the specification does not provide any specific definitions or guidance. The claim recites “a peptide agent” (and, in dependent claims, “a peptide agent comprising two or more of the peptides”) without specifying whether the peptide agent is a single peptide, a covalently linked multi-peptide construct, or a mixture of separate peptides. The specification describes each of these as distinct embodiments (see ¶[0045]–[0047]). Because the claim does not delineate which embodiment is required, the scope of the claim cannot be determined with reasonable certainty. See MPEP §2173.02.
Claim 8 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Claim 8 recites 'the linker,' but Claim 7, from which it depends, recites 'one or more linkers.' There is no singular 'linker' in Claim 7 to provide antecedent basis for 'the linker' in Claim 8. It is unclear if 'the linker' refers to each and every linker present or only a specific one." It is suggested that applicant amend the claim to refer to “wherein the one or more linker” or “wherein at least one linker” or “wherein each linker” to clarify this point of confusion.
Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Claim 9 recites 'the linker,' but Claim 7, from which it depends, recites 'one or more linkers.' There is no singular 'linker' in Claim 7 to provide antecedent basis for 'the linker' in Claim 9. It is unclear if 'the linker' refers to each and every linker present or only a specific one." It is suggested that applicant amend the claim to refer to “wherein the one or more linker” or “wherein at least one linker” or “wherein each linker” to clarify this point of confusion.
Claim 9 is rejected under 35 U.S.C. 112(b) as being indefinite. Claim 9 recites linker sequences selected from GSGTSGSS (SEQ ID NO:35), ASGTSGSS (SEQ ID NO:36), GAGTSGSS (SEQ ID NO:37), GSATSGSS (SEQ ID NO:38) and GSGTSGSSGS (SEQ ID NO:50). However, SEQ ID NO:35 identified in claim 9 does not correspond to the sequence as set forth in the sequence listing. Because the claimed linker sequence is inconsistent with the sequence listing, the scope of claim 9 cannot be determined with reasonable certainty.
Claim 11 recites "two or more of the one or more peptides." The use of a numerical limitation ("two or more") nested within a reference to a previously defined numerical range ("the one or more peptides" from Claim 1) creates a circular and confusing limitation. It is unclear if the applicant intends to narrow the quantity of the peptide units or the variety of the peptide sequences. For example, if the one or more is 5 peptides, the two or more of the one or more could be actually 10 peptides. Furthermore, the claim could also be interpreted that applicants are just further defining that there has to be two or more peptides (no longer inclusive to one peptide). Applicant should clarify this point of confusion.
A suggested claim amendment would be “Claim 11 (Amended): The peptide agent of claim 7, comprising at least two of said peptides connected by said one or more linkers.”
Claim 28 is rejected for the following reason. Claim 1 requires the agent to comprise sequences (SEQ ID NOs: 1-8) that are 10 amino acids long. Claim 28 limits the length to "10 amino acids or less."
This creates a logical contradiction: a peptide of 9 amino acids or "less" cannot physically contain (comprise) the 10-amino acid sequence required by Claim 1. Because the "less" portion of the range is inoperable and inconsistent with the parent claim, the metes and bounds of the invention are unclear. MPEP 2173.05(c).
Claim 13 recites specific peptide constructs comprising multiple peptide domains joined by intervening elements, expressed using shorthand notations such as “HD1–SP5–HD8,” “HD8–Q–HD8,” “HD1–HD1,” and “HD1–SP4–HD1.” However, the claim fails to define with reasonable certainty the structural requirements of these constructs. More specifically, there are undefined and Inconsistently characterized Linkers. Claim 13 recites multiple intervening elements (e.g., SP5, SP10, SP4, Q), but does not clearly define whether these elements are peptide linker, individual amino acids, spacers, mandatory components etc…This is further evidenced by the specification not defining the characters and having conflicting sequence information. In particular, there is conflict between Claim 13, Figure 17, and the Sequence Listing.
Figure 17 depicts peptide constructs and explicit amino acid sequences (e.g., HD8–Q–HD8; HD1–SP4–HD1) that do not consistently correspond to the peptide sequences recited in claim 13 or to the sequences as set forth in the sequence listing. Certain constructs shown in Figure 17 appear to include spacer sequences or residue arrangements that are not clearly identified by a corresponding SEQ ID NO in the claims or the sequence listing.
Where the specification, figures, and sequence listing describe differing peptide structures without clear reconciliation, the scope of the claimed peptide constructs cannot be determined with reasonable certainty. Accordingly, because claim 13 fails to clearly define the structure of the recited peptide constructs and is inconsistent with the sequences depicted in the specification and sequence listing, the metes and bounds of the claim are unclear, rendering claim 13 indefinite under 35 U.S.C. §112(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 is dependent on claim 1. Claim 1 is directed to a peptide agent comprising specific amino acid sequences (SEQ ID NOs: 1–12). Claim 2, however, claims the peptide agent of Claim 1 "wherein the one or more peptides comprise one or more conservative amino acid substitutions." By allowing for substitutions, Claim 2 encompasses a genus of peptides that are not literally present in Claim 1. For example, if a prior art reference discloses a peptide that differs from SEQ ID NO: 1 by a single conservative substitution (e.g., Leucine for Valine), this prior art would fall within the scope of Claim 2 but would not fall within the literal scope of Claim 1. Because Claim 2 encompasses embodiments that are excluded by the specific sequence limitations of Claim 1, it does not "further limit" Claim 1 as required by the MPEP § 608.01(n). Instead, it attempts to broaden the scope of the independent claim by removing the strict requirement for the exact sequences listed.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fontana (W02002079243 A2).
Fontana teaches a peptide comprising SEQ ID NO:9 (see SEQID NO:1796, in the attached sequence. The peptide of Fontana comprises the sequence MHFRHQRASR which falls within the scope of instant SEQ ID NO:9. Regarding the limitation of “selectively binds to unbundled fibrils of Huntingtin exon 1”, While Fontana may not explicitly state this specific binding preference, the property is inherent to the peptide sequence (see MPEP2112) The peptide taught by Fontana is identical to instant SEQ ID NO:9 and thus necessarily has the same property of binding unbundled fibrils of Huntington exon 1.
Claim(s) 1 and 14 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitcham (WO2003033515 A1).
Mitcham teaches a peptide comprising SEQ ID NO:9 (see SEQID NO:25800, in the attached sequence. The peptide of Mitcham comprises the sequence MLRRTLRRPP which falls within the scope of instant SEQ ID NO:9. Regarding the limitation of “selectively binds to unbundled fibrils of Huntingtin exon 1”, While Mitcham may not explicitly state this specific binding preference, the property is inherent to the peptide sequence (see MPEP2112). The peptide taught by Mitcham is identical to instant SEQ ID NO:9 and thus necessarily has the same property of binding unbundled fibrils of Huntington exon 1.
Regarding claim 14, the peptide of Mitcham is a 92mer which is less than 100 amino acids.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fontana (W02002079243 A2).
Fontana teaches a peptide comprising SEQ ID NO:9 (see SEQID NO:1796, in the attached sequence. The peptide of Fontana comprises the sequence MHFRHQRASR which falls within the scope of instant SEQ ID NO:9. Regarding the limitation of “selectively binds to unbundled fibrils of Huntingtin exon 1”, While Fontana may not explicitly state this specific binding preference, the property is inherent to the peptide sequence (see MPEP2112) The peptide taught by Fontana is identical to instant SEQ ID NO:9 and thus necessarily has the same property of binding unbundled fibrils of Huntington exon 1.
Regarding claim 6, given the broadest reasonable interpretation of a “peptide agent” (and without any specific definition), this could be inclusive to a peptide comprising but also a composition comprising a mixture and thus, a peptide agent comprising two, three or four of the peptides do not have to be in the same peptide itself but could be in a mix in a composition (see paragraph 0047). Duplication of parts (in this case peptides) is obvious. Although the reference did not disclose a plurality of the peptides, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144) and thus is obvious.
Claim(s) 1, 6-8, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mitcham (WO2003033515 A1).
Mitcham teaches a peptide comprising SEQ ID NO:9 (see SEQID NO:25800, in the attached sequence. The peptide of Mitcham comprises the sequence MLRRTLRRPP which falls within the scope of instant SEQ ID NO:9. Regarding the limitation of “selectively binds to unbundled fibrils of Huntingtin exon 1”, While Mitcham may not explicitly state this specific binding preference, the property is inherent to the peptide sequence (see MPEP2112).
Regarding claim 14, the peptide of Mitcham is a 92mer which is less than 100 amino acids. Regarding claim 7, Mitcham teaches wherein the polypeptides of the invention can include a linker for ease of synthesis, purification or identification (e.g. His tag) (see page 96, bottom, into page 97). Regarding claim 8, Mitcham teaches linkers comprising Glycine and serine residues (see page 98, last paragraph). It would have been obvious before the effective filing date of the claimed invention to modify the peptide disclosed by Mitcham to include a linker. One of ordinary skill in the art would have been motivated to do so given Mitcham teaches that polypeptides of the invention may include linkers or tags to ease synthesis, purification, or identification and the use of such linkers or tags in peptide constructs is well known, routine and convention in the art. The claim modification therefore represents the predictable use of a known technique to a known peptide to achieve a known result (purification and improved handling). Regarding claim 6, given the broadest reasonable interpretation of a “peptide agent” (and without any specific definition), this could be inclusive to a peptide comprising but also a composition comprising a mixture and thus, a peptide agent comprising two, three or four of the peptides do not have to be in the same peptide itself but could be in a mix in a composition (see paragraph 0047). Duplication of parts (in this case peptides) is obvious. Although the reference did not disclose a plurality of the peptides, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced MPEP 2144.
Furthermore, Mitcham teaches including multiple peptides of the invention (see page 97, bottom paragraph)
.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654