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
This Non-Final Office Action is responsive to the communication received 11/24/2025.
Election/Restrictions
Applicant’s election with traverse in the Reply filed on 11/24/2025 of Group VII, Claim(s) 96-105 is acknowledged.
In view of the Applicant's arguments, the Restriction Requirement between all groups has been withdrawn.
Applicant has elected in the Reply filed on 11/24/2025 the following species:
A. the amino acid sequence of the N-terminal capping module is SEQ ID NO 5 (claim 96)
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Election Requirements are thus deemed proper and are made FINAL.
Claims 79-108 are pending.
Claims 84-87, 91, 101-105 and 108 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 11/24/2025.
Claims 79-83, 88-90, 92-100 and 106-107 are under examination in this Office Action.
Claim Rejections - 35 USC § 112 (New Matter)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ):
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 79-83, 88-90, 92-100 and 106-107 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. Claims 80-83, 88-90, 93-95, 97-100 and 107 depend directly or indirectly from claims 79, 92, 96 or 106.
New claim 79 states "A library comprising designed ankyrin repeat proteins, wherein said designed ankyrin repeat proteins comprise an N-terminal capping module having the amino acid sequence of SEQ ID NO: 5, 6 or 7, wherein leucine (L) at position 17 of SEQ ID NO: 5, 6 or 7 is optionally substituted with valine (V), isoleucine (I), methionine (M), or alanine (A), and wherein G at position 1 and/or S at position 2 of SEQ ID NOs: 5 to 7 are optionally missing."
New claim 92 states "A library comprising designed ankyrin repeat proteins, wherein said designed ankyrin repeat proteins comprise an N-terminal capping module having a leucine (L), valine (V), isoleucine (I), methionine (M), or alanine (A) at a position corresponding to position 17 of SEQ ID NO: 5."
New claim 96 states "A designed ankyrin repeat protein comprising an N-terminal capping module having the amino acid sequence of SEQ ID NO: 5, 6 or 7, wherein leucine (L) at position 17 of SEQ ID NO: 5, 6 or 7 is optionally substituted with valine (V), isoleucine (I), methionine (M), or alanine (A), and wherein G at position 1 and/or S at position 2 of SEQ ID NOs: 5 to 7 are optionally missing."
New claim 106 states "A designed ankyrin repeat protein comprising an N-terminal capping module having a leucine (L), valine (V), isoleucine (I), methionine (M), or alanine (A) at a position corresponding to position 17 of SEQ ID NO: 5."
Applicant cites page 6 lines 21-22 in the originally filed specification for support (corresponding to [0023] in the instant PG Publication) in the Reply filed 8/2/2021.
At this location the specification states "In one particular aspect, the invention provides such a recombinant binding protein comprising a first ankyrin repeat domain with binding specificity for a first target peptide-MHC complex, wherein said first ankyrin repeat domain comprises an N-terminal capping module having an amino acid sequence wherein the amino acid at position 8 is Q and/or the amino acid at position 15 is L, wherein said position numbers of positions of the N-terminal capping module are determined by alignment to SEQ ID NO: 276 using the position numbers of SEQ ID NO: 276. SEQ ID NO: 276 is an N-terminal capping module that is identical to SEQ ID NO: 5, except that the G at position 1 and the S at position 2 of SEQ ID NO: 5 are missing. Thus, position 8 in SEQ ID NO: 276 corresponds to position 10 in SEQ ID NO: 5, and position 15 in SEQ ID NO: 276 corresponds to position 17 in SEQ ID NO: 5. In other words, said first ankyrin repeat domain comprises an N-terminal capping module having an amino acid sequence wherein the amino acid at position 10 is Q and/or the amino acid at position 17 is L, wherein said position numbers of positions of the N-terminal capping module are determined by alignment to SEQ ID NO: 5 using the position numbers of SEQ ID NO: 5. Preferably, said alignment comprises no amino acid gaps. Sequence alignment generation is a procedure well known in the art."
Applicant cites page 71 lines 24-29 in the originally filed specification for support (corresponding to [0293] in the instant PG Publication) in the Reply filed 8/2/2021.
At this location the specification states "Methods to generate designed ankyrin repeat protein libraries have been described, e.g. in U.S. Pat. No. 7,417,130; Binz et al. 2003, loc. cit.; Binz et al. 2004, loc. cit. By such methods designed ankyrin repeat protein libraries having randomized ankyrin repeat modules and/or randomized capping modules can be constructed. For example, such libraries could accordingly be assembled based on a fixed N-terminal capping module (e.g. the N-terminal capping module of SEQ ID NO: 5, 6 or 7) or a randomized N-terminal capping module according to SEQ ID NO: 8, one or more randomized repeat modules according to the sequence motif of SEQ ID NO: 9, 10 or 11, and a fixed C-terminal capping module (e.g. the C-terminal capping module of SEQ ID NO: 12, 13 or 14) or a randomized C-terminal capping module according to SEQ ID NO: 15. Preferably, such libraries are assembled to not have any of the amino acids C, G, M, N (in front of a G residue) and P at randomized positions of repeat or capping modules. In addition, randomized repeat modules according to the sequence motif of SEQ ID NO: 9, 10 or 11 could be further randomized at position 10 and/or position 17; the randomized N-terminal capping module according to the sequence motif of SEQ ID NO: 8 could be further randomized at position 7 and/or position 9; and the randomized C-terminal capping modules according to the sequence motif of SEQ ID NO: 15 could be further randomized at positions 10, 11 and/or 17."
The cited support is not commensurate in scope with the current claims. The disclosure contains a number of limitations such as, "valine (V), isoleucine (I), methionine (M), or alanine (A) at a position corresponding to position 17" that are not contained in the instant claims.
Claim Rejections - 35 USC § 112-1st paragraph (Written Description)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ):
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 88-90 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses chemicals, such as a designed ankyrin repeat protein has an amino acid sequence selected from SEQ ID NOs: 20-22, 29-33, 96, 105-110 and 167-173 which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 88-90 is(are) directed to encompass ankyrin repeat proteins selected from a library, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these ankyrin repeat proteins selected from a library, meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of ankyrin repeat proteins selected from a library. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claims 94-95 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. Claim 95 depends directly or indirectly from claim 94.
The specification discloses chemicals, such as a designed ankyrin repeat protein has an amino acid sequence selected from SEQ ID NOs: 20-22, 29-33, 96-97, 105-110 and 167-173 which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 94 is(are) directed to encompass ankyrin repeat proteins selected from a library, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these ankyrin repeat proteins selected from a library, meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of ankyrin repeat proteins selected from a library. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claims 106-107 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention. Claim 107 depends directly or indirectly from claim 106.
The specification discloses chemicals, such as a designed ankyrin repeat protein has an amino acid sequence selected from SEQ ID NOs: 20-22, 29-33, 96-97, 105-110 and 167-173 which meet the written description and enablement provisions of 35 USC 112, first paragraph. However, claim(s) 106-017 is(are) directed to encompass ankyrin repeat proteins, which only correspond in some undefined way to specifically instantly disclosed chemicals. None of these ankyrin repeat proteins meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus encompassed by the claim.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed derivatives, analogs, etc., regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmacentical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 USC § 112, first paragraph. A search of the prior art fails to identify any examples of ankyrin repeat proteins. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
Claim Rejections - 35 USC § 102
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.
Claims 106-107 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCBI Reference Sequence: XP_022289373.1, tankyrase-1-like [Crassostrea virginica] (09/14/2017) https://www.ncbi.nlm.nih.gov/protein/xp_022289373.1 pages 1 to 2 cited in the 2/24/2023 IDS (hereinafter referred to as "NCBI Reference Sequence: XP_022289373.1").
With regards to claims 106-107, NCBI Reference Sequence: XP_022289373.1 teaches:
a) as in claims 106-107, a designed ankyrin repeat protein comprising an N-terminal capping module having a leucine (L) at a position corresponding to position 17 of SEQ ID NO: 5 (see entire document).
Thus, NCBI Reference Sequence: XP_022289373.1 anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684