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
Claim Status
Claims 1-8 and 10-14 are pending. Claim 9 has been canceled. In the response to the restriction requirement, Applicants elected Group I and SEQ ID NO: 13.
Applicants elected species (i.e. SEQ ID NO: 13) was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that rendered it obvious. As a result, claims 1, 3, 5-7 and 12 have been examined and claims 2, 4, 8, 10-11 and 13-14 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Terminal Disclaimer
The terminal disclaimer filed on 11/13/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US11242369 and US11981710 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112
The rejection of claim 9 under 35 USC 112(a) is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 3, 5-7 and 12 under 35 U.S.C. 102(a)(2) as being anticipated by Binz et al. is withdrawn in view of Applicant’s arguments.
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.
This rejection is maintained.
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minter et al. (WO 2016/023898).
With respect to claim 1, Minter et al. teach a Designed Ankyrin Repeat Protein (DARPin) that specifically binds to an antigen, the DARPin comprising an N-terminal cap section, at least two Ankyrin Repeat (AR) module sections, and a C-terminal cap section, characterized in that the DARPin has a charge that is less negative than the DARPin of SEQ ID NO: 1, excluding the charge contribution of the variable antigen-binding residues (claim 1), wherein the DARPin has an amino acid substitution at one or more of amino acid residues D15, E17, 120, G25, D27, L48, E49, E52, D60, N62, L81, E82, E85, D93, N95, L114, E115, E118, D126, N128, D143, E147, D148 and/or E151, numbered relative to SEQ ID NO: 1 (claims 10-11).
Given the finite possibilities (4 out of 19 (i.e. 20 amino acids minus D)), one of ordinary skill in the art would have at once envisaged D15 substituted with I, A, V or M as instantly claimed.
With respect to claim 7, the resulting sequence (i.e. SEQ ID NO: 1 wherein D15 is substituted with I, A, V or M) comprises A at position 23.
Response to Arguments
Applicant’s arguments filed on 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that “[M]inter et al. broadly discuss reducing net negative charge in designed ankyrin repeat proteins by altering various acidic residues distributed throughout the scaffold. The reference lists at least 24 potential residues, one of which is position 15 (see claim 1 of Minter et al.), without any indication of its importance, particularly with respect to thermal stability. Further, specific substitutions taught by Minter for this position are E, K or N. Nothing in Minter teaches or enables substitution of D at position 15 of the N-terminal capping module with I, V, M or A as claimed. Accordingly, Minter clearly does not show the identical invention in as complete detail as is contained in the claim to either expressly or inherently describe the invention and therefore fails to anticipate the claimed invention”.
Applicant also argues that “[M]inter does not teach all the elements of the claims. The reference also does not offer any motivation or reasonable expectation that the specific mutations as claimed would increase thermostability. Applicant has demonstrated that the claimed mutations yield a surprising increase in thermal stability, an effect wholly absent and unexpected from Minter's teaching”.
Applicant’s arguments are not persuasive because Minter et al. clearly teach a Designed Ankyrin Repeat Protein (DARPin) having an amino acid substitution at one or more of amino acid residues D15, E17, 120, G25, D27, L48, E49, E52, D60, N62, L81, E82, E85, D93, N95, L114, E115, E118, D126, N128, D143, E147, D148 and/or E151, numbered relative to SEQ ID NO: 1.
The MPEP 2141 states that rationales to support rejections under 35 U.S.C. 103 include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In the instant case, given the finite possibilities (4 out of 19 (i.e. 20 amino acids minus D)), it would have been "Obvious to try" to substitute D15 with I, A, V or M in the DARPin of Minter et al., and thus arrive at the instantly claimed invention.
With respect to Applicant’s alleged unexpected results, the MPEP 716.02(d) states that unexpected results must be commensurate in scope with the claimed invention. In the instant case they are not.
The specification exemplifies the thermal stability of SEQ ID NOs: 93-95, 101 and 108-109 (see Figs. 1-3). However, it is noted that said SEQ ID NOs: 93-95, 101 and 108-109 comprise D, L or V at the position corresponding to position 15 of SEQ ID NO: 3. Therefore, the alleged unexpected results are NOT commensurate in scope with the claimed invention.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
Claims 1, 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Minter et al. (WO 2016/023898).
The teachings of Minter et al. with respect to claims 1 and 7 have been discussed above.
Minter et al. does not teach a pharmaceutical composition comprising the protein and a pharmaceutically acceptable carrier.
However, Minter et al. suggest using DARPin antibodies as drug for the treatment of various diseases (page 1, 3rd para).
Therefore, one of ordinary skill in the art would have been motivated to make a pharmaceutical composition comprising the protein (i.e. the DARPin antibody) and a pharmaceutically acceptable carrier.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
This rejection is maintained.
Claims 1 and 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 79-108 of copending Application No. 18/174086 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same protein.
With respect to claim 1, ‘086 teaches 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 (claim 79).
It is noted that position 17 of SEQ ID NO: 5, 6 or 7 corresponds to position 15 of instantly claimed SEQ ID NO: 3. SEQ ID NOs: 5-7 of ‘086 have amino acid sequences which have 83.33%, 86.66% and 90% sequence identity, respectively, with instantly claimed SEQ ID NO: 3 (see alignment below).
DLGKKLLEAARAGQXDEVRILMANGADVNA (instant SEQ ID NO: 3; X is I, A, V or M).
GSDLGKKLLQAARAGQXDEVRELLKAGADVNA (SEQ ID NO: 5)
GSDLGKKLLQAARAGQXDEVRILLKAGADVNA (SEQ ID NO: 6)
GSDLGKKLLQAARAGQXDEVRILLAAGADVNA (SEQ ID NO: 7).
With respect to claim 5, SEQ ID NO: 5 has E at position 20 relative to instant SEQ ID NO: 3.
With respect to claim 6, SEQ ID NOs: 5-7 have L at position 22 relative to instant SEQ ID NO: 3.
With respect to claim 7, SEQ ID NOs: 6-7 have A or K at position 23 relative to instant SEQ ID NO: 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that the present application has a different inventive entity to copending Application No. 18/174086.
Applicant’s arguments are not persuasive because copending Application No. 18/174086 and the instant application have a common applicant (see MPEP 804).
Therefore, the rejection on the ground of nonstatutory double patenting is proper.
For the reasons stated above the rejection is maintained.
This rejection is maintained.
Claims 1 and 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 18/153576 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same protein.
With respect to claim 1, ‘576 teaches a designed ankyrin repeat domain comprising an N-terminal capping module having a glutamine (Q) at a position corresponding to position 8 of SEQ ID NO: 69 and/or a leucine (L), valine (V), isoleucine (I), methionine (M) or alanine (A) at a position corresponding to position 15 of SEQ ID NO: 69 (claim 16).
SEQ ID NO: 69 of ‘576 has an amino acid sequence which has 86.66% sequence identity with instantly claimed SEQ ID NO: 3 (see alignment below).
DLGKKLLEAARAGQXDEVRILMANGADVNA (instant SEQ ID NO: 3; X is I, A, V or M).
DLGKKLLXAARAGQXDEVRELLKAGADVNA (SEQ ID NO: 69, wherein X at position 8 is E or Q, and wherein X at position 15 is L, V, I, M or A).
With respect to claim 5, SEQ ID NO: 69 has E at position 20 relative to instant SEQ ID NO: 3.
With respect to claim 6, SEQ ID NO: 69 has L at position 22 relative to instant SEQ ID NO: 3.
With respect to claim 7, SEQ ID NO: 69 has K at position 23 relative to instant SEQ ID NO: 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that the present application has a different inventive entity to copending Application No. 18/153576.
Applicant’s arguments are not persuasive because copending Application No. 18/153576 and the instant application have a common applicant (see MPEP 804).
Therefore, the rejection on the ground of nonstatutory double patenting is proper.
For the reasons stated above the rejection is maintained.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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