Prosecution Insights
Last updated: October 25, 2026
Application No. 17/628,142

SEPARATED PEPTIDE

Final Rejection §103§112
Filed
Jan 18, 2022
Priority
Jul 18, 2019 — JP 2019-132490 +1 more
Examiner
NIEBAUER, RONALD T
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
National University Corporation Tokai National Higher Education and Research System
OA Round
4 (Final)
41%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
75%
With Interview

Examiner Intelligence

Grants 41% of resolved cases
41%
Career Allowance Rate
299 granted / 732 resolved
-19.2% vs TC avg
Strong +34% interview lift
Without
With
+34.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
59 currently pending
Career history
804
Total Applications
across all art units

Statute-Specific Performance

§101
7.4%
-32.6% vs TC avg
§103
26.4%
-13.6% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
29.2%
-10.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 732 resolved cases

Office Action

§103 §112
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 . Election/Restrictions and Claim Status Applicants’ amendments and arguments filed 8/11/26 are acknowledged. Any objection or rejection from the 3/11/26 office action that is not addressed below is withdrawn based on the amendments. Previously, SEQ ID NO:5, streptavidin and AVL were elected. Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution. Claim 15 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/10/24. Claims 1-11 and 13 have been canceled. Claims 12, 14 and 16-21 are being examined. Priority The priority information is found in the filing receipt dated 12/6/22. Information Disclosure Statement The information disclosure statement (IDS) submitted on 8/25/26 has been considered by the examiner. Claim Rejections - 35 USC § 112 Claims were previously rejected under 112. Since the claims have been amended, the rejection is updated to correspond to the instant claims. 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 12, 14 and 16-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: “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 (Fed. Cir. 1997); In re Gostelli, 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.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below. Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art. (1) Scope of the invention/Partial structure/disclosure of drawings: Claim 12 requires at least a first subject, a second subject and a separating peptide. With respect to the first subject, claim 12 refers to 70% identity to positions 2 to 258 of SEQ ID NO:1. Varying 30% of the sequence allows for variations at 76 positions (.3x(258-2)). When 76 of the amino acids are varied to any of the 20 standard amino acids there are at least 2076 (75,557,863,725,914,323,419,136,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000) different possible polypeptides. Claim 12 merely states that the second subject is a support and dependents 16-21 provide no additional description at all of the second subject. Claim 14 refers to variants with 90% identity. Streptavidin and avidin are over 100 amino acids in length so at least 10 positions are not required to be identical. When 10 of the amino acids are varied to any of the 20 standard amino acids there are at least 2010 (10240000000000) different possible polypeptides. (2) Level of skill and knowledge in the art/predictability in the art: The level of skill in the art is high. With respect to the mechanism of action, Ohara et al. (cite 14 of IDS 1/18/22) suggests that inhibition is due to the LB medium (page 554 last paragraph). However, no adequate direction is provided as to how such mechanism of action would relate to releasing for the scope of polypeptides and subjects as claimed. (3) Physical and/or chemical properties and (4) Functional characteristics: Instant claim 12 recites ‘bound together’ and ‘to release’. There is no adequate specific disclosed correlation between structure and function particularly related to what structures are adequate to result in the functions as recited in the claims. Further, there is no adequate disclosure of which variants would allow for the required function. With respect to the mechanism of action, Ohara et al. (cite 14 of IDS 1/18/22) suggests that inhibition is due to the LB medium (page 554 last paragraph). However, there is no adequate disclosure as to which variants (of the many discussed above) would be suitable for this mechanism of action. It is not adequately set forth as to which polypeptide residues can be varied and what they can be varied to while allowing for the claimed function. Claim 12 refers to 70% identity to positions 2 to 258 of SEQ ID NO:1. Varying 30% of the sequence allows for variations at 76 positions (.3x(258-2)). When 76 of the amino acids are varied to any of the 20 standard amino acids there are at least 2076 (75,557,863,725,914,323,419,136,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000) different possible polypeptides. It is also not adequately set forth as to what features of a second subject or what residues of streptavidin are required to result in the desired functionality. There is no adequate disclosure of what positions can be substituted and how they can be substituted and what can be varied for the first and second subjects. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that there is a lack of the predictability in the art thus that the applicant was not in possession of the claimed genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that there is a lack of the predictability in the art thus that the applicant was not in possession of the claimed genus. (5) Method of making the claimed invention/actual reduction to practice: The specification (figure 2) provides a specific example. However, a limited number of examples does not show what substitutions, deletions, insertions or additions would have the same function. Further, the example is not representative of any and all types of second subjects or modified sequences of SEQ ID NO:1. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. Response to Arguments - 112 Applicant's arguments filed 8/11/26 have been fully considered but they are not persuasive with respect to the rejections set forth above. Although applicants argue about claim amendments, the amended claims are addressed above. Although applicant argue about an example, the example is not representative of any and all types of second subjects or modified sequences of SEQ ID NO:1. With respect to the first subject, claim 12 refers to 70% identity to positions 2 to 258 of SEQ ID NO:1. Varying 30% of the sequence allows for variations at 76 positions (.3x(258-2)). When 76 of the amino acids are varied to any of the 20 standard amino acids there are at least 2076 (75,557,863,725,914,323,419,136,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000) different possible polypeptides. Although applicants argue that certain positions are associated with adhesion, claim 12 refers to 70% identity to positions 2 to 258 of SEQ ID NO:1. Varying 30% of the sequence allows for variations at 76 positions (.3x(258-2)). When 76 of the amino acids are varied to any of the 20 standard amino acids there are at least 2076 (75,557,863,725,914,323,419,136,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000) different possible polypeptides. There is no adequate disclosure of which of these polypeptides would retain the requisite activity upon substitution. It is not adequately set forth as to where substitutions are acceptable and it is not adequately set forth as to what substitutions or combination of substitutions is acceptable. Although applicants argue about AtaA binding, claim 12 recites 70% identity to positions 2 to 258 of SEQ ID NO:1. Varying 30% of the sequence allows for variations at 76 positions (.3x(258-2)). When 76 of the amino acids are varied to any of the 20 standard amino acids there are at least 2076 (75,557,863,725,914,323,419,136,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000) different possible polypeptides. Although applicants argue about a species and co-crystal work, instant claim 12 encompasses much more than a single species. The relevance of the co-crystal work cannot be ascertained since it is not of record. Claim Rejections - 35 USC § 103 Claims were previously rejected based on the references cited below. Since the claims have been amended, the rejection is updated to correspond to the instant claims. 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. Claim(s) 12 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hori (US 2016/0046923; cited with IDS 1/18/22; ‘Hori’) in view of Sezonov et al. (‘Escherichia coli physiology in luria-bertani broth’ Journal of Bacteriology Dec 2007 pages 8746-8749; ‘Sezonov’) in view of Nass et al. (NPL cite 13 of IDS 1/18/22; ‘Nass’). Hori teach that the protein AtaA is represented by SEQ ID NO:2 (section 0061; the sequence listing on page 16-25 recites the sequence) which is from the Acinetobacter Tol5 strain (section 0057). Hori teach the polypeptide as oligomeric (section 0056). Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium where the culturing was conducted with shaking (section 0108). Hori recognizes the inclusion of casein hydrolysate (section 0081). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055). Hori teach the adhesin is linked to the bacteria surface through a noncovalent bond (section 0055). Hori does not recite a method using a separating peptide as claimed. Sezonov teach that Luria-Bertani (LB) broth is popular because it permits fast growth and good yields of many species (first paragraph after abstract on page 8746). Sezonov teach that the recipe includes tryptone as a digest of casein from cow’s milk (first paragraph after abstract on page 8746). Nass teach hydrolysates from bovine casein (abstract) and specifically teach FPPQSVL as a known peptide in casein hydrolysate (Table 2). Nass teach hydrolysates that are prepared by adding HCl and enzymes for example (last paragraph of column 1 on page 4988). Nass recognize various lengths of peptides including tripeptides (Table 2). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Hori because Hori teach ataA gene was expressed in LB medium (section 0108) and teach the inclusion of casein hydrolysate (section 0081). Since Sezonov teach that Luria-Bertani (LB) broth is popular because it permits fast growth and good yields of many species (first paragraph after abstract on page 8746) and teach that the recipe includes tryptone as a digest of casein from cow’s milk (first paragraph after abstract on page 8746) one would have been motivated to use the known digest of casein as taught by Nass which contains FPPQSVL as a known peptide in casein hydrolysate (Table 2). Since Nass teach hydrolysates that are prepared by adding HCl and enzymes for example (last paragraph of column 1 on page 4988) one would have been motivated to optimize the conditions and obtain peptides of various lengths. Since Hori teach that the Tol5 strain was cultured and ataA gene was expressed where the culturing was conducted with shaking (section 0108) one would have been motivated to do such. One would have had a reasonable expectation of success since expression methods were known (Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium (section 0108)). In relation to the separated peptide recited in claims 12, 16-17 and 21, Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium (section 0108) and recognizes the inclusion of casein hydrolysate (section 0081). One would have been motivated to use the known digest of casein as taught by Nass which contains FPPQSVL as a known peptide in casein hydrolysate (Table 2). FPPQSVL comprises SVL. Further, since Nass teach hydrolysates that are prepared by adding HCl and enzymes for example (last paragraph of column 1 on page 4988) one would have been motivated to optimize the conditions and obtain peptides of various lengths including tripeptides. Since the prior art teach peptides as claimed, it is interpreted as functioning as claimed. In relation to the first subject of claims 12 and 18-20, Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium (section 0108). Hori teach that the protein AtaA is represented by SEQ ID NO:2 which comprises the instant AtaA protein (SEQ ID NO:1). Hori teach the polypeptide as oligomeric (section 0056). In relation to the second subject of claim 12, Hori teach the adhesin is linked to the bacteria surface through a noncovalent bond (section 0055). Thus, the cell itself is the support. Alternately, Hori teach the polypeptide as oligomeric (section 0056) and containing beta barrel structures (section 0055). The individual monomers act as support (with noncovalent beta barrel hydrogen bonds). In relation to the contacting step of claim 12, Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium specifically with shaking (section 0108). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055) thus the LB media is in contact with the protein. Since the prior art teach components as claimed they are interpreted as functioning as claimed. Claim(s) 12, 14 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hori (US 2016/0046923; cited with IDS 1/18/22; ‘Hori’) in view of Sezonov et al. (‘Escherichia coli physiology in luria-bertani broth’ Journal of Bacteriology Dec 2007 pages 8746-8749) in view of Nass et al. (NPL cite 13 of IDS 1/18/22) in view of Lichty et al. (‘Comparison of affinity tags for protein purification’ Protein Expression and Purification v41 2005 pages 98-105; ‘Lichty’ first cited 7/16/25). Hori teach that the protein AtaA is represented by SEQ ID NO:2 (section 0061; the sequence listing on page 16-25 recites the sequence) which is from the Acinetobacter Tol5 strain (section 0057). Hori teach the polypeptide as oligomeric (section 0056). Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium where the culturing was conducted with shaking (section 0108). Hori recognizes the inclusion of casein hydrolysate (section 0081). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055). Hori teach the adhesin is linked to the bacteria surface through a noncovalent bond (section 0055). Hori does not recite a method using a separating peptide as claimed or the second subject of claim 14. Sezonov teach that Luria-Bertani (LB) broth is popular because it permits fast growth and good yields of many species (first paragraph after abstract on page 8746). Sezonov teach that the recipe includes tryptone as a digest of casein from cow’s milk (first paragraph after abstract on page 8746). Nass teach hydrolysates from bovine casein (abstract) and specifically teach FPPQSVL as a known peptide in casein hydrolysate (Table 2). Nass teach hydrolysates that are prepared by adding HCl and enzymes for example (last paragraph of column 1 on page 4988). Nass recognize various lengths of peptides including tripeptides (Table 2). Lichty teach that affinity tags are known and include Strep II and teach that the results suggest that Strep II tag may provide an acceptable compromise of excellent purification with good yields at a moderate cost (abstract). Lichty teach that the Strep II tag appears to be an excellent candidate for purification since it is a short tag that produces high purity material in good yields at moderate costs (page 104 last complete paragraph). Lichty teach that Strep II is known to bind streptavidin (page 100 last paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Hori because Hori teach ataA gene was expressed in LB medium (section 0108) and teach the inclusion of casein hydrolysate (section 0081). Since Sezonov teach that Luria-Bertani (LB) broth is popular because it permits fast growth and good yields of many species (first paragraph after abstract on page 8746) and teach that the recipe includes tryptone as a digest of casein from cow’s milk (first paragraph after abstract on page 8746) one would have been motivated to use the known digest of casein as taught by Nass which contains FPPQSVL as a known peptide in casein hydrolysate (Table 2). Since Nass teach hydrolysates that are prepared by adding HCl and enzymes for example (last paragraph of column 1 on page 4988) one would have been motivated to optimize the conditions and obtain peptides of various lengths. One would have had a reasonable expectation of success since expression methods were known (Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium (section 0108)). In addition, Lichty teach advantages of using a Strep II based tag. Thus one would have been motivated to use the Strep II based tag of Lichty for the expression and purification of the protein. Since Lichty teach that Strep II is known to bind streptavidin (page 100 last paragraph) one would have been motivated to contact with such protein. One would have had a reasonable expectation of success since Nakatani teach that methods of expression and purification were known (sections 2.1, 2.4 and 3.4). In relation to the separated peptide recited in claims 12, 16-17 and 21, Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium (section 0108) and recognizes the inclusion of casein hydrolysate (section 0081). One would have been motivated to use the known digest of casein as taught by Nass which contains FPPQSVL as a known peptide in casein hydrolysate (Table 2). FPPQSVL comprises SVL. Further, since Nass teach hydrolysates that are prepared by adding HCl and enzymes for example (last paragraph of column 1 on page 4988) one would have been motivated to optimize the conditions and obtain peptides of various lengths including tripeptides. Since the prior art teach a peptide as claimed, it is interpreted as functioning as claimed. In relation to the first subject of claims 12 and 18-20, Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium (section 0108). Hori teach that the protein AtaA is represented by SEQ ID NO:2 which comprises the instant AtaA protein (SEQ ID NO:1). Hori teach the polypeptide as oligomeric (section 0056). In relation to the second subject of claim 12, Hori teach the adhesin is linked to the bacteria surface through a noncovalent bond (section 0055). Thus, the cell itself is the support. Alternately, Hori teach the polypeptide as oligomeric (section 0056) and containing beta barrel structures (section 0055). The individual monomers act as support (with noncovalent beta barrel hydrogen bonds). In relation to the contacting step of claim 12, Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium specifically with shaking (section 0108). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055) thus the LB media is in contact with the protein. Since the prior art teach components as claimed they are interpreted as functioning as claimed. In relation to the second subject of claim 14, Lichty teach streptavidin (page 100 last paragraph). Since the art suggest expression streptavidin in a cell and the cell acts as the support the claim limitation is met. Since the prior art teach components as claimed they are interpreted as functioning as claimed. Response to Arguments - 103 Applicant's arguments filed 8/11/26 have been fully considered but they are not persuasive with respect to the rejections set forth above. Although applicants argue that Hori does not anticipate the claims, the instant rejection is a 103 rejection and as such any single reference does not necessarily anticipate the claims. Although applicants argue about a lack of motivation, Hori teach ataA gene was expressed in LB medium (section 0108) and teach the inclusion of casein hydrolysate (section 0081). Since Sezonov teach that Luria-Bertani (LB) broth is popular because it permits fast growth and good yields of many species (first paragraph after abstract on page 8746) and teach that the recipe includes tryptone as a digest of casein from cow’s milk (first paragraph after abstract on page 8746) one would have been motivated to use the known digest of casein as taught by Nass which contains FPPQSVL as a known peptide in casein hydrolysate (Table 2). Although applicants argue about release of a subject from a support, the active step recited in claim 12 is contacting. Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium specifically with shaking (section 0108). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055) thus the LB media is in contact with the protein. Although applicants argue that the claims have been amended, the amended claims are addressed above. Although applicants argue that the references do not identify the problem solved by applicant, it is first noted that the instant claims are not drawn to methods of identifying problems. MPEP 2144 expressly recognizes that the reason or motivation to modify a reference can be for a different purpose or to solve a different problem. Although applicants argue that Nass does not associate FPPQSVL with AtaA or fill methodological gaps, the active step recited in claim 12 is contacting. Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium specifically with shaking (section 0108). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055) thus the LB media is in contact with the protein. Although applicants argue that the references do not provide a reason to release AtaA containing subject, MPEP 2144 expressly recognizes that the reason or motivation to modify a reference can be for a different purpose or to solve a different problem. The active step recited in claim 12 is contacting. Hori teach that the Tol5 strain was cultured and ataA gene was expressed in LB medium specifically with shaking (section 0108). Hori teach that the protein is secreted and appears on the surface of bacteria (section 0055) thus the LB media is in contact with the protein. Although applicants argue about using the applicant’s discovery as a roadmap, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Although applicants argue about the ATL sequence in AtaA signal peptide, such portion is not used as the basis of the rejection. Hori teach that the protein AtaA is represented by SEQ ID NO:2 which comprises the instant AtaA protein (SEQ ID NO:1) which is recited in claim 12 as a polypeptide of the first subject. Although applicants argue about motivation with respect to Lichty, Lichty teach that affinity tags are known and include Strep II and teach that the results suggest that Strep II tag may provide an acceptable compromise of excellent purification with good yields at a moderate cost (abstract). Although applicants allude to an unexpected discovery, MPEP 716.02(b) recognizes that the burden is on the applicant to establish results are unexpected and significant. MPEP 716.02(e) refers to a comparison with the closest art. MPEP 716.02(d) states that any unexpected results are to be commensurate in scope with the claimed invention. There are inadequate facts to conclude any unexpected results or unexpected results commensurate in scope with the claimed invention. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST. 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. 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. RONALD T. NIEBAUER Primary Examiner Art Unit 1658 /RONALD T NIEBAUER/Examiner, Art Unit 1658
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Prosecution Timeline

Show 5 earlier events
Oct 14, 2025
Applicant Interview (Telephonic)
Nov 16, 2025
Request for Continued Examination
Nov 18, 2025
Response after Non-Final Action
Mar 11, 2026
Non-Final Rejection mailed — §103, §112
Jul 02, 2026
Applicant Interview (Telephonic)
Jul 02, 2026
Examiner Interview Summary
Aug 11, 2026
Response Filed
Oct 07, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
41%
Grant Probability
75%
With Interview (+34.0%)
3y 7m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 732 resolved cases by this examiner. Grant probability derived from career allowance rate.

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