Prosecution Insights
Last updated: April 19, 2026
Application No. 18/394,284

PHARMACEUTICAL COMPOSITION COMPRISING AN APL TYPE PEPTIDE

Final Rejection §103§DP
Filed
Dec 22, 2023
Examiner
REYNOLDS, FRED H
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Centro De Ingenieria Genética Y Biotecnologia
OA Round
3 (Final)
33%
Grant Probability
At Risk
4-5
OA Rounds
2y 10m
To Grant
72%
With Interview

Examiner Intelligence

Grants only 33% of cases
33%
Career Allow Rate
269 granted / 815 resolved
-27.0% vs TC avg
Strong +40% interview lift
Without
With
+39.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
104 currently pending
Career history
919
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
33.3%
-6.7% vs TC avg
§102
13.2%
-26.8% vs TC avg
§112
26.5%
-13.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 815 resolved cases

Office Action

§103 §DP
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 . 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 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. Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 Aug, 2025 has been entered. Claims Status Claims 1 and 8-11 are pending Claim 1 has been amended. Maintained/Modified Rejections Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. first rejection Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over Dominguez Horta et al (US 20090171069) in view of Izutsu (in Therapeutic Proteins, Smales and James, ed. (2005) ISBN 1-58829-390-4, p287-292) and Zapadka et al (Interface Focus (Oct 2017) 7 20170030). Dominguez Horta et al discuss peptides from HSP60 to treat rheumatoid arthritis (RA)(abstract). Typical therapies for this disorder are anti-inflammatory and cytokine blockers (paragraph 22). Among the sequences listed as effective for this utility is SEQ ID 18 (paragraph 38), which is identical to SEQ ID 1 of the instant claims. Note that this sequence is explicitly claimed (claim 5), indicating that it is a sequence appropriate as a starting point for modifications. Actual formulation is not given, except that they were added to cell culture media (paragraph 125). Izutsu discusses stabilization of polypeptides (title). This is done by altering the environment (p287, 2nd paragraph), i.e. formulation design. Preformulation design looks at solubility and stability while varying pH, ionic strength, varying possible ligands, and decomposition pathways, and how the various formulation parameters affect stability (p289, section 3.1). Aqueous formulations are the preferred choice; after pre-formulation, the stability profiles with various excipients are determined (p289, section 3.2). Buffers and salts are selected for optimizing stability, solubility, and pharmaceutical acceptance (p290, section 3.3.1), while sugars, such as sucrose, protect the conformation of proteins in aqueous solutions (section 3.3.2). This reference describes optimizing polypeptide formulations for stability and solubility. Zapadka et al also discuss the factors affecting the stability of polypeptide therapeutics (title). Polypeptide concentration is one of the most important factors (4th page, 1st column, 1st paragraph). Deamidation is a factor when the pH is below 3 or higher than 6 (8th page, 1st column, 3d paragraph). PH plays an important role, with acetate, histidine, phosphate, Tris, and glycine buffers most commonly used (10th page, 1st column, 4th paragraph). This reference also discusses stabilization of polypeptides. Therefore, it would be obvious to optimize the stability and solubility of the polypeptide of Dominguez Horta et al et al, to yield a pharmaceutical formulation with improved stability, as described by Izutsu. As this is a standard methodology in this art, an artisan in this field would attempt this process with a reasonable expectation of success. Furthermore, it would be obvious to try the common buffering agents after optimizing the pH, as Izutsu teaches that changing this factor can affect both solubility and stability. As these are commonly used, an artisan in this field would attempt this process with a reasonable expectation of success. Finally, it would be obvious to optimize the sugar and concentration in this formulation, as Izutsu teaches that these excipients, such as sucrose, can increase the stability of the formulation. As this has been successful with other polypeptide formulations (or it would not be suggested by Izutsu), an artisan in this field would attempt this optimization with a reasonable expectation of success. Dominguez Horta et al teaches pharmaceutical formulations of SEQ ID 1. Izutsu teaches optimizing solubility and stability by optimizing buffers, salts, and sugars. Zapadka et al teaches similar optimization, and teaches the most common buffers to use. The MPEP states that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”) (MPEP2144.05.II). Dominguez Horta discusses liquid formulations (cell culture media). Thus, the combination of references renders obvious claim 1. response to applicant’s arguments Applicants argue that there is no motivation in Dominguez Horta et al to optimize the stability, that the formulation is more than mere optimization, that the excipients act synergistically, that it is surprising that the peptide is less stable in phosphate buffer at physiological pH, that the formulation reduced neutrophil viability in numerous disease models, and that the material reduces formulation of anti citrulline antibodies. After arguments were filed, a declaration by Prof. Maria del Carmen Dominguez Horta, applicant, further argued that a phase 1 clinical trial showed more rapid benefits than would normally be expected, and that interstitial fluid had poor buffering capacity. Applicant's arguments filed 15 and 27 Aug, 2025 have been fully considered but they are not persuasive. Applicants argue that there is no motivation in Dominguez Horta et al to optimize the stability. However, both Izutsu and Zapadka et al discuss optimizing stability, providing the required motivation. Applicants argue that the formulation is more than mere optimization and that the excipients act synergistically. This has not been demonstrated. In any event, the formulation can be arrived at by the optimization methods described by both Izutsu and Zapadka et al – optimize the pH, optimize the ionic strength, and optimize the excipients and concentrations. Applicants argue that it is surprising and unexpected that the peptide is less stable at physiological pH than the claimed pH. Applicants have not shown any reason a person of skill in the art would assume that the sequence was more stable at physiological pH. As noted by both Izutsu and Zapadka et al, the optimum pH for stability has to be determined experimentally. This would not be the case if the optimum pH was always around physiological. Applicants have argued that the formulation has unexpected results of better activity than other pH ranges. However, these are for ex vivo samples; as noted in the previous office action, once the material is in blood, the pH will be 7.4. Applicants have argued that interstitial fluid has poor buffering, and that in subcutaneous injection, it will go to interstitial fluid rather than blood. However, this argument fails because the peptide goes from the injection site to the blood (Richter et al, AAPS J. (2012) 14(3) p559-570, abstract). Applicants argue that the claimed formulation reduces levels of anti-citrulline antibodies. As previously noted, applicants have not compared this experiment to the closest prior art, which is Dominguez Horta et al. Applicants argue that this reference is not the closest prior art, because it does not anticipate the claims, and that it is not possible to make the comparison because the formulation of that reference differs in multiple aspects. However, applicants have provided no law, regulation, or case law that supports these arguments. The case law states that unexpected results are compared to the closest prior art (MPEP 716.02(e)). Applicants can propose a reference that is closer to the invention than that used in the rejection (MPEP 716.02(e)(I)), but there must be a comparison against the closest prior art. Finally, applicants argued that the claimed formulation provided a benefit faster than would be expected. However, once again, there is no comparison to the closest prior art (MPEP 716.02(e)). second rejection Claim(s) 1 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Dominguez Horta et al (US 20090171069) in view of Izutsu (in Therapeutic Proteins, Smales and James, ed. (2005) ISBN 1-58829-390-4, p287-292), Zapadka et al (Interface Focus (Oct 2017) 7 20170030), and Betancourt et al (US 20120035106) Dominguez Horta et al discuss peptides from HSP60 to treat rheumatoid arthritis (RA)(abstract). Typical therapies for this disorder are anti-inflammatory and cytokine blockers (paragraph 22). Among the sequences listed as effective for this utility is SEQ ID 18 (paragraph 38), which is identical to SEQ ID 1 of the instant claims. Note that this sequence is explicitly claimed (claim 5), indicating that it is a sequence appropriate as a starting point for modifications. Actual formulation is not given, except that they were added to cell culture media (paragraph 125). Izutsu discusses stabilization of polypeptides (title). This is done by altering the environment (p287, 2nd paragraph), i.e. formulation design. Preformulation design looks at solubility and stability while varying pH, ionic strength, varying possible ligands, and decomposition pathways, and how the various formulation parameters affect stability (p289, section 3.1). Aqueous formulations are the preferred choice; after pre-formulation, the stability profiles with various excipients are determined (p289, section 3.2). Buffers and salts are selected for optimizing stability, solubility, and pharmaceutical acceptance (p290, section 3.3.1), while sugars, such as sucrose, protect the conformation of proteins in aqueous solutions (section 3.3.2). This reference describes optimizing polypeptide formulations for stability and solubility. Zapadka et al also discuss the factors affecting the stability of polypeptide therapeutics (title). Polypeptide concentration is one of the most important factors (4th page, 1st column, 1st paragraph). Deamidation is a factor when the pH is below 3 or higher than 6 (8th page, 1st column, 3d paragraph). PH plays an important role, with acetate, histidine, phosphate, Tris, and glycine buffers most commonly used (10th page, 1st column, 4th paragraph). This reference also discusses stabilization of polypeptides. Please note that these three references render obvious claim 1. The difference between these references and the remaining claims is that these references do not discuss subcutaneous administration. Betancourt et al discuss the same sequence as Dominguez Horta et al (paragraph 16), for treatment of intestinal inflammation (title). Subcutaneous administration is mentioned as an effective dosing route (paragraph 20). This reference discusses administration routes of the therapeutic Therefore, it would be obvious to administer the sequence of Dominguez Horta et al via subcutaneous administration, as Betancourt et al discuss this route of administration for a similar formulation. As this is the same therapeutic agent, an artisan in this field would attempt this administration route with a reasonable expectation of success. Dominguez Horta et al teaches treatment of rheumatoid arthritis. Betancourt et al teach subQ injextion. Thus, the combination of references renders obvious claims 8 and 9. Dominguez Horta et al teaches anti-inf Dominguez Horta et al discusses anti-inflammatory therapies. While the reference does not discuss using the two therapies together, it is considered obvious to combine two known formulations used for the same purpose (MPEP 2144.06(I)). Thus, the combination of references renders obvious claim 10. response to applicant’s arguments Applicants have repeated the same arguments as were used for the first rejection under this statute, which were answered above. In addition, applicants argue that the rejection is based in hindsight reasoning. Applicant's arguments filed 15 Aug, 2025 have been fully considered but they are not persuasive. Applicants argue that the rejection is based on hindsight reasoning. The courts have ruled 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). Applicants have not pointed to any facet of the rejection that is obtained from applicant’s disclosure. 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. first rejection Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,410,057 in view of Izutsu (in Therapeutic Proteins, Smales and James, ed. (2005) ISBN 1-58829-390-4, p287-292) and Zapadka et al (Interface Focus (Oct 2017) 7 20170030). Competing claim 1 describes a method of treating inflammatory bowel disease and type 1 diabetes, comprising administering a peptide of SEQ ID 1, identical to SEQ ID 1 of the instant claims. Note that this is a disorder characterized by increased neutrophil levels (as evidenced by column 2, line 1-4 of competing disclosure). The difference between the competing claims and the instant claims is that this reference does not discuss acetate buffer, pH, or sugars. Izutsu discusses stabilization of polypeptides (title). This is done by altering the environment (p287, 2nd paragraph), i.e. formulation design. Preformulation design looks at solubility and stability while varying pH, ionic strength, varying possible ligands, and decomposition pathways, and how the various formulation parameters affect stability (p289, section 3.1). Aqueous formulations are the preferred choice; after pre-formulation, the stability profiles with various excipients are determined (p289, section 3.2). Buffers and salts are selected for optimizing stability, solubility, and pharmaceutical acceptance (p290, section 3.3.1), while sugars, such as sucrose, protect the conformation of proteins in aqueous solutions (section 3.3.2). This reference describes optimizing polypeptide formulations for stability and solubility. Zapadka et al also discuss the factors affecting the stability of polypeptide therapeutics (title). Polypeptide concentration is one of the most important factors (4th page, 1st column, 1st paragraph). Deamidation is a factor when the pH is below 3 or higher than 6 (8th page, 1st column, 3d paragraph). PH plays an important role, with acetate, histidine, phosphate, Tris, and glycine buffers most commonly used (10th page, 1st column, 4th paragraph). This reference also discusses stabilization of polypeptides. Therefore, it would be obvious to optimize the stability and solubility of the polypeptide of the competing claims, to yield a pharmaceutical formulation with improved stability, as described by Izutsu. As this is a standard methodology in this art, an artisan in this field would attempt this process with a reasonable expectation of success. Furthermore, it would be obvious to try the common buffering agents after optimizing the pH, as Izutsu teaches that changing this factor can affect both solubility and stability. As these are commonly used, an artisan in this field would attempt this process with a reasonable expectation of success. Finally, it would be obvious to optimize the sugar and concentration in this formulation, as Izutsu teaches that these excipients, such as sucrose, can increase the stability of the formulation. As this has been successful with other polypeptide formulations (or it would not be suggested by Izutsu), an artisan in this field would attempt this optimization with a reasonable expectation of success. response to applicant’s arguments Applicants argue that a double patenting rejection requires that the claims be patentably indistinct, which they interpret as preventing a secondary reference to meet claim limitations. Applicant's arguments filed 15 Aug, 2025 have been fully considered but they are not persuasive. Applicants argue that a double patenting rejection with a secondary reference is improper. However, the courts have ruled that the consideration is similar to that for obviousness (MPEP 804), which allows for secondary references. Applicants have pointed to MPEP 804(II)(B)I)) for support (in arguments for a different double patenting rejection), but that merely states that the only part of the competing application that can be used is (with a few exceptions), the claims. It states nothing about a secondary reference. second rejection Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/918,299 (US 20230190866) in view of Izutsu (in Therapeutic Proteins, Smales and James, ed. (2005) ISBN 1-58829-390-4, p287-292) and Zapadka et al (Interface Focus (Oct 2017) 7 20170030). Competing claim 1 describes a formulation for treating cytokine storms, comprising a peptide of SEQ ID 1, identical to SEQ ID 1 of the instant claims. Note that this is a disorder characterized by increased neutrophil levels (as evidenced by second page, 1st paragraph, competing disclosure). The difference between the competing claims and the instant claims is that this reference does not discuss acetate buffer, pH, or sugars. Izutsu discusses stabilization of polypeptides (title). This is done by altering the environment (p287, 2nd paragraph), i.e. formulation design. Preformulation design looks at solubility and stability while varying pH, ionic strength, varying possible ligands, and decomposition pathways, and how the various formulation parameters affect stability (p289, section 3.1). Aqueous formulations are the preferred choice; after pre-formulation, the stability profiles with various excipients are determined (p289, section 3.2). Buffers and salts are selected for optimizing stability, solubility, and pharmaceutical acceptance (p290, section 3.3.1), while sugars, such as sucrose, protect the conformation of proteins in aqueous solutions (section 3.3.2). This reference describes optimizing polypeptide formulations for stability and solubility. Zapadka et al also discuss the factors affecting the stability of polypeptide therapeutics (title). Polypeptide concentration is one of the most important factors (4th page, 1st column, 1st paragraph). Deamidation is a factor when the pH is below 3 or higher than 6 (8th page, 1st column, 3d paragraph). PH plays an important role, with acetate, histidine, phosphate, Tris, and glycine buffers most commonly used (10th page, 1st column, 4th paragraph). This reference also discusses stabilization of polypeptides. Therefore, it would be obvious to optimize the stability and solubility of the polypeptide of the competing claims, to yield a pharmaceutical formulation with improved stability, as described by Izutsu. As this is a standard methodology in this art, an artisan in this field would attempt this process with a reasonable expectation of success. Furthermore, it would be obvious to try the common buffering agents after optimizing the pH, as Izutsu teaches that changing this factor can affect both solubility and stability. As these are commonly used, an artisan in this field would attempt this process with a reasonable expectation of success. Finally, it would be obvious to optimize the sugar and concentration in this formulation, as Izutsu teaches that these excipients, such as sucrose, can increase the stability of the formulation. As this has been successful with other polypeptide formulations (or it would not be suggested by Izutsu), an artisan in this field would attempt this optimization with a reasonable expectation of success. This is a provisional nonstatutory double patenting rejection. response to applicant’s arguments Applicants have repeated the same arguments for all double patenting rejections, which were answered above. third rejection Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/997,777 in view of Izutsu (in Therapeutic Proteins, Smales and James, ed. (2005) ISBN 1-58829-390-4, p287-292) and Zapadka et al (Interface Focus (Oct 2017) 7 20170030), with evidentiary support from Blackburn et al (J. Lipid. Res. (1991) 32 p1911-1918). Please note that, while this is a new rejection, it is necessitated by applicants filing of the competing application after the previous office action was submitted. As applicants are assumed to know what they have filed, this will not negate the finality of this office action. Competing claim 1 describes a formulation for treating a disease involving an affection of apolipoprotein A1, which, as evidenced by Blackburn et al (title), affects neutrophil activation. The difference between the competing claims and the instant claims is that this reference does not discuss acetate buffer, pH, or sugars. Izutsu discusses stabilization of polypeptides (title). This is done by altering the environment (p287, 2nd paragraph), i.e. formulation design. Preformulation design looks at solubility and stability while varying pH, ionic strength, varying possible ligands, and decomposition pathways, and how the various formulation parameters affect stability (p289, section 3.1). Aqueous formulations are the preferred choice; after pre-formulation, the stability profiles with various excipients are determined (p289, section 3.2). Buffers and salts are selected for optimizing stability, solubility, and pharmaceutical acceptance (p290, section 3.3.1), while sugars, such as sucrose, protect the conformation of proteins in aqueous solutions (section 3.3.2). This reference describes optimizing polypeptide formulations for stability and solubility. Zapadka et al also discuss the factors affecting the stability of polypeptide therapeutics (title). Polypeptide concentration is one of the most important factors (4th page, 1st column, 1st paragraph). Deamidation is a factor when the pH is below 3 or higher than 6 (8th page, 1st column, 3d paragraph). PH plays an important role, with acetate, histidine, phosphate, Tris, and glycine buffers most commonly used (10th page, 1st column, 4th paragraph). This reference also discusses stabilization of polypeptides. Therefore, it would be obvious to optimize the stability and solubility of the polypeptide of the competing claims, to yield a pharmaceutical formulation with improved stability, as described by Izutsu. As this is a standard methodology in this art, an artisan in this field would attempt this process with a reasonable expectation of success. Furthermore, it would be obvious to try the common buffering agents after optimizing the pH, as Izutsu teaches that changing this factor can affect both solubility and stability. As these are commonly used, an artisan in this field would attempt this process with a reasonable expectation of success. Finally, it would be obvious to optimize the sugar and concentration in this formulation, as Izutsu teaches that these excipients, such as sucrose, can increase the stability of the formulation. As this has been successful with other polypeptide formulations (or it would not be suggested by Izutsu), an artisan in this field would attempt this optimization with a reasonable expectation of success. This is a provisional nonstatutory double patenting rejection. response to applicant’s arguments Applicants have repeated the same arguments for all double patenting rejections, which were answered above. Conclusion All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30. Examiner interviews are available via telephone 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. /FRED H REYNOLDS/Primary Examiner, Art Unit 1658
Read full office action

Prosecution Timeline

Dec 22, 2023
Application Filed
May 29, 2024
Response after Non-Final Action
Sep 23, 2024
Non-Final Rejection — §103, §DP
Jan 23, 2025
Response Filed
Jan 23, 2025
Examiner Interview Summary
Jan 23, 2025
Applicant Interview (Telephonic)
Feb 10, 2025
Response after Non-Final Action
Mar 10, 2025
Final Rejection — §103, §DP
Aug 15, 2025
Request for Continued Examination
Aug 27, 2025
Response after Non-Final Action
Aug 27, 2025
Response after Non-Final Action
Sep 05, 2025
Response after Non-Final Action
Nov 18, 2025
Final Rejection — §103, §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12590131
ANTIMICROBIAL PEPTIDES WITH ALPHA-CORE HELICES
2y 5m to grant Granted Mar 31, 2026
Patent 12576132
ISTHMIN 1 FOR TREATMENT OF LUNG INFLAMMATION
2y 5m to grant Granted Mar 17, 2026
Patent 12559532
EMBRYONIC ANGIOGENESIS MARKERS AND DIAGNOSTIC AND THERAPEUTIC STRATEGIES BASED THEREON
2y 5m to grant Granted Feb 24, 2026
Patent 12551535
PEPTIDE PHARMACEUTICALS FOR INSULIN RESISTANCE
2y 5m to grant Granted Feb 17, 2026
Patent 12545707
PEPTIDIC MACROMOLECULAR ASSEMBLIES
2y 5m to grant Granted Feb 10, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

4-5
Expected OA Rounds
33%
Grant Probability
72%
With Interview (+39.5%)
2y 10m
Median Time to Grant
High
PTA Risk
Based on 815 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month