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 .
Status of Application, Amendments and/or Claims
The amendment of 08 December 2025 has been entered in full. Claims 9 and 13 are amended. Claims 1-8 are cancelled.
Claims 9-13 are under consideration in the instant application.
Withdrawn Objections and/or Rejections
1. The Sequence Listing Requirement deficiency set forth at pages 2-4 of the previous Office Action of 06 June 2025 is withdrawn in view of Applicant’s amendment to the instant specification (08 December 2025).
2. The objections to the specification as set forth at page 4 of the previous Office Action of 06 June 2025 are withdrawn in view of the amended specification and abstract (08 December 2025).
3. The objections to claims 1, 2, and 9 as set forth at page 5 of the previous Office Action of 06 June 2025 are withdrawn in view of the cancelled and amended claims (08 December 2025).
4. The rejections of claims 1-3 and 9-13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph as set forth at pages 5-6 of the previous Office Action of 06 June 2025 are withdrawn in view of the cancelled and amended claims (08 December 2025).
5. The rejection of claim of claim 3 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph as set forth at pages 6-7 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claim (08 December 2025).
6. The rejection of claims 1-3 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Dominguez Horta et al. (WO 2019/129315) as set forth at pages 7-10 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claims (08 December 2025).
7. The rejection of claims 1 and 3 under 35 U.S.C. 102(a)(1) as being anticipated by Barbera Betancourt et al. (U.S. Patent 8,410,057 or US 2012/0035106) as set forth at pages 10-11 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claims (08 December 2025).
8. The rejection of claims 1, 3, 9, 10, 12, and 13 under 35 U.S.C. 102(a)(1) as being anticipated by Venegas-Rodriguez et al. (medRxiv, https://www.medrxiv.org/content/10.1101/2020.05.27.20110601v1; posted 02 June 2020), as evidenced by Cabrales-Rico et al., (J Pharmaceut Biomed Analysis 143: 130-140, 2017) as set forth at pages 11-12 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled and amended claims (08 December 2025).
9. The rejection of claims 1, 3, and 9-13 under 35 U.S.C. 102(a)(1) as being anticipated by Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., (J Pharmaceut Biomed Analysis 143: 130-140, 2017) as set forth at pages 12-13 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled and amended claims (08 December 2025).
10. The rejection of claims 1-3 under 35 U.S.C. 103 as being unpatentable over Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., (J Pharmaceut Biomed Analysis 143: 130-140, 2017) and Dominguez Horta et al. (WO 2019/129315) as set forth at pages 14-16 of the previous Office Action of 06 June 2025 is withdrawn in view of cancelled claims 1-3 (08 December 2025).
11. The rejection of claims 1 and 3 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8,383,771 as set forth at pages 18-19 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claims (08 December 2025).
12. The rejection of claims 1 and 3 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8,410,057 as set forth at pages 22-23 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claims (08 December 2025).
13. The provisional rejection of claims 1-3 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-11 of copending Application No. 18/394,284 as set forth at page 27 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claims (08 December 2025).
14. The provisional rejection of claims 1 and 3 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/997,777 as set forth at pages 29-30 of the previous Office Action of 06 June 2025 is withdrawn in view of the cancelled claims (08 December 2025).
New Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
15. Claims 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
15a. Claims 9-13 are rejected as being indefinite because claim 9 recites the limitation "the pharmaceutically acceptable excipient" in line 8. There is insufficient antecedent basis for this limitation in the claim. It is noted that this issue could be overcome by amending line 8 to recite “a pharmaceutically acceptable excipient”.
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 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.
16. Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., J Pharmaceut Biomed Analysis 143: 130-140, 2017); and Dominguez Horta et al. (WO 2019/129315; published 04 July 2019; filed 21 December 2018; see attached English translation provided by WIPO; cited on the IDS of 28 November 2022). The basis for this rejection is set forth at pages 14-16 of the previous Office Action of 06 June 2025 and is reiterated herein below for convenience.
Hernandez-Cedeno et al. teach the intravenous administration of a composition comprising CIGB-258 (either 2 mg or 1 mg every 12 hours) to patients with COVID-19 (abstract; page 516, column 2, “design of study”; Figure 1). Thirteen patients are classified as critically ill with acute respiratory distress syndrome (page 517, column 2, last paragraph). Hernandez-Cedeno et al. state that CIGB-258 is also known as APL1 or CIGB-814 (page 515, column 2, 1st full paragraph). It is noted that it was well-known in the art at the time the invention was made that the amino acid sequence of CIGB-258/APL1/CIGB-814 is a 27-mer altered peptide ligand with the sequence of SIDLKDKYKNIGAKLVQLVANNTNEEA (see Cabrales-Rico et al. abstract; page 131, column 1, 2nd paragraph). The amino acid sequence of CIGB-258 is 100% identical to the peptide amino acid sequence of SEQ ID NO: 1 of the instant application. Hernandez-Cedeno et al. disclose that CIGB-258 therapy reduces cytokines and molecules linked to cytokine storm (page 516, column 1, 2nd full paragraph; page 519; page 521, column 1, 3rd-4th paragraphs through the top of column 2; Figure 7).
Hernandez-Cedeno et al. do not teach that the composition comprising CIGB-258 comprises CIGB-258 in a concentration range between 1.8 mg/mL – 3.6 mg/mL in conjunction with sucrose in a concentration between 20-30 mg/mL.
Dominguez Horta et al. teach a modified peptide type APL (Altered Peptide Ligand) comprising the amino acid sequence of SEQ ID NO: 1 (page 1, 1st paragraph; page 4, line 3). It is noted that the amino acid sequence of SEQ ID NO: 1 of Dominguez Horta et al. is 100% identical to the CIGB-258 peptide of Hernandez-Cedeno et al. Furthermore, Dominguez Horta et al. teach a pharmaceutical composition comprising the APL type peptide amino acid sequence of SEQ ID NO: 1 in a concentration between 0.5 mg/mL and 10 mg/mL (including 2.5 mg/mL) and a pharmaceutically acceptable excipient (such as sucrose in a concentration between 10-40 mg/mL) (page 4, 1st , 2nd, and last paragraph; Figure 2; Figure 3C; entirety of page 8; Table 1; page 9, 1st full paragraph; page 11, last paragraph; page 12, Table 3; page 14, line 15).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the administered composition comprising CIGB-258 to treat cytokine storm syndrome as taught by Hernandez-Cedeno et al. by formulating the peptide in a concentration range between 1.8 mg/mL – 3.6 mg/mL with sucrose in a concentration between 20-30 mg/mL as taught by Dominguez Horta et al. The person of ordinary skill in the art would have been motivated to make those modifications to improve stability and complete solubility of the administered peptide (see Dominguez Horta et al., page 4, 1st paragraph; page 8, 2nd paragraph; entirety of page 9). The person of ordinary skill in the art reasonably would have expected success because Dominguez Horta et al. successfully optimize a pharmaceutical composition comprising the same CIGB-258 peptide as Hernandez-Cedeno et al. The person of ordinary skill in the art also reasonably would have expected success because optimization of pharmaceutical compositions is routine in the art. See In re Aller 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. 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."); See In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). See also In re Williams, 36 F.2d 436, 438 (CCPA 1929).
(i) At page 6 of the Response of 08 December 2025, Applicant states that the method of the present invention was investigated in animal models and that surprisingly, the mice treated with the pharmaceutical composition (sucrose: 20-30 mg/ml, sodium acetate buffer pH 4, and peptide: 1.8 mg/ml 3.6 mg/ml) showed a significant increase in the percentage of regulatory T cells compared to the animals treated out of these concentration ranges. Applicant also submits that surprising results were obtained in the treatment of 10 patients positive to COVID-19 virus infection with ages between 42 and 87 years old and relevant comorbidities that represent risk factors.
Applicant’s arguments have been fully considered but are not found to be persuasive. The Examiner acknowledges Applicant’s general comments regarding the Examples of the instant specification. However, in view of the teachings of Hernandez-Cedeno et al., Cabrales-Rico et al., and Dominguez Horta et al., the results of the instant specification are not unexpected or unpredictable. In other words, upon reading the combined teachings of the prior art of Hernandez-Cedeno et al., Cabrales-Rico et al., and Dominguez Horta et al., one of ordinary skill in the art would expect benefits of the administration of the pharmaceutical composition of the instant claims. "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989); MPEP § 716.02(c).
(ii) At the middle of page 6, Applicant argues that cytokine storm syndrome involves elevated levels of circulating cytokines and immune cell hyperactivation that can be triggered by various therapies, pathogens, cancers, autoimmune conditions, and monogenic disorders. Applicant states that it is important to distinguish between Cytokine storm from naturally occurring microbial infections, and Autoimmune diseases. For instance, Applicant points out that in the Cytokine storm, disseminated infections induce the production of many cytokines that can lead to fever, cell death, coagulopathies, and multi-organ dysfunction (citing Fajgenbaum DC. N. Engl. J. Med. 2020; 383: 2255-2273). Applicant indicates that autoimmune diseases, on the other hand, are derived from genetic factors and environmental triggers and characterized by immune disturbances that cause the aberrant activation of autoreactive immune cells, resulting in tissue damage, and immune tolerance is established both centrally and peripherally (citing Song Y. Sig. Transd. Targ. Therapy 2024; 9: 263). Applicant contends that examples of the present application are evidence of complete uncoupling of two different biological activities of the peptide identified as the amino acid sequence SEQ ID NO. 1.
First, Applicant’s arguments regarding Fajgenbaum and Song are not found to be persuasive since Fajgenbaum and Song were not submitted for the Examiner's independent review.
Second, Hernandez-Cedeno et al. teach administration of the CIGB-258 peptide (instant SEQ ID NO: 1) to patients with COVID-19, as required by the instant claims (abstract; page 516, column 2; Figure 1; page 517, column 2, 1st full paragraph). Hernandez-Cedeno et al. also clearly teach that CIGB-258 therapy reduces cytokines and molecules linked to cytokine storm, as required by the instant claims (page 516, column 1, 2nd full paragraph; page 519; page 521, column 1, 3rd-4th paragraphs through the top of column 2; Figure 7).
(iii) At the bottom of page 6 through page 7, Applicant argues that the problem solved in the present application is a new clinical situation that can be distinguished from the situation of the prior art. The technical effect in the claimed invention identifies a new clinical situation over the disclosure of the prior art. Applicant argues that Dominguez Horta does not disclose any effect of the peptide identified as the amino acid sequence SEQ ID NO. 1 on treating or preventing cytokine storm syndrome. Applicant contends that Dominguez-Horta is completely silent on cytokine storm syndrome. Dominguez Horta only suggests therapeutic effects associated with a decrease in the levels of anti-CCP antibodies, NETosis antibodies, and the subsequent protein citrullination, but not a therapeutic effect of a pharmaceutical composition on cytokine storm syndrome. Applicant asserts that although there are some similarities between the pharmaceutical compositions of the present invention and that claimed by Dominguez Horta, a deep research process was necessary to obtain these results. In Dominguez Horta, the peptide concentration is significantly wider than in the present invention, because several complex autoimmune diseases are involved (rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Alzheimer's disease, and liver or lung fibrosis) that would require different treatment schedules and doses in daily medical practice, after finishing clinical development of each commercial product. However, a skilled person in the art would not at all be guided to investigate a therapeutic effect of the peptide identified as the amino acid sequence SEQ ID NO. 1 on cytokine storm syndrome. Thus, reading Dominguez Horta the skilled person would not at all be pointed to the problem underlying the present invention, which is the provision of a pharmaceutical composition for treatment or prevention of cytokine storm syndrome. The present invention does not claim the peptide identified as amino acid sequence SEQ ID NO. 1, but a pharmaceutical composition comprising this peptide for treatment of cytokine storm syndrome from naturally occurring microbial infections, specifically Covid-19 and Dengue. There is nothing in the disclosure of Hernandez-Cedeno that would lend one skilled in the art to utilize the composition as set forth in Claim 9 as amended.
Applicant’s arguments have been fully considered but are not found to be persuasive. In response to applicant's arguments against the Dominguez Horta reference individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Furthermore, Dominguez Horta et al. teach pharmaceutical formulations comprising the APL type peptide amino acid sequence of SEQ ID NO: 1 in a concentration between 0.5 mg/mL and 10 mg/mL (including 2.5 mg/mL) and a pharmaceutically acceptable excipient (such as sucrose in a concentration between 10-40 mg/mL) (page 4, 1st , 2nd, and last paragraph; Figure 2; Figure 3; entirety of page 8; Table 1; page 9, 1st full paragraph; page 11, last paragraph; page 12, Table 3; page 14, line 15). Thus, the peptide and sucrose concentrations taught in Dominguez Horta et al. overlap with the ranges recited in the instant claims. Applicant is reminded that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Dominguez Horta et al. also disclose that concentrations of the peptide in the pharmaceutical composition allow an effective immunological response in the host (page 4, 1st paragraph). Dominguez Horta et al. teach that their pharmaceutical formulations are characterized by high stability, safety, and were well-tolerated in patients (page 4, 3rd paragraph). Dominguez Horta et al. state that no serious adverse events were identified and these results were unexpected (page 4, 3rd full paragraph).
Therefore, the person of ordinary skill in the art would have been motivated to modify the administered composition comprising CIGB-258 to treat cytokine storm syndrome as taught by Hernandez-Cedeno et al. by formulating the peptide in a concentration range between 1.8 mg/mL – 3.6 mg/mL with sucrose in a concentration between 20-30 mg/mL as taught by Dominguez Horta et al. to improve stability and complete solubility of the administered peptide (see Dominguez Horta et al., page 4, 1st paragraph; page 8, 2nd paragraph; entirety of page 9). The person of ordinary skill in the art reasonably would have expected success because Dominguez Horta et al. successfully optimize a pharmaceutical composition comprising the same CIGB-258 peptide as Hernandez-Cedeno et al. The person of ordinary skill in the art also reasonably would have expected success because optimization of pharmaceutical compositions is routine in the art. See In re Aller 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. 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."); See In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). See also In re Williams, 36 F.2d 436, 438 (CCPA 1929).
(iv) At the top of page 8 of the Response, Applicant argues that the cited documents Venegas-Rodriguez et al. and Hernández-Cedeño et al were published after the priority date. Therefore, these references are not prior art and do not interfere with the novelty or impart obviousness.
Applicant’s arguments have been fully considered but are not found to be persuasive. Applicant is reminded that the certified copy of the foreign priority application cannot be relied upon to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Maintained 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
U.S. Patent No. 8,383,771 in view of Dominguez Horta et al., Hernandez-Cedeno et al., and Cabrales-Rico et al.
17. Claims 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 8,383,771 in view of Dominguez Horta et al. (WO 2019/129315; published 04 July 2019; filed 21 December 2018; see attached English translation provided by WIPO; cited on the IDS of 28 November 2022); and Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., J Pharmaceut Biomed Analysis 143: 130-140, 2017). The basis for this rejection is set forth at pages 19-22 of the previous Office Action of 06 June 2025.
U.S. Patent No. 8,410,057 in view of Dominguez Horta et al., Hernandez-Cedeno et al., and Cabrales-Rico et al.
18. Claims 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 8,410,057 in view of Dominguez Horta et al. (WO 2019/129315; published 04 July 2019; filed 21 December 2018; see attached English translation provided by WIPO; cited on the IDS of 28 November 2022); and Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., J Pharmaceut Biomed Analysis 143: 130-140, 2017). The basis for this rejection is set forth at pages 24-26 of the previous Office Action of 06 June 2025.
Copending Application No. 18/394,284 in view of Hernandez-Cedeno et al. and Cabrales-Rico et al.
19. Claims 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-11 of copending Application No. 18/394,284 in view of Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., J Pharmaceut Biomed Analysis 143: 130-140, 2017). The basis for this provisional rejection is set forth at pages 28-29 of the previous Office Action of 06 June 2025.
Copending Application No. 18/997,777 in view of Dominguez Horta et al., Hernandez-Cedeno et al., and Cabrales-Rico et al.
20. Claims 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/997,777 in view of Dominguez Horta et al. (WO 2019/129315; published 04 July 2019; filed 21 December 2018; see attached English translation provided by WIPO; cited on the IDS of 28 November 2022); and Hernandez-Cedeno et al. (Cell Stress Chaperones 26: 515-525, 24 February 2021), as evidenced by Cabrales-Rico et al., J Pharmaceut Biomed Analysis 143: 130-140, 2017). The basis for this rejection is set forth at pages 30-33 of the previous Office Action of 06 June 2025.
(i) At the bottom of page 8 of the Response of 08 December 2025, Applicant argues that remaining claims 9-13 are nonobvious at least for the reasons set forth above in response to the rejections under 35 U.S.C. §103 and 35 U.S.C. §102.
Applicant’s arguments have been fully considered but are not found to be persuasive for the reasons set forth in detail above and at pages 17-33 of the previous Office Action of 06 June 2025. Applicant is encouraged to submit terminal disclaimers at Applicant’s earliest convenience.
Conclusion
No claims are allowable.
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.
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BEB
Art Unit 1647
11 March 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647