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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, filed 6/26/2026, with respect to all prior claim rejections been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in view of the amended claims.
Claim Status
Claims 2, 5, 7, 17, 18, 25, 29, 35, 42, 54, 61, 64, 65, 113, 126-128, and 130 are pending. Claim 130 is new. Claims 2, 5, 17, 25, 35, 64, and 113 are currently amended. Claims 1, 3, 4, 6, 8-16, 19-24, 26-28, 30-34, 36-41, 43-53, 55-60, 62-63, 66-112, 114-124 and 129 are cancelled.
Priority
The instant application is a CON of PCT/US2022/016023, filed 2/10/2022, which claims priority to the provisional applications 63/245,769, filed 9/17/2021, and 63/148,320, 2/11/2021. The priority date of 2/11/2021 is acknowledged.
Claim Interpretation
Claim 2 is being interpreted as a method of treating a microbial, viral, or fungal infection or cancer cell, wherein treatment also results in the reduction of an infusion related reaction or the severity of said reaction over a time period of about 1-48 hours relative to a time period of about 5-30 minutes. In other words, an infusion related reaction is reduced during 1-48 hours of administration as compared to during 5-30 minutes of administration.
Claim Rejections - 35 USC § 112
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.
Claims 7 and 126 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.
Claim 7 depends from claim 2 and recites “wherein said time period is from about 1 hr to about 4 hr.” Claim 2 recites two time periods, a first period of 1-48hr and a second time period of 5-30min. As there are multiple time periods recited in claim 2, claim 7 is indefinite as it is unclear which of the two potential time periods “said time period” is referring to.
Claim 126 depends from claim 125, which is cancelled. For purposes of examination, claim 126 is being interpreted as if depending from claim 2.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 2, 5, 7, 17, 18, 25, 29, 35, 42, 54, 61, 64, 65, 113, 127,128, and 130 are rejected under 35 U.S.C. 103 as being unpatentable over Steckbeck et al. (WO 2019178274 A1, published 9/19/2019) in view of Deslouches et al. (US20200079827A1, published 3/12/2020) and Rombouts et al. (Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment. Anticancer Res. 2020 Mar;40(3):1201-1218.).
Steckbeck teaches peptides with antimicrobial, antiviral, antifungal, and antitumor activity administered to subjects (Abstract). Steckbeck teaches the peptide SEQ ID NO: 1, which is 100% identical to the instant SEQ ID NO: 1. The peptide can be used to disrupt the integrity of a membrane by (a) binding to a negatively charged surface on a membrane; and/or (b) integrating into a membrane. The ability of a peptide to bind to a negatively charged surface on a membrane and/or integrate into a membrane can allow a peptide to act as a toxic agent to cells with a negatively charged surface by disrupting membrane integrity ([0030, 0034]).
Steckbeck further teaches administering pharmaceutical compositions containing SEQ ID NO: 1 to a subject in need thereof ([0003]). The pharmaceutical composition can be administered intravenously ([0161]). The pharmaceutical formulations can comprise a peptide of the invention (SEQ ID NO: 1) and at least one of an excipient, diluent, or a carrier ([0004, 0005, 0124-0129]). In some instances, the pharmaceutical composition comprises the peptide and a phosphate buffer with a pH of 7.2 ([0335]).
Steckbeck does not teach intravenously administering said pharmaceutical composition comprising SEQ ID NO: 1 over a period of about 1-48 hours, wherein the method reduces an infusion related reaction or severity thereof relative to administering said same pharmaceutical composition over a period of 5-30 min.
Deslouches teaches administration of compositions comprising the instant SEQ ID NO: 1 and a pharmaceutically acceptable excipient ([0089]). Deslouches teaches administration of AMPs by infusion (intravenous) can occur over a period of about 15 minutes to 24 hours ([0104]).
Rombouts teaches that treating cancer patients with monoclonal antibodies can result in complications, particularly the occurrence of infusion-related reactions. Mild to moderate reactions are associated with chills, fever, mild hypotension, dyspnea and rash, and more severe symptoms can also occur. Most infusion reactions occur within 30 minutes to 2 hours after the start of administration (Pg 1201, first column, paragraph after Abstract – second column, first paragraph).
In summary, Steckbeck teaches a method of treating microbial infections or certain cancers comprising intravenously administering a peptide with 100% sequence identity to the instant SEQ ID NO: 1. Deslouches teaches a method of treating a microbial infections or certain cancers comprising intravenous administration of a peptide with 100% sequence identity to the instant SEQ ID NO: 1 for 15 minutes – 24 hours. Rombouts teaches treating cancer through intravenous administration of monoclonal antibodies, which sometimes causes infusion related reactions within 30 minutes-2 hours of administration.
Thus, regarding claim 2, it would be prima facie obvious to incorporate the time period of administration taught by Deslouches into the method of Steckbeck. One skilled in the art would be motivated to do so as both Steckbeck and Deslouches are drawn to similar methods of treating similar diseases (infections and cancer) using the same AMPs. Moreover, one would have a reasonable expectation of success given that the instant SEQ ID NO: 1 is known to effectively treat microbial infections and some cancers, as taught by Deslouches.
Moreover, per MPEP 2144.06(I), combining equivalents known for the same purpose is one legal precedent recognized by the courts as directed to common practices that normally require only ordinary skill in the art and are considered routine expedients: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
By extension of this, it would be obvious to combine the method of Steckbeck and Deslouches and the method of Rombouts because both method methods effectively treat cancer. Additionally, one skilled in the art would recognize that combining the treatment of Steckbeck and Deslouches with that of Rombouts would allow one to effectively treat cancer as well as any possible infusion related reactions simultaneously because the time period during which most infusion related reactions occur (30 minutes – 2 hours) overlaps with the time period during which SEQ ID NO: 1 and monoclonal antibodies are administered (15 min – 24 hours).
Regarding claim 5, Rombouts teaches infusion related reactions include symptoms such as chills, fever, mild hypotension, dyspnea and rash, among others (Pg 1201, first column, paragraph after Abstract – second column, first paragraph).
Regarding claim 7, as stated above, Deslouches teaches that intravenous administration occurs from a time period of 15 minutes – 24 hours ([0104]).
Regarding claims 17 and 18, Deslouches teaches administration of the AMP in about 1mg/kg to about 150mg/kg ([0093, 0095]).
Regarding claims 25 and 29, Steckbeck teaches the peptide or pharmaceutically acceptable salt thereof can have a half-life from about 1 minute to 600 minutes (10 hours; [0201]).
Regarding claims 35 and 42, Steckbeck teaches that the maximum observed plasma concentration (Cmax) of the peptide or pharmaceutically acceptable salt thereof can be from about 50ng/mL to about 1000ng/mL ([0194]).
Regarding claims 54 and 61, Steckbeck teaches that the AUC(O-t) of said peptide or pharmaceutically acceptable salt thereof ranges from about 1900ng*h/mL – 10000ng*h/mL, wherein t is 90 hours after administration, wherein t=90.
Regarding claims 64 and 65, Steckbeck teaches the Tmax of a peptide or pharmaceutically acceptable salt thereof is about 1m to 600m (10h) ([0192]).
Regarding claims 113, Steckbeck teaches treating the following microbial species: Staphylococcus spp., Chlamydia spp., Enterococcus spp., Listeria spp.; Pseudomonas spp.; Mycobacterium spp.; Enterobacter spp.; Campylobacter spp.; Salmonella spp.; Streptococcus spp.; Helicobacter spp., e.g.; Neisseria spp; Borrelia burgdorferi; Shigella spp.; Escherichia coli; Haemophilus spp.; Francisella tularensis; Bacillus spp.; Clostridia spp.; Yersinia spp.; Treponema spp.; Burkholderia spp.; Burkholderia cepacia complex, B. mallei, B pseudomallei; Propionibacterium spp.; Acinetobacter species; an Actinomyces species; a Campylobacter species; a Candida species; Corynebacterium minutissium; Corynebacterium pseudodiphtheriae; Corynebacterium stratium; Corynebacterium group G1; Corynebacterium group G2; Enterobacteriaceae; an Enterococcus species; Klebsiella pneumoniae; a Moraxella species; a non-tuberculous mycobacteria species; a Porphyromonas species; Prevotella melaninogenicus; Serratia marcescens; Vibrio cholerae; a Coccidioides species, and a Cryptococcus species ([0208]).
Regarding claim 127, Deslouches teaches that the composition can take forms such as suspensions, solutions or emulsions in oily or aqueous vehicles (aqueous carrier) ([0104]).
Regarding claim 130, Steckbeck teaches treating the following fungal species:
Candida spp., (e.g. C. albicans), Epidermophyton spp., Exophiala spp., Microsporum spp., Trichophyton spp., (e.g. T. rubrum and T. interdigitale), Tinea spp.,
Aspergillus spp., Blastomyces spp., Blastoschizomyces spp., Coccidioides spp., Cryptococcus spp. (e.g. Cryptococcus neoformans), Histoplasma spp., Paracoccidiomyces spp., Sporotrix spp., Absidia spp., Cladophialophora spp., Fonsecaea spp., Phialophora spp., Lacazia spp.,
Arthrographis spp., Acremoniwn spp., Actinomadura spp., Apophysomyces spp., Emmonsia spp., Basidiobolus spp., Beauveria spp., Chrysosporium spp., Conidiobolus spp.,
Cunninghamella spp., Fusarium spp., Geotrichum spp., Graphiwn spp., Leptosphaeria spp., Malassezia spp. (e.g Malassezia Furfur), Mucor spp., Neotestudina spp., Nocardia spp.,
Nocardiopsis spp., Paecilomyces spp., Phoma spp., Piedraia spp., Pneunwcystis spp.,
Pseudallescheria spp., Pyrenochaeta spp., Rhizoinucor spp., Rhizopus spp., Rhodotorula spp., Saccharomyces spp., Scedosporium spp., Scopulariopsis spp., Sporobolomyces spp.,
Syncephalastrum spp., Trichoderma spp., Trichosporon spp., Ulocladium spp., Ustilago spp., Verticillium spp., and Wangiella spp ([0232]).
Claim(s) 2, 7, 17, 18, 25, 29, 35, 42, 54, 61, 64, 65, 113, and 126-130 are rejected under 35 U.S.C. 103 as being unpatentable Steckbeck et al. (WO 2019178274 A1, published 9/19/2019), Deslouches et al. (US20200079827A1, published 3/12/2020) and Rombouts et al. (Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment. Anticancer Res. 2020 Mar;40(3):1201-1218.), as applied to claims 2, 5, 7, 17, 18, 25, 29, 35, 42, 54, 61, 64, 65, 113, 127,128, and 130 above, and further in view of Lebowitz et al. (The pH and acidity of intravenous infusion solutions. JAMA. 1971 Mar 22;215(12):1937-40.).
The teachings of Steckbeck, Deslouches, and Rombout have been set forth above. Steckbeck, Deslouches, and Rombout do not teach the that the pharmaceutical formulation has a pH of about 5.
Lebowitz teaches that typical intravenous infusion solutions have pH values ranging from 4.2 to 7.1 (Abstract; Pg 1937, first column, first paragraph).
Thus, regarding claim 126, Steckbeck, Deslouches, and Rombout teach a method of treating an infection or cancer through intravenously administering a pharmaceutical composition comprising the instant SEQ ID NO: 1 and a pharmaceutically acceptable excipient over a time period of 1-48 hours such that the method treats an infection or a cancer tumor and an infusion related reaction. Lebowitz teaches that intravenous infusion solutions typically have a pH of 4.2-7.1. Based on these teachings, it would be obvious to formulate the pharmaceutical composition Steckbeck, Deslouches, and Rombout with a pH of about 5. One skilled in the art would be motivated to do so because Leibowitz taught that this pH falls within the range of what is typically administering to patients who receive intravenous infusions. One would have a reasonable expectation of success as Lebowitz taught that this is the standard for intravenous infusions.
Regarding claims 127 and 128, the instant specification teaches that an aqueous carrier can be lactated Ringer’s solution or normal saline (0.9% w/v) ([0161]). Leibowitz teaches lactated Ringer’s solution as well as normal saline (0.9% w/v; Pg 1, middle column, “Method” and Tables 2 and 3).
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.
Claims 2, 113, 126, and 130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, and 14-15 of copending Application No. 19/072,538 (‘538; claim set filed 5/13/2025).
Claim 1 of copending Application No. ‘538 recites a pharmaceutical formulation comprising (a) a peptide or pharmaceutically acceptable salt thereof comprising at least about 70% identity to a polypeptide sequence of SEQ ID NO: 1 or 15-25 and (b) at least one pharmaceutically acceptable excipient; wherein the pharmaceutical formulation has a pH of about 3.5 to 5.5; and wherein the pharmaceutical formulation comprise at most 5% by weight of at least one impurity as measured when stored for at least 50 days at 40°C. SEQ ID NO: 1 of copending Application No. ‘538 and the instant SEQ ID NO: 1 are 100% identical. The instant specification of copending Application No. ‘538 teaches that SEQ ID NO: 1 can be used to treat a microbial and/or fungal infection ([0111, 0112, 0119]), and the pharmaceutical formulation can be formulated for intravenous administration ([0076]).
Dependent claims include specific pH values of the pharmaceutical formulation (claims 5-7) and species of the peptide (claims 14-15).
This is a provisional nonstatutory double patenting rejection.
Claims 2, 113, 126, and 130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 19, 38, 40, and 54 copending Application No. 18/606,023 (‘023; claim set filed 11/22/2024).
Claim 1 of copending Application No. ‘023 recites a pharmaceutical formulation comprising: (a) a peptide or pharmaceutically acceptable salt thereof comprising at least about 70% sequence identity to a polypeptide sequence of SEQ ID NO: 1 or 15-25 or any combination thereof and (b) aqueous sodium bicarbonate at a concentration from about 50mM to about 300 mM. A method of making a pharmaceutical formula thereof from a kit is also recited in claim 38.
SEQ ID NO: 1 of copending Application No. ‘023 and the instant SEQ ID NO: 1 are 100% identical. The instant specification of copending Application No. ‘023 teaches that SEQ ID NO: 1 can be used to treat a microbial and/or fungal infection ([00152, 00153, 00161]), and the pharmaceutical formulation can be formulated for intravenous administration ([00129]).
Dependent claims include specific pH values of the pharmaceutical formulation (claims 3 and 40) and species of the peptide (claims 19 and 54).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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 Sara E Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658 /Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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