Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant’s election without traverse of Group I, claims 1-5 in the reply filed on April 24, 2026 is acknowledged.
Claims 1-8 and 11-19 are pending.
Claims 6-8 and 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions or species, there being no allowable generic or linking claim.
Claims 1-5 are pending and under consideration.
Priority
It is acknowledged that this application is a U.S. National Phase of International Application No. PCT/EP2021/085139, filed December 10, 2021, which claims the priority benefit of International Application No. PCT/EP2021/082892, filed November 24, 2021, PCT/EP2021/064326, filed May 28, 2021, and European Patent Application No. 20213562.0, filed December 11, 2020.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Examiner has established a priority date of November 24, 2021 (PCT/EP2021/082892) for claims 1-5 because the claims as currently constituted recite a formulation comprises a broad genus of antibody or antigen-binding fragment thereof (or two or more antibodies) in an aqueous solution with recited components (e.g. histidine) in claimed ranges and a review of the parent applications (PCT/EP2021/064326, European Patent Application No. 20213562) does not reveal the broadly claimed formulations. Applicant is invited to submit evidence pointing to the serial number, page and line where support can be found establishing an earlier priority date.
Information Disclosure Statement
The Information Disclosure Statements filed on 06/09/2023 and 06/30/2025 have been considered and entered by examiner.
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.
Claim 5 is 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 5, which depends on claim 1, recites “the formulation comprises two or more antibodies or antigen-binding fragment thereof”; and claim 1 recites “a formulation comprising an antibody or antigen-binding fragment thereof”. It is unclear whether the “two or more antibodies or antigen-binding fragment thereof” recited by claim 5 are additional “antibodies or antigen-binding fragment thereof” besides the “antibody or antigen-binding fragment thereof” of claim 1. To overcome the rejection, claim 5 may be amended as: “The formulation according to claim 1, wherein the formulation further comprises …”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Becker (Becker et al., US 2021/0371503 A1, Filing Date: May 28, 2021).
Becker teaches several neutralizing antibodies against SARS-related coronavirus ([0008], [0045]-[0072], [0105]).
Becker teaches a pharmaceutical composition comprising the antibody ([0222]), a liquid pharmaceutical composition suitable for injection or infusion ([0227]).
Becker teaches pharmaceutical formulation may comprise a buffering agent (including histidine or acetate), the histidine concentration can be about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100 mM ([0233]).
Becker teaches the pH of the buffer is about 5.0 to about 7.0, or about 5.5 to about 7.5, or about 6.0 ([0234]).
Becker teaches that trehalose can be used as a stabilizing sugar for the pharmaceutical composition ([0237]), and the pharmaceutical formulation also comprises a stabilizer, such as glycine ([0238]).
Becker teaches that the pharmaceutical formulation may comprise nonionic surfactant, such as polysorbate 20; wherein the concentration of polysorbate 20 is about 0.005 to 0.5% (w/v), or about 0.04% (w/v) ([0239]).
Regarding claims 1-2, Becker teaches antibody formulations comprising an antibody or antigen-binding fragment thereof in an aqueous solution at a concentration of 10-260 mg/mL, 10-25 mM acetate, 172.7-259.1 mM glycine, 17.3-25.9 mM trehalose, 0.2-0.6 g/L polysorbate 20 (polyoxyethylene (20)-sorbitan-monolaurate), at a pH of 5.2-5.8. The formulation provided has been shown to work for different antibodies ([0308], Example 15).
Regarding claims 3-4, Becker teaches a pharmaceutical composition is provided comprising an antibody comprising a heavy chain of sequence SEQ ID NO: 229, and a light chain of sequence SEQ ID NO: 230, or antigen-binding fragment thereof, at 50 mg/ml in 20 mM acetate, 220 mM glycine, 20 mM trehalose, 0.4 g/L polysorbate 20 (=0.04 w/v Polysorbate 20) at pH 5.5 ([0310]).
Claim Rejections - 35 USC § 103
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.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Becker (Becker et al., US 2021/0371503 A1, Filing Date: May 28, 2021), as applied to claims 1-4 above, and further in view of Both (Both et al., Vaccine, Vol. 31, Issue 12, pages: 1553-1559, Publication Date: 03/15/2013).
Becker teaches the formulation of instant claim 1 as set forth above. Becker further teaches that the formulation is applicable as high-concentration liquid formulation, essential in order to accommodate high dose administration s.c. vis syringe by injection; and compatible with commercial clinical dilution media ([0311]). The pharmaceutical formulation can be used as vaccine ([0087], [0223]).
However, Becker does not teach that the formulation comprises two or more antibodies or antigen-binding fragment thereof.
Both teaches that cocktails of mAbs and bispecific constructs can be used to simultaneously target multiple viral epitopes and to overcome issues of neutralization escape (Abstract).
Both teaches that cocktails of mAbs have been developed for SARS-CoV (§ 5. Cocktails of mAbs; and Table 1).
It would have prima facie been obvious to one of ordinarily skilled in the art before the effective filing date of the claimed invention to make a formulation of instant claim 1 containing an antibody against SARS-CoV, as taught by Becker, and to add additional antibodies to further improve the efficacy of the pharmaceutical formulation as taught by Both. One of ordinary skill in the art would have had a reasonable expectation of success because Becker teaches the formulation is suitable for high concentration of antibodies and Both teaches that cocktails of mAbs and bispecific constructs can be used to simultaneously target multiple viral epitopes and to overcome issues of neutralization escape. The motivation would have been to develop a better vaccine for SARS-CoV.
Claims 1-4 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Goldbach (Goldbach et al. WO 2009/007272 A1, Publication Date: 01/15/2009, cited in IDS of 06/09/2023, of record).
Goldbach teaches a pharmaceutical formulation comprising: 1 to 200 mg/mL of an antibody; 1 to 100 mM of a buffer; 0.001 to 1% of a surfactant; 10 to 500 mM of a stabilizer and 5 to 500 mM of a tonicity agent (claim 1).
Goldbach teaches that the buffer may comprise acetate or histidine and the pH can be adjusted at a range between about 5.0 to about 6.5 (page 4, para. 3); the stabilizer can be sugar e.g. the preferred sugar is trehalose (page 5, para. 2 to page 6, para. 1).
Goldbach teaches that glycine is a type of tonicity agent, and tonicity agents are generally used in an amount of about 5-500 mM, preferably 50-300 mM (page 7, para. 1).
Goldbach teaches that polysorbate 20 is a pharmaceutically acceptable excipient which is used to protect protein formulations against mechanical stresses in a concentration range of about 0.001 to about 1% (w/v) (the bridging paragraph of pages 4-5).
Goldbach teaches an exemplary formulation comprising 1 to 50 mg/mL antibody, 20 mM histidine, 160 mM trehalose, 100 mM glycine, 0.02% polysorbate 20, at pH 6.0.
Goldbach teaches the antibody in the formulation can be antibodies produced by recombinant means (page 4, para. 2).
Goldbach teaches that the formulation can be used to for treatment of asthma or allergy (page 9, lines 18-19); and can be administered by intravenous, subcutaneous, or any other parental administration means (page 10, para. 2).
Goldbach teaches various formulations according the ranges of claim 1 of Goldbach which have good properties, including stability (Table 1).
Taken together, Goldbach teaches all the components of the instantly claimed formulation, and possible range for each components which overlap range of instant claim 1. Although Goldbach does not teach the claimed ranges in a single embodiment, one of ordinary skill in the art would have known to adjust these components for specific antibody and/or administration regimens to reach the claimed formulation.
Regarding claims 2-4 which recited different concentrations and/or ranges, one of ordinary skilled in the art would have been motivated to optimize the concentrations of various buffers, excipients and other components in the composition, since "it is the normal desire of scientists or artisans to improve upon what is already generally known". The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the genera I conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller. 220 F.2d 454,456, 105 USPQ233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ809 (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.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc .. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Claim 5 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Goldbach (Goldbach et al. WO 2009/007272 A1, Publication Date: 01/15/2009, cited in IDS of 06/09/2023, of record), as applied to claims 1-4 above, and further in view of Domingo (Domingo et al., Frontiers in Pharmacology, Vol. 11, Article 587621, Publication Date: 09/30/2020).
Goldbach teaches the formulation of instant claim 1 and the method of using the formulation for treating diseases such as asthma, as set forth above.
However, Goldbach does not teach that the formulation comprises two or more antibodies or antigen-binding fragment thereof.
Domingo teaches that omalizumab, antibody inhibitor of the Th2 cascade, is the first biological treatment for severe allergic bronchial asthma (Abstract -Introduction).
Domingo teaches that mepolizumab, a blocker of IL-5, is also available for treatment of severe allergic bronchial asthma (Abstract – Introduction and Case Study).
Domingo teaches that the clinical improvement was limited for single antibody treatment (Abstract – Case Study).
Domingo teaches that the dual therapy significantly improve the treatment efficacy (Abstract – Results; and Fig. 1).
Domingo teaches that in some severe allergic asthma patients with persistently high eosinophil counts in peripheral blood and who are considered non- or mild responders to antibody administered individually, a combination of the two antibodies covering the entire T2 spectrum may be effective (Abstract – Conclusions).
It would have prima facie been obvious to one of ordinarily skilled in the art before the effective filing date of the claimed invention to make a formulation of instant claim 1 containing an antibody for treatment diseases such as asthma, as taught by Goldbach, and to add additional antibodies to further improve the efficacy of the pharmaceutical formulation as taught by Domingo. One of ordinary skill in the art would have had a reasonable expectation of success because Goldbach teaches the formulation is suitable for therapeutic antibodies and Domingo teaches that combinations of antibodies can be more effective for some asthma patients (non-responders to single antibody treatment). The motivation would have been to develop a better treatment for asthma.
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/353,133 (reference application, hereinafter Appl. 133) in view of Goldbach (Goldbach et al. WO 2009/007272 A1, Publication Date: 01/15/2009, cited in IDS of 06/09/2023, of record).
Claim 1 of Appl. 133 teaches a pharmaceutical formulation comprising: a. an anti-IL-36R antibody or an antigen binding fragment thereof present at a concentration within the range from 0.5 mg/mL to 220 mg/mL, …; b. a buffer present at a concentration within the range from 20 mM to 80 mM, wherein the buffer comprises acetate, histidine, or citrate; c. a tonicifying agent present at a concentration within the range from 100 mM to 250 mM, wherein the tonicifying agent is one or more sugar and/or polyol comprising sucrose, trehalose, sorbitol, glycerol, mannitol or dextrose; wherein the formulation is characterized by a pH within the range from 5 to 8 when in aqueous form.
Claim 3 of Appl. 133 teaches wherein the formulation is in liquid form.
Claims 6 and 7 of Appl. 133 teach wherein the formulation further comprises a stabilizer present at a concentration within the range from 0 mM to 80 mM; wherein the stabilizer comprises an amino acid comprising … glycine …, or glutamate.
Claims 10 and 11 of Appl. 133 teach wherein the formulation further comprises a surfactant present at a concentration within the range from 0.1 g/L to 1.5 g/L; wherein the surfactant comprises …, polysorbate 20 … or polysorbate 80.
Claims 21 and 22 of Appl. 133 teaches wherein the formulation has a pH of between 5 to 6 in liquid form or when reconstituted with water; wherein the formulation has a pH of 6 in liquid or when reconstituted with water.
The scope of the claims of Appl. 133 overlap with the scope of the instantly claimed invention, because both are drawn to a liquid antibody formulation with the same components. In addition, the claims of Appl. 133 teach the ranges of antibody, histidine, trehalose and pH overlap with the ranges of instant claim 1. However, the claims of Appl. 133 do not teach the range of glycine (120 mM-260 mM) of instant claim 1, or the ranges and/or concentrations of instant claims 2-4.
Goldbach’s teachings are described above. In particular, Goldbach teaches all the components of the instantly claimed formulation, and possible ranges for the components which overlap range of instant claim 1. Goldbach teaches various formulations according the ranges of claim 1 of Goldbach which have good properties, including stability (Table 1). Goldbach teaches that the formulation can be used to for treatment of asthma or allergy (page 9, lines 18-19); and can be administered by intravenous, subcutaneous, or any other parental administration means (page 10, para. 2). One of ordinary skill in the art would have known to adjust components (e.g. glycine) for specific antibody and/or administration regimens to reach the claimed formulation, because Goldbach teaches that different concentrations and/or ranges of these claimed components can form a pharmaceutical formulation suitable for therapeutic antibodies.
In addition, one of ordinary skilled in the art would have been motivated to optimize the concentrations of various buffers, excipients and other components in the composition, since "it is the normal desire of scientists or artisans to improve upon what is already generally known". The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the genera I conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller. 220 F.2d 454,456, 105 USPQ233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ809 (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.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc .. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHENG LU/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/
Supervisory Patent Examiner, Art Unit 1642
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