DETAILED OFFICE ACTION
The present application is being examined under the pre-AIA first to invent provisions.
The request filed on 18 September 2025 for a Continued Examination (RCE) under 37 CFR 1.114 based on parent Application No. 18/405,772 is acceptable, and an RCE has been established. An action on the RCE follows.
Applicant’s amendment filed on 18 September 2025 is acknowledged and entered. Following the amendment, claim 10 is canceled, claims 5-9 and 12-16 are amended, and the new claim 30 is added.
Note, in the previous version of the claims filed on 3/17/2025, claim 5 recited “comprises histidine” in line 5; however, the word “histidine” simply disappeared without any mark in the current version filed on 9/18/2025, which is not in compliance with 37 C.F.R. 1.121 (c)(2). See also, MPEP 714 II. C. (B). Appropriate correction is required.
Currently, claims 5-9, 12-16 and 30 are pending and under consideration.
Withdrawal of Objections and Rejections:
All objections and rejections of claim 10 are moot as the applicant has canceled the claim.
The lack of adequate written description rejection of claim 14 under 35 U.S.C. 112, first paragraph, is withdrawn in view of applicant’s amendment.
The rejection of claim 14 under 35 U.S.C. 112, fourth paragraph, is withdrawn in view of applicant’s amendment.
The prior art rejection of claim 14 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over N.W. Warne (Eur J Pharm Biopharm. 2011 Jun; 78(2):208-12), and Presta et al. (US 2010/0272731 A1, 10/28/2010), and further in view of Banks et al. Banks et al. (J Pharm Sci. 2009 Dec; 98(12):4501-10), and as evidenced by Bishop et al. (US 2015/0071943, 3/12/2015) is withdrawn in view of applicant’s amendment.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 9/18/2025 is acknowledged and has been considered. A signed copy is attached hereto.
Claims
Claim 5 is objected to for the following informalities, appropriate correction is required:
Claim 5 recites “comprises about 80 to 120 mg/mL anti-IL-23p19 antibody hum13B8-b”; the following is suggested: “comprises about 80 to 120 mg/mL of the anti-IL-23p19 antibody hum13B8-b”.
Rejections under 35 U.S.C. §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 5-9 and 12-16 remain rejected, and claim 30 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 pre-AIA the applicant regards as the invention.
The amended claim 5 recites “A high concentration solution formulation comprising ...”, which is indefinite because it is unclear what “A high concentration” is for (there are multiple ingredients in the formulation), i.e., a high concentration of what? The metes and bounds of the claim, therefore, cannot be determined. The following is suggested: “A high antibody concentration solution formulation comprising …”; or simply, “An aqueous antibody formulation comprising ...”. Claims 6-9, 12-16 and 30 are similarly indefinite.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 5-9, 12, 13, 15 and 16 remain rejected, and claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention, for the reasons of record set forth in the previous Office Actions mailed on 9/17/2024, and 6/18/2025.
Applicants argument filed on 18 September 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At pages 6-7 of the response, the applicant argues that claim 5 has been amended to recite about 80 to 120 mg/mL anti-IL-23p19 antibody hum13B8-b, a buffer, a surfactant, and a tonicifying agent; that the instant application describes experiments in which formulations comprising buffers such as acetate, citrate, and histidine; surfactants; and tonicifying agents; that in view of the application, one skilled in the art would reasonably conclude that the inventors had possession of the claimed invention at the time the application was filed; and could readily prepare formulations that exhibit the recited features of claim 5(a)-(d).
This argument is not persuasive for the reasons of record. The features of the formulation recited in (a) - (d) of claim 5 represent the end results after the storage at 5o+3o C for up to 12 months, which can be only determined by the ingredients and their concentrations (besides the antibody) in the formulation. However, the independent claim 5 does not specify any ingredients (other than the antibody itself), but merely broadly recites “the formulation comprises … a buffer, a surfactant, and a tonicifying agent”, let alone, their concentrations. As discussed in the previous Office Actions, the specification does not disclose any formulation (0 species) meeting the limitations of claim 5. No other formulation meeting the limitations of the claims is ever identified or particularly described in the specification. It is further noted that the features recited in (a) - (d) of claim 5 do not seem predictable, even among different lots of production (assuming the same formulation?), for example, lot D vs. lot E (see Table 4 vs Table 7, for example), neither of which meets all limitations in (a) - (d) of claim 5 Therefore, it is unclear as to how one skilled in the art would reasonably conclude that the inventors had possession of the claimed invention. Further, the issue is not even that one skilled in the art could readily prepare formulations that exhibit the recited features of claim 5(a)-(d) (enablement), rather, the issue is that the specification does not provide adequate written description for the extremely broad genus claimed.
Once again, therefore, only the pharmaceutical formulation comprising said anti-IL-23p19 antibody hum13B8-b and the ingredients as defined in Table 2 of the specification, but not the full breadth of the claims (the variables recited in parts (a) - (d) of claim 5; and “the formulation comprises a surfactant, and tonicity adjustment agent”; for example) meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Rejections Over Prior Art:
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 5-9, 12, 13, 15 and 16 remain rejected, and claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over N.W. Warne (Eur J Pharm Biopharm. 2011 Jun; 78(2):208-12; provided by applicant), and Presta et al. (US 2010/0272731 A1, 10/28/2010; provided by applicant), and further in view of Banks et al. Banks et al. (J Pharm Sci. 2009 Dec; 98(12):4501-10; provided by applicant), and as evidenced by Bishop et al. (US 2015/0071943, 3/12/2015; claiming priority to U.S. Provisional Applications 60/909,232 and 60/909,117 filed 03/30/2007), for the reasons of record set forth in the previous Office Actions mailed on 9/17/2024, and 6/18/2025.
Applicants argument filed on 18 September 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At pages 8-9 of the response, the applicant made similar arguments as previously: one of ordinary skill in the art, absent the teachings in the instant application, would not have been motivated to combine the teachings of Warne, Presta, Banks, and Bishop to achieve the claimed formulation; the teachings of the cited references, when considered as a whole, lead away from the claimed formulation and discourage the skilled artisan from using the components and conditions recited in the pending claims; one of ordinary skill in the art, when referring to the teachings of Warne, would not recognize a single, reasonable starting point, but rather would be confronted with numerous options for developing an antibody formulation (Table 1 of Warne); and of the twenty-one antibody formulations listed in Table 1, seven are lyophilized formulations, and fourteen are liquid formulations, of which only a single formulation (golimumab) comprises an antibody at a high concentration (80 to 120 mg/mL); and four of the five formulations disclosed in Table 1 that comprise an antibody at a high concentration are lyophilized formulations; thus, the skilled artisan would have been led to a lyophilized formulation rather than a solution formulation.
These arguments are not persuasive for the reasons of record. Contrary to applicants argument that absent the teachings in the instant application, one of ordinary skill in the art would not have been motivated to combine the teachings of the cited references, as discussed above, the instant application does not disclose any formulation that meets the limitation of claim 5. Further, once again, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as discussed previously, Presta teaches the claimed antibody, hum13B8-b; Warne teaches antibody “platform formulations” in which a suitable, high concentration, robust formulation, or dosage form is utilized broadly across a number of early stage biologics at a savings of time and effort, and is a highly pragmatic approach; and Banks and Bishop teach the use of sucrose in solution formulations. Therefore, it would have been instantly obvious to the person of ordinary skill in the art to combine the teachings of the four references to make a stable pharmaceutical formulation as claimed.
Furthermore, once again, contrary to applicants argument that the teachings of the cited references lead away from the claimed formulation, and the skilled artisan would have been led to a lyophilized formulation rather than a solution formulation, Warne specifically teaches that the development of highly concentrated solutions of monoclonal antibodies has become increasingly popular in biotechnology firms as doses increase, and the demand for sub-cutaneous injection formulations rises for reasons of convenience and compliance, which has driven many laboratories to develop so-called “platform formulations”. Further, contrary to applicants argument that one of ordinary skill in the art, when referring to the teachings of Warne, would be confronted with numerous options for developing an antibody formulation, Warne teaches “platform formulations”, which clearly does not mean numerous options, and Warne merely discusses the elements in the platform formulation individually. Furthermore, contrary to applicants argument that only a single liquid formulation (golimumab) comprises an antibody at a high concentration, STELARA (ustekinumab) also is a liquid formulation comprising an antibody at a high concentration (90 mg/mL); and both liquid formulations comprise histidine buffer. In addition, HUMIRA (adalimumumab) is another liquid formulation comprising 50 mg/mL antibody, which could be considered high concentration according to the present specification.
At pages 10-11 of the response, the applicant made similar arguments as previously: among the 21 antibody formulations listed in Table 1 of Warne, 9 use phosphate as a buffer (seven of which are solution formulations), 8 use histidine as a buffer (only three of which are solution formulations), 3 use citrate as a buffer (all three of which are solution formulations), and one uses acetate as a buffer (which is a solution formulation), thus, if one of ordinary skill in the art were to look to Warne for teachings regarding the development of a high concentration solution formulation - such as the claimed formulation -
These arguments are not persuasive for the reasons of record; and all issues raised have addressed in detail previously. Applicant simply ignores the rest of teachings of Warne, but focus on Table 1 only, which is merely a list of formulations for recently approved at the time. As discussed previously, the Warne reference focus on the development of highly concentrated solutions of monoclonal antibodies by teaching “platform formulations”, which comprise all ingredients of those in the present claim 14, for example. Once again, as discussed previously, Warne specifically teaches that since the majority of the high concentration antibody formulations are formulated at pH 6.0 ± 0.4, one must ask whether there is value in examining formulations outside this range; and given the limited number of choices for a suitable buffer in this range (succinic acid has a pKa of 5.6, L-histidine 6.0 and sodium phosphate 7.21 all at 20 oC), we must ask why we would consider a buffer other than L-histidine (page 209, 2nd column, last paragraph). As shown in Table 1 of Warne, all 6 high concentration antibody formulations (> 90 mg/ml), lyophilized or liquid, use histidine. Thus, Warne provides clear and strong evidence for choosing histidine for high concentration antibody formulations, and it is unclear as to why applicant chooses to ignore these teachings by Warne; and what additional “rationale” applicant or one of ordinary skill in the art would need in this regard?
Double Patenting Rejections:
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 5-9, 12-16 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,509,509 (US application 14/651,946). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons of record set forth in the provisional nonstatutory double patenting rejection over claims 1, 7, 12 and 13 of US Application No. 14/651,946 (new patented) in the previous Office Action mailed on 9/17/2024, at page 14.
Applicants argument filed on 18 September 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At page 12 of the response, the applicant stated that Applicant elects to address this ground of rejection upon notification that the rejection has been made non-provisional, all other conditions for patentability have been met, and the instant claims are otherwise in condition for allowance.
As such, the rejection is maintained. Note, the instant rejection is non-provisional as the ‘946 application has been patented. Applicant is reminded that filing a terminal disclaimer will overcome the instant rejection. However, Applicant is advised that traversal of the rejection at such a time when all other conditions for patentability have been met and the instant claims are otherwise in condition for allowance would not be considered timely.
Claims 5-9, 12-16 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-28 of copending Application No. 17/114,754 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the similar reasons of record set forth in the previous Office Action mailed on 9/17/2024, at pages 14-15.
Applicants argument filed on 18 September 2025 has been fully considered, but is not deemed persuasive for the reasons below.
At page 12 of the response, the applicant stated that Applicant elects to address this ground of rejection upon notification that the rejection has been made non-provisional, all other conditions for patentability have been met, and the instant claims are otherwise in condition for allowance.
As such, the rejection is maintained. Applicant is reminded that filing a terminal disclaimer will overcome the instant rejection. However, Applicant is advised that traversal of the rejection at such time would not be considered timely.
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DONG JIANG/
Primary Examiner, Art Unit 1674
2/16/26