DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment of 11/17/25 has been entered in full. Claim 27 is amended. Claims 1-34 are pending.
Election/Restrictions
Applicants’ election of “another type of immunosuppressive agent” as the species of “additional drug” in the reply filed on 11/17/25 is acknowledged.
Claims 1-34 are under consideration, as they read upon the elected species.
Claim Objections
Claims 5, 9-11, 19, 22-25, and 32-33 are objected to for following informalities:
In each of claims 5 and 19, line 1 of each, “wherein wherein” should be “wherein”, and in lines 2-3 of each claim, “wherein the clinical endpoint is clinical response” should be “wherein the clinical endpoint is a clinical response”.
In each of claims 9, 10, 23, 24 and 33, each use of “SEQ ID NO: X” should be written as “SEQ ID NO:X”. Compare with parent claim 1. Alternately, the format used in claim 1 should be amended to match that of claims 9 and 10.
In each of claims 11 and 25, in line 2 of each claim, “4.0mM” should be “4.0 mM”, and in line 3 of each claim “monohydrate;” should be “monohydrate, and”
In claim 22, line 2, “therafter” should be “thereafter”.
In claim 32, line 2, “Mayo … subscore” should be “a Mayo … subscore”
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
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.
Claims 2-5, 7-25, 27 and 31-34 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 pre-AIA the applicant regards as the invention.
Claims 2-3, 7-8, 21 and 33-34 are indefinite with regard to the recitation "about 4 weeks", “about 8 weeks”, “about 12 weeks”, “about 4, 8, 12, 16, 20, 28, 32, 36, 40, 44 and/or 48 weeks” and/or “about 24 weeks” due to the use of the term "about" in relation to the time period. Per MPEP 2173.05(b)(III)(A), “In determining the range encompassed by the term “about”, one must consider the context as it is used in the specification and claims”. In the instant case, the specification does not define the term, either generally, or even use it in relation to a time period. As such, the specification does not provide any guidance such that the skilled artisan would know what number of weeks are encompassed by the claim. Thus, due to the use of the term "about", the claim is indefinite as to what degree of variation is encompassed; for example, "about 4 weeks" could encompass a range of 2, 3, 5 or 6 weeks, to list several of the many alternate possibilities. For purposes of advancing prosecution, the term is interpreted as encompassing each of the alternate possibilities that the indefinite term reads upon.
Claims 5, 14, 19 and 33 each recite the limitation “the modified Mayo score” in line 3. There is insufficient antecedent basis for this limitation in each claim. Specifically, there is no preceding recitation in each claim or a parent claim directed to “a modified Mayo score” to provide the necessary antecedent basis.
Claims 7 and 8 each recites the limitation “the clinical endpoint(s)” in line 1. There is insufficient antecedent basis for this limitation in the claim. Specifically, claims 7 and 8 depend from claim 5, which recites “a clinical endpoint”, which is only singular and not sufficient antecedent basis for “the clinical endpoint(s)” which includes both singular and multiple endpoints.
Claims 11 and 25 each recite “a composition comprising 7.9% (w/v) sucrose, 4.0 nM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80”. This group lacks a conjunction, and thus it is unclear whether the composition requires only one component (“or”) or all of the components (“and”).
Claims 11 and 25 each recite the limitation “the pharmaceutical composition” in line 3. There is insufficient antecedent basis for this limitation in each claim. Specifically, there is no preceding recitation in each claim or a parent claim directed to “a pharmaceutical composition” to provide the necessary antecedent basis. Furthermore, it is unclear what is meant by the overall recitation in lines 2-4 of “a composition comprising …of the pharmaceutical composition”.
Claims 12 and 14 indefinite because it is not clear how the recitation that the method comprises “further administering to the patient the antibody specific to IL23” related to the parent methods, which already require that the antibody is administered. It is unclear whether the limitation is directed to a second administering step or somehow further limits the administration step of the parent claim(s).
Claim 27 recites the limitation “the additional drug”. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 27 depends from claim 26, which recites “one or more additional drugs”, which includes both singular and plural alternatives and does not provide sufficient antecedent basis for “the additional drug” which is only directed to the singular. In this regard, claim 27 could be clarified by amending it to recite “the one or more additional drugs”.
Claim 31 is indefinite because it further limits the patient of claim 30, who has moderately to severely active UC a patient having endoscope evidence of active Crohn’s disease prior to the initial dose. It is unclear how the UC patient can have evidence of active CD, as they are two different types of IBD.
Claim 33, an independent claim, recites the limitation “the modified Mayo score” in line 10 and “the rectal bleeding subscore” in line 11. There is insufficient antecedent basis for each limitation in the claim. Specifically, there is no preceding recitation in each claim or a parent claim directed to “a modified Mayo score” or “a rectal bleeding subscore” to provide the necessary antecedent basis.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Double Patenting, Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-6, 14-17 and 28-34 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 2-6, 18-21 and 32-38 of copending Application No. 18/517,248 (reference application).
The ‘248 application shares the same Applicant and three Inventors with the instant application.
Instant claim 1 is word-for-word identical to claim 1 of the ‘248 application.
Instant dependent claims 2-6 depend from claim 1 and present further limitations that are identical to the further limitations of claims 2-6 of ‘248.
Instant dependent claims 14-17 depend from claim 1 and present further limitations that are identical to the further limitations of claims 18-21 of ‘248.
Instant dependent claims 28-32 depend from claim 1 and present further limitations that are identical to the further limitations of claims 32-36 of ‘248.
Independent instant claim 33 is word-for-word identical to independent claim 37 of ‘248, and instant dependent claim 34, which depends from claim 33, presents further limitations that are identical to claim 38 of ‘248.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Double Patenting, Nonstatutory
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7-13 and 18-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending application 18/517,248, flied 11/22/23 and which shares the same Applicant and three inventors with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Instant claims 7-13 depend from claim 5, which as indicated above, is identical to claim 5 of the ‘248 application. Of these, instant claims 7 and 8 present further limitations regarding the timing of the endpoint measurement that correspond to limitations found within dependent claims 10 and 11 of ‘248, which depend from claim 5 (as well as 6-9) of ‘248. As such, the two sets of claims are not patentably distinct.
Instant claims 9-13 and 18-27 present further limitations regarding the sequences of the antibody (claims 9, 10, 23 and 24), the composition the antibody is in (claims 11 and 25), further administration (claim 12), further administration that is subcutaneous at a dose of 200 mg (claims 13 and 18), further define the responder (claims 19-20), the time of clinical endpoint measurement (claim 21), further administering every 4 or 8 weeks (claim 22), and further administration of one or more drugs that is an immunosuppressive agent (claims 26 and 27). These further limitations correspond to limitations found in dependent claims 14-16, 19-20, 22-24, 25, 27 and 31-32 of ‘248. As such, the two sets of claims, while not identical in scope, are not patentably distinct because they include embodiments encompassed by the other claim set.
This is a provisional non-statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Note on Prior Art Rejection(s)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
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.
Claims 1, 5-10, 12, 14-17, 23-24 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Record for Clinical Trial NCT04033445, Version 16, 10/27/20. 61 pages as printed from https://clinicaltrials.gov/study/NCT04033445; no author indicated. The earliest date to which the instant application claims priority is 11/23/21.
Claim 1 encompasses a method of treating ulcerative colitis (UC) in a patient, comprising administering to the patient an antibody specific to IL23 that comprises a light chain variable region comprising CDR1-3 of SEQ ID NO: 4-6 and a heavy chain variable region comprising CDR1-3 of SEQ ID NO: 1-3, and wherein the patient is deemed a responder to the antibody. The specification teaches that the antibody known as guselkumab has these sequences (¶ 42, page 12), and thus guselkumab is encompassed by the antibody used in the claimed method.
The concluding wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, the wherein clause of claim 1 simply expresses the intended result (deeming the patient a responder to the antibody) of a process step positively recited (administering the antibody). As such, claim 1 encompasses a method of treating UC in a patient, comprising administering to the patient the anti-IL23 antibody guselkumab.
The record for NCT04033445 (hereafter ‘445) teaches treatment of patients with UC by administering guselkumab (e.g., at page 4). As such, the teachings of ‘445 anticipate claim 1.
In claims 5, 6, and 14, each depending from claim 1, each further wherein clause has been fully considered in context of the entire claim, but does not render the method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. Specifically, the wherein clause of each of claims 5, 6 and 14 simply expresses the intended result (the patient meeting or not meeting a clinical endpoint) of a process step positively recited (administering the antibody). As such, the teachings of ‘445 also anticipate claims 5 and 6.
Claims 7 and 8 each encompass a method of claim 5 wherein the clinical endpoint is measured at week 12 after initial treatment. ‘445 further teaches determining “the participant’s clinical response status at Week 12” (page 10). As such, the teachings of ‘445 also meet the limitations of claims 7 and 8.
Claims 9 and 10 each encompass a method of claim 7 wherein the antibody comprises light and heavy chain variable regions of SEQ ID NO: 8/7 (claim 9) or light and heavy chain sequences of SEQ ID NO: 10/9 (claim 10). The specification teaches that the antibody guselkumab has these sequences, and thus guselkumab is encompassed by the antibody used in these claims. As such, the teachings of ‘445 set forth above also meet the limitations of claims 9 and 10.
Claims 12 and 15 encompass a method of claim 9 (claim 12) or 14 (claim 15), that comprises “further administering to the patient the antibody specific to IL23”. As set forth above, in the section titled, “Claim Rejections - 35 USC § 112(b)” this further limitation is indefinite with respect to how it relates to the administration required by the parent claims. As such, the further limitation is interpreted as encompassing the administration of guselkumab, which is taught by ‘445. As such, the teachings of ‘445 set forth above also anticipate claims 12 and 15.
Claims 16 and 17 encompass a method of claim 15 wherein the antibody is administered 12 weeks after initial treatment (claim 16) and further at 16 and 20 weeks after initial treatment (claim 17). ‘445 further teaches that guselkumab will be administered “every 4 weeks (q4w)” up to “Week 44” (page 6). This dosage schedule includes administration at weeks 12, 16 and 20. As such, the teachings of ‘445 also anticipate claims 16 and 17.
Claims 23 and 24 encompass a method of claim 14 wherein the antibody comprises a LCVR/HCVR pair of SEQ ID NO: 8/7 (claim 23) or a light/heavy chain pair of SEQ ID NO: 10/9 (claim 24). The specification teaches that the antibody known as guselkumab has these sequences (¶ 42, page 12; pages 124-125), and thus guselkumab is encompassed by the antibody used in the claimed method. As such, claims 23 and 24 are anticipated by ‘445 for the same reasons as for parent claim 14.
Claim 30 encompasses a method of claim 1 wherein the UC is “moderately to severely active” UC. ‘445 further teaches that the UC to be treated is “moderately to severely active”; e.g., page 8. As such, the teachings of ‘445 also anticipate claim 30.
Claim Rejections - 35 USC § 103
The following is a quotation of 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 the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claims 2-4, 13, 18-20, 26-28, 29 and 33-34 are rejected under 35 U.S.C. 103(a) as being unpatentable over the Record for Clinical Trial NCT04033445 (Version 16, 10/27/20; no author indicated. 61 pages as printed), as applied to claim 1 above, and further in view of Canavan et al, WO 2019191464, published 10/3/2019.
Claims 2-4 encompass a method of claim 1 wherein the antibody is administered in an initial dose, a dose about 4 weeks after the initial dose, and a dose about 8 weeks after the initial dose (claim 2) and further wherein each dose is 200 mg (claim 3) and further wherein the antibody is administered intravenously.
The teachings of the Record for Clinical Trial NCT04033445 (hereafter ‘445) that anticipate parent claim 1 are set forth above. ‘445 further teaches that guselkumab can be administered intravenously (IV) (page 5). ‘445 does not teach the specific dosage regimen of claim 2 or the specific dosages of claim 3.
Canavan teaches an invention that “generally relates to the treatment of ulcerative colitis with an anti-IL-23p19 antibody, in particular dosage regimens for the treatment of the disease” (see Abstract). Canavan further teaches specific dosage regimens suitable for treatment of ulcerative colitis (UC) with an anti-IL23 antibody, including treatment at Week 0, Week 4 and Week 8 (page 3, lines 11-13). Canavan further teaches that each dose can be 200 mg (page 3, line 25). Canavan further teaches that doses are administered intravenously (page 4, lines 5-6).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of UC with guselkumab taught by ‘445 and modify the method to administer the guselkumab at a dosage (e.g., 200 mg) and dosage regimen (e.g., Week 0, Week 4, and Week 8) taught by Canavan. Because the teachings of Canavan are directed to use of a genus of products (anti-IL23 antibodies), and guselkumab represents a species within such a genus, it would have been a simple and predictable substitution to apply the teachings of Canavan regarding anti-IL23 antibodies in general to the specific anti-IL23 antibody that is guselkumab. Thus, such a modified method represents a simple and predictable application of teachings directed to a genus to a species within said genus. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 13 and 18 each encompass a method of, respectively, claim 12 (which depends from claims 1, 5, 7, and 9) or 16 (which depends from claims 1, 15, 16 and 17), wherein the antibody is further administered subcutaneously at a dose of 200 mg. Canavan further teaches subcutaneous administration (¶ 6, lines 23-24). As such, it would have further been obvious to modified the method of ‘445 to administer the guselkumab subcutaneously at 200 mg, for the same reasons as for intravenous administration of 200 mg that are set forth above.
Claims 19 and 20 each depend from claim 18 and recite a further wherein clause indicating that the patient is a responder if meeting certain criteria. As with claim 1, each wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. As such, the methods of claims 19 and 20 are met by the teachings of ‘445 in view of Canavan for the same reasons as for parent claim 18.
Claim 21 depends from claim 19 and further limits the method to one wherein the clinical endpoint is measured at 24 weeks after initial treatment. Canavan further teaches that the induction dose is typically “4, 8 or 12 weeks” that an “end-of-induction assessment” typically occurs “4 or 8 weeks after the last induction dose has been administered” (page 3, lines 5-8). Canavan further teaches that “one, two or three induction dose(s)” can be administered (page 4, lines 9-10), with “dose and dosing intervals during the extended induction period are typically the same as dose and dosing intervals during the initial induction period” (page 4, lines 19-21); i.e., every 4 weeks, in which case the induction period would end at either weeks 16, 20 or 24. Furthermore, Canavan also teaches an “extended-induction assessment” (page 4 , which would be 4 or 8 weeks after the last extended-induction dose per the guidance on page 3 described above. Thus, the teachings of Canavan include assessment of clinical responses at 24 weeks; e.g., 4 weeks after an extended-induction ending on week 20. As such, it would have further been obvious to make an assessment on week 24 when practicing the method obvious over the teachings of ‘445 in view of Canavan set forth above.
Claim 22 depends from claim 19 and further limits the method to one wherein the antibody is further administered every 4 weeks thereafter. Canavan further teaches that maintenance doses can be given every 4 weeks after the last induction dose (page 6, lines 7-11). As such, it would have further been obvious to further administer a maintenance dose every 4 weeks as taught by Canavan, when practicing the method obvious over the teachings of ‘445 in view of Canavan set forth above.
Claims 26 and 27 encompass a method of claim 1 further comprising administering an additional drug used to treat UC (claim 26) that is an immunosuppressive agent (claim 27).
The teachings of the Record for Clinical Trial NCT04033445 (hereafter ‘445) that anticipate parent claim 1 are set forth above. ‘445 does not teach further administering an additional drug used to treat UC that is an immunosuppressive agent.
Canavan teaches that “as many as 40% of patients with UC do not respond or maintain a response to conventional medications and require secondary drug treatment” (page 1, lines 12-13). Canavan further teaches that “conventional medicines for the treatment of UC” include “immunosuppressive drugs” (page 34, lines 6-8).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of UC with guselkumab taught by ‘445 and modify the method to further administer a conventional treatment for UC that is an immunosuppressive drug as taught by Canavan. The skilled artisan would recognize that the teachings of Canavan are directed to a secondary treatment that can be applied to a patient taking a conventional medicine for UC such as an immunosuppressive drug, and thus would recognize that the method of ‘445 can be modified to apply it to a patient taking an immunosuppressive drug. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 28 and 29 each encompass a method of claim 1 wherein the patient is considered a failure for therapy of UC with either biologic therapy (claim 28) or conventional therapy (claim 29), prior to treatment with the anti-IL23 antibody.
The teachings of the Record for Clinical Trial NCT04033445 (hereafter ‘445) that anticipate parent claim 1 are set forth above. ‘445 does not teach the patient is considered a failure for therapy of UC with either biologic therapy (claim 28) or conventional therapy (claim 29), prior to treatment with the anti-IL23 antibody.
Canavan teaches that in embodiments of the invention, “the patient is biologic-failed or conventional failed” (page 24, lines 25-27).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of UC with guselkumab taught by ‘445 and modify the method to administer the guselkumab to a patient that is biologic-failed or conventional-failed as taught by Canavan. Because the teachings of Canavan are directed to use of a genus of products (anti-IL23 antibodies), and guselkumab represents a species within such a genus, it would have been a simple and predictable substitution to apply the teachings of Canavan regarding anti-IL23 antibodies in general to the specific anti-IL23 antibody that is guselkumab. Thus, such a modified method represents a simple and predictable application of teachings directed to a genus to a species within said genus. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 33 and 34 encompass a method of treating moderately to severely active UC comprising administering an initial IV dose of 200 mg of an antibody specific to IL23 and that comprises a LCVR/HCVR of SEQ ID NO: 8/7 (which encompasses guselkumab) and 200 mg doses at 4 and 8 weeks, and wherein the patient is a responder if meeting certain criteria (claim 33), and further wherein the antibody is administering at 200 mg every 4 or 8 weeks after administering the dose 8 weeks after the initial dose (claim 34).
As with claim 1, the concluding wherein clause of claim 33 has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited.
The record for NCT04033445 (hereafter ‘445) teaches treatment of patients with moderately to severely active UC by administering guselkumab (e.g., at page 4). ‘445 does not teach the specific dosage administration regimen of claim 2 or the specific dosages of claim 3.
Canavan teaches an invention that “generally relates to the treatment of ulcerative colitis with an anti-IL-23p19 antibody, in particular dosage regimens for the treatment of the disease” (see Abstract). Canavan teaches various induction dosage regimens suitable for treatment of ulcerative colitis (UC) with an anti-IL23 antibody, including treatment at Week 0, Week 4 and Week 8 (page 3, lines 11-13). Canavan further teaches that each dose can be 200 mg (page 3, line 25). Canavan further teaches that maintenance doses can be given every 4 weeks after the last induction dose (page 6, lines 7-11), and can be 200 mg (page 6, lines 1-2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of moderately to severely active UC with guselkumab taught by ‘445 and modify the method to administer the guselkumab at a dosage (e.g., 200 mg) and dosage regimen (e.g., induction dosages at Week 0, Week 4, and Week 8 followed by maintenance dosages every 4 weeks) taught by Canavan. Because the teachings of Canavan are directed to use of a genus of products (anti-IL23 antibodies), and guselkumab represents a species within such a genus, it would have been a simple and predictable substitution to apply the teachings of Canavan regarding anti-IL23 antibodies in general to the specific anti-IL23 antibody that is guselkumab. Thus, such a modified method represents a simple and predictable application of teachings directed to a genus to a species within said genus. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 11 and 25 are rejected under 35 U.S.C. 103(a) as being unpatentable over the Record for Clinical Trial NCT04033445 (Version 16, 10/27/20; no author indicated. 61 pages as printed), as applied to claim 1 or 23 above, and further in view of Rose et al, U.S. Patent Application Publication 20200197517, published 6/25/20.
Claims 11 and 25 encompass a method of claim 9 (claim 11) or claim 23 (claim 25) wherein the antibody is in a composition comprising 7.9% (w/v) sucrose, 4.0 nM Histidine, and 6.9 mM L-Histidine monohydrochloride monohydrate; wherein the diluent is water at standard state.
The teachings of the Record for Clinical Trial NCT04033445 (hereafter ‘445) that anticipate parent claim 1 are set forth above. ‘445 does not teach that the antibody is in a composition having the components required by claim 11 or 25.
Rose teaches compositions for administering anti-IL23 antibodies, including guselkumab, that include “7.9% (w/v) sucrose, 4.0 mM Histidine, 6.9 mM L-Histidine monohydrochloride monohydrate; 0.053% (w/v) Polysorbate 80 of the pharmaceutical composition; wherein the diluent is water at standard state” (¶ 29).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to take the method of treatment of UC with guselkumab taught by ‘445 and modify said method to administer the guselkumab in a composition as taught by Rose. ‘445 teaches a method of treatment of UC that requires administration of guselkumab, but fails to specify a composition for administering said antibody, and Rose provides an example of such a composition for administering IL-23 antibodies, including guselkumab. Thus, such a modified method represents a simple and predictable use of a teaching known in the art to supply information for another reference that is silent as to a particular aspect of a method that required to employ said method. This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (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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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674