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 .
Applicant’s amendment, filed 12/16/2025, is acknowledged.
Claims 1-4, 6-10, 12, 13, 15, 16, 18, 19, 21-25, 28-37, 39, 40, 42, 43, 47, and 49 are cancelled.
Claims 5, 11, 14, 17, 20, 26, 27, 38, 41, 44-46, 48, 50, and 51 are currently pending.
Claims 27, 48, and 51 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Species.
Claims 5, 11, 14, 17, 20, 26, 38, 41, 44-46, and 50 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/16/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
Applicants amendments and remarks, filed 12/16/2025, have obviated the 35 U.S.C. § 112(a) and 112(b) rejections in the Office Action mailed on 6/16/2025.
Applicant’s amendment of the claims to recite “the CDRX domain as set forth in SEQ ID NO: Y” instead of “a CDRX domain as set forth in SEQ ID NO: Y” has overcome the written description rejection. Applicant’s amendments of the claims to recite specific therapeutic IL-23 antibodies “risankizumab, guselkumab, or tildrakizumab” have obviated the enablement rejection.
Applicants amendment of claims 17 and 45 to depend on instant claim 5 has obviated the indefiniteness rejection.
In view of the amendments and remarks filed on 12/16/2025, the following rejections remain.
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.
Claims 5, 11, 17, 38, 41, 44, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Huff-Hardy et al. (Inflamm Bowel Dis. 2017 Oct;23(10):E49. doi: 10.1097/MIB.0000000000001232, on IDS filed 12/16/2025) in view of Feagan et al. (Lancet. 2017 Apr 29;389(10080):1699-1709. doi: 10.1016/S0140-6736(17)30570-6. Epub 2017 Apr 12, in Office Action mailed 6/16/2025), Sands et al. (Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21), and Schmechel et al. (Inflamm Bowel Dis. 2008 Feb;14(2):204-12. doi: 10.1002/ibd.20315, in Office Action mailed 6/16/2025), as evidenced by Cingoz (MAbs. 2009 May-Jun;1(3):216-21. doi: 10.4161/mabs.1.3.8593). This is a new grounds of rejection necessitated by Applicant’s amendments.
Applicant has amended claim 5 to include that the subject “has been characterized as a nonresponder or nonremitter at week 6 and/or week 10 after beginning treatment with the humanized anti-α4β7 antibody”, which necessitates the new grounds of rejection.
Huff-Hardy et al. teaches a method of treating a subject in need with Crohn’s disease (Title), comprising administration of vedolizumab and ustekinumab (Title, Col. 1-2): “[b]ecause of the unresponsive nature of the disease, vedolizumab, which had been ineffective as a monotherapy in this patient, was added to the ustekinumab…This patient has now been on combination therapy with vedolizumab, ustekinumab, and methotrexate for over 1 year and has achieved deep remission for the first time in 10 years.” The antibody vedolizumab inherently comprises the CDRs recited in instant claim 5 and the VH/VL sequences recited in instant claim 17 (see, for example, the instant specification on pg. 33, lines 16-25).
Huff-Hardy et al. teaches that the combination therapy was successful in a human patient that was previously refractory to vedolizumab therapy (Col. 1): “[h]ere, we report the case of a 22-year-old woman who present to us with refractory Crohn’s disease…over the course of her disease, she received infliximab, adalimumab, certolizumab, natalizumab, and vedolizumab combined with immunomodulators with poor responses…”
Cingoz et al. is provided as an evidentiary reference to demonstrate that ustekinumab is an anti-IL23 inhibiting antibody (Abstract): “Ustekinumab is an anti-IL12/23 IgG1 kappa human monoclonal antibody currently undergoing US Food and Drug Administration for use as a psoriasis treatment. The candidate has also been evaluated in Phase 2 studies as a treatment for… Crohn disease…”
Huff-Hardy et al. does not teach a combination therapy for Chron’s disease comprising administration of vedolizumab and risankizumab, guselkumab, or tildrakizumab.
Feagan et al., in the same field of endeavor, teaches a method of treating Chron’s Disease comprising administration of the anti-p19 IL23 antibody risankizumab (entire document). Feagan et al. teaches that as expected, IL23 blockade reduced IL22 serum levels in patients that were treated with the antibody (last ¶ of pg. 1706 and Figure 3).
While Huff-Hardy et al. teaches a method of treating a human subject with Chron’s disease that is a nonresponder to vedolizumab, neither Huff-Hardy et al. nor Feagan et al. teach that the nonresponser is characterized as a nonresponder or nonremitter at week 6 and/or week 10.
Sands et al. in the same field of endeavor, teaches a method of treating Crohn’s disease with a vedolizumab monotherapy (Entire Document). Sands et al. teaches that patients were evaluated at week 6 and week 10 after beginning therapy for responses to vedolizumab (Abstract): “…we determined the proportion of patients in clinical remission (CDAI, ≤ 150 points” at week 6. Secondary analyses evaluated outcomes at weeks 6 and 10 in this population and in the overall population…” Sands et al. teaches that clinical remission was evaluated at both week 6 and week 10, with 19.1% of the patient population meeting the requirements for remission at week 6 and 28.7 at week 10 (Fig. 3): “Treatment efficacy: clinical remission (CDAI score, ≤ 150 points) at (A) week 6, at (B) week 10…”
Sands et al. demonstrates that in vedolizumab monotherapy studies, patients are characterized as nonresponsers/nonremitters at weeks 6 and 10.
Neither Sandborn et al., Feagan et al., nor Sands et al. teaches a method of treating Chron’s disease in a human patient wherein the patient had elevated IL-22 levels compared to a control level (i.e., the limitations of claim 1).
Schmechel et al., in the same field of endeavor, teaches that human patients suffering from Chron’s disease have elevated serum IL-22 levels compared to healthy human controls, and increased IL-22 is correlated with increased disease activity in patients (“IL-22 serum expression is increased in CD and correlates with disease activity” section and Figure 1A). The study included 242 patients with Chron’s disease, and 32 healthy controls (i.e., the limitations of instant claim 41; “Study Population” section), and protein levels of IL-22 were measured via ELISA (i.e., the limitations of instant claim 44; “IL-22, IL-17A, and IL-17F Enzyme-linked Immunosorbent Assay (ELISA) Measurements” section). The IL-22 levels were elevated by more than 50% in patients with Chron’s disease (i.e., the limitations of instant claim 45; Figure 1A). Schmechel et al. concludes (last ¶ of Discussion): “the IL-22 serum level may be a clinically useful marker to evaluate disease severity and Th17 cell activity in patients with CD”.
It would have been obvious to one of ordinary skill in the art, to have replaced the art-recognized IL-23 therapeutic antibody ustekinumab taught in the combination therapy of Huff-Hardy et al. with the IL-23 therapeutic antibody taught by Feagan et al., risankizumab with a reasonable expectation of success, as both antibodies have been demonstrated to be anti-IL23 therapeutic antibodies used to treat Chron’s disease. Further, Risankizumab reduces IL22 serum levels in patients. Those of skill in the art would have had reason to use risankizumab anti-IL23 antibody of Feagan e al. as a substitute for ustekinumab taught in Huff-Hardy et al. because, like ustekinumab, risankizumab inhibits IL-23. Substituting a known element for another, to yield the known result, is obvious. See KSR, 550 U.S. at 416, 421 (2007).
"[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR Int'l v. Teleflex Inc., 550 U.S. 398,416 (2007).
"Structural similarity, alone, may be sufficient to give rise to an expectation that compounds similar in structure will have similar properties." In re Merck & Co., Inc., 231 USPQ 375,379.
Regarding the limitations “has been characterized as a nonresponder or nonremitter at week 6 and/or week 10 after beginning treatment with the humanized anti-α4β7 antibody”, Huff-Hardy et al. teaches the combination therapy is effective in a patient that has been characterized as a nonresponder to previous vedolizumab therapy. Sands et al. demonstrates that patients are characterized as nonresponsers/nonremitters at weeks 6 and 10 in vedolizumab monotherapy trials. One with ordinary skill in the art would appreciate that the patient that was a nonresponder to vedolizumab monotherapy taught by Huff-Hardy et al. would have been characterized at a nonresponder/nonremitter at weeks 6 and 10 in light of the teachings of Sands et al.
Regarding the limitation “wherein the patient is characterized as having elevated levels of IL-22 and/or STAT5A as compared to control level” in instant claim 5, Schmechel et al. teaches that patients with Chron’s disease have elevated IL-22 when compared to healthy patient controls, and also IL-22 levels are correlated with increased disease activity, thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the combination therapy of vedolizumab and risankizumab taught by the combined references of Sandborn et al. in view of Feagan et al. to treat Chron’s disease patients that have elevated IL-22 levels, as Schmechel et al. teaches that patients with Chron’s disease have elevated IL-22 levels that correlate with disease activity, and these patients would also have elevated serum IL-22 levels at baseline during a combination therapy. One would have been motivated to make this change for the purposes of treating patients with Chron’s disease and more active cases of Chron’s disease.
Claim 38 is included (i.e., the limitation of the elected patient outcome of “having elevated level of serum IL-22 at baseline, and wherein serum IL-22 level decreases less than three-fold from baseline to week 10)” because Schmechel et al. teaches patients with Chron’s disease have elevated IL-22 when compared to healthy controls at baseline. Additionally, Feagan et al. teaches risankizumab therapy reduces serum IL-22 levels to approximately 40% of baseline at week 10 (Figure 3D, note that serum IL-22 levels remained at a steady level between weeks 8 and 10, and one with ordinary skill in the art would assume that the IL-22 level at week 10 would be along the blue lines). This corresponds to approximately a 2.5-fold decrease, meeting the limitations of instant claim 38. One with ordinary skill in the art would expect this patient outcome in the combination therapy of Huff-Hardy et al. in view of Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, as it is taught by Feagan et al.
Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Huff-Hardy et al. (supra) in view of Feagan et al. (supra), Sands et al. (supra), and Schmechel et al. (supra), as evidenced by Cingoz (supra), as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Sandborn et al. (N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739, in Office Action mailed 6/16/2025). This is a new grounds of rejection necessitated by Applicant’s amendments.
The combined teachings of Huff-Hardy et al. in view of Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz are discussed supra. The combined teachings don’t teach the vedolizumab dosing regiments of claims 20.
Sandborn et al., in the same field of endeavor, teaches a method of treating Chron’s Disease in humans comprising administration of the antibody vedolizumab (entire document). The antibody vedolizumab inherently comprises the CDRs recited in instant claim 5 and the VH/VL sequences recited in instant claim 17 (see, for example, the instant specification on pg. 33, lines 16-25). Vedolizumab was administered at a dosage of 300mg at week 0, followed by 300mg at week 2, and a third dose of 300mg at week 6 (i.e., the limitations of instant claim 20; “Randomization” section: “patients were randomly assigned, in a 3:2 ratio, to receive intravenous vedolizumab, at a dose of 300mg, or placebo at weeks 0 and 2…[p]atients who did not have a clinical response at week 6 to vedolizumab induction therapy received vedolizumab at a dose of 300mg every 4 weeks…”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the combined teachings of Huff-Hardy et al. in view of Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, further in view Sandborn et al. to have administered vedolizumab at a dose of 300 on weeks 0, 2, and 6, as Sandborn et al teaches this dosing regimen. One would have been motivated to make this change for the purposes of using a vedolizumab dosing regimen to treat Chron’s disease.
Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 26, 46, and 50 is rejected under 35 U.S.C. 103 as being unpatentable over Huff-Hardy et al. (supra) in view of Feagan et al. (supra), Sands et al. (supra), Schmechel et al. (supra), and Sandborn et al. (supra), as evidenced by Cingoz (supra), as applied to claims 5, 11, 17, 20, 38, 41, 44, and 45 above, and further in view of Diluzio et al. (US PGPub 20140341885, in Office Action mailed 6/16/2025). This is a new grounds of rejection necessitated by Applicant’s amendments.
The combined teachings of Huff-Hardy et al. in view of Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz are discussed supra. The combined teachings don’t teach the vedolizumab dosing regimens of claims 26, 46, and 50.
Diluzio et al., in the same field of endeavor, teaches dosing regimens for vedolizumab for the treatment of ulcerative colitis and Chron’s disease comprising an induction regimen and a maintenance regimen (Example 15, ¶[0182] and [0312]-[0317]). The induction phase can last 6 weeks (¶[0185]) and can comprise administration of vedolizumab at 300mg every two weeks (¶[0312]) and the maintenance regimen can be either 300mg every 8 weeks (i.e., the limitations of instant claim 46; ¶[0314]) or 108mg every 2 weeks (i.e., the limitations of instant claim 26; ¶[0316]). Additionally, Diluzio et al. teaches ¶[0179]: “[t]he dosage can be determined by methods known in the art and can be dependent, for example, upon the individual's age, sensitivity, tolerance and overall well-being”. Diluzio et al. additionally teaches (¶[0189]): “[i]n one aspect, the treatment regimen is treatment at day 0, about week 2, about week 6 and every 1 or 2 weeks thereafter”.
Diluzio et al. further teaches maintenance dosing maintains mean steady state trough serum concentrations (¶[0030]):
“the humanized immunoglobulin or antigen-binding fragment thereof is administered to the patient according to the following dosing regimen: (a) a plurality of induction phase doses of the humanized immunoglobulin or antigen-binding fragment thereof sufficient to achieve a mean trough serum concentration of about 20 to about 30 μg/mL of the humanized immunoglobulin or antigen- binding fragment thereof by about six weeks of initial dosing; (b) followed by a plurality of maintenance phase doses of the humanized immunoglobulin or antigen-binding fragment thereof as needed to maintain a mean steady state trough serum concentration…”
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the combined teachings of Huff-Hardy et al. in view of Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, further in view of Diluzio et al. to arrive at the vedolizumab dosing regiments recited in instant claims 26, and 46 with a reasonable expectation of success. There is a reasonable expectation of success because the combined teachings of Huff-Hardy et al. in view of Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz teach the combination therapy of vedolizumab and risankizumab, and Diluzio et al. teaches a induction phase of vedolizumab comprising the specific maintenance regimens of 108mg every two weeks (i.e., instant claim 20) and 300mg every 8 weeks (i.e., instant claim 46) that one with ordinary skill in the art would be able to together. One would have been motivated to make this change for the purposes of adding a maintenance dosing regimen to the vedolizumab dosing taught by the combined teachings of Sandborn et al., Feagan et al., and Schmechel et al. to maintain a mean antibody steady state trough serum concentration. Additionally, using the guidance of the references, one with ordinary skill in the art would be able to arrive at the claimed dosing regimens through routine experimentation (see MPEP § 2144.05(II)).
Claim 50 is included because Schmechel et al. teaches that the control level of IL22 and/or STAT5A is from a healthy subject (“IL-22 serum expression is increased in CD and correlates with disease activity” section and Figure 1A).
Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Huff-Hardy et al. (supra) in view of Feagan et al. (supra), Sands et al. (supra), and Schmechel et al. (supra), as evidenced by Cingoz (supra), as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (US. PGPub 20170002069, in Office Action mailed 6/16/2025). This is a new grounds of rejection necessitated by Applicant’s amendments.
The combined teachings of Huff-Hardy et al. in view of Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz are discussed supra. The combined teachings do not teach the administration sequence of the combination therapy (i.e., the limitations of instant claim 14).
Crowe et al., in the same field of endeavor, teaches combination therapies comprising vedolizumab and an IL-23 inhibitor such as ustekinumab (¶[0301]). Crowe et al. teaches the combination therapy can be administered “sequentially, simultaneously or separately” (¶[0303]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the combination therapy of Huff-Hardy et al. in view of Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, further in view of Crowe et al. to administer the vedolizumab and risankizumab sequentially, and one with ordinary skill in the art would arrive at administration of the vedolizumab first through routine experimentation (see MPEP § 2144.05(II)).
Applicant’s arguments, filed 12/16/2025, have been fully considered, but have been found to be not convincing.
Applicant argues that the amendments to claim 5 obviate the previous rejection, however this argument has been rendered moot by the new grounds of rejection.
Applicant additionally argues that Crowe teaches other suitable combination therapies, and therefore would not be motivated to combine an anti-α4β7 with an anti-IL23 inhibitor “sequentially, simultaneously, or separately”.
This has been found to be not convincing. In response to applicant’s arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combination of references. See MPEP 2145. Contrary to applicant’s arguments against the references individually, note that One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). See MPEP 2145 IV.
It is noted that in considering the disclosure of a reference, it is proper to take into account not only specific teaching of the reference but also the inferences which one skilled in the art would be reasonably be expected to draw therefrom In re Preda, 401 F.2d 825, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01.
Furthermore, specific statements in the references themselves which would spell out the claimed invention are not necessary to show obviousness, since questions of obviousness involves not only what references expressly teach, but what they would collectively suggest to one of ordinary skill in the art. See CTS Corp. v. Electro Materials Corp. of America 202 USPQ 22 (DC SNY ); and In re Burckel 201 USPQ 67 (CCPA). In re Burckel is cited in MPEP 716.02.
Here, given the teachings of Huff-Hardy et al. regarding a combination therapy of vedolizumab and ustekinumab for refractory Chron’s disease, Feagan et al. teaching risankizumab, Sands et al. teaching patients are evaluated for remission at weeks 6 and 10 of vedolizumab monotherapy, and Schmechel et al. teaching measurement of STAT5/IL-22 levels and changes in these levels during treatment, the ordinary artisan at the time the invention was made would have had a reasonable expectation of success of administering vedolizumab and risankizumab sequentially with vedolizumab first.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 5, 11, 17, 38, 41, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,147,851 (herein Pat '851, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (Inflamm Bowel Dis. 2017 Oct;23(10):E49. doi: 10.1097/MIB.0000000000001232, supra), Feagan et al. (Lancet. 2017 Apr 29;389(10080):1699-1709. doi: 10.1016/S0140-6736(17)30570-6. Epub 2017 Apr 12, in Office Action mailed 6/16/2025, supra), Sands et al. (Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21, supra) and Schmechel et al. (Inflamm Bowel Dis. 2008 Feb;14(2):204-12. doi: 10.1002/ibd.20315, in Office Action mailed 6/16/2025, supra), as evidenced by Cingoz (MAbs. 2009 May-Jun;1(3):216-21. doi: 10.4161/mabs.1.3.8593). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘851 claims methods of treating IBD comprising administration of an anti-α4β7 antibody comprising an identical VH to the antibody claimed by the instant application (claim 2):
Qy 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 79
Qy 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 139
Qy 121 S 121
|
Db 140 S 140
And an identical VL to the antibody claimed by the instant application (i.e., the limitations of instant claim 17):
Qy 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 21 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 80
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 81 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 132
Pat ‘851 additionally claims treating UC and Chron’s disease (claims 3 and 4).
Pat ‘851 does not claim a method of treatment comprising the anti-α4β7 and an IL-23 inhibitor such as risankizumab, wherein the patient has elevated IL-22 levels as compared to a healthy control), or treatment of subject that have been characterized as a nonresponder or nonremitter at week 6 and/or week 10 after beginning treatment with the humanized anti-α4β7 antibody.
Huff-Hardy et al. teaches a method of treating a subject in need with Crohn’s disease (Title), comprising administration of vedolizumab and ustekinumab (Title, Col. 1-2): “[b]ecause of the unresponsive nature of the disease, vedolizumab, which had been ineffective as a monotherapy in this patient, was added to the ustekinumab…This patient has now been on combination therapy with vedolizumab, ustekinumab, and methotrexate for over 1 year and has achieved deep remission for the first time in 10 years.” The antibody vedolizumab inherently comprises the CDRs recited in instant claim 5 and the VH/VL sequences recited in instant claim 17 (see, for example, the instant specification on pg. 33, lines 16-25).
Huff-Hardy et al. teaches that the combination therapy was successful in a human patient that was previously refractory to vedolizumab therapy (Col. 1): “[h]ere, we report the case of a 22-year-old woman who present to us with refractory Crohn’s disease…over the course of her disease, she received infliximab, adalimumab, certolizumab, natalizumab, and vedolizumab combined with immunomodulators with poor responses…”
Cingoz et al. is provided as an evidentiary reference to demonstrate that ustekinumab is an anti-IL23 inhibiting antibody (Abstract): “Ustekinumab is an anti-IL12/23 IgG1 kappa human monoclonal antibody currently undergoing US Food and Drug Administration for use as a psoriasis treatment. The candidate has also been evaluated in Phase 2 studies as a treatment for… Crohn disease…”
Pat ‘851 does not claim, and Huff-Hardy et al. does not teach a combination therapy for Chron’s disease comprising administration of vedolizumab and risankizumab, guselkumab, or tildrakizumab.
Feagan et al., in the same field of endeavor, teaches a method of treating Chron’s Disease comprising administration of the anti-p19 IL23 antibody risankizumab (entire document). Feagan et al. teaches that as expected, IL23 blockade reduced IL22 serum levels in patients that were treated with the antibody (last ¶ of pg. 1706 and Figure 3).
While Huff-Hardy et al. teaches a method of treating a human subject with Chron’s disease that is a nonresponder to vedolizumab, neither Pat ‘851, Huff-Hardy et al., nor Feagan et al. teach that the nonresponser is characterized as a nonresponder or nonremitter at week 6 and/or week 10.
Sands et al. in the same field of endeavor, teaches a method of treating Crohn’s disease with a vedolizumab monotherapy (Entire Document). Sands et al. teaches that patients were evaluated at week 6 and week 10 after beginning therapy for responses to vedolizumab (Abstract): “…we determined the proportion of patients in clinical remission (CDAI, ≤ 150 points” at week 6. Secondary analyses evaluated outcomes at weeks 6 and 10 in this population and in the overall population…” Sands et al. teaches that clinical remission was evaluated at both week 6 and week 10, with 19.1% of the patient population meeting the requirements for remission at week 6 and 28.7 at week 10 (Fig. 3): “Treatment efficacy: clinical remission (CDAI score, ≤ 150 points) at (A) week 6, at (B) week 10…”
Sands et al. demonstrates that in vedolizumab monotherapy studies, patients are characterized as nonresponsers/nonremitters at weeks 6 and 10.
Neither Pat ‘851, Sandborn et al., Feagan et al., nor Sands et al. teaches a method of treating Chron’s disease in a human patient wherein the patient had elevated IL-22 levels compared to a control level (i.e., the limitations of claim 1).
Schmechel et al., in the same field of endeavor, teaches that human patients suffering from Chron’s disease have elevated serum IL-22 levels compared to healthy human controls, and increased IL-22 is correlated with increased disease activity in patients (“IL-22 serum expression is increased in CD and correlates with disease activity” section and Figure 1A). The study included 242 patients with Chron’s disease, and 32 healthy controls (i.e., the limitations of instant claim 41; “Study Population” section), and protein levels of IL-22 were measured via ELISA (i.e., the limitations of instant claim 44; “IL-22, IL-17A, and IL-17F Enzyme-linked Immunosorbent Assay (ELISA) Measurements” section). The IL-22 levels were elevated by more than 50% in patients with Chron’s disease (i.e., the limitations of instant claim 45; Figure 1A). Schmechel et al. concludes (last ¶ of Discussion): “the IL-22 serum level may be a clinically useful marker to evaluate disease severity and Th17 cell activity in patients with CD”.
It would have been obvious to one of ordinary skill in the art, to have combined the antibody claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, to have used the anti-α4β5 antibody claimed by Pat ‘851 with an anti-IL23 antibody such as ustekinumab to treat human patients with Chron’s disease that are refractory to vedolizumab monotherapy, as Huff-Hardy et al. teaches such a therapy. One would have been motivated to make this change for the purposes of treating refractory Chron’s disease. Additionally, it would have been obvious to replace the art-recognized IL-23 therapeutic antibody ustekinumab taught in the combination therapy of Huff-Hardy et al. with the IL-23 therapeutic antibody taught by Feagan et al., risankizumab, with a reasonable expectation of success, as both antibodies have been demonstrated to be anti-IL23 therapeutic antibodies used to treat Chron’s disease. Those of skill in the art would have had reason to use risankizumab anti-135 antibody of Feagan e al. as a substitute for ustekinumab taught in Huff-Hardy et al. because, like ustekinumab, risankizumab inhibits IL-23. Substituting a known element for another, to yield the known result, is obvious. See KSR, 550 U.S. at 416, 421 (2007).
"[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR Int'l v. Teleflex Inc., 550 U.S. 398,416 (2007).
"Structural similarity, alone, may be sufficient to give rise to an expectation that compounds similar in structure will have similar properties." In re Merck & Co., Inc., 231 USPQ 375,379.
Regarding the limitations “has been characterized as a nonresponder or nonremitter at week 6 and/or week 10 after beginning treatment with the humanized anti-α4β7 antibody”, Huff-Hardy et al. teaches the combination therapy is effective in a patient that has been characterized as a nonresponder to previous vedolizumab therapy. Sands et al. demonstrates that patients are characterized as nonresponsers/nonremitters at weeks 6 and 10 in vedolizumab monotherapy trials. One with ordinary skill in the art would appreciate that the patient that was a nonresponder to vedolizumab monotherapy taught by Huff-Hardy et al. would have been characterized at a nonresponder/nonremitter at weeks 6 and 10 in light of the teachings of Sands et al.
Regarding the limitation “wherein the patient is characterized as having elevated levels of IL-22 and/or STAT5A as compared to control level” in instant claim 5, Schmechel et al. teaches that patients with Chron’s disease have elevated IL-22 when compared to healthy patient controls, and also IL-22 levels are correlated with increased disease activity, thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the combination therapy of vedolizumab and risankizumab taught by the combined references of Sandborn et al. in view of Feagan et al. to treat Chron’s disease patients that have elevated IL-22 levels, as Schmechel et al. teaches that patients with Chron’s disease have elevated IL-22 levels that correlate with disease activity, and these patients would also have elevated serum IL-22 levels at baseline during a combination therapy. One would have been motivated to make this change for the purposes of treating patients with Chron’s disease and more active cases of Chron’s disease.
Claim 38 is included (i.e., the limitation of the elected patient outcome of “having elevated level of serum IL-22 at baseline, and wherein serum IL-22 level decreases less than three-fold from baseline to week 10)” because Schmechel et al. teaches patients with Chron’s disease have elevated IL-22 when compared to healthy controls at baseline. Additionally, Feagan et al. teaches risankizumab therapy reduces serum IL-22 levels to approximately 40% of baseline at week 10 (Figure 3D, note that serum IL-22 levels remained at a steady level between weeks 8 and 10, and one with ordinary skill in the art would assume that the IL-22 level at week 10 would be along the blue lines). This corresponds to approximately a 2.5-fold decrease, meeting the limitations of instant claim 38. One with ordinary skill in the art would expect this patient outcome in the combination therapy of Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, as this is taught by Feagan et al.
Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Therefore, the invention as a whole was a prima facia obvious variant of the invention claimed by Pat ‘851 in view of Feagan et al. and Schmechel et al. to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,147,851 (Pat '851, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Sandborn et al. (N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 20.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Sandborn et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 26, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,147,851 (Pat '851, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra), Schmechel et al. (supra), and Sandborn et al. (supra) as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 20, 38, 41, 44, and 45 above, and further in view of Diluzio et al. (US PGPub 20140341885, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 26, 46 and 50.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, and further in view of Diluzzio et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 7,147,851 (Pat '851, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (US. PGPub 20170002069, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the administration schedule of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 5, 11, 17, 20, 38, 41, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,663,579 (herein Pat '579, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘579 claims methods of treating Chron’s disease comprising administration of an anti-α4β7 antibody comprising an identical VH to the antibody claimed by the instant application (amino acids 20-140 of SEQ ID NO: 2 and claims 1 and 2 of Pat ‘579):
Qy 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 79
Qy 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 139
Qy 121 S 121
|
Db 140 S 140
And an identical VL to the antibody claimed by the instant application (i.e., the limitations of instant claim 17; amino acids 20-131 of SEQ ID NO: 4 and claims 1 and 2 of Pat ‘579):
Qy 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 79
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 131
Pat ‘579 additionally claims anti-α4β7 doses of 300mg at weeks 0, 2, and 6 for the first six weeks of treatment (claims 1, 2, and 5).
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘579 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz for the same reasons discussed for Pat 851 supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 26, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,663,579 (Pat ‘579, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Diluzzio et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘579 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 26, 46 and 50.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘851 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Diluzzio et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9,663,579 (Pat ‘579, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘579 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose sequence of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘579 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 5, 11, 17, 20, 26, 38, 41, 44, 45, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,918,716 (herein Pat '716, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘716 claims a method of treating Chron’s disease comprising administration of an anti-α4β7 antibody comprising an identical VH to the antibody claimed by the instant application (amino acids 20-140 of SEQ ID NO: 1 and claim 2 of Pat ‘716):
Qy 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 79
Qy 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 139
Qy 121 S 121
|
Db 140 S 140
And an identical VL to the antibody claimed by the instant application (i.e., the limitations of instant claim 17; amino acids 20-131 of SEQ ID NO: 2 and claim 2 of Pat ‘716):
Qy 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 79
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 131
Pat ‘716 additionally claims anti-α4β7 doses of 300mg at weeks 0, 2, and 6 for the first six weeks of treatment (claim 1), as well as subsequent doses of 300mg every eight weeks afterwards (the limitations of instant claim 46; claim 7 of Pat ‘716) or 108mg every two weeks afterwards (the limitations of instant claim 26, claim 9 of Pat ‘716).
Pat ‘716 does not claim a method of treatment comprising the anti-α4β7 and an IL-23 inhibitor such as risankizumab (i.e., the limitations of instant claim 32), wherein the patient has elevated IL-22 levels as compared to a healthy control (i.e., instant claim 1)
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘579 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz for the same reasons discussed for Pat 851 supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,918,716 (Pat ‘716, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 20, 26, 38, 41, 44, 45, 46, and 50 above, and further in view of Crowe et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘716 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose sequence of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘716 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 5, 11, 17, 38, 41, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,246,064 (herein Pat '064, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘064 claims methods of treating Chron’s Disease comprising administration of an anti-α4β7 antibody comprising an identical VH to the antibody claimed by the instant application (amino acids 20 to 140 of SEQ ID NO: 1 and claims 1-3 of Pat ‘064):
Qy 1 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 20 QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNY 79
Qy 61 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 80 NQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVS 139
Qy 121 S 121
|
Db 140 S 140
And an identical VL to the antibody claimed by the instant application (i.e., the limitations of instant claim 17; amino acids 20 to 131 of SEQ ID NO: 2 and claims 1-3 of Pat ‘064):
Qy 1 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 21 DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRF 80
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 81 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIK 132
Pat ‘064 does not claim a method of treatment comprising the anti-α4β7 and an IL-23 inhibitor such as risankizumab wherein the patient has elevated IL-22 levels as compared to a healthy control, and wherein the subject is a nonresponder to anti-α4β7 therapy at week 6 and/or 10 (i.e., instant claim 5).
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz for the same reasons discussed for Pat ‘851 supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,246,064 (Pat '064, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Sandborn et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 20.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Sandborn et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 26, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,246,064 (Pat '064, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra), Schmechel et al. (supra), and Sandborn et al. (supra) as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 20, 38, 41, 44, and 45 above, and further in view of Diluzio et al. (US PGPub 20140341885, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 26, 46 and 50.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, and further in view of Diluzzio et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,246,064 (Pat '064, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (US. PGPub 20170002069, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the administration schedule of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘064 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 5, 11, 17, 38, 41, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,560,434 (herein Pat '434, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘434 claims antibody formulations comprising the antibody vedolizumab, which inherently comprises the amino acid sequences recited in instant claims 5 and 17 (claims 1 and 6).
Pat ‘434 does not claim a method of treatment comprising administration of the anti-α4β7 and an IL-23 inhibitor such as risankizumab (i.e., the limitations of instant claim 32), wherein the patient has elevated IL-22 levels as compared to a healthy control and the patient has been characterized as a nonresponder/nonremitter to prior vedolizumab therapy at week 6 and/or week 10 (i.e., instant claim 5).
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘434 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz for the same reasons discussed for Pat ‘851 supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,560,434 (Pat '434, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Sandborn et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘434 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 20.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘434 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Sandborn et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 26, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,560,434 (Pat '434, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra), Schmechel et al. (supra), and Sandborn et al. (supra) as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 20, 38, 41, 44, and 45 above, and further in view of Diluzio et al. (US PGPub 20140341885, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ’434 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 26, 46 and 50.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘434 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, and further in view of Diluzzio et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,560,434 (Pat '434, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (US. PGPub 20170002069, in Office Action mailed 6/16/2025, supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘434 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the administration schedule of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘434 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 5, 11, 17, 38, 41, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,764,033 (herein Pat ‘033, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘033 claims antibody formulations comprising the antibody vedolizumab, which inherently comprises the amino acid sequences recited in instant claims 5 and 17 (claims 1 and 6).
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘033 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz for the same reasons discussed for Pat ‘851 supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,764,033 (Pat '033, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Sandborn et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘033 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 20.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘033 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Sandborn et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 26, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,764,033 (Pat '033, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra), Schmechel et al. (supra), and Sandborn et al. (supra) as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 20, 38, 41, 44, and 45 above, and further in view of Diluzio et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ’033 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 26, 46 and 50.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘033 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, and further in view of Diluzzio et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 9,764,033 (Pat '033, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘033 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the administration schedule of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘033 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 5, 11, 17, 38, 41, 44, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,040,855 (herein Pat '855, in Office Action mailed 6/16/2025) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
Pat ‘855 claims antibody formulations comprising the antibody vedolizumab, which inherently comprises the amino acid sequences recited in instant claims 5 and 17 (claims 1 and 6-8).
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘855 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz for the same reasons discussed for Pat ‘851 supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,040,855 (Pat '855, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Sandborn et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘855 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 20.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘855 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Sandborn et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 26, 46, and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,040,855 (Pat '855, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra), Schmechel et al. (supra), and Sandborn et al. (supra) as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 20, 38, 41, 44, and 45 above, and further in view of Diluzio et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ’855 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the vedolizumab dose regiment of instant claim 26, 46 and 50.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘855 in view of Huff-Hardy et al., Feagan et al., Sands et al., Schmechel et al., and Sandborn et al., as evidenced by Cingoz, and further in view of Diluzzio et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been rendered moot in light of the new grounds of rejection.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,040,855 (Pat '855, supra) in view of Huff-Hardy et al. (supra), Feagan et al. (supra), Sands et al. (supra) and Schmechel et al. (supra), as evidenced by Cingoz (supra) as applied to claims 5, 11, 17, 38, 41, 44, and 45 above, and further in view of Crowe et al. (supra). This is a new ground of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘855 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, for the reasons discussed supra. The combined references don’t teach the administration schedule of instant claim 14.
The invention encompassed by the instant claims was a prima facie obvious variant of the invention claimed by Pat ‘855 in view of Huff-Hardy et al., Feagan et al., Sands et al., and Schmechel et al., as evidenced by Cingoz, and further in view of Crowe et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra. Applicant’s arguments, filed 12/16/2025, have been found to be not convincing for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
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.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641