RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 04/27/2026, is acknowledged.
2. Claims 1, 3-5, 7-8, 10, 11, 13, 14, 16, 17, 18, 20, 22, 24, 25, 27-29, and 34-37 are pending.
3. Claims 1, 7-8, 10-11, 16-17, 25, 29, 33-35, 37 are under examination as they read on the species of (i) a human patient who has perianal fistulizing moderately to severely active Crohn’s disease and had a lack of an adequate response with, lost response to, or was intolerant to treatment with an immunomodulator and/or a corticosteroid (ii) and measuring a PDAI score.
4. Claims 3-5, 13-14, 18, 20, 22, 24, 27-28, 32, 36 are withdrawn from consideration as being directed to non-elected species.
5. Applicant’s IDS, filed 04/27/2026, is acknowledged.
6. The Terminal Disclaimer, filed 05/02/2026, is sufficient to overcome the NS-ODP rejection over US Pat. 11884731.
7. The following new ground of rejections are necessitated by the amendment submitted 04/27/2026.
8. 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.
9. Claims 1,7-8, 10-11, 16-17, 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Sandborn et al (N Engl J Med, Aug. 2013;369:711-21, IDS), in view of the Shafran et al. (Gastroenterology. 120(5), Suppl 1, 2001) and Sandborn et al (GASTROENTEROLOGY 2002;122:512–530, IDS#26).
Sandborn-2013 et al teach that in an integrated study with separate induction and maintenance trials, Sandborn et al assessed intravenous vedolizumab therapy (300 mg) (comprising claimed SEQ ID NOs: 1-9) in adults with active Crohn’s disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6. In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52 (i.e., 0, 2, 6, 10, 14, 18 . . . wks or 0, 2, 6, 14, 22, . . . wks from the initial dose, up to 52 wks) (abstract). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52 (as measured by clinical remission (i.e., had a score on the Crohn’s Disease Activity Index [CDAI]), as compared with 21.6% assigned to placebo (P<0.001 and P = 0.004 for the two vedolizumab groups, respectively, vs. placebo). Sandborn concluded that vedolizumab-treated patients with active Crohn’s disease were more likely than patients receiving placebo to have a remission, but not a CDAI-100 response, at week 6; patients with a response to induction therapy who continued to receive vedolizumab (rather than switching to placebo) were more likely to be in remission at week 52. Adverse events were more common with vedolizumab (see abstract). Sandborn et al teach that among the eligible patients are those who had had no response to or had had unacceptable side effects from one or more of the following: glucocorticoids, immunosuppressive agents (i.e., azathioprine, mercaptopurine, or methotrexate), or TNF antagonists (page 712, under Patients). Antibiotics treatment was permitted (page 712, right col., 1st ¶ under Patients).
Sandborn-2013 et al teach that study visits were scheduled at weeks 0, 2, 4, and 6 in the trial of induction therapy and every 4 weeks thereafter during the trial of maintenance therapy until week 52. Adverse events, CDAI score, neurologic symptoms of PML as assessed by means of questionnaires (see the Supplementary Appendix), the use of concomitant medications, and the presence or absence of fistulae were evaluated at all visits.
Table 1. Demographic and Baseline Clinical Characteristics and History of Crohn’s Disease Medication among Patients in the Induction Trial.
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191
1377
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140
1381
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Sandborn teaches that information regarding draining fistulae (manifest as anal fistula) is shown in Figure S6 in the Supplementary Appendix. Table S4 shows:
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272
1461
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379
1460
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Fig. S6 illustrates the maintenance trial: closure of draining fistulae in patients with draining fistulae at baseline.
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458
851
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Regarding the “at least 50% of the perianal draining fistulae are closed 30 weeks after the initial dose”, the prior art teaches the same method of treating the same target population with the same antibody regimen, the claimed results of at least 50% of perianal draining fistulae are closed would be inherent.
Claim 7 is included because although Sandborn et al is silent with regard "100% of the draining perianal fistula are closed by the treatment" per se; the method, the product used in the reference method are the same as the claimed method. Therefore “100% of the draining perianal fistula are closed by the treatment” is considered inherent properties.
The reference teachings differs for the claimed invention only in the recitation of administering antibiotics during week 0 to 6 of treatment with the humanized antibody in claims 1, 11 and 25 and the treatment is further measured by a Perianal Disease Activity Index (PDAI) scope of the human patient, and wherein the PDAI score of patients is reduced by at least 3 points from baseline in claims 1, 11, 25, 31.
Shafran et al teaches fistula healing in Mycobacterium avium subspecies paratuberculosis (MAP)-positive Crohn's Disease patients following Rifabutin and Macrolide antibiotic therapy (RMAT). Shafran et al teach that prior studies have shown the beneficial role of Rifabutin and Macrolide Antibiotic Therapy in the treatment of intractable, fistulizing, Crohn's disease. Shafran et al identified a subset of 10 MAP positive patients (3 males and 7 females) ages 41-20 presenting acute lower GI Crohn s with fistulization. These patients failed to respond to prior corticosteroid and anti-inflammatory therapy and presented a mean Crohn's Disease Activity Index (CDAI) score of 269 (250 - 300). The distribution of fistula was scrotal 1 (10%), scrotal-anal 1 (10%), vaginal-anal 1 (10%), perianal 5 (50%), ileocecal 1(10%) and colonic 1 (10%). These patients were treated with RMAT consisting of 250 mgm 1 po bid Clarithromycin and 150 mgm 1 po bid Rifabutin. Antibiotic therapy was complemented with 200 mgm po bid of probiotic containing equal amounts of Lactobacillus acidophilus and Lactobacillus rhamnosus. The results show that patients treated with RMAT had complete closure of fistuli in all cases within an average time of 32 weeks (8 - 60) of treatment and presenting a mean of 126.5 points in their final CDAI score. All patients reached a state of remission classically defined by a CDAI score below 150 points with a minimum differential of 100 points from initial to final score. Subsequent follow up showed a recurrence of fistuli within an average time of 8 months (2-13) in 4 (40%) patients who chose to discontinue RMAT. Shafran concluded that this subset of MAP positive patients may represent a particularly responsive group of Crohn's patients whose disease is remarkably responsive to antimycobacterial therapy but who require effective alternative therapies for the maintenance of remission in their Crohn's disease. Double blind, placebo-controlled trials are required to further examine the effectiveness of antibiotics in the management of fistulizing Cronh's disease.
Those of skilled in the art would have had a reason to combined the RMAT taught by the Shafran et al with the vedolizumab treatment perianal fistulizing Crohn's disease taught by Sandborn-2013 because antibiotics would heal fistulas with Crohn's disease and anti-inflammatory agents such as vedolizumab is useful for treating Crohn's disease. It is prima facie obvious to combine two compositions each of which is taught by prior art to be useful for same purpose in order to form third composition that is to be used for very same purpose; idea of combining them flows logically from their having been individually taught in prior art. In re Kerkhoven, 205 USPQ 1069, CCPA 1980. See MPEP 2144.06. Further, “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc. 550 U.S. 398, 416 (2007).
The motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combine for their common known purpose. Section MPEP 2144.07.
Sandborn-2002 et al described an instrument to measure the severity of perianal Crohn’s disease called the Perianal Disease Activity Index (PDAI) (Table 3) and its validation in patients undergoing treatment with metronidazole (i.e., antibiotics). The PDAI incorporates 5 items: discharge, pain, restriction of sexual activity, type of perianal disease, and degree of induration. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4). A higher score indicates more severe disease. The PDAI has been used as a secondary endpoint in a placebo-controlled trial of infliximab for the closure of perianal fistulas. It is likely that the PDAI will become the perianal Crohn’s disease equivalent of the CDAI. The authors recommend that the fistula drainage assessment be used to measure fistula closure in patients whose symptoms are predominantly because of actively draining enterocutaneous or perianal fistulas. However, once additional prospective trials have been performed with the PDAI score as a secondary endpoint, and the minimum clinically significant difference in the PDAI and the cut-off value indicating remission have been determined, the PDAI may become the preferred instrument to measure the disease activity of perianal fistulas. Sandborn 2002 teaches that the endpoints for closure of enterocutaneous fistulas using the antibiotics metronidazole in the perianal fistulas is to decrease the PDAI from the entry point of ≥ 5 to endpoint of ≥2 (see Table 12).
Given that Sandborn-2002 teaches that the endpoints for closure of enterocutaneous fistulas using the antibiotics metronidazole in the perianal fistulas is to decrease the PDAI from the entry point of ≥ 5 to endpoint of ≥2, those of skill in the art would combined the metronidazole taught by Sandborn-2002 with vedolizumab taught by Sandborn-2013 in the treatment of a subject suffering from perianal fertilization Crohn’s disease so that metronidazole treat perianal fistulas while vedolizumab treats Crohn.s disease. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure the severity of perianal Crohn’s disease using PDAI score and its validation in patients undergoing treatment with metronidazole and vedolizumab for the closure of perianal fistulas because PDAI is equivalent of the CDAI and because PDAI is the preferred instrument to measure the disease activity of perianal fistulas.
The combination treatment of antibiotics and vedolizumab would result in the “(PDAI) score of the patient is reduced by at least 3 points from baseline” in the absence of evidence to the contrary.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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.
Applicant’s arguments, filed 04/27/2026, have been fully considered, but have not been found convincing.
One of ordinary skill in the art could not have predicted from the teachings of Sandborn 2013 and/or Sandborn 2002 that the claimed method comprising first identifying the claimed patient for treatment and then administering antibiotics during weeks 0 to 6 treatment with a humanized antibody having binding specificity for human α4β7 integrin could achieve closure of at least 50% of perianal draining fistulae 30 weeks after the initial dose of the antibody and a reduction in PDAI score by at least 3 points from base line. In particular, Sandborn 2013 describes the results of clinical study Gemini II, which evaluated the efficacy of 300 mg vedolizumab for treating active Crohn’s disease in adults. Figure S6 of Sandborn 2013 indicates that 40.2% (vedolizumab Q8W) and 22.7% (vedolizumab Q4W) of the patients having at least one draining fistula(e) achieved closure at 52 weeks. However, Sandborn 2013 does not teach or suggest closure of at least 50% of perianal draining fistulae at 30 weeks after starting treatment, let alone in the claimed patient. The Office suggests that any clinical achievement would essentially be inherent to the teachings of Sandborn 2013. Sandborn 2013, however, does not teach or suggest identifying a patient having the claimed features for treatment, namely a patient having fistulizing moderately to severely active Crohn's disease who had a lack of an adequate response with, lost response to, or was intolerant to treatment with an immunomodulator and/or a corticosteroid and has at least one perianal draining fistula(e).
This is not found persuasive because the claimed “closure of at least 50% of perianal draining fistulae at 30 weeks after starting treatment” recited in the claims are directed to the use of the combination of antibiotics and vedolizumab, while Sandborn 2013 results are based on the treatment of only vedolizumab. Given that Shafran et al teaches the results show that patients treated with RMAT had complete closure of fistuli in all cases within an average time of 32 weeks (8 - 60) of treatment and presenting a mean of 126.5 points in their final CDAI score. All patients reached a state of remission classically defined by a CDAI score below 150 points with a minimum differential of 100 points from initial to final score. The recited effects in the claims are additive effects of the combination of both the antibiotics and vedolizumab, while applicant is arguing the results of monotherapy of vedolizumab in Sandborn 2013.
Sandborn 2013 also does not teach that antibiotics are administered during weeks 0 to 6 of treatment. Further, there is no teaching in Sandborn 2013 that the claimed clinical success could
be achieved. A post-hoc analysis of patients with active fistulae at baseline of the GEMINI 2
Crohn's disease trial found fistula closure in 28% of patients at week 14 and 33% of patients at
week 52, indicating that fistula closure is not an inherent property of treating fistulizing Crohn's
disease with vedolizumab². Thus, Applicant submits that it is not predictable based on the teachings of Sandborn 2013 that the claimed method comprising administering antibiotics during weeks 0 to 6 of treatment could achieve closure of least 50% of perianal draining fistulae at 30 weeks and a reduction in PDAI score of the patient by at least 3 points from baseline.
This is not found persuasive because the Shafran et al teaches the results show that patients treated with RMAT had complete closure of fistuli in all cases within an average time of 32 weeks (8 - 60) of treatment and presenting a mean of 126.5 points in their final CDAI score. All patients reached a state of remission classically defined by a CDAI score below 150 points with a minimum differential of 100 points from initial to final score. The rejection is based on the combined reference teachings and not only on Sandborn 2013 teachings alone. 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). See MPEP 2145.
The Office acknowledges that Sandborn 2013 does not teach measuring a PDAI score (see
Item 11, para. 3 of the Office Action), as required by the claims, and therefore cites Sandborn
2002. However, Sandborn 2002 does not remedy the deficient teachings of Sandborn 2013.
Sandborn 2002 is a review article that describes "Activity Indices and Efficacy Endpoints for
Clinical Trials of Medical Therapy in Adults With Crohn's Disease" (see Title) and describes "the Perianal Disease Activity Index (PDAI) (Table 3) and its validation in patients undergoing treatment with metronidazole" (see page 515, left column). Although Sandborn 2002 describes a "Decrease in PDAI ≥2" in Table 12 as an endpoint, Sandborn 2002 alone or in combination with Sandborn 2013 does not teach or suggest that said endpoint could be achieved by the claimed method, let alone a reduction in PDAI by at least points from baseline.
This is not found persuasive because given that Sandborn-2002 teaches that the endpoints for closure of enterocutaneous fistulas using the antibiotics metronidazole in the perianal fistulas is to decrease the PDAI from the entry point of ≥ 5 to endpoint of ≥2, those of skill in the art would combined the metronidazole taught by Sandborn-2002 with vedolizumab taught by Sandborn-2013 in the treatment of a subject suffering from perianal fertilization Crohn’s disease so that metronidazole treat perianal fistulas while vedolizumab treats Crohn.s disease. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure the severity of perianal Crohn’s disease using PDAI score and its validation in patients undergoing treatment with metronidazole and vedolizumab for the closure of perianal fistulas because PDAI is equivalent of the CDAI and because PDAI is the preferred instrument to measure the disease activity of perianal fistulas.
Applicant submits that neither Sandborn 2013 nor Sandborn 2002 teach or suggest subcutaneous administration of 108 mg doses of the claimed antibody every two, three, or four weeks, as required by independent claim 25.
It remains the Examiner’s position that those of skilled in the art would have had a reason to adapt the dosing regimen taught by the `479 patent in treatment of human patient suffering from perianal fistulizing Crohn’s disease taught by Sandborn-2013 et al because the efficacy of the subcutaneous vedolizumab 108 mg every 2 weeks following IV doses of 300 mg of VDZ at weeks 0, 2 and 6 achieved clinical response.
10. Claims 1, 7-8, 10-11, 16-17, 25, 29, 34-35, 37 are rejected under 35 U.S.C. 103 as being unpatentable over Sandborn et al (N Engl J Med, Aug. 2013;369:711-21, IDS), in view of the Shafran et al. (Gastroenterology. 120(5), Suppl 1, 2001) and Sandborn et al (GASTROENTEROLOGY 2002;122:512–530, IDS) and further in view of WO/2012/151247/US 12286479 (of record).
The teachings of Sandborn-2013, Sandborn-2002 and the Shafran et al references have been discussed, supra.
The reference teachings differ from the instant claims only in the recitation that of a fourth and subsequent doses of 108 mg of the humanized antibody by subcutaneous administration every 2, 3 or four weeks after the third subsequent dose in claim 25.
US 12286479 claims priority to WO/2012/151247, their teachings are identical. The teachings of the `479 is used in the rejection.
The `479 claims methods for treating inflammatory bowel disease (IBD) in a human patient in need thereof, the method comprising intravenously administering an initial dose of 300 mg of a humanized antibody having binding specificity for human α4β7 integrin to the human patient, intravenously administering a second dose of 300 mg of the humanized antibody to the human patient 2 weeks after the initial dose, intravenously administering a third dose of 300 mg of the humanized antibody to the human patient 6 weeks after the initial dose, and subcutaneously administering a dose of 108 mg of the humanized antibody to the human patient via a prefilled syringe or an autoinjector every two weeks starting at 14 weeks after the initial dose, wherein the IBD is ulcerative colitis or Crohn's disease, wherein the treated human patient is in clinical remission, and wherein the humanized antibody is an IgG1 isotype and comprises the following CDRs: Light chain: CDR1 SEQ ID NO: 11 CDR2 SEQ ID NO: 12 CDR3 SEQ ID NO: 13 Heavy chain: CDR1 SEQ ID NO: 8 CDR2 SEQ ID NO: 9 CDR3 SEQ ID NO: 10 (see issued claim 12), wherein the antibody is vedolizumab (see issued claim 16), wherein the treated human patient having ulcerative colitis has mucosal healing (see issued claim 18), the Crohn's disease is moderately to severely active Crohn's disease (see issued claim 20), wherein the human patient has Crohn's disease and has a clinical response for at least 6 months or at least 9 months (see issued claims 26-27), wherein the treated human patient reduces or discontinues use of corticosteroids (see issued claim 30).
Those of skilled in the art would have had a reason to adapt the dosing regimen taught by the `479 patent in treatment of human patient suffering from perianal fistulizing Crohn’s disease taught by Sandborn-2013 et al because the efficacy of the subcutaneous vedolizumab 108 mg every 2 weeks following IV doses of 300 mg of VDZ at weeks 0, 2 and 6 achieved clinical response.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure the severity of perianal Crohn’s disease using PDAI score and its validation in patients undergoing treatment with metronidazole taught by Sandborn 2002 and vedolizumab taught by Sandborn 2013 for the closure of perianal fistulas because PDAI is equivalent of the CDAI and because PDAI is the preferred instrument to measure the disease activity of perianal fistulas.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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.
Applicant’s arguments, filed 04/27/2026, have been fully considered, but have not been found convincing.
The teachings and deficiencies of Sandborn 2013 and Sandborn 2002 are described above. The Office acknowledges that Sandborn 2013 and Sandborn 2002 do not teach `108 mg of the humanized antibody by subcutaneous administration every 2, 3 or four weeks" as required by claim 25 (see Item 12, para. 3 of the Office Action), and therefore cites the '479 patent, which claims priority to WO 2012/151247 (Diluzio et al.; Applicant's own work). In particular, the Office alleges that those skilled in the art "would have had a reason to adapt the dosing regimen taught by the '479 patent in treatment of human patient suffering from perianal fistulizing Crohn's disease taught by Sandborn 2013" (see Item 12, para. 6 of the Office Action) and "measure the severity of perianal Crohn's disease using PDAI score" as taught by Sandborn 2002. However, none of the cited art teaches or suggests identifying the claimed patient for treatment and then administering antibiotics during weeks 0 to 6 of treatment, as required by the claims, as amended. Moreover, one of ordinary skill could not have predicted based on Sandborn 2013, alone or in combination with the '479 patent and Sandborn 2002, that the claimed method could result in closure of at least 50% of perianal draining fistulae 30 weeks after the initial dose of the antibody and a reduction in PDAI score by at least 3 points from baseline, in contrast to the teachings of Applicant's specification, evidenced by Schwartz.
This is not found persuasive because the rejection has been modified to address the newly added limitation the claimed patient for treatment and then administering antibiotics during weeks 0 to 6 of treatment by adding Shafran et al. (Gastroenterology. 120(5), Suppl 1, 2001) as a reference. Regarding the specific treatment duration “during weeks 0 to 6 of treatment” the Board stated that "all that remained to be achieved over the prior art was the determination that a specific dose within a previously suggested dose range, and its corresponding dosing schedule, would have been safe and effective for the treatment of human patients." Genzyme Therapeutic Prods. v. Biomarin Pharms., No. 2015-1720.
"[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
11. No claim is allowed.
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(i) Irvine EJ. Usual therapy improves perianal Crohn's disease as measured by a new disease activity index. McMaster IBD Study Group. J Clin Gastroenterol 1995;20:27-32.
Irvine et al teach that
(ii) US 20130046374
The `674 publication teaches symptoms of Crohn's disease may include abdominal cramps, fever, fatigue, loss of appetite, tenesmus, diarrhea, weight loss, constipation, eye inflammation, fistulas near the rectum, joint pain and swelling, mouth ulcers, rectal bleeding, bloody stools, skin lumps, and swollen gums. Crohn's disease is typically treated by the administration of various drugs, e.g., orally, rectally, or by injection. Such drugs generally include anti-inflammatory drugs (e.g., sulfasalazine, mesalamine, corticosteroids, and budesonide) to reduce inflammation commonly associated with Crohn's disease, an/or immune system suppressors (e.g., azathioprine, mercaptopurine, infliximab, adalimumab, certolizumab pegol, methotrexate, cyclosporine, and natalizumab). Immune system suppressors suppress immune system response, which prevents inflammation indirectly. Antibiotics (e.g., Metronidazole and Ciproflaxacin) are also used. These antibiotics reduce the amount of drainage and sometimes heal fistulas and abscesses in people with Crohn's disease. Antibiotics may also help reduce harmful intestinal bacteria and suppress the intestine's immune system, which can trigger symptoms. Other categories of medications that are prescribed to individuals having Crohn's disease include: anti-diarrheals, laxatives, pain relievers, iron supplements, vitamin b-12, calcium, and vitamin D [0047].
(iii) US 20130116341
Incorporation of antibiotics and anti-inflammatory agents is useful for fistula repair, for example in Crohn's disease or other fistulas in contaminated places [0078] .
13. 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 extension fee 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 date of this final action.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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June 5, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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