RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 08/16/2024, is acknowledged.
2. Claims 1, 7, 11, 14-15, 18-19, 33, 38-42 are pending.
3. Claims 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. Claims 1, 7, 11, 14, 15, 18, 19, 33 and 38-40 are under examination as they read on the following species (i) intravenous administration, a 300 mg dose at 0, 2 and 6 weeks and every 4/8 weeks thereafter; (ii) a subject that had a modified Pouchitis Disease Activity Index (PDAI) of 5 or greater at selection; (iii) the method further comprising administering an antibiotic and “the human subject has a proctocolectomy and ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) at selection”.
5. Applicant’s IDS, filed 08/16/2024, is acknowledged.
6. The following new grounds of rejection are necessitated by the amendment submitted 08/16/2024.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 1, 7, 11, 14, 15, 18-19, 33, 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ClinicalTrils (NCT02790138, 5/31/2016, IDS #2) for the same reasons set forth in the previous Office Action, mailed 02/16/2024.
Further, the NCT `138 further teaches that the inclusion criteria including a pouchitis patient undergone proctocolectomy (see the specification page 9, last ¶) and an ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) criteria #3 and has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (criteria #4).
The functions recited in the wherein clause flow naturally from the teachings of the prior art. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)). Here, the recited functional outcome “achieves remission of pouchitis by about 14 weeks following the initial dose of the anti-α4β7 antibody, wherein remission is defined as pouchitis having a modified Pouchitis Disease Activity Index (mPDAI) of <5 and a reduction in overall mPDAI score of >2 from baseline” would naturally and necessarily flow from inhibition of α4ß7 by administering Vedolizumab. Accordingly, the prior art teaches the same method, the product used in the reference method are the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from inhibition of α4ß7 with the Vedolizumab in treating chronic pouchitis patient has a mPDAI of 5 or greater, a minimum endoscopic subscore of 2 and IPAA for UC.
Applicant’s arguments, filed 08/16/2024, have been fully considered, but have not been found convincing.
Applicant submits that the NCT `138 does not teach selecting a human subject that has a minimum endoscopic subscore of 2.
Contrary to Applicant assertion, the NCT `138 teaches under eligibility inclusion criteria #4 to include participants with a minimum endoscopic subscore of 2.
9. 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.
10. Claims 1, 7, 11, 14, 15, 18-19, 33, 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bethge et al. (BMJ Open Gastro Feb. 2017;4: e000127, IDS #5) or Mangla et al. (American Journal of Gastroenterology, (October 2016); 111(1):S824‐S825, Abstract #: 1729), each in view of ClinicalTrils (NCT02790138, 5/31/2016, IDS #2) for the same reasons set forth in the previous Office Action mailed 02/16/2024.
Applicant’s arguments, filed 08/16/2024, have been fully considered, but have not been found convincing.
Applicant submits that the claims as amended, specify selecting a human subject that has a modified Pouchitis Disease Activity Index (PDAI) of 5 or greater and a minimum endoscopic subscore of 2 for treatment. The claimed method first identifies a patient having pouchitis and selects said patient based on criteria. The claims, as amended, further specify that the subject achieves remission by about 14 weeks following the initial dose, wherein remission is defined as pouchitis having a mPDAI of <5 and a reduction in overall mPDAI score of >2 from baseline. Thus, the invention is based on identification of a certain patient having pouchitis who the Applicant has identified as being able to be treated and achieve certain levels of disease remission and reduction, as required by the amended claims.
Applicant provides support in Example 1 of the application as filed, describes “a phase 4, randomized, double- blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of vedolizumab intravenous (IV) 300 mg over a 34-week treatment period (with the last dose at week 30) in subjects with a proctocolectomy and ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) who have developed chronic or recurrent pouchitis” (see page 29, lines 19-23). Chronic or recurrent pouchitis in the study was defined “as a modified Pouchitis Disease Activity Index (mPDAD) score of 5 or more assessed as the average from 3 days immediately prior to the baseline endoscopy and a minimum endoscopic subscore of 2 ( outside the staple or suture line)” (see page 29, lines 29-32).
Applicant points to Travis et al. 2023, NEJM, 388(13), 1191-1200 (provided in a SIDS filed herewith; hereinafter “Travis et al.”’), provides results from the clinical study described in Example 1. Travis et al. states that “[t]he primary end point was mPDAI-defined remission (an mPDAI score of <4 and a reduction from baseline of >2 in the mPDAI total score) at week 14” (see page 1193, right col., last paragraph). Travis et al. reports that “the incidence of mPDAI defined remission at week 14 was 31% (16 of 51 patients) with vedolizumab” wherein eligible patients “had undergone a proctocolectomy and IPAA for ulcerative colitis that had been performed at least 1 year before screening, and had active chronic pouchitis. Active chronic pouchitis was defined by an mPDAI score of at least 5 and a minimum subscore of 2 on the endoscopic domain (on the basis of findings outside the staple or suture line)” (see page 1191, Abstract, Results and page 1192, right column, last paragraph).
Applicant submits that none of the cited art teaches or suggests selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2 for treatment. For at least the reason that the cited art fails to teach all of the elements of the claims (i.e., selection of the claimed subject), the rejection should be overcome.
This is not found persuasive because the NCT `138 teaches that the inclusion criteria including a pouchitis patient undergone proctocolectomy (see the specification page 9, last ¶) and an ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) criteria #3 and has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (criteria #4).
The functions recited in the wherein clause flow naturally from the teachings of the prior art. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)). Here, the recited functional outcome “achieves remission of pouchitis by about 14 weeks following the initial dose of the anti-α4β7 antibody, wherein remission is defined as pouchitis having a modified Pouchitis Disease Activity Index (mPDAI) of <5 and a reduction in overall mPDAI score of >2 from baseline” would naturally and necessarily flow from inhibition of α4ß7 by administering Vedolizumab. Accordingly, the prior art teaches the same method, the product used in the reference method are the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from inhibition of α4ß7 with the Vedolizumab in treating chronic pouchitis patient has a mPDAI of 5 or greater, a minimum endoscopic subscore of 2 and IPAA for UC.
Further, Bethge et al teaches that after 6 weeks of therapy with VDZ, the clinical symptoms of pouchitis disappeared.
Mangla et al further teaches that vedolizumab was successful in the treatment of inflammatory conditions of the pouch in three out of four IPAA patients.
Applicant submit that Bethge et al. describes a case study of a single patient who was administered combination therapy with vedolizumab and etanercept for treatment of pouchitis and spondylarthritis (see Title). Bethge et al. does not teach or suggest selecting a subject having a minimum endoscopic subscore of 2. Moreover, although Bethge et al. describes that “[a]fter 20 weeks of VDZ endoscopic and histopathological assessment of the pouch revealed normal, uninflamed mucosa” (see page 2, left column, first full paragraph), Bethge et al. does not teach or suggest that remission, defined as pouchitis having a mPDAI score <5 and a reduction of mPDAI score by >2 from baseline, is achieved 14 weeks following the initial dose of anti-a4B7 antibody, as specified by the amended claims.
This is not found persuasive because by definition a mPDAI score of ≥ 5 suggests a diagnosis of pouchiti, while mPDAI score of <5 and a reduction of mPDAI score by >2 from baseline indicates normal pouch and uniflammed mucosa. Moreover, the NCT `138 teaches that the inclusion criteria including a pouchitis patient undergone proctocolectomy (see the specification page 9, last ¶) and an ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) criteria #3 and has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (criteria #4).
Applicant submits that Mangla et al. is an abstract that describes “4 patients with ulcerative colitis who underwent restorative proctocolectomy with IPAA and were exposed to vedolizumab after IPAA” (see page 824, right col., last full sentence). Mangla et al. does not teach or suggest selecting a subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2. Mangla et al. discloses that “[vJedolizumab was successful in the treatment of inflammatory conditions of the pouch in three out of four IPAA patients” (see page 825, right col., third full sentence); however, Mangla et al. does not teach or suggest remission defined as pouchitis having a mPDAI score <5 and a reduction of mPDAI score by >2 from baseline, much less in the claimed chronic pouchitis subject selected for treatment.
This is not found persuasive because persuasive because by definition a mPDAI score of ≥ 5 suggests a diagnosis of pouchitis, while mPDAI score of <5 and a reduction of mPDAI score by >2 from baseline indicates treatment of inflammatory conditions of the pouch. Moreover, NCT `138 teaches that the inclusion criteria including a pouchitis patient undergone proctocolectomy (see the specification page 9, last ¶) and an ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) criteria #3 and has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (criteria #4).
Applicant submits that the Office cites to NCT02790138 to remedy the deficient teachings in Bethge et al. and Mangla et al. of intravenous administration in claims 1, 11, 14, 15; further comprising administering an antibiotic, wherein the antibiotic is discontinued by 4 weeks following the initial administration of the anti-α4β7 antibody, or antigen binding fragment thereof, as specified by claim 19; and wherein the antibiotic is ciprofloxacin as specified in claim 40. Applicant submits that NCT02790138 describes a clinical trial study to evaluate the efficacy and safety of vedolizumab in the treatment of chronic pouchitis (see Title). NCT02790138 does not teach or suggest selecting a subject having a minimum endoscopic subscore of 2. Moreover, NCT02790138 merely teaches determining the percentage of participants who achieve remission at Week 14 as a Primary Outcome Measure without disclosing what said remission entails, much less a reasonable expectation that the claimed remission defined as pouchitis having a mPDAI of <5 and a reduction in overall mPDAI score of > 2 from baseline can be achieved at Week 14.
This is not found persuasive because the NCT `138 teaches that the inclusion criteria including a pouchitis patient undergone proctocolectomy (see the specification page 9, last ¶) and an ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) criteria #3 and has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (criteria #4).
The functions recited in the wherein clause flow naturally from the teachings of the prior art. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)). Here, the recited functional outcome “achieves remission of pouchitis by about 14 weeks following the initial dose of the anti-α4β7 antibody, wherein remission is defined as pouchitis having a modified Pouchitis Disease Activity Index (mPDAI) of <5 and a reduction in overall mPDAI score of >2 from baseline” would naturally and necessarily flow from inhibition of α4ß7 by administering Vedolizumab. Accordingly, the prior art teaches the same method, the product used in the reference method are the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from inhibition of α4ß7 with the Vedolizumab in treating chronic pouchitis patient has a mPDAI of 5 or greater, a minimum endoscopic subscore of 2 and IPAA for UC.
Applicant concluded that the teachings of Bethge et al., Mangla et al., and/or NCT02790138, one of ordinary skill would not arrive at the claimed invention for at least the reason that the cited art does not teach all of the elements of the claims (1.e., selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2). Thus, without the benefit of Applicant’ s specification, one of ordinary skill would not be able to predict that the claimed methods could achieve the defined remission of pouchitis 14 weeks following the initial dose of anti-α4β7 antibody.
It remains the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the VDZ antibody intravenously as taught by the NCT`138 , and further administer an antibiotic such as ciprofloxacin together with the VDZ and discontinue the antibiotic treatment after 4 weeks in the treatment of chronic pouchitis taught by Bethge et al and Mangla et al reafferences because "[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. Claims 1, 7, 11, 14, 15, 18-19, 33, 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid et al (Int. J. Colorectal Dis, published online: 01/17/2017, IDS), each in view of ClinicalTrils (NCT02790138, 5/31/2016, IDS #2) for the same reasons set forth in the previous Office Action mailed 02/16/2024.
Applicant’s arguments, filed 08/16/2024, have been fully considered, but have not been found convincing.
Applicant submits that Schmid et al. and NCT02790138 do not teach or suggest selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2. Thus, for at least the reason that the cited art fails to teach all of the elements of the claims (i.e., selection of the claimed subject), the rejection should be overcome.
Applicant further submits that Schmid et al. is a case study that describes “treatment of pouchitis with vedolizumab, but not fecal microbiota transfer (FMT), after proctocolectomy in ulcerative colitis” (see Title) for a single 54-year-old patient. Schmid et al. does not teach or suggest selecting a subject having a minimum endoscopic subscore of 2. Moreover, although Schmid et al. describes that “[a]fter 5 doses, pouch and ileal ulcerations had healed completely” (see page 597, right column, penultimate paragraph), Schmid et al. does not teach or suggest achieving remission about 14 weeks following the initial dose of the anti-a4B7 antibody, wherein the remission is defined as pouchitis having an mPDAI score <5 and a reduction in overall mPDAI score >2 from baseline, as specified by the claims, as amended.
Applicant assets that NCT02790138 does not teach or suggest selecting a subject having a minimum endoscopic subscore of 2. Moreover, NCT02790138 merely teaches determining the percentage of participants who achieve remission at Week 14 as a Primary Outcome Measure without disclosing what said remission entails, much less a reasonable expectation that the claimed remission defined as pouchitis having a mPDAI of <5 and a reduction in overall mPDAI score of > 2 from baseline can be achieved at Week 14.
Applicant concluded that one of ordinary skill would not arrive at the claimed invention for at least the reason that Schmid et al. and/or NCT02790138 do not teach all of the elements of the claims (i.e., selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2). Thus, without the benefit of Applicant’s specification, one of ordinary skill would not be able to predict that the claimed methods could achieve the defined remission of pouchitis 14 weeks following the initial dose of anti-α4β7 antibody.
This is not found persuasive because the NCT `138 teaches that the inclusion criteria including a pouchitis patient undergone proctocolectomy (see the specification page 9, last ¶) and an ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) criteria #3 and has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (criteria #4).
The functions recited in the wherein clause flow naturally from the teachings of the prior art. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)). Here, the recited functional outcome “achieves remission of pouchitis by about 14 weeks following the initial dose of the anti-α4β7 antibody, wherein remission is defined as pouchitis having a modified Pouchitis Disease Activity Index (mPDAI) of <5 and a reduction in overall mPDAI score of >2 from baseline” would naturally and necessarily flow from inhibition of α4ß7 by administering Vedolizumab. Accordingly, the prior art teaches the same method, the product used in the reference method are the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from inhibition of α4ß7 with the Vedolizumab in treating chronic pouchitis patient has a mPDAI of 5 or greater, a minimum endoscopic subscore of 2 and IPAA for UC.
Applicant concluded that the teachings of Bethge et al., Mangla et al., and/or NCT02790138, one of ordinary skill would not arrive at the claimed invention for at least the reason that the cited art does not teach all of the elements of the claims (1.e., selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2). Thus, without the benefit of Applicant’ s specification, one of ordinary skill would not be able to predict that the claimed methods could achieve the defined remission of pouchitis 14 weeks following the initial dose of anti-α4β7 antibody.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the VDZ antibody intravenously as taught by the NCT`138 , and further administer an antibiotic such as ciprofloxacin together with the VDZ and discontinue the antibiotic treatment after 4 weeks in the treatment of chronic pouchitis taught by Schmid et al because "[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).
It is obvious to continue treatment with antibiotic along with the anti-α4β7 antibody in the chronic pouchitis treatment and to eliminate the antibiotic after one month after the initial anti-α4β7 antibody treatment since VDZ alone was effective to treat chronic pouchitis as taught by Schmid et al.
12. No claim is allowed.
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(i) Philpott et al. Efficacy of Vedolizumab in Patients with Antibiotic and Anti-tumor Necrosis Alpha Refractory Pouchitis. Inflammatory Bowel Diseases, Volume 23, Issue 1, 1 January 2017, Pages E5–E6.
Philpott et al teaches that a small case series of 4 patients treated with vedolizumab for antibiotic and anti-tumor necrosis factor refractory pouchitis. Four patients were identified as having refractory pouchitis and underwent pouch endoscopy before and after 3 months of therapy with vedolizumab during the period 2015 to 2016.
(ii) Rabbenou and Chang. Medical treatment of pouchitis: a guide for the clinician. Ther Adv Gastroenterol. 2021, Vol. 14: 1–15.
(iii) US Application # 18344724.
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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
September 3, 2024
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644