The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 9-11, 19, 25 and 29-45 are presented for examination.
Applicant’s Amendment filed January 30, 2025 has been received and entered into the present application.
Claims 9-11, 19, 25 and 29-45 are pending. Claims 9, 11, 19 and 25 are amended. Claims 17, 20-21, 23 and 27-28 are cancelled. Claims 29-45 are newly added.
Applicant’s arguments, filed January 30, 2025, have been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Requirement for Restriction/Election
Applicant is reminded of his election of the invention of Group II (original claims 9-17), directed to a method for preventing and/or treating a cerebrovascular condition comprising administering an effective amount of at least one cystic fibrosis transmembrane conductance regulator (CFTR) modulator to a patient in need thereof, and the election of (i) lumacaftor (VX-809) as the single disclosed species of CFTR modulator, and (ii) subarachnoid hemorrhage (SAH) as the single disclosed species of condition to which the reduced cerebral perfusion is associated (as recited in original claim 11), as stated in the reply filed May 31, 2022, which is still in effect over the claims.
In the January 30, 2025 claim listing, Applicant now amends claim 19 to limit the CFTR modulator to “tezacaftor” only, which no longer reads on the elected species of CFTR modulator originally elected for examination on the merits (lumacaftor) and to which consideration of the claims has been heretofore restricted. As a result of this amendment, Applicant’s amended claim 19 is now withdrawn from consideration as being directed to non-elected subject matter to which examination has not yet been extended.
Additionally, Applicant amends claim 25 to limit the condition to which the reduced cerebral perfusion is associated to “heart failure”, which no longer reads on the elected species of condition originally elected for examination on the merits (SAH) and to which consideration of the claims has been heretofore restricted. As a result of this amendment, Applicant’s amended claim 25 (as well as newly added claims 32-34 that depend therefrom) is withdrawn from consideration as being directed to non-elected subject matter to which examination has not yet been extended.
Applicant also seeks the addition of new claims 35-45 in the January 30, 2025 claim listing. As new claims 35-45 are directed to the non-elected species of CFTR modulator tezacaftor, such claims are properly withdrawn from consideration at this time as being directed to non-elected subject matter to which examination has not yet been extended.
Accordingly, claims 19, 25 and 32-45 are properly withdrawn from consideration pursuant to 37 C.F.R. §1.142(b) as being directed to non-elected subject matter.
The claims that are drawn to the elected invention and elected species are claims 9-11 and 29-31 and such claims are herein acted on the merits infra.
Status of Objections/Rejections in the July 30, 2024 Office Action
In reply to the objection to claim 9 as set forth at p.8 of the previous Office Action dated July 30, 2024, Applicant now amends claim 9 to remove the extraneous comma following the preamble objective of the method. Accordingly, the objection is now hereby withdrawn.
In reply to the objection to claims 11, 21 and 28, Applicant cancels claims 21 and 28 and amends claim 11 to remove the duplicative recitation of “heart disease”. Accordingly, the objection is now hereby withdrawn.
The following rejections are not reiterated herein as Applicant’s amendments to such claims now directing them to non-elected subject matter necessitates the withdrawal of such claims from examination on the merits:
(i) the rejection of claims 19-21 and 23 under the written description requirement of 35 U.S.C. §112(a) (pre-AIA first paragraph) for new matter, as set forth at p.8-12 of the previous Office Action dated July 30, 2024;
(ii) the rejection of claims 19-21 and 23 under 35 U.S.C. §102(a)(1) as being anticipated by Lidington et al. (“CFTR Therapeutics Normalize Cerebral Perfusion Deficits in Mouse Models of Heart Failure and Subarachnoid Hemorrhage”, Microcirculation, 2019 May 1; 26:e12524, Abstract MOPE045, p.62), as set forth at p.12-14 of the previous Office Action dated July 30, 2024; and (iii) the rejection of claims 19-21 and 23 under 35 U.S.C. §102(a)(1) as being anticipated by Lidington et al. (“CFTR Therapeutics Normalize Cerebral Perfusion Deficits in Mouse Models of Heart Failure and Subarachnoid Hemorrhage”, JACC: Basic to Translational Science, 2019 December; 4(8):940-958, Published Online November 27, 2019), as set forth at p.15 of the previous Office Action dated July 30, 2024.
Priority
Acknowledgement is again made of the present application as a National Stage (371) entry of PCT Application No. PCT/EP2019/074011, filed September 9, 2019, which claims benefit under 35 U.S.C. §119(a-d) to European Patent Application No. EP 18193319.3, filed September 9, 2018.
As previously set forth in the non-final Office Action dated July 30, 2024, Applicant was advised that the subject matter of claims 9-11 was entitled to the benefit of the earlier filing date of the EP ‘319.3 application. As the amendments to claims 9 and 11 are editorial in nature only and do not substantially alter the scope of subject matter circumscribed therein, Applicant’s claims 9 and 11 – as well as claim 10 that depends from claim 9 – continue to be entitled the benefit of the earlier filing date of the EP ‘319.3 application.
Regarding newly added claims 29-31, Applicant now recites that the lumacaftor to be administered is in an amount of “about 0.1 to about 10 mg per kg body weight of the human” (claim 29), “about 1 to about 10 mg per kg body weight of the human” (claim 30), or that the lumacaftor is administered as a pharmaceutical composition, which comprises the lumacaftor with “at least one pharmaceutically acceptable excipient, diluent, carrier or vehicle” (claim 31).
The disclosure of prior-filed EP ‘319.3, filed September 9, 2018, fails to provide adequate written description and/or enabling guidance in the manner provided by 35 U.S.C. §112(a) or pre-AIA 35 U.S.C. §112, first paragraph, for newly added claims 29-31. Specifically, the EP ‘319.3 disclosure lacks any description of the administration of lumacaftor in an amount of “about 0.1 to about 10 mg per kg body weight of the human” to be treated (claim 29) or “about 1 to about 10 mg per kg body weight of the human” to be treated (claim 30), or that the lumacaftor is administered in the form of a pharmaceutical composition with “at least one pharmaceutically acceptable excipient, diluent, carrier or vehicle” (claim 31). For these reasons, Applicant’s claims 29-31 are not entitled to the benefit of the earlier filing date of the EP ‘319.3 disclosure.
Accordingly, the effective filing date of claims 9-11 is September 9, 2018 (the filing date of EP ‘319.3) and the effective filing date of claims 29-31 is September 9, 2019 (the filing date of the ‘011 PCT application).
The Examiner will revisit the issue of priority as necessary each time the claims are amended.
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.
(1) Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Fares (“Therapeutically Targeting the Cystic Fibrosis Transmembrane Conductance Regulator in Cerebrovascular Dysfunction Associated with Subarachnoid Hemorrhage”, Master’s Thesis, University of Toronto, Published November 2015) in view of Sabri et al. (“Anterior Circulation Mouse Model of Subarachnoid Hemorrhage”, Brain Research, 2009; 1295:179-185) and Wainwright et al. (“Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR”, N Engl J Med, 2015; 272:220-233, previously cited by the Examiner on the 06/24/22 PTO-892), each already of record, for the reasons of record set forth at p.15-18 of the previous Office Action dated July 30, 2024, of which said reasons are herein incorporated by reference.
Applicant’s claims 17 and 27-28 are now cancelled, which necessitates the removal of such claims from the statement of the rejection above.
Applicant’s claim 25 is now amended to circumscribe non-elected subject matter that is not presently under examination. As a result, such claim has been removed from the statement of the rejection above, as it no longer comports with the originally elected species under examination in the instant Office Action.
Response to Applicant’s Arguments
In reply, Applicant traverses the rejection, stating that “[t]he Fares Thesis” relied upon in the rejection “does not state a specific publication date” (Remarks, p.9). Applicant contends that “[w]hile the Fares Thesis bears a ‘2015’ date, that date is not a date of publication, rather, it is a date indicating the year the thesis was completed, not a date of publication” (Remarks, p.10). Applicant alleges that “because the Office Action fails to present evidence of the date that the disclosure was publicly posted, it is improper to rely on the Fares Thesis as prior art” (Remarks, p.10).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant fails to provide evidence supporting his assertion that the Fares Thesis relied upon as the primary reference of the rejection was not first publicly available as of its clearly printed date of 2015 – or, specifically, November 2015, per the hosting website from which it was retrieved (see University of Toronto, TSpace repository, which provides the date of the Fares Thesis as November 2015). Nevertheless, even if Applicant fails to agree that the Fares Thesis was publicly available as of the November 2015 date, a further detailed analysis of the information provided by the University of Toronto TSpace repository demonstrates that the document was at least publicly available no later than November 25, 2016 (see University of Toronto, TSpace repository, “dc.date.available”, which is given as “2016-11-25”). Thus, even if Applicant is correct in stating that the Fares Thesis was not made publicly available in 2015 (which the Examiner does not necessarily concede), the data provided directly by the University of Toronto demonstrates that it most certainly was publicly available on the University of Toronto, TSpace repository website no later than November 25, 2016 – which still pre-dates the effective filing date of claims 9-11 of September 9, 2018 (the filing date of EP ‘319.3) by more than one year, thereby rendering such document applicable prior art under subsection (a)(1) of AIA 35 U.S.C. §102.
Applicant goes on to argue that “[t]he Fares Thesis discloses treatment of mice with C18, beginning 2 days after subarachnoid hemorrhage, at a dose of 3 mg/kg/day for 2 days”, but “does not disclose or suggest use of tezacaftor for treatment of reduced cerebral perfusion” or “either lumacaftor or tezacaftor in connection with heart failure” (Remarks, p.10).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant fails to consider that the instant claims have been examined only insofar as they read on the originally elected species of (i) lumacaftor (not tezacaftor) as the single disclosed species of CFTR modulator, and (ii) SAH (not heart failure) as the single disclosed species of condition to which the reduced cerebral perfusion is associated. Applicant’s contention that the Fares Thesis (or the entire rejection as a whole based upon the primary Fares Thesis) fails to describe tezacaftor for reduced cerebral perfusion due to SAH, or lumacaftor or tezacaftor for reduced cerebral perfusion due to heart failure is unavailing, as neither tezacaftor nor reduced cerebral perfusion as a result of heart failure are presently under examination.
Applicant further argues that “therapeutic efficacy of different pharmaceutical compounds cannot be assumed, because changes in molecular structure can yield vastly different biological results” (Remarks, p.10). Applicant cites to “the Fares Thesis at 62”, in which a study of ivacaftor (VX-770) and C-18 (VRT-534) were shown to have opposite effects on CFTR (Remarks, p.10).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant’s position is unavailing. Here, the Fares Thesis describes the functionality of the CFTR corrector C18 to normalize cerebral perfusion as a result of cerebrovascular constriction due to SAH in a mouse model of human SAH. Such teachings reasonably suggest that another CFTR corrector – in this case, lumacaftor as taught by Wainwright et al. – would have also been effective for normalizing cerebral perfusion following reduced cerebral perfusion due to SAH as a result of this same CFTR correcting function (and further given the association that Fares teaches between reduced CFTR expression in SAH and elevated cerebrovascular constriction). The ordinarily skilled artisan, therefore, would have been imbued with a reasonable expectation of success in substituting the CFTR corrector lumacaftor of Wainwright et al. for the CFTR corrector C18 of Fares to yield this same, or substantially similar, effect to normalize cerebral perfusion following elevated cerebrovascular constriction in SAH.
Applicant separately argues that newly amended or newly added claims 25, 32-34 and 45 are not taught or suggested by the cited prior art teachings of record (Remarks, p.11).
The arguments have been fully and carefully considered, but are not found persuasive.
As the subject matter of newly amended claim 25 or newly added claims 32-34 and 45 is directed to non-elected species not presently under examination, Applicant’s arguments that instant claims 25, 32-34 or 45 distinguish over the prior art of record as they are directed to subject matter that is not taught or suggested by the cited prior art references cannot be accepted because such claims are withdrawn from consideration as being directed to non-elected subject matter under 37 C.F.R. §1.142(b).
Finally, Applicant contends that “it could not be assumed that lumacaftor would have the same effect as C18 in treating of [SAH]” and attempts to support this assertion by citing to Fig.7D and para.[0040] of the as-filed specification as evidence that “C18 provides a more substantial reduction of Fluoro-Jade staining in cortical cell samples (Fluoro-Jade staining is used to label degenerating neurons in ex vivo tissue)” (Remarks, p.12). Applicant opines that “[t]he mechanism of action of CFTR therapeutics, correctors and potentiators was not known to Fares”, noting that “[t]he Fares Thesis characterizes C18 as ‘a CFTR trafficking corrector’” and that a Lidington et al. publication from 2022 first describes the “proteostatic effect mechanism of action of lumacaftor” (Remarks, p.12). Applicant asserts that “there would have been no basis to use lumacaftor as claimed” in light of this information (Remarks, p.12).
The arguments have been fully and carefully considered, but are not found persuasive.
Applicant proffers the data of Fig.7D and para.[0040] of the as-filed specification as evidence that the function of C18 – the CFTR compound employed by Fares – differs from that of lumacaftor such that the ordinarily skilled artisan would not have expected substantially similar efficacy in substituting lumacaftor for C18 in the treatment of reduced cerebral perfusion due to SAH, but this is unavailing. The data presented in Fig.7D and para.[0040] of the as-filed specification pertains to the effects of either C18 or lumacaftor in the reduction of neuronal injury - not a reduction in cerebral perfusion - and, thus, is not clearly relevant to establishing the expectation of an ordinarily skilled artisan as to the function of C18 or lumacaftor in affecting cerebral perfusion.
Even if the ordinarily skilled artisan were to analyze the data presented in Fig.7D and para.[0040] of the as-filed specification as being informative of what function could be expected from lumacaftor as compared to C18, the data does not demonstrate a significant difference in properties between C18 and lumacaftor to the extent that the ordinarily skilled artisan would not have considered the two compounds to be substantially interchangeable. Here, Fig.7D clearly demonstrates that both C18 and lumacaftor exhibited a statistically significant reduction in neuronal injury in a mouse SAH model. Though Applicant is correct that C18 provided a slightly greater reduction than lumacaftor, the fact remains that both C18 and lumacaftor were effective for this purpose in a statistically significant manner, thereby supporting at least a reasonable expectation of similar properties from lumacaftor as compared to C18.
Applicant goes on to argue that Fares did not understand the mechanism of action of CFTR therapeutics, correctors and potentiators, but this is unavailing. At p.62 of the Fares Thesis to which Applicant cites, Fares explains that CFTR correctors and potentiators may “have different roles in modulating CFTR expression”. It does not, however, postulate that the ordinarily skilled artisan would have expected differing effects on CFTR expression from different members of the same class of CFTR correctors, like C18 or lumacaftor. Here, Fares clearly documents the functionality of the CFTR corrector C18 to normalize reduced cerebral perfusion caused by SAH, thereby suggesting that another CFTR corrector – such as lumacaftor, which is explicitly described by Wainwright et al. as a CFTR corrector – would have also substantially similarly normalized reduced cerebral perfusion caused by SAH with a reasonable expectation of success.
Lastly, Applicant neglects to consider that Wainwright et al. expressly documents lumacaftor as a CFTR corrector, which is the same function of C18 as described in Fares. Even if the post-filing Lidington et al. publication of 2022 describes a mechanism of action of lumacaftor that is different than a CFTR corrector, the fact remains that Wainwright et al. documents the knowledge in the art before the effective filing date of the claimed invention – namely, that lumacaftor was recognized as a CFTR corrector - and, therefore, would have been substantially interchangeable with C18 used in Fares to normalize reduced cerebral perfusion due to SAH based upon this functional equivalency.
For these reasons supra, rejection of claims 9-11 is proper.
Claim Rejections - 35 USC § 103 (New Grounds of Rejection)
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.
(2) Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Fares (“Therapeutically Targeting the Cystic Fibrosis Transmembrane Conductance Regulator in Cerebrovascular Dysfunction Associated with Subarachnoid Hemorrhage”, Master’s Thesis, University of Toronto, Published November 2015) in view of Sabri et al. (“Anterior Circulation Mouse Model of Subarachnoid Hemorrhage”, Brain Research, 2009; 1295:179-185) and Wainwright et al. (“Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR”, N Engl J Med, 2015; 272:220-233, previously cited by the Examiner on the 06/24/22 PTO-892),
as applied above to claims 9-11,
further in view of Reagan-Shaw et al. (“Dose Translation from Animal to Human Studies Revisited”, FASEB J, 2007 October; 22(3):659-661).
Fares in view of Sabri and Wainwright, as applied above to claims 9-11.
Fares in view of Sabri and Wainwright differ from the instant claims only insofar as they do not explicitly teach (i) administration of lumacaftor in an amount of “about 0.1 to about 10 mg per kg body weight of the human” (claim 29) or “about 1 to about 10 mg per kg body weight of the human” (claim 30), or (ii) administration of lumacaftor in a pharmaceutical composition with “at least one pharmaceutically acceptable excipient, diluent, carrier or vehicle” (claim 31).
Reagan-Shaw et al. teaches that allometric scaling of drug doses between species uses body surface area (BSA) to scale the dose and that a human equivalent dose (HED) is equivalent to multiplying the animal dose (mg/kg) by the animal Km factor divided by the human Km factor (HED in mg/kg = animal dose (mg/kg) * (animal Km/human Km)) (col.1, para.2, p.660; Fig.1, p.660). Reagan-Shaw et al. teaches that the Km factor for mouse is 3, the human Km factor for an adult is 37 (Table 1, p.660).
Fares teaches a 3 mg/kg body weight per day dose of the CFTR corrector C18 for use in the mouse model of human SAH, which was effective to normalize reduced cerebral perfusion and reasonably suggests to the ordinarily skilled artisan to employ a substantially equivalent dose of the CFTR corrector lumacaftor for this same purpose that is then scaled for treatment of a human subject.
Such dose described in Fares, then, suggests a similar dose of 3 mg/kg mouse dose of lumacaftor, which is equivalent to a scaled human dose of:
3 mg/kg mouse dose * (3 mouse Km factor/37 human adult Km factor) = 0.24 mg/kg body weight of the human SAH subject to be treated.
A person of ordinary skill in the art would have had a reasonable expectation of success in employing a human equivalent dose of the CFTR corrector lumacaftor to that of the 3 mg/kg mouse dose of the CFTR corrector C18 employed in Fares for the treatment of a human with reduced cerebral perfusion due to SAH for the purpose of normalizing cerebral perfusion as detailed above because Fares teaches the efficacy of the CFTR corrector C18 to normalize cerebral perfusion in a mouse model of human SAH with reduced cerebral perfusion. The skilled artisan would have been motivated to do so in view of the established efficacy observed by Fares using a CFTR corrector to normalize cerebral perfusion in a clinically relevant animal model of human SAH – thereby suggesting the substitution of another well-known CFTR corrector lumacaftor as taught by Wainwright et al. to yield this same effect with a reasonable expectation of success - and further in view of Reagan-Shaw’s established methods of allometrically scaling drug doses between animals (such as mice) and humans. The ordinarily skilled artisan, therefore, would have found it prima facie obvious to administer the CFTR corrector lumacaftor to a human with reduced cerebral perfusion due to SAH as detailed above in an amount of 0.24 mg/kg body weight of the human, which is a human equivalent dose to the 3 mg/kg murine dose employed by Fares and falls within Applicant’s instantly claimed ranges of “about 0.1 to about 10 mg per kg body weight” (claim 29) or “about 1 to about 10 mg per kg body weight” (claim 30), particularly absent any specific definition of the amount of variation tolerated by the term “about” as used in the instant claims.
The skilled artisan would have also found it prima facie obvious to formulate the CFTR corrector lumacaftor as taught by Wainwright et al. into a pharmaceutical composition with “at least one pharmaceutically acceptable excipient, diluent, carrier or vehicle” (claim 31) suitable for formulating the lumacaftor into a dosage form to facilitate administration of the lumacaftor to a human subject with SAH and reduced cerebral perfusion to normalize the same using an easily administrable pharmaceutical formulation.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Rejection of claims 9-11 and 29-31 is proper.
Claims 19, 25 and 32-45 are withdrawn from consideration pursuant to 37 C.F.R. 1.142(b).
No claims of the present application are allowed.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Leslie A. Royds Draper whose telephone number is (571)272-6096. The examiner can normally be reached Tuesday to Thursday (08:30 AM to 05:00 PM).
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/Leslie A. Royds Draper/Primary Examiner, Art Unit 1629
March 27, 2025