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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/17/2026 has been entered.
The Amendment filed 04/17/2026, amended claims 220-223, 225-226, 228-232, 234-235, 237-241, and 243-244, and cancelled claims 224, 233, and 242.
Claims 220-223, 225-232, 234-241, and 243-245 are pending and examined on the merits herein.
Priority
This application claims the following priority:
PNG
media_image1.png
140
670
media_image1.png
Greyscale
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Double Patenting
The terminal disclaimer filed on 04/06/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 18/390,537 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The abandonment of Application No. 17/775,375 is sufficient to overcome the rejection over this application.
The rejection over copending Application No. 19/082967 is withdrawn. While ‘967 teaches a method of treating HCM by administering mavacamten, it does not teach the instantly claimed dosing regimen, or teach modifying a dosing regimen based on a Valsalva LVOT gradient of less than 20 mmHg. As such, this rejection is withdrawn.
REJECTIONS-MODIFIED
The rejections have been modified. Semigran continues to be relied upon as a primary reference and Caffrey as a secondary reference. Young and Cleveland Clinic are no longer relied upon as secondary references. Jensen and Maron are now relied upon as secondary references.
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 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 220-223, 225-232, 234-241, and 243-245 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/028360 to Semigran (published 2019, IDS of 07/31/2025) in view of Jensen (Comparison of Valsalva manoeuvre and exercise in echocardiographic evaluation of left ventricular outflow tract obstruction in hypertrophic cardiomyopathy, published 2010, PTO-892), Maron (Hypertrophic Cardiomyopathy is Predominantly a Disease of Left Ventricular Outflow Tract Obstruction, published 2006, IDS of 04/17/2026), and Caffrey (The art and science of drug titration, Therapeutic Advances in Drug Safety, published 2020, PTO-892).
Semigran teaches a method for treating oHCM in an individual by administering a daily dose of 2-15 mg mavacamten for at least 1 week, monitoring said individual, and adjusting the daily dose of compound 1 based on pharmacokinetic and/or pharmacodynamics measures, every 1 to 12 weeks, and a) increasing the daily dose of mavacamten when the individual demonstrates no clinical improvement of the noninvasive monitoring technique; b) decreasing the daily dose of mavacamten when the individual demonstrates clinical regression in one or more of the noninvasive monitoring techniques, or c) continuing the same daily dose of mavacamten when the individual demonstrates a clinical improvement in one or more of the noninvasive monitoring techniques (pg. 98-101, claims 174-175, 177, 182-188, 192).
Semigran teaches the initial daily dose as 5mg and increasing or decreasing mavacamten to the next highest or lowest dosage, i.e., 2, 2.5. 5, 10 or 15mg, based on the non-invasive monitoring technique (pg. 100, claims 189-191).
Semigran teaches the noninvasive monitoring technique as selected from measuring peak VO2 levels, assessing NYHA functional classification, measuring Valsalva gradient, measuring heart activity with an electrocardiogram or an echocardiogram, and combinations thereof (pg. 98, claims 175-176).
Semigran teaches oHCM as defined as at least 30mmHg ([0044]).M
Regarding claims 220, 228, and 237, while Semigran teaches a method of treating oHCM by administering a starting dose of 5mg per day and adjusting the daily dose according to individual patient requirements, by monitoring the patient with noninvasive measures, such as a subject’s Valsalva gradient LVOT, every 4 weeks, it differs from that of instant claims 220, 228, and 237, in that it does not teach a Valsalva LVOT below 20 mmHg during the 4th and 8th week, and does not specifically teach administering a dose of 2.5 mg/day or 5 mg/day during weeks 5-8, does not teach stopping administration at the end of week 8 or administering a dose of 2.5mg/day of mavacamten during weeks 9-12.
Semigran additionally teaches:
-adjusting the total daily dose according to individual patient requirements (pg. 81, claim 17);
-adjusting the dose after 1 to 8 weeks, after 2 weeks, after 4 weeks, after 6 weeks, or after 8 weeks, of mavacamten administration (pgs. 81-82, claims 19-22);
-increasing the total daily dose when the LVEF is greater than or equal to 55% or the LVOT peak gradient is greater than or equal to 30 or 50 mm Hg (pg. 82, claims 27-30; pg. 86, claim 71);
-administering a therapeutically effective amount of mavacamten to lower a post-exercise peak gradient LVOT to less than or equal to 30 mmHg, 20 mmHg, or 10 mmHg (pg. 83, claims 33-35); and
-the therapeutically effective amount as producing a change in baseline to week 12 post-exercise peak LVOT gradient of -100 mmHg or more in the subject (pg. 83, claim 36).
Semigran teaches that, in some embodiments, the therapeutically effective amount is sufficient to lower a post-exercise or resting LVOT gradient to 5-29mmHg upon administration of the compound ([0075]).
Semigran teaches characterizing the effect of 12 weeks of mavacamten treatment on reducing post-exercise peak LVOT gradient in subjects with symptomatic HCM and LVOT obstruction. Semigran teaches the objective of the study as assessing the proportion of subjects achieving an LVOT gradient response of post-exercise peak gradient less than 10 mmHg in subjects with symptomatic HCM and LVOT obstruction. ([0205]-[0206]).
Jensen teaches LVOT gradients in patients with hypertrophic cardiomyopathy (title, abstract). Jensen teaches that Valsalva manoeuvre should be the primary choice of stress modality in HCM patients treated with percutaneous transluminal septal myocardial ablation (PTSMA) (abstract).
Jensen teaches that left ventricular outflow tract obstruction (LVOTO) is present in 25-30% of HCM patients at rest and during exercise echocardiography, and during exercise echocardiography in 70-75% of patients with HCM. The LVOTO is caused by narrowing of the LVOT due to septal hypertrophy and systolic anterior movement of the mitral leaflets. In the individual patient, the LVOTO is highly variable over time and is dependent on factors such as level of hydration, physical activity, intra-thoracic pressure, posture, and drugs. Consequently, measurements of LVOTO are highly dependent on a standardized environment (pgs. 763-764, Introduction).
Jensen teaches the clinical characteristics of percutaneous transluminal septal myocardial ablation-treated patients categorized by phenotype:
PNG
media_image2.png
596
831
media_image2.png
Greyscale
(pg. 766).
Thus, the Valsalva manoeuvre LVOT gradient for non-obstructive is 10mm HG, while that for latent obstruction is 35mm HG.
Jensen teaches that Valsalva manoeuvre is a test that is used to make decisions about treatment in HCM. Jensen teaches Valsalva LVOT as a good assessment of treatment effect (pgs. Paragraph spanning pgs. 767-768).
Jensen teaches Valsalva manoeuvre as cheaper, less time-consuming, feasible in most patients and possibly safer than exercise echocardiography, and related to symptomatic improvement. Jensen further teaches Valsalva manoeuvre as the first choice of stress modality in HCM patients with suspected LVOTO (pg. 768, Clinical implications, Conclusion).
Maron teaches that in patients with HCM, LVOT obstruction at rest is a strong, independent predictor of progression to severe symptoms of heart failure and death (abstract).
Maron teaches that historically, from the first clinical descriptions, the left ventricular outflow tract gradient has been a prominent and quantifiable feature of hypertrophic cardiomyopathy and that major interventions have been introduced to relieve disabling symptoms associated with outflow tract obstruction (pg. 296, Col. 1; pg. 299, Discussion).
Maron teaches that 25% of patients initially diagnosed had a LVOT gradient of at least 30 mm Hg under basal conditions while 75% had a gradient less than 30 mm Hg or no gradient and were considered to be without obstruction. Those with LVOT obstruction were older, had more severe limiting symptoms (NYHA class III or IV), and had thicker left ventricular walls and larger left atrial dimensions. During the follow-up period, patients with obstruction had a significantly greater likelihood of death related to hypertrophic cardiomyopathy than patients without obstruction, and that the probability of reaching the end point of progression to NYHA class III or IV or death from heart failure or stroke was significantly greater in patients with obstruction. Among patients with obstruction, those with mild symptoms (NYHA class II) at entry were more likely to have progression to more severe symptoms or to die from heart failure or stroke than were asymptomatic patients. In addition, patients with obstruction had a significantly increased risk of death from any cause, as compared with patients without obstruction. The probability of sudden death among patients with obstruction was significantly higher than that among patients without obstruction. (pg. 296, Results).
Maron teaches that age-adjusted multivariate analysis showed that LVOT obstruction was a strong, independent determinant of outcome, including the overall risk of death related to HCM, progression to severe heart failure or death from heart failure or stroke, and death from any cause. With regard to sudden death, LVOT obstruction was the only clinical variable independently associated with this outcome (pg. 299, Col. 1).
Maron teaches a gradient of at least 50 mm Hg as the threshold for performing major invasive interventions (pg. 299, Discussion), and a gradient of 30 mm Hg as the threshold for diagnosing patients with hypertrophic cardiomyopathy leading to an increased risk, and as a strong, independent determinant of limiting symptoms and death after adjustment for other relevant disease-related and demographic variables (pg. 300, Col. 2).
Maron emphasizes the importance of clinical judgment in planning a strategy to reduce LVOT obstruction in patients with HCM (pg. 301, Col. 1).
Caffrey teaches the art and science of drug titration (title).
Caffrey teaches that a one-size fits all approach has been a standard for drug dosing, in particular for agents with a wide therapeutic index. The scientific principles of drug titration, most commonly used for medication with a narrow therapeutic index, are to give the patient adequate and effective treatment, at the lowest dose possible, with the aim of minimizing unnecessary medication use and side effects. The art of drug titration involves the interplay of scientific drug titration principles with the clinical expertise of the healthcare providers, and an individualized patient-centered partnership between the provider and the patient to review the delicate balance of perceived benefits and risks from both perspectives. Drug titration may occur as up, down, or cross-titration depending on whether the goal is to reach or maintain a therapeutic outcome, decrease the risk of adverse effects, or prevent withdrawal/discontinuation syndromes or recurrence of disease. Drug titration is a personalized approach to drug dosing that blends science with art, and with supportive real-world outcomes-based evidence that is effective for optimizing pharmacotherapeutic outcomes and improving drug safety (abstract).
Caffrey teaches that drug titration is a change in dosing based on a specific PK/PD, clinical pharmacogenetic, or laboratory parameter, or is based on a set titration schedule as per the prescribing information. It is dosing that is individualized to the specific patient, with the goal of reaching a specific laboratory or clinical target with the lowest dose possible, while mitigating adverse effects, and/or preventing withdrawal/discontinuation symptoms or disease recurrence (pg. 2, “Drug Titration”). For some medications, set titration schedules may be recommended by the manufacturer. Alternatively, response guided titration may be used alone or in combination with target titration schedules per the package insert. When available, dosing algorithms based on PGT (pharmogenetic testing) can be used to optimize the dose for individual patients. Clinical parameters can be used to facilitate drug titrations (pg. 3, “Titration schedule”).
In summary, in view of the teachings of Semigran, Jensen, and Maron, the prior art teaches Valsalva LVOT as a known, independent measure of HCM that is applied in the art to determine severity of the disease state and treatments.
Moreover, in view of the teachings of Jensen and Maron, 30 mm HG is a known threshold of diagnosing patients with obstruction in HCM that leads to increased risk of death. However, as discussed by Maron, only 25% of patients initially diagnosed with HCM have a LVOT gradient greater than or equal to 30 mm HG. As taught by Jensen and Maron, HCM patients are known to have LVOT gradients as low as 5 mm HG, though these patients are not at the threshold for severe disease.
Thus, in view of the teachings of Semigran, Jensen, and Maron, Valsalva LVOT is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. Furthermore, MPEP 2144.05(II)(B) states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
As such, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of Semigran to obtain a Valsalva LVOT gradient measurement of below 20 mmHg during the fourth week and eighth week of the initiation phase, administering a dose of 2.5 mg/day or 5mg/day mavacamten during weeks 5-8, and ending administration at the end of week eight, or administering a dose of 2.5 mg/day mavacamten during weeks 9-12, to arrive at instant claim 220, 228, and 237. One of ordinary skill in the art would have been motivated to make such modifications with a reasonable expectation of success, because:
-as discussed above, Semigran, Jensen, and Maron teach Valsalva LVOT as a result effective variable that is known in the art to predict severity of disease in HCM and as a measurement utilized to direct treatment of the disease,
-Jensen teaches the Valsalva LVOT for non-obstructive HCM as 10 mmHg and 35 mmHg for latent obstruction in HCM,
-Maron teaches that only 25% of patients initially diagnosed with HCM have an LVOT gradient of at least 30 mm Hg under basal conditions,
-Caffrey teaches drug titration as a way to give the patient adequate and effective treatment, at the lowest dose possible, with the aim of minimizing unnecessary medication use and side effects,
-Caffrey teaches that drug titration may occur as up, down, or cross-titration depending on whether the goal is to reach or maintain a therapeutic outcome, decrease the risk of adverse effects, or prevent withdrawal/discontinuation syndromes or recurrence of disease, and
-Caffrey teaches that drug titration is a personalized approach to drug dosing that blends science with art, and with supportive real-world outcomes-based evidence that is effective for optimizing pharmacotherapeutic outcomes and improving drug safety,
Thus, an ordinary skilled artisan would have been motivated to make such modifications to predictably arrive at a method of treating oHCM that is adjusted based on Valsalva LVOT gradient measures, to arrive at the most optimized, safe, inexpensive, non-invasive, and therapeutically effective treatment regimen, that minimizes the side effects of mavacamten, while maximizing its therapeutic effect; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
Regarding claims 221-223, 226, 229-232, 235, 238-241, and 244, while the combination of Semigran, Jensen, Maron, and Caffrey, do not teach measuring LVEF at the instantly claimed specific intervals, Semigran teaches measuring LVEF prior to providing administration of mavacamten, and adjusting the total daily dosage based on the percentage of change of the LVEF measurement form the initial measurement (pg. 85, claims 56-62; [0083]).
Semigran teaches its subjects as having an LVEF of 55% or higher prior to treatment (pg. 86, claim 70; [0094]).
Semigran teaches the combination of LVEF and LVOT measurements to modify the mavacamten dosage ([0081]). Semigran teaches that down-titration of mavacamten requires LVEF greater than or equal to 50% ([0278]-[0279]).
Thus, in view of the teachings of Semigran, LVEF is a result effective variable that is routinely determined and optimized in the pharmaceutical art. MPEP 2144.05(II)(B) states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
As such, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to modify the combined method of Semigran, Jensen, Maron, and Caffrey, by obtaining a LVEF measurement of greater than or equal to 50%, or of 50% to 55%, or of greater than or equal to 55% in the 12th week, and then treating the patient with a dose of 2.5mg/day or 5mg/day of mavacamten during a 12 week maintenance phase, and by obtaining a LVEF of greater than or equal to 50% during the fourth and eighth weeks of the initiation phase, to arrive at the instant claims. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Semigran teaches that the total daily dose of mavacamten may be adjusted after 1 to 8 weeks of initiating mavacamten therapy depending on the response profile of the subject, such as the subject’s resting LVEF and LVOT peak gradient ([0080]-[0081]),
-Semigran teaches measuring LVEF prior to providing administration of mavacamten, and adjusting the total daily dosage based on the percentage of change of the LVEF measurement subsequently during the treatment regimen (pg. 85, claims 56-62; [0083]).
-Semigran teaches the subject as initially having an LVEF of 55% or higher prior to treatment,
-Semigran teaches that down-titration of mavacamten requires LVEF greater than or equal to 50%,
-Caffrey teaches drug titration as a way to give the patient adequate and effective treatment, at the lowest dose possible, with the aim of minimizing unnecessary medication use and side effects,
-Caffrey teaches that drug titration may occur as up, down, or cross-titration depending on whether the goal is to reach or maintain a therapeutic outcome, decrease the risk of adverse effects, or prevent withdrawal/discontinuation syndromes or recurrence of disease, and
-Caffrey teaches that drug titration is a personalized approach to drug dosing that blends science with art, and with supportive real-world outcomes-based evidence that is effective for optimizing pharmacotherapeutic outcomes and improving drug safety,
As such, an ordinary skilled artisan would have been motivated to make such modifications to predictably arrive at a method of treating oHCM that is adjusted based on LVEF, to arrive at the most optimized, safe, non-invasive, and therapeutically effective treatment regimen; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
Regarding claims 225, 234, and 243, Semigran teaches adjusting the daily dose according to LVOT or LVEF ([0080]-[0082]; [0089]; pg. 46, #8; pg. 98, claims 175-177). Thus, Semigran teaches adjusting dosages not based on a blood plasma concentration of mavacamten.
Regarding claim 227, 236, and 245, Semigran teaches the symptomatic obstructive hypertrophic cardiomyopathy is NYHA class II-III symptomatic obstructive hypertrophic cardiomyopathy ([0049]; [0076]-[0078], [0206]). See also Jensen, pg. 764, Col. 1 and pg. 766, Table 1, and Maron, pg. 298, Table 1; pg. 299, Col. 1; pg. 301, Table 2
Response to Arguments
The rejection has been modified. Though Semigran continues to be relied upon as a primary reference, neither Young nor Cleveland Clinic are relied upon as secondary references. Moreover, Jensen and Maron have been added as secondary references.
In view of the modified prior art rejections, arguments pertinent to the instant prior art rejections are addressed below.
On pgs. 11-14, Remarks are an introduction to the arguments.
On pg. 15, Remarks, Applicant argues that obstruction in oHCM is defined by an LVOT gradient greater than 30 mmHg, which was an established threshold, and a POSITA would not have been motivated to depart from this threshold.
This argument has been fully considered. As discussed in the above rejection, the examiner agrees that HCM patients with an obstruction have an LVOT gradient greater than 30 mm Hg.
On pg. 16, Remarks, Applicant argues that 30 mmHg was the standard of care cutoff value at the time of the invention and a POSITA would not have had any reason to depart from it, and references the Merali declaration.
It is respectfully pointed out that the Merali declaration is fully responded to on pgs. 17-29, in the 02/04/2026 Final rejection.
While the prior art teaches 30 mmHg or higher as indicative of obstructive HCM, the prior art does not teach 30 mm Hg as the standard of care cutoff value, as argued.
As pointed out in the above rejection:
Semigran teaches:
-modifying the dosage amount of mavacamten based on the Valsalva LVOT gradient measurement;
Jensen teaches:
-obstruction is only present in 25-30% of HCM patients;
-Valsalva LVOT is a test used to make decisions about HCM treatment;
-Valsalva LVOT is a cheaper, less time-consuming, feasible and safer measurement for relating symptomatic improvement, and is the first choice of stress modality in HCM patients with suspected obstruction;
Maron teaches:
-LVOT obstruction as a strong, independent predictor of progression to severe symptoms of heart failure and death in patients with HCM;
- left ventricular outflow tract gradient is a prominent and quantifiable feature of HCM;
-25% of patients initially diagnosed with HCM had a LVOT gradient of at least 30 mm Hg under basal conditions while 75% had a gradient less than 30 mmHg or no gradient;
-age-adjusted multivariate analysis showed that LVOT obstruction is a strong, independent determinant of outcome;
-a gradient of at least 50 mmHg as the threshold for performing major invasive interventions (pg. 299, Discussion), and a gradient of 30 mm Hg as the threshold for diagnosing patients with hypertrophic cardiomyopathy leading to an increased risk, and is a strong, independent determinant of limiting symptoms and death after adjustment for other relevant disease-related and demographic variables;
-the importance of clinical judgment in planning a strategy to reduce LVOT obstruction in patients with HCM.
Thus, in view of the teachings of Semigran, Jensen, and Maron, the prior art teaches LVOT as a known, independent measure of HCM that is applied in the art to determine severity of the disease state and treatment guidance.
Moreover, in view of the teachings of Jensen and Maron, 30 mmHg is a known threshold of diagnosing patients with obstruction in HCM that leads to increased risk of death. However, as discussed by Maron, only 25% of patients initially diagnosed with HCM have a LVOT gradient greater than or equal to 30 mmHg. As taught by Jensen and Maron, HCM patients are known to have LVOT gradients as low as 5 mm HG, though these patients are not at the threshold for severe disease.
In view of these teachings, Valsalva LVOT is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. Furthermore, MPEP 2144.05(II)(B) states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” See also, the above obviousness rationale.
Though on pgs. 16-17, Remarks, Applicant states that Dr. Merali explains that the 20 mmHg threshold is critical to the effectiveness of the claimed invention, Applicant has provided no evidence to substantiate this assertion.
As seen by the prior art, it is known that while a HCM patient may have a 20 mmHg LVOT gradient, such a measurement is lower than the threshold for obstruction and severe disease. As such, a PHOSITA would be motivated to modify the dosage of mavacamten and the dosing regimen, based on this measurement, as discussed above.
As discussed in MPEP 2144.05, “Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. . .the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. . .modification of a process parameter may be patentable if it produces a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.”
On pgs. 19-20, Remarks, it is acknowledged that post-exercise and Valsalva LVOT gradients are not synonymous. It is respectfully pointed out that the prior art rejection does not solely rely on Semigran’s teachings of post-exercise LVOT gradients for motivation to arrive at the instant invention. However, it is respectfully pointed out that both Valsalva and post-exercise LVOT provoke left ventricular outflow tract gradients to diagnose obstruction.
The remainder of the arguments have been fully addressed in the previous Office Action or addressed by the substantially modified rejection, above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN WELLS/Examiner, Art Unit 1622
Prosecution Insights