DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a U.S. national phase of International Application No. PCT/US2022/034212, filed on 06/21/2022, which claims domestic benefit to US provision application 63/214,97, filed 06/25/2021.
Claim Status
The Amendment, filed on 12/18/2023, is acknowledged in which:
Claims 4-6, 8-11, 15-16, 18-19, and 21-22 are currently amended.
Claims 1-3, 7, 12-14, 17, 20, and 23-24 are original.
Claims 1-24 are pending in the instant application and are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2023 has been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
“a obstructive sleep apnea” should read “an obstructive sleep apnea” (pg 3, line 2)
The “s” in “the s obstructive” should be defined or deleted if added in error (pg 7, line 29)
Line break is missing between “oldIn” (pg 9, line 1)
Added comma after “period.” (pg 10, line 20)
“nonsymptomatic OSA” should read “asymptomatic OSA”
Appropriate correction is required.
Claim Objections
Applicant is advised that should claim 8 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 20 is objected to because of the following informalities: “in a patient” is repeated (line 2). Appropriate correction is required.
Claim Interpretation
Regarding claim 10, while the plain meaning for “composite” implies a combination of elements, applicant has defined the term as “refers to the first to occur of any of the outcomes” (pg 6, lines 16-17). Therefore, examiner has interpreted the instant claim to mean that when the patient has risk of developing a combination of OSA, transient ischemic attack, or death, the first to occur (i.e. anyone one of OSA, transient ischemic attack or death) is reduced.
If this is not the intended scope of the claim, examiner recommends amending to either redefine the term “composite” or, if the intention is to claim reducing risk of a combination of outcomes, to amend the claim to recite “…the patient’s risk of developing two or more of the following outcomes is reduced…”
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this instance, claims 2 and 16 recite “wherein the sleep apnea is obstructive sleep apnea….” This does not further limit base claim 1, which already recites “treating, preventing, or delaying the development of obstructive sleep apnea”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claims 1-14, 16-20, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Gottlieb (JAMA. 2020;323(14):1389-1400) and Min (Diabetes Ther. 2021;12(1):143-157).
Gottlieb teaches overweight or obese patients (i.e. patients in need of improved weight management) have increased risk of developing OSA in comparison to patients with normal weight (Table 1). Gottlieb teaches weight loss improves obstructive sleep apnea (OSA) and should be recommended for all patients with over-weight or obesity in conjunction with other therapies; and further teaches greater weight loss is associated with greater benefit in improving OSA severity (pg 1393, left column, ¶ 2). Gottlieb also teaches weight loss for OSA treatment can be achieved via lifestyle interventions or via medication or bariatric surgery (Table 3).
Gottlieb does not teach specific medications for weight loss or OSA treatment.
Min teaches once weekly tirzepatide treatments (pg 5, left column, ¶ 3) at 5, 10, and 15 mg induces dose-dependent weight loss in comparison to placebo in patients with type 2 diabetes mellitus (T2DM) above and below BMI 30 kg/m2 (Table 2) (i.e. above and below obese weight as defined by the instant specification; pg 6, lines 4-5). Min further teaches a clinical trial, SURPASS-CVOT (NCT04255433), wherein recruited patients having T2DM, BMI ≥ 25 kg/m2 (i.e. within scope of obesity as defined in the instant specification), and established cardiovascular disease are treated weekly with tirzepatide (pg 9, right column, ¶ 2).
One of ordinary skill in the art would recognize that weight loss through medication would be a viable way to treat OSA as taught by Gottlieb. As Min teaches tirzepatide has potent weight loss effects, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that tirzepatide treatment for T2DM with or without cardiovascular disease as taught by Min would have a reasonable expectation of success in reducing the risk of developing and/or treating OSA because Gottlieb teaches overweight and obese patients have increased risk of developing OSA and overall weight loss is associated with improving OSA (See MPEP 2143(I)(G)).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gottlieb and Min as applied to claim 1 above, and further in view of Le Roux (Lancet. 2017;389(10077):1399-1409).
Gottlieb and Min teach claim 11 as discussed above. Min further teaches dual GIP/GLP-1 receptor agonist tirzepatide has potent glucose lowering and weight loss with adverse effects comparable to those of established GLP-1 receptor agonists (pg 1, right column). Min also teaches GIP and GLP-1 receptor co-agonist therapy produces a dose-dependent reduction in blood glucose, body weight, food intake and fat mass compared to placebo, equimolar dose of exendin-4 or liraglutide (GLP-1 based therapy) (pg 5, left column ¶ 2). Studies referenced by Min had treatment durations of tirzepatide up to 26 weeks (Table 2) with additional reference to clinical trials testing up to 72 weeks of treatment (pg 12, left column, ¶ 1)
However, neither Gottlieb nor Min explicitly teach administration of tirzepatide continued for at least 2 years.
Le Roux teaches a 3-year trial of GLP-1 receptor agonist liraglutide treatment to evaluate long-term efficacy and safety in weight loss and reducing the incidence of T2DM (pg 1399, “Introduction”). Study participates had BMI of at least 30 kg/m2, or at least 27kg/m2 with treated or untreated dyslipidemia, or hypertension, or both (pg 1400, “Participants”). After 160-week treatment period patients treated with liraglutide induced greater sustained weight loss than placebo and, a 12-week off-treatment follow-up period revealed some weight regain after cessation (Figure 3).
It would have been obvious to one of ordinary skill would that administration for 3 years as taught by Le Roux for an alternative GLP-1 agonist is sufficient to test long-term effects and safety. Moreover, as Le Roux teaches that with cessation of treatment with comparable GLP-1 inhibitor can result in weight gain, it would be likely that weight-dependent reduction in severity of OSA without long-term tirzepatide treatment could also be impacted. Therefore, it would be obvious to one of ordinary skill to substituted liraglutide for tirzepatide within a 3-year treatment study as taught by Le Roux (i.e. at least 2 years) to determine efficacy and safety, and would be motivated to do so because Min teaches tirzepatide as potentially more effective to weight loss than liraglutide as studied by Le Roux, and therefore long-term treatment with tirzepatide would have a reasonable expectation of assessing lasting effects to weight-dependent reduction in OSA (See MPEP 2143(I)(G)).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Gottlieb and Min as applied to claim 1 above, and further in view of American Heart Association (Understanding your risks to prevent a heart attack. Heart.org. Published 2016. Archived on Internet Archive Jun 3, 2021; herein AHA)
Gottlieb and Min teach claim 1 as discussed above. Min further teachers tirzepatide has been shown to induce weight loss greater than 5-15% in a percentage of patients treated (pg 8, left column).
Neither reference teaches that treatment with tirzepatide reduces risk of hospitalization for myocardial infarction (MI).
AHA teaches obesity and being overweight as independent risk factors for heart disease and stroke and teaches sustained weight loss of 3-5% in individuals above healthy weight may lead to significant reductions in some risk factors (pg 3, “Obesity and being overweight”).
One of ordinary skill would recognize that weight loss induced by tirzepatide as taught by Min would independently reduce risk of MI and thus hospitalization for MI. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that treating OSA with tirzepatide-based weight loss as taught by the combined teachings of Gottlieb and Min would have a reasonable expectation of independently reducing MI risk as AHA teaches sustained weight loss above 5% is sufficient to reduce MI risk as instantly claimed (See MPEP 2144.07).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gottlieb and Min as applied to claim 1 above, and further in view of US 2019/0388502 A1 (herein Corvari; published 12/26/2019).
Gottlieb and Min teach claim 1 as discussed above.
However, they do not teach administration of tirzepatide as a pharmaceutically acceptable salt.
Corvari teaches methods of treating obesity (e.g. therapeutic weight loss; column 2, ¶ 6) comprising administering an effective dose of a pharmaceutical composition comprising tirzepatide, or a pharmaceutically acceptable salt thereof (¶ [0012]-[0014]; claims 33 and 39).
One of ordinary skill in the art would recognize that tirzepatide and pharmaceutically acceptable salts thereof are both suitable to treat obesity as taught by Corvari. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention that a pharmaceutically acceptable salts of tirzepatide can be substituted for tirzepatide within the methods as taught by the combined teachings of Gottlieb and Min to treat OSA as discussed above with a reasonable expectation of success as Corvari teaches both tirzepatide and salts thereof as interchangeable for therapeutic weight loss (See MPEP 2144.07).
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNAH SUNSHINE whose telephone number is (571)270-7417. The examiner can normally be reached M-Th & Second Friday 8:30am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANNAH SUNSHINE/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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