DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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Claim Status
Claims 1-22 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
1) Claims 1-3 and 6-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (WO 2005/034871 A2; cited in IDS dated 8/29/2025).
It is noted that the terms “formulated to treat mucus hypersecretion,” recited in claims 1 and 7-8, and “formulated to treat mucus hypersecretion associated with nicotine withdrawal,” recited in claims 6, 13, 15, and 20-21 is interpreted by the Examiner as a statement of intended use or purpose since the term does not appear to be a structural limitation of the claimed invention.
As set forth by the Federal Circuit, “It is well established that “[a]n intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003).
The term “formulated to treat mucus hypersecretion” is disclosed in the instant Specification in broad terms: “Pharmaceutical compositions according to the present invention can be formulated for administration via a transdermal patch or as chewing gum (see [0042]), and “Depending on the specific conditions being treated, such agents may be formulated and administered systemically or locally. Typically, administration is systemic. Techniques for formulation and administration may be found in Remington's Pharmaceutical Sciences, 18th ed., Mack Publishing Co., Easton, Pa. (1990) (see [0113]).”
It is noted that Bond teaches that “Many diseases and conditions are mediated by beta-adrenergic receptors. In particular, these receptors are involved in many pulmonary airway diseases. Pulmonary airway diseases are characterized by reduced pulmonary function and airway flow. These symptoms are often due to secretion of mucus.” See pg 2, [0004].
As such, Bond teaches the limitation of claim 6
The claim term “a therapeutically effective quantity of a beta-adrenergic inverse agonist” is defined in the instant disclosure ([0108]) as follows:
with nadolol administered orally, treatment can begin with 1 mg dosages, then progress through 3 mg, 5 mg, 10 mg, 15 mg, and then to higher maintenance dosages such as 25 mg, 30 mg, 50 mg, 75 mg, 100 mg, 150 mg or higher as deemed necessary, depending on the particular condition to be treated, the severity, and the response of the condition to the treatment. One particularly preferred dosage regimen begins at 10 mg, then progresses through 25, 50, 75, 100 and 150 mg based on defined dose escalation criteria determined by lung function, symptoms, heart rate, and blood pressure, as detailed further below. When the beta-adrenergic inverse agonist is administered to treat or prevent mucus hypersecretion in a subject attempting smoking cessation, criteria related to the effect of the beta-adrenergic inverse agonist treatment on the physiological state, mood, behavior, or craving of the subject for nicotine can also be included in the dose escalation calculation.
Regarding claim 1, Bond teaches a pharmaceutical composition comprising: (1) nadolol, a beta-adrenergic inverse agonist; and (2) a pharmaceutically acceptable carrier (pg 6, [0022]).
Regarding the claim term therapeutically effective quantity of a beta-adrenergic inverse agonist,” the term is defined in the instant disclosure ([0108]) as an amount of 1 mg, 3 mg, 5 mg, 10 mg, 15 mg, 25 mg, 30 mg, 50 mg, 75 mg, 100 mg, 150 mg or higher as deemed necessary (pgs 37-38, [0108]), Bond teaches a therapeutically effective amount of the beta-adrenergic inverse agonist nadolol as 1 mg, 3 mg, 5, mg, 10 mg, 15 mg, 30 mg, and 50 mg (pg 6, [0022]), amounts disclosed by the instant disclosure as therapeutically effective. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (I). This teaching also reads on claims 2 and 3.
For the recitation of claim 1 of “at least one pharmaceutically acceptable carrier suitable for administration of the composition for treating mucus hypersecretion,” Bond teaches the following regarding carriers (pg 26, [0096]):
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The instant specification discloses the following regarding a pharmaceutically acceptable carrier suitable for administration of the composition for treating mucus hypersecretion (pg 29, [0087]):
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As such, it is clear that the description of the carrier(s) utilized for a composition formulated for mucus hypersecretion is identical to that taught by Bond since the instant disclosure is identical to that taught by Bond.
Therefore, for claim 1, Bond teaches a therapeutically effective of nadolol as the beta-adrenergic inverse agonist, as discussed above. Bond teaches the beta-adrenergic inverse agonist is present in a composition comprising a pharmaceutically acceptable carrier (pg 6, [0022]).
As discussed above, the limitation of the “pharmaceutical composition is formulated to treat mucus hypersecretion” is considered an expression of intended use and is not afforded patentable weight since it does not limit the structure of the formulation.
For claim 7, Bond teaches administration of the b-adrenergic inverse agonists together with corticosteroids such as methylprednisolone and prednisolone (pg 43, [0137]).
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed methods in view of Bond. However, the claimed combination of components, including the therapeutically effective amount of nadolol, is taught as known and used for administration to a subject with a pulmonary airway disease such as asthma, bronchiectasis, bronchitis, chronic obstructive pulmonary disease, Churg-Strauss syndrome, pulmonary sequelae of cystic fibrosis, emphysema, allergic rhinitis, and pneumonia (pgs 75-76, claim 18). Further, Bond teaches administration with the same excipients (pg 26, [0096] as disclosed in the instant specification ([0087]).
It would have therefore been prima facie obvious to a person having ordinary skill in the art to formulate the pharmaceutical composition comprising the claimed combination of ingredients, including nadolol, with a reasonable expectation of success that the treatment would be efficacious for the treatment of a pulmonary airway disease, as taught by Bond.
2) Claim 4 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (cited above), in view of Gale (US 5,635,203; cited in IDS dated 8/29/2025).
Claim 4 is directed to the composition of claim 1 in the form of a transdermal patch.
The teachings of Bond are discussed above.
While Bond teaches delivery of the composition by transdermal means (pg 38, [0123]), Bond does not teach a transdermal patch as a form of delivery.
Gale teaches the missing element of Bond.
Gale teaches a transdermal patch for administration of a drug (Abstract). Gale teaches nadolol as a drug that may be administered by the patch (col 6: 61). Regarding the recitation “wherein the administration via the transdermal patch results in continuous levels of the nadolol in the bloodstream of the subject,” Gale teaches the transdermal patch is designed to “effectively deliver drug for an extended period of time from several hours up to seven days or longer. Seven days is generally the maximum time limit for application of a single device because the adverse effect of inclusion of a skin site increases with time” (col 5: 67 to col 6:4).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the composition of Bond as a transdermal patch. A person of ordinary skill would have been motivated to administer the composition of Bond as a transdermal patch because Gale Franklin teaches a transdermal patch formulation comprising nadolol has the advantage of providing the nadolol continuously over the period of a week, providing controlled release of the drug over an extended time period.
3) Claim 5 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (cited above), in view of McCarty (US 2007/0071806 A1).
The teachings of Bond are discussed above.
While Bond teaches delivery of the composition by oral means, including buccal tablets, (pg 27, [0098]), Bond does not teach chewing gum as a form of delivery.
McCarty teaches the missing element of Bond.
McCarty teaches chewing gum for administration of a drug (pg 6, [0051]). McCarty teaches nadolol, as well as expectorants, bronchodilators, mucolytics, anti-inflammatory agents, and antibiotics as drugs that may be administered by the patch (pgs 3-4, [0026]; pg 7, [0063]).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the composition of Bond as a chewing gum. A person of ordinary skill would have been motivated to administer the composition of Bond as a chewing gum because McCarty teaches a chewing gum formulation comprising nadolol and an additional drug such as an expectorant, bronchodilator, mucolytic, anti-inflammatory agent, and antibiotic has the advantage of providing the nadolol and the second drug in a controlled release formulation (pg 7, [0059]).
4) Claims 8-10, 13-14, 15-16 and 20-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (cited above), in view of Apgar (“Use of Bupropion as an Aid in Smoking Cessation,” Am Fam Physician, 1998, 57(7): 1641-1646).
The teachings of Bond are discussed above.
Bond does not teach the addition of a compound to promote smoking cessation.
Apgar teaches the missing element of Bond.
Apgar teaches bupropion hydrochloride is approved as an effective smoking cessation aid and is effective for alleviation of some of the withdrawal effects from smoking cessation (pgs 1-2).
It is noted that claim 20 is considered an expression of intended use of the composition of claim 15
The person of ordinary skill would have had a reasonable expectation of success in adding Apgar's bupropion to the composition of Bond since Bond teaches nadolol, a beta-adrenergic receptor agonist, is useful in treating many pulmonary airway diseases characterized by reduced pulmonary function and airway flow, and bupropion is taught by Apgar for smoking cessation, a known causative for pulmonary disease. The skilled artisan would have been motivated to select Apgar's bupropion as an active agent in Bond’s composition because Apgar teaches that bupropion is effective in reducing smoking and reduction of smoking is a key element in treating pulmonary disease.
5) Claim 11 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (cited above), in view of Apgar (cited above) and Gale (cited above).
Claim 11 is directed to the composition of claim 8 in the form of a transdermal patch.
The teachings of Bond, Apgar, and Gale are discussed above. Gale further teaches the transdermal patch is effective as a delivery device for antimicrobial agents (col 6: 27).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the composition of Bond and Apgar, comprising bupropion and nadolol, in the form of a transdermal patch. A person of ordinary skill would have been motivated to administer the composition of Bond and Apgar as a transdermal patch because Gale teaches a transdermal patch formulation has the advantage of providing the nadolol continuously over the period of a week, providing controlled release of the drug over an extended time period.
6) Claims 12 and 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (cited above), in view of Apgar (cited above) and McCarty (cited above).
The teachings of Bond, Apgar, and McCarty are discussed above. Briefly, Bond teaches diseases and conditions that are mediated by beta-adrenergic receptors such as nadolol, in particular, pulmonary airway diseases. Apgar teaches bupropion for smoking cessation and McCarty teaches a chewing gum composition that may comprise agents for smoking cessation, bronchodilators, anti-infectives, antifungals, antivirals, bupropion, and nadolol (pg 7, [0063]).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to administer the composition of Bond and Apgar, comprising bupropion and nadolol, in the form of a chewing gum. A person of ordinary skill would have been motivated to administer the composition of Bond and Apgar as a chewing gum because McCarty teaches a chewing gum formulation is a formulation that is useful for administering a broad range of pharmaceuticals including bupropion and nadolol, as well as agents for smoking cessation, bronchodilators, anti-infectives, antifungals, antivirals, bupropion, and nadolol.
7) Claim 18 is rejected under 35 U.S.C. 103(a) as being unpatentable over Bond (cited above), in view of Apgar (cited above) and Gale (cited above) and Suffin (US 2005/0096311 A1).
The teachings of Bond, Apgar, and Gale are discussed above. Briefly, Bond teaches diseases and conditions that are mediated by beta-adrenergic receptors such as nadolol, in particular, pulmonary airway diseases; Apgar teaches bupropion for smoking cessation; and Gale teaches a transdermal patch formulation is effective as a delivery device for antimicrobial agents.
The combination of Bond, Apgar, and Gale does not teach a transdermal patch comprising bupropion.
Suffin teaches the missing element of the combination of Bond, Apgar, and Gale.
Suffin teaches bupropion, as well as nadolol, may be formulated as a transdermal patch composition (pg 1, [0007]; pg 10, [0051]).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to add bupropion to the composition of Bond, Apgar, and Gale, comprising nadolol and an antimicrobial agent, to comprise a dosage in the form of a chewing gum. A person of ordinary skill would have been motivated to administer the composition of Bond, Apgar, Gale, and Suffin as a chewing gum because Gale and Suffin teach a chewing gum formulation useful for administering a broad range of pharmaceuticals including bupropion, nadolol, and bupropion as well as agents for smoking cessation, bronchodilators, anti-infectives, antifungals, and antivirals.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571)272-0580. The phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612