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 .
Response to Arguments
Applicant's arguments, see pages 6-8, filed 22 October 2025, with respect to the rejection(s) of claims 1, 4-7, 10-11 and 21 under 35 U.S.C. 103 as being unpatentable over DUNAWAY (US 2006/0100290 A1) in view of LEMAHIEU (US 2008/0066741 A1) and AGGARWAL (“Exercise-induced bronchoconstriction: prevalence, pathophysiology, patient impact, diagnosis and management”, npj Primary Care Respiratory Medicine, 28:31, pages 1-8, 14 August 2018) have been considered and are persuasive. Therefore, the previous rejection filed on 03 June 2025 has been withdrawn. However, upon further consideration, a new grounds of rejection is made over AGGARWAL (“Exercise-induced bronchoconstriction: prevalence, pathophysiology, patient impact, diagnosis and management”, npj Primary Care Respiratory Medicine, 28:31, pages 1-8, 14 August 2018) in view of DUNAWAY (US 2006/0100290 A1) and LEMAHIEU (US 2008/0066741 A1).
Status of Claims
Claims 12-20 remains withdrawn from consideration. Claims 1, 4-7, 10-11 and 21 are presented for examination herein. Applicant amended the claims to be directed towards treating exercised-induced bronchoconstriction in an individual without asthma. Therefore, the species of respiratory disorder is shifted to exercised-induced bronchoconstriction without asthma.
Claim Interpretation
Claim 10 and claim 11 which depends from claim 10, contain the transitional language “consisting essentially of”. For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant's invention. PPG Industries Inc. V Guardian Industries Corp. 48 USPQ2d 1351 (Fed. Cir. 1998) and In re De Lajarte 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See MPEP 2111.03.
The instant specification does not define the term “consisting essentially of” in a manner that would allow one skilled in the art to determine what basic and novel characteristics are being materially affected. The specification of the instant application teaches that the compositions is useful for/has the activity treating exercise-induced bronchoconstriction (EIB) without asthma. This is the same activity described by Aggarwal for its compositions. The addition of ingredients to this composition/method including excipients and drugs for treating including exercise-induced bronchoconstriction (EIB) without asthma, but does not change or “materially affect” composition’s property to treat exercise-induced bronchoconstriction (EIB) without asthma. Thus, additional drugs for treating including exercise-induced bronchoconstriction (EIB) and excipients are not excluded from the instant claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the norepinephirine reuptake inhibitor" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 of this title, 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 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 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, 4-7, 10-11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over AGGARWAL (“Exercise-induced bronchoconstriction: prevalence, pathophysiology, patient impact, diagnosis and management”, npj Primary Care Respiratory Medicine, 28:31, pages 1-8, 14 August 2018) in view of DUNAWAY (US 2006/0100290 A1).
Aggarwal is primarily directed towards exercise-induced bronchoconstriction which can occur in individuals with and without asthma (abstract).
Regarding claims 1 and 6-7, Aggarwal discloses that symptoms of EIB include dyspnoea, wheezing and cough (page 1, second column, second paragraph). Aggarwal discloses treatment for including EIB in patients without asthma (page 5, second column, third paragraph), wherein treatment includes short-acting β2-agonists (SABAs) 15 min before exercise and leukotriene receptor antagonists (LTRAs) (page 5, second column, third paragraph). Aggarwal discloses that SABAs stimulate β2-receptors on the surface of the airway smooth muscle, causing relaxation and bronchodilation, as well as possibly preventing mast cell degranulation (page 6, second column, third paragraph). Aggarwal discloses dry powder inhalation of SABAs using including pressurized metered dose inhaler (Figure 4; page 6, second column, third paragraph). Aggarwal discloses that LTRAs have also been shown to be efficacious for EIB in patients with and without asthma (page 6, second column, sixth paragraph). Aggarwal discloses that “during exercise-related hyperventilation, transient osmotic change at the airway surface occurs owing to reductions in epithelium liquid volume, which in turn triggers mast cell degranulation. Consequently, there is mast cell-mediated release of prostaglandins (prostaglandin D2), leukotrienes, histamine and tryptase. These signaling molecules are known to mediate airway smooth muscle contraction and increase mucus production and microvascular permeability and sensory nerve activation, and their release is thought to be the main stimulus for bronchoconstriction and airway oedema” (e.g., non-inflammatory symptoms) (page 3, first column, first paragraph).
Regarding claim 21, Aggarwal discloses dry powder inhalation of SABAs using including pressurized metered dose inhaler (Figure 4; page 6, second column, third paragraph). Aggarwal discloses that LTRAs have also been shown to be efficacious for EIB in patients with and without asthma (page 6, second column, sixth paragraph).
Aggarwal does not specifically teach that the composition comprises an effective amount of atomoxetine and administration of the atomoxetine by inhalation. The deficiency is made up for by the teachings of Dunaway and LeMahieu.
Dunaway is primarily directed towards a method of treating use of atomoxetine for treating including asthma (paragraph [0004]).
Regarding claims 1-2, 6-7 and 10, Dunaway discloses effective dose of atomoxetine for treatment of including asthma for humans (paragraph [0009]). Dunaway discloses that the precise mechanism by which atomoxetine produces its therapeutic affects for including asthma is unknown (paragraph [0004]). Dunaway discloses that asthma is manifested physiologically by a widespread narrowing of the airways and clinically by including paroxysms of dyspnea, cough and wheezing (paragraph [0008]). Dunaway discloses effectiveness of atomoxetine in treating symptoms of asthma (paragraph [0011]). Dunaway discloses effective dose of atomoxetine ranging from about 5 mg/day to about 100 mg/day (e.g., lies inside the range of about0.5 mg to 100 mg per day disclosed in the instant specification (paragraph [0032])) (paragraph [0009]). Dunaway discloses that administration of atomoxetine allowed patients to wean treatments including bronchodilators and leukotriene modifiers (paragraphs [0013-0014] and [0017]).
LeMahieu is primarily directed towards systems and method for delivery of a drug to the respiratory system of a patient (abstract).
Regarding claim 1, LeMahieu teaches methods of administering drugs to the respiratory system of a patient (paragraph [0018]). LeMahieu teaches drugs for including prevention of exercise-induced bronchospasm (e.g., exercise-induced bronchoconstriction) (paragraph [0057] and TABLE 1) and for drugs including atomoxetine (paragraph [0058] and TABLE 2). LeMahieu teaches that pulmonary delivery of drugs provides including avoiding complications with digestive tract chemistry, avoiding first pass metabolism, a non-invasive delivery and a fast and efficient means of getting medicine into the bloodstream (paragraph [0097]).
Regarding claims 4-5, LeMahieu teaches delivery of medicine by inhalation through the nose or mouth using a mask (paragraph [0144]).
Regarding claim 11, LeMahieu teaches pharmaceutically acceptable formulations that including pharmaceutically acceptable excipient materials (paragraph [0071]).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat including exercise-induced bronchoconstriction in a patient without asthma comprising administration by using a mask for inhalation of a composition comprising an effective dose of atomoxetine. The person of ordinary skill in the art would have been motivated to make those modifications because: 1) as taught by Dunaway, atomoxetine can be used to effectively treat symptoms of asthma that includes dyspnea, cough and wheezing which are the same symptoms of exercise-induced bronchoconstriction in a patient without asthma, and administration of atomoxetine can wean treatment of including bronchodilator and leukotriene modifiers which are the same treatments for exercise-induced bronchoconstriction; and 2) administration by inhalation provides advantages including avoiding complications with digestive tract chemistry, avoiding first pass metabolism, and fast and efficient drug delivery. The person of ordinary skill in the art would have b reasonably expected success because Aggarwal discloses that symptoms of EIB include dyspnoea, wheezing and cough (page 1, second column, second paragraph). Aggarwal discloses treatment for including EIB in patients without asthma (page 5, second column, third paragraph), wherein treatment includes short-acting β2-agonists (SABAs) 15 min before exercise and leukotriene receptor antagonists (LTRAs) (page 5, second column, third paragraph). Aggarwal discloses that SABAs stimulate β2-receptors on the surface of the airway smooth muscle, causing relaxation and bronchodilation, as well as possibly preventing mast cell degranulation (page 6, second column, third paragraph). Aggarwal discloses dry powder inhalation of SABAs using including pressurized metered dose inhaler (e.g., through the mouths) (Figure 4; page 6, second column, third paragraph). Aggarwal discloses that LTRAs have also been shown to be efficacious for EIB in patients with and without asthma (page 6, second column, sixth paragraph). Aggarwal discloses that “during exercise-related hyperventilation, transient osmotic change at the airway surface occurs owing to reductions in epithelium liquid volume, which in turn triggers mast cell degranulation. Consequently, there is mast cell-mediated release of prostaglandins (prostaglandin D2), leukotrienes, histamine and tryptase. These signaling molecules are known to mediate airway smooth muscle contraction and increase mucus production and microvascular permeability and sensory nerve activation, and their release is thought to be the main stimulus for bronchoconstriction and airway oedema” (page 3, first column, first paragraph). Dunaway discloses effective dose of atomoxetine for treatment of including asthma for humans (paragraph [0009]). Dunaway discloses that the precise mechanism by which atomoxetine produces its therapeutic affects for including asthma is unknown (paragraph [0004]). Dunaway discloses that asthma is manifested physiologically by a widespread narrowing of the airways and clinically by including paroxysms of dyspnea, cough and wheezing (paragraph [0008]). Dunaway discloses effectiveness of atomoxetine in treating symptoms of asthma (paragraph [0011]). Dunaway discloses effective dose of atomoxetine ranging from about 5 mg/day to about 100 mg/day (e.g., lies inside the range of about0.5 mg to 100 mg per day disclosed in the instant specification (paragraph [0032])) (paragraph [0009]). Dunaway discloses that administration of atomoxetine allowed patients to wean treatments including bronchodilators and leukotriene modifiers (paragraphs [0013-0014] and [0017]). LeMahieu teaches methods of administering drugs to the respiratory system of a patient (paragraph [0018]). LeMahieu teaches drugs for including prevention of exercise-induced bronchospasm (e.g., exercise-induced bronchoconstriction) (paragraph [0057] and TABLE 1) and for drugs including atomoxetine (paragraph [0058] and TABLE 2). LeMahieu teaches that pulmonary delivery of drugs provides including avoiding complications with digestive tract chemistry, avoiding first pass metabolism, a non-invasive delivery and a fast and efficient means of getting medicine into the bloodstream (paragraph [0097]).
Regarding claims 6-7, although the combination of Aggarwal, Dunaway and LeMahieu do not specifically teach treating non-inflammatory symptoms of EIB, the claimed method of treating exercise-induced bronchoconstriction (EIB) in an individual without asthma comprising administering by inhalation a pharmaceutical composition to a person in need thereof, wherein the pharmaceutical composition comprises an effective amount of atomoxetine (Aggarwal: page 1, second column, second paragraph, page 5, second column, third paragraph, page 5, second column, third paragraph; Dunaway: paragraphs [0008-0009] and [0011]; LeMahieu: paragraphs [0018], [0057-0058] and [0097]) appears the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method of the prior art does not possess the same material, structural and steps-like characteristics of the claimed method. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Response to Arguments
Applicant’s arguments will be addressed as they pertain to the new grounds of rejection above.
Applicant argues on page 6 that EIB is distinct from asthma, with different pathophysiology and treatments. Applicant argues on page 6 that Dunaway is directed to treatment of asthma and allergic rhinitis, and not relevant to EIB in non-asthmatic individuals. Applicant argues on page 6 that Aggarwal does not suggest use of drugs with activity of atomoxetine for treatment of EIB without asthma. Applicant argues on page 6 that in the absence of the present disclosure, one would not have a reasonable expectation of success that atomoxetine would be useful for treatment of EIB in the absence of asthma. Applicant argues on page 11 that LeMahieu only mentions atomoxetine twice and that in both instances atomoxetine is included within a list of over 2,000 drugs. Applicant argues that LeMahieu mentions treatment of exercised induced bronchospasm using only drugs already known to treat bronchospasm. Applicant argues that LeMahieu does not suggest use of any of those bronchodilators for treatment of EIB in the absence of asthma. Applicant argues that atomoxetine acts locally on airway smooth muscle to relieve bronchoconstriction in EIB (citing instant paragraph [0018] and that this is not suggested in the cited art. Applicant argues that without guidance provided from the instant disclosure, a person skilled in the art would have no reason to select atomoxetine from the 2,000 listed drugs, nor the use of inhaled atomoxetine, other than to promote systemic effects, nor the use of inhaled atomoxetine for treatment of EIB without asthma.
Applicant's arguments filed on 22 October 2025 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413,208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413,208 USPQ 871 (CCPA 1981). In the instant case, the obviousness rejection described above is based on Aggarwal in view of Dunaway and LeMahieu. Aggarwal teaches both management of EIB in patients with and without asthma (page 4, second column, second to last paragraph and ) wherein patients without asthma EIB can be managed with the use of pre-exercise short acting Beta2-agonists (SABAs). Pre-exercise SABAs are widely used and recommended as first line therapy) along with leukotriene receptor antagonists (LTRAs) or chromones (abstract and page 5 column 2 paragraph 3). Short acting beta 2 agonist (SABAs) stimulate β2-receptors on the surface of the airway smooth muscle, causing relaxation and bronchodilation, as well as possibly preventing mast cell degranulation. Dry powder inhalation include DPI. Aggarwal discloses that “during exercise-related hyperventilation, transient osmotic change at the airway surface occurs owing to reductions in epithelium liquid volume, which in turn triggers mast cell degranulation. Consequently, there is mast cell-mediated release of prostaglandins (prostaglandin D2), leukotrienes, histamine and tryptase. These signaling molecules are known to mediate airway smooth muscle contraction and increase mucus production and microvascular permeability and sensory nerve activation, and their release is thought to be the main stimulus for bronchoconstriction and airway oedema.” (page 3, first column, first paragraph). Thus, Aggarwal is not limited to treating EIB in patients with asthma, but includes delivering DPI to manage EIB without asthma. It would be obvious to administer atomoxetine in order to prevent or mitigate smooth muscle, bronchoconstriction, and airway oedema; wherein said smooth muscle, bronchoconstriction, and airway oedema can be caused by EIB without asthma as disclosed by Aggarwal. Wherein the treatments using atomoxetine is known to reduce the symptoms of widespread narrowing of the airways and clinically by including paroxysms of dyspnea, cough, and wheezing (paragraph [0008]) for months as disclosed by Dunaway. LeMahieu teaches administering drugs by inhalation for including prevent exercise-induced bronchospasm (Table 1). LeMahieu teaches that drugs that can be administered by inhalation includes atomoxetine (Table 2). LeMahieu teaches that pulmonary delivery of drugs provides including avoiding complications with digestive tract chemistry, avoiding first pass metabolism, a non-invasive delivery and a fast and efficient means of getting medicine into the bloodstream (paragraph [0097]). Accordingly, the combination of Aggarwal, Dunaway and LeMahieu, renders prima facie obvious a method of treating EIB without asthma for individuals in need thereof comprising administering by inhalation an effective amount of atomoxetine.
Applicant argues on page 7 that Aggarwal discloses that “In patients with EIB and chronic asthma, the pathophysiological mechanisms described above simply represent a trier of underlying airway hyperactivity associated with poorly controlled asthma. On the other hand, in patients with EIB who do not have asthma, the mechanisms described by the osmotic theory are believed to be directly responsible for causing bronchoconstriction and associated symptoms.” (page 3, Precipitating factors for EIB), which reinforces the distinction that asthma is inflammatory while EIB is not. Applicant argues one pages 7-8 that distinguishes between EIB and asthma and points out that they are distinct entities requiring distinct treatment, stating, “A key consideration for physicians when a patient presents with symptoms of wheeze and shortness of breath triggered by exercise is whether a diagnosis of asthma with EIB or EIB alone is appropriate. The management of EIB in patients without asthma is very different from the management of patients who experience EIB in association with poorly controlled asthma", which Applicant argues further emphasizes that asthma and EIB are distinct entities requiring distinct treatments. Applicant argues that Aggarwal emphasizes how the mechanism of disease is distinct between EIB and asthma and that EIB should focus on bronchoconstriction and mitigation of bronchoconstriction, stating, "For patients without underlying asthma, management of EIB should focus on relief of bronchoconstriction and the reduction in risk (or prevention entirely) of the occurrence of bronchoconstriction, to allow the patient to continue to engage in physical exercise with minimal respiratory symptoms (Aggarwal p. 5 Treatment of EIB - Treatment of EIB in patients without asthma). Applicant argues that Gauvreau et al. conclude that "exercise-induced bronchoconstriction does not cause eosinophilic airway inflammation or airway hyperresponsiveness" in subjects with asthma, indicating that EIB lacks the inflammatory hallmarks of asthma (Gauvreau, G.M., et a1., Exercise-induced broncho constriction does not cause eosinophilic airway inflammation or airway hyperresponsiveness in subjects with asthma. Am J Respir Crit Care Med, 2000. 162(4 Pt 1): p. 1302-7.) Applicant argues that O'Byrne notes that EIB incidence is 5-20% in the general population (non- asthmatics) versus 90% in asthmatics. Further, O'Byrne notes that eosinophil increases, indicative of inflammation, do not necessarily correlate with EIB (Specification, para. [0020], citing O'Byrne, P.M., UpToDate, 2016). These references substantiate that EIB in patients without asthma is distinct from asthma and EIB in patients with asthma, and that the treatments are therefore different and unrelated. Applicant argues on page 8 that Dunaway makes no mention of EIB and is limited to the treatment of asthma and allergic rhinitis, (Dunaway [0004] "However, it has now been found that atomoxetine is useful in the treatment of allergic rhinitis and/or asthma."). Applicant argues that, as noted by Dunaway, asthma involves chronic inflammation, eosinophil infiltration, and mucus plugs (Dunaway, [0008]). In contrast, EIB in non-asthmatics is driven by smooth muscle constriction without inflammation (Aggarwal, p. 3, col. 1, 3). Applicant argues that Dunaway's description of Atomoxetine's efficacy in asthma does not suggest it would address EIB's non-inflammatory mechanism. Applicant argues that Dunaway's focus on allergens ([0004]) is inapplicable to EIB, which is not triggered by allergens. Applicant argues on page 9 that while Dunaway proposes atomoxetine for treatment of allergic rhinitis and asthma, there is nothing in Dunaway disclosing or suggesting the use of atomoxetine for treatment of EIB in the absence of asthma as the pathology of asthma and EIB in the absence of asthma are fundamentally different. Applicant argues that Aggarwal, lists treatments like β2-agonists and leukotriene antagonists but never mentions atomoxetine (p. 5, col. 1). Applicant argues that without their instant disclosure, even a skilled practitioner wouldn't have considered atomoxetine for EIB, thus demonstrating that their invention is non-obvious. Applicant points to Aggarwal disclosing “If EIB symptoms continue despite these non-pharmacological approaches, use of methods such short-acting β2-agonists ('SABAs) 15 min before exercise, leukotriene (LTRAs) or chromones should be considered as alternative pre-exercise treatments in accordance with guideline recommendations” (Aggarwal P5, TREATMENT OF EIB - Treatment of in patients without asthma). Applicant argues that based on the teachings of Aggarwal and Dunaway, when the teachings of Aggarwal and Dunaway are considered in combination, there is nothing that discloses, teaches or suggests the use of atomoxetine via inhalation for treatment of EIB in the absence of asthma with a reasonable expectation of success; the pathologies of asthma and EIB in the absence of asthma are fundamentally different. Applicant argues on page 11 that atomoxetine is not a known treatment for EIB. Aggarwal references leukotriene antagonists for EIB but does not reference atomoxetine. Dunaway references only asthma and allergic rhinitis. Applicant argues that it is not reasonable to expect that, simply because a drug improves FEV in an asthmatic subject, it can be used to treat any distinct and different disorder characterized by a decrease in FEV. A person of ordinary skill in the art would have no reasonable expectation of success in treating EIB in the absence of asthma, a disorder characterized by smooth muscle constriction without inflammation, with a drug used to treat a distinct inflammatory disorder such as asthma. Applicant argues that for this reason, the Office fails to present a prima facie case for obviousness and the rejection should be withdrawn.
Applicant's arguments filed on 22 October 2025 have been fully considered but they are not persuasive. In response, while Aggarwal discloses that asthma and EIB without asthma are distinct in the cause and possible treatment and other references including Gauvreau and O’Byrne discloses differences between asthma and EIB, Aggarwal discloses that some treatment for asthma can be used to treat EIB without asthma including short acting Beta2-agonists (SABAs) and leukotriene receptor antagonists (LTRAs) (page 6, second column, third and sixth paragraph). Aggarwal discloses that symptoms of EIB include dyspnoea, wheezing and cough (page 1, second column, second paragraph). Aggarwal discloses treatment for including EIB in patients without asthma (page 5, second column, third paragraph), wherein treatment includes short-acting β2-agonists (SABAs) 15 min before exercise and leukotriene receptor antagonists (LTRAs) (page 5, second column, third paragraph). Dunaway discloses that asthma is manifested physiologically by a widespread narrowing of the airways and clinically by including paroxysms of dyspnea, cough and wheezing (paragraph [0008]). Dunaway discloses effectiveness of atomoxetine in treating symptoms of asthma (paragraph [0011]). Dunaway discloses that administration of atomoxetine allowed patients to wean treatments including bronchodilators and leukotriene modifiers (paragraphs [0013-0014] and [0017]). LeMahieu teaches that pulmonary delivery of drugs provides including avoiding complications with digestive tract chemistry, avoiding first pass metabolism, a non-invasive delivery and a fast and efficient means of getting medicine into the bloodstream (paragraph [0097]). In light of the disclosure of Aggarwal and the teachings of Dunaway and LeMahieu, it would have been prima facie obvious to administer atomoxetine in order to prevent or mitigate dyspnoea, wheezing and cough caused by EIB without asthma as disclosed by Aggarwal, wherein the treatments using atomoxetine is known to treat asthma with symptoms of widespread narrowing of the airways, paroxysms of dyspnea, cough, and wheezing (paragraph [0008]), which can allow patients to wean treatments including bronchodilators and leukotriene modifiers as disclosed by Dunaway (paragraphs [0013-0014] and [0017]), and reasonably expected that administration by inhalation of atomoxetine would be able to treat EIB without asthma. The person of ordinary skill in the art would have been motivated to make those modifications because it would have been prima facie obvious to try atomoxetine, which is a known drug that can be used to treat asthma with symptoms including widespread narrowing of the airways, paroxysms of dyspnea, cough, and wheezing, and that allow patients to wean treatments including bronchodilators and leukotriene modifiers, as a drug to treat EIB without asthma that has symptoms including dyspnoea, wheezing and cough, especially without any evidence of unexpected results from using atomoxetine. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). The person of ordinary skill in the art would reasonably expected success because Aggarwal discloses that symptoms of EIB include dyspnoea, wheezing and cough (page 1, second column, second paragraph). Aggarwal discloses treatment for including EIB in patients without asthma (page 5, second column, third paragraph), wherein treatment includes short-acting β2-agonists (SABAs) 15 min before exercise and leukotriene receptor antagonists (LTRAs) (page 5, second column, third paragraph). Dunaway discloses that asthma is manifested physiologically by a widespread narrowing of the airways and clinically by including paroxysms of dyspnea, cough and wheezing (paragraph [0008]). Dunaway discloses effectiveness of atomoxetine in treating symptoms of asthma (paragraph [0011]). Dunaway discloses that administration of atomoxetine allowed patients to wean treatments including bronchodilators and leukotriene modifiers (paragraphs [0013-0014] and [0017]).
Applicant argues on page 9 that Dunaway posits a central nervous system mechanism that curbs allergen transport ([0004]). The central nervous system mechanism and the allergen transport have no relationship to EIB. The present specification discloses that atomoxetine acts locally on airway smooth muscle to relieve bronchoconstriction in EIB (Specification, [0018]). This mechanistic difference further distinguishes the presently claimed treatment of exercise-induced bronchoconstriction (EIB) in an individual without asthma by administering atomoxetine by inhalation from Dunaway's use of atomoxetine for the treatment of asthma.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., atomoxetine acts locally on airway smooth muscle to relieve bronchoconstriction in EIB) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, Aggarwal discloses administration of a composition in DPI (e.g., dry powder inhalation) from (Figure 4). Aggarwal discloses treatment for including EIB in patients without asthma (page 5, second column, third paragraph), wherein treatment includes short-acting β2-agonists (SABAs) 15 min before exercise and leukotriene receptor antagonists (LTRAs) (page 5, second column, third paragraph). Dunaway discloses that asthma is manifested physiologically by a widespread narrowing of the airways and clinically by including paroxysms of dyspnea, cough and wheezing (paragraph [0008]). Dunaway discloses effectiveness of atomoxetine in treating symptoms of asthma (paragraph [0011]). Dunaway discloses that administration of atomoxetine allowed patients to wean treatments including bronchodilators and leukotriene modifiers (paragraphs [0013-0014] and [0017]). LeMahieu teaches that pulmonary delivery of drugs provides including avoiding complications with digestive tract chemistry, avoiding first pass metabolism, a non-invasive delivery and a fast and efficient means of getting medicine into the bloodstream (paragraph [0097]). Thus, from the disclosure of Aggarwal and the teachings of Dunaway and LeMahieu, it would have been prima facie obvious for one of ordinary skill in the art to treat including EIB in patients without asthma by administering by inhalation a composition comprising atomoxetine to avoid complications of oral administration including complications with digestive tract chemistry and first pass metabolism, and which is fast and efficient for getting medicine in the bloodstream.
Additionally, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In the instant case, it is prima facie obvious to administer by inhalation an effective amount of atomoxetine to including EIB in patients without asthma, which is the same as the instantly claimed method, would necessarily provide the same characteristics, e.g., atomoxetine acts locally at the lung when administered by inhalation.
Thus, for the reasons of record and for the reasons presented above claims 1, 4-7, 10-11 and 21 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are found allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P NGUYEN whose telephone number is (571)270-5877. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/John P Nguyen/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600