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 .
Status of the Claims
Claims 1-20 are pending and under current examination.
Claim Objections
Claims 1, 6, 8, 11, 15, and 18 are objected to because of the following informalities:
Claim 1 recites the limitation “…by inhalation through a nostril or mouth to the lungs to a human subject in need thereof”. This is grammatically incorrect and should be amended to read “…by inhalation through a nostril or mouth to the lungs of a human subject in need thereof”.
Claim 6 recites the limitation “wherein nebulizer is a jet nebulizer…”. This is grammatically incorrect and should be amended to read “wherein the nebulizer is a jet nebulizer…”.
Claim 8 recites the limitation “wherein the nebulizer is vibrating mesh nebulizer….”. This grammatically incorrect and should be amended to read “wherein the nebulizer is a vibrating mesh nebulizer….”.
Claim 11 recites the limitation “…diagnosed with bacterial infection”. This is grammatically incorrect and should be amended to read “…diagnosed with a bacterial infection”.
Claim 15 recites the limitation “…in combination with anti-inflammatory agent”. This is grammatically incorrect and should be amended to read “…in combination with an anti-inflammatory agent”.
Claim 18 recites “the pharmaceutical container of claim 17 comprising an aerosolizing propellant”. An aerosolizing propellant is not required by the independent claim so it is suggested to amend claim 18 to read “the pharmaceutical container of claim 17 further comprising an aerosolizing propellant”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for the treatment of lung fibrosis, does not reasonably provide enablement for the prevention of lung fibrosis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
This rejection is based on the absence of an enabling disclosure for the method of preventing pulmonary fibrosis. In determining whether Applicant’s claims are enabled, it must be found that one of skill in the art at the time of invention by Applicant would not have had to perform “undue experimentation” to make and/or use the invention claimed. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112(a) have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404:
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
MPEP § 2164.04 states:
“[W]hile the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection.”
When given their broadest reasonable interpretation, in view of the as filed specification, the claims encompass methods of treating pulmonary fibrosis. However, the specification does not provide an enabling disclosure for the methods of preventing pulmonary fibrosis.
The instant specification teaches that pulmonary fibrosis refers to thickening or scarring of lung tissue and idiopathic pulmonary fibrosis refers to someone with pulmonary fibrosis for unknown reasons, e.g., a subject that has pulmonary fibrosis without a diagnosis of cystic fibrosis or caused by exposure to lung toxin, coal miner, or cigarette smoker (pg. 6 lines 18-21). Furthermore, it is noted that the instant specification states that “the terms ‘treat’ and ‘treating’ are not limited to the case where the subject is cured and the disease is eradicated. Rather, embodiments of the present disclosure also contemplate treatment that merely reduced symptoms, and/or delays disease progression” (pg. 6 line 10). There are no examples that are directed to the prevention of pulmonary fibrosis.
The guidance provided by the specification amounts to an invitation for the skilled Artisan to try and follow the disclosed instructions to make and use the claimed invention. The specification merely discloses methods for treating pulmonary fibrosis.
The detail of the disclosure provided by Applicant, in view of the prior art, must encompass a wide knowledge, so that the Artisan of skill would be able to practice the invention as claimed by Applicant, without undue burden being imposed on such Artisan. This burden has not been met because it would require undue experimentation to use the composition to prevent pulmonary fibrosis, as claimed in the instant application.
Therefore, in view of the art recognized high level of unpredictability of prevention of pulmonary fibrosis, and the large quantity of research required to define these unpredictable variables, and the lack of guidance provided in the specification regarding such prevention, it is the position of the examiner that it would require undue experimentation for one of skill in the art to practice the scope of the invention as broadly claimed. Hence, absent a strong showing by Applicant, in the way of specific guidance and direction, and/or working examples demonstrating the same, such invention as claimed by Applicant is not enabled.
Regarding claims 2-16, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the enablement concerns outlined above.
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.
Claims 17 and 18 are 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 17 recites the limitation “a pharmaceutical container comprising dimethyl fumarate”. This renders the claim indefinite because it is not clear if the pharmaceutical container itself comprises dimethyl fumarate or if the pharmaceutical container contains a composition that comprises dimethyl fumarate.
Claim 18 recites the limitation “the pharmaceutical container of claim 17 comprising an aerosolizing propellant”. This renders the claim indefinite because it is not clear if the pharmaceutical container itself comprises aerosolizing propellant or if the pharmaceutical container contains a composition that comprises an aerosolizing propellant.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Vliet (U.S. Patent No. 10, 143718, issue date: 12/4/2018, cited in the IDS filed 11/20/2024).
Regarding claim 17, van der Vliet discloses an inhaler comprising dimethyl fumarate (col. 2 line 12).
Claims 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kahrs (U.S. 2019/0381023, publication year: 2019, cited in the IDS filed 11/20/2024, as evidenced by Heliovaara (Journal of Endocrinological Investigation, pg. 292-287; publication year: 2007).
Regarding claims 19 and 20, Kahrs discloses tablets containing pioglitazone and dimethyl fumarate [0422]. Heliovaara teaches that pioglitazone treatment has an anti-inflammatory effect (pg. 292, Abstract).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1, 3, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kahrs (U.S. 2019/0381023, publication year: 2019, cited in the IDS filed 11/20/2024), as evidenced by Hashimoto et. al. (Journal of Allergy and Clinical Immunology, pg. S213, publication year: 2005).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Kahrs teaches a treatment or preventative measure to a patient having fibrosis such as lung fibrosis comprising a therapeutically effective amount of a combination of a PPAR gamma agonist and an Nrf2 activator [0161]. Dimethyl fumarate may be the Nrf2 activator [0110] and the PPAR gamma agonist may be non-steroidal anti-inflammatory drugs (NSAIDs) [0032]. The PPAR gamma agonist and Nrf2 activator may together be incorporated into pharmaceutical compositions to be administered by inhalation [0141]. Hashimoto teaches that inhalation occurs through the nose or the mouth (no. 849).
Regarding claim 3, Kahrs teaches a treatment or preventative measure to a patient having fibrosis such as lung fibrosis comprising a therapeutically effective amount of a combination of a PPAR gamma agonist and an Nrf2 activator [0161].
Regarding claim 15, Kahrs teaches a treatment or preventative measure to a patient having fibrosis such as lung fibrosis comprising a therapeutically effective amount of a combination of a PPAR gamma agonist and an Nrf2 activator [0161]. Dimethyl fumarate may be the Nrf2 activator [0110] and the PPAR gamma agonist may be non-steroidal anti-inflammatory drugs (NSAIDs) [0032].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 1, 3, and 15, Kahrs does not teach a single embodiment or example meeting all limitation of the invention of claims 1, 3, and 15.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 1, 3, and 15, within the broader scope of Kahrs all of the limitations of the invention of claims 1, 3, and 15 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Kahrs and arrive at this conclusion because such was contemplated by Kahrs.
Claims 2, 4, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kahrs (U.S. 2019/0381023, publication year: 2019, cited in the IDS filed 11/20/2024), as applied to claims 1, 3, and 15 above, and further in view of Glass et. al. (Clinical Respiratory Journal, pg. 84-89; publication date: 1/20/2022), as evidenced by Hashimoto et. al. (Journal of Allergy and Clinical Immunology, pg. S213, publication year: 2005).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 2, 4, 13, and 14, Kahrs teaches the relevant limitations of claim 1 as described in the obviousness rejection above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 2, Kahrs does not teach an age of a patient treated by the composition. However, this deficiency is cured by Glass.
Glass teaches that idiopathic pulmonary fibrosis has an average onset at about age 65 years (pg. 84, Introduction).
Regarding claim 4, Kahrs does not teach that the method may be used to treat a patient diagnosed with bronchiectasis. However, this deficiency is cured by Glass.
Glass teaches that high-resolution computer tomography (CT) in patients diagnosed with idiopathic pulmonary fibrosis often shows honeycomb changes, traction bronchiectasis, and a reticular pattern that is predominantly in the periphery of the lower lobes (pg. 86, Presentation and Diagnosis).
Regarding claims 13 and 14, Kahrs does not teach administration of dimethyl fumarate in combination with nintedanib or pirfenidone. However, this deficiency is cured by Glass.
Glass teaches that nintedanib and pirfenidone are antifibrotic and anti-inflammatory drugs used to treat idiopathic pulmonary fibrosis that slow the rate of decline in forced vital capacity associated with the disease (pg. 87, Table 1).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 2, it would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the method of treatment of Kahrs in a patient that is older than 55 years old. One would have understood in view of Kahrs that the composition is suitable to treat lung fibrosis and in view of Glass that idiopathic pulmonary fibrosis has an average onset at about age 65. It would have been obvious that a patient receiving treatment for pulmonary fibrosis is likely about 65 years old. One of ordinary skill in the art would have been motivated to utilize the treatment method of Kahrs in a patient older than 55 years old in order to treat a patient that is likely to have been diagnosed with pulmonary fibrosis. The artisan of ordinary skill in the art would have had reasonable expectation of success because Glass teaches that idiopathic pulmonary fibrosis has an average onset at about age 65.
Regarding claim 4, it would have been prima facie obvious to one of ordinary skill in the art of filing that the method of Kahrs may be used to treat a patient diagnosed with bronchiectasis. One would have understood in view of Glass that a patient diagnosed with idiopathic pulmonary fibrosis may also show traction bronchiectasis via CT imaging. It would have been obvious that a patient diagnosed with pulmonary fibrosis may also be diagnosed with traction bronchiectasis. One of ordinary skill in the art of filing would have been motivated to utilize the treatment method of Kahrs in a patient diagnosed with bronchiectasis in order to treat idiopathic pulmonary fibrosis that is diagnosed along with the bronchiectasis. The artisan of ordinary skill would have had reasonable expectation of success because Kahrs teaches that the method may be used to treat lung fibrosis and Glass teaches that a patient diagnosed with idiopathic pulmonary fibrosis may also show traction bronchiectasis.
Regarding claims 13 and 14, it would have been prima facie obvious to one of ordinary skill in the art of filing to administer the treatment method of Kahrs in combination with nintedanib or pirfenidone. One would have understood in view of Glass that that nintedanib and pirfenidone are antifibrotic and anti-inflammatory drugs used to treat idiopathic pulmonary fibrosis that slow the rate of decline in forced vital capacity associated with the disease (pg. 87, Table 1). It would have been obvious to utilize the treatment method of Kahrs in combination with nintedanib or pirfenidone. One of ordinary skill in the art would have been motived to utilize nintedanib or pirfenidone in combination with the treatment of Kahrs in order to slow the rate of decline in forced vital capacity associated with pulmonary fibrosis (pg. 87, Table 1). The artisan of ordinary skill would have had reasonable expectation of success Glass teaches that nintedanib and pirfenidone are antifibrotic and anti-inflammatory drugs used to treat idiopathic pulmonary fibrosis (pg. 87, Table 1). See MPEP 2144.06 (I).
Claims 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kahrs (U.S. 2019/0381023, publication year: 2019, cited in the IDS filed 11/20/2024), as applied to claims 1, 3, and 15 above, and further in view of McCarthy et. al. (Journal of Personalized Medicine, pg. 1-22, publication year: 2020), as evidenced by Hashimoto et. al. (Journal of Allergy and Clinical Immunology, pg. S213, publication year: 2005) and Cohen (U.S. Patent Application No. 2021/0260144, publication year: 2021, cited in the IDS filed 11/20/2024).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 5-10, Kahrs teaches that the composition may be administered by administered by inhalation [0141]. Kahrs also teaches that the composition may be used to treat chronic obstructive pulmonary disease (COPD). COPD encompasses chronic obstructive bronchiolitis with fibrosis and obstruction of small airways [0175].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 5-8, Kahrs does not teach the administration of the composition for inhalation via nebulizer. However, this deficiency is cured by McCarthy.
McCarthy teaches that aerosol therapy improves therapeutic effects by directly targeting diseased lung regions for rapid onset of action, requiring smaller doses than oral or intravenous delivery and minimizing systemic side effects (pg. 1 Abstract). Nebulized drugs may be used to tread COPD and cystic fibrosis (pg. 1-2, Introduction). Nebulizers are generally used to deliver inhalational therapy in patient populations that cannot effectively used pressurized metered dose inhalers or dry powder inhalers, such as pediatric, geriatric and critically ill patients where difficulties with synchronization of inhalation and device actuation are likely (issues relate to coordination, age, cognitive status, dexterity, and strength), leading to reduced lung delivery (pg. 2, Development of Nebulizers). Jet nebulizers are the standard and lowest cost device for inhaled medications while vibrating mesh nebulizers are quiet and portable which confers benefits in both home and ICU settings. Vibrating mesh nebulizers are associated with low residual drug volumes and greater inhaled mass. Ultrasonic nebulizers are also aerosol generating devices used to generate therapeutic nebulizers for ventilated patients (pg. 3, Vibrating Mesh Nebulizers). Cohen teaches that jet nebulizers work on the mechanism of utilizing the gas flow from a compressor [0061], that ultrasonic nebulizers generate vibration via a piezo-electric crystal to generate droplets from a liquid formulation [0063], and that vibrating mesh nebulizers utilize the vibration mechanism to deliver liquid drug via the mesh with an annular piezo-element [0065].
Regarding claims 9 and 10, Kahrs does not teach administration of the composition via an inhaler. However, this deficiency is cured by McCarthy.
McCarthy teaches that pressurized metered dose inhalers may deliver respiratory drug and are highly portable and do not require electrical power or compressed gas to drive nebulization (pg. 1, Introduction).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 5-10, it would have been prima facie obvious to one of ordinary skill in the art of filing to utilize aerosolized therapy such as a pressurized metered dose inhaler or nebulizer to deliver the inhaled therapy of Kahrs. One of ordinary skill in the art would have been capable of applying these known techniques (aerosolized therapy rendered by an inhaler or nebulizer) to a known method (the inhalation therapy of Kahrs to treat lung fibrosis rendered by conditions such as COPD) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art (improved therapeutic effects rendered by directly targeting diseased lung tissue). The artisan of ordinary skill in the art would have had reasonable expectation of success because McCarthy teaches that nebulizers and inhalers may be utilized to treat lung diseases such as COPD. See MPEP 2143 (I) (D).
Claims 11, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kahrs (U.S. 2019/0381023, publication year: 2019, cited in the IDS filed 11/20/2024), as applied to claims 1, 3, and 15 above, and further in view of Lander (U.S. Patent Application No. 2012/0263680, publication year: 2012), as evidenced by Hashimoto et. al. (Journal of Allergy and Clinical Immunology, pg. S213, publication year: 2005).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 11, Kahrs teaches the relevant limitations of claim 1 as described in the obviousness rejection above.
Regarding claim 12, Kahrs teaches the relevant limitations of claim 1 as described in the obviousness rejection above. Kahrs also teaches that the composition may be used to treat chronic obstructive pulmonary disease (COPD). COPD encompasses chronic obstructive bronchiolitis with fibrosis and obstruction of small airways [0175].
Regarding claim 16, Kahrs teaches the relevant limitations of claim 1 as described in the obviousness rejection above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 11, Kahrs does not teach utilization of the treatment method in a patient diagnosed with a bacterial infection. However, this deficiency is cured by Lander.
Lander teaches that pulmonary fibrosis can result from a bacterial infection [0149].
Regarding claim 12, Kahrs does not teach administration of the composition in combination with a bronchodilator. However, this deficiency is cured by Lander.
Lander teaches that therapeutic agents used to treat fibrotic diseases such as COPD include bronchodilators [0064 and 0095].
Regarding claim 16, Kahrs does not teach administration of the composition in combination with an antibiotic agent. However, this deficiency is cured by Lander.
Lander teaches that antibiotics may be administered in combination with therapeutic peptides to treat pulmonary fibrosis [0353].
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 11, it would have been prima facie obvious to one of ordinary skill in the art of filing that the method of Kahrs may be used to treat a patient diagnosed with a bacterial infection. One would have understood in view of Lander that pulmonary fibrosis can result from a bacterial infection. It would have been obvious that a patient diagnosed with pulmonary fibrosis may also be diagnosed with a bacterial infection. One of ordinary skill in the art of filing would have been motivated to utilize the treatment method of Kahrs in a patient diagnosed with a bacterial infection in order to treat the pulmonary fibrosis results from such an infection. The artisan of ordinary skill would have had reasonable expectation of success because Kahrs teaches that the method may be used to treat lung fibrosis and Landers teaches that pulmonary fibrosis can result from a bacterial infection.
Regarding claims 12 and 16, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the composition of Kahrs and a bronchodilator or antibiotic for the purpose of treating COPD or pulmonary fibrosis), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over van der Vliet (U.S. Patent No. 10, 143718, issue date: 12/4/2018, cited in the IDS filed 11/20/2024).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 17, van der Vilet teaches the limitations as described in the anticipation rejection above.
Regarding claim 18, van der Vliet teaches that for administration by inhalation, the compositions for use may be delivered in the form of an aerosol spray presentation from pressurized packs or a nebulizer with the use of a suitable propellant (col. 9 lines 17-20).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 17, van der Vilet teaches the limitations as described in the anticipation rejection above.
Regarding claim 18, van der Vliet does not teach a single embodiment or example meeting all limitation of the invention of claim 18.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 17, As noted in the anticipation in the rejection above van der Vliet anticipated claim 17; so in anticipating claim 17, said claim is also considered obvious under 35 U.S.C. 103 over van der Vliet for the reasons set forth below (“lack of novelty is the epitome of obviousness” May, 574 F.2d at 1089, 197 USPQ at 607 (citing in re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Regarding claim 18, within the broader scope of van der Vliet all of the limitations of the invention of claim 18 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by van der Vliet and arrive at this conclusion because such was contemplated by van der Vliet.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 13-14, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application no. 19/688,859.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘859 application embrace a method for treating pulmonary fibrosis comprising administering inhalable microparticles comprising pirfenidone, nintedanib, and dimethyl fumarate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application no. 19/688,859, as applied to claims 1, 3, 13-14, and 19 above, and further in view of Glass et. al. (Clinical Respiratory Journal, pg. 84-89; publication date: 1/20/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘859 application render obvious the relevant limitations above. The claims of the ‘859 application do not teach an average age for patients receiving treatment or that the subject is diagnosed with bronchiectasis. However, this deficiency is cured by Glass. Glass teaches that idiopathic pulmonary fibrosis has an average onset at about age 65 years (pg. 84, Introduction). High-resolution computer tomography (CT) in patients diagnosed with idiopathic pulmonary fibrosis often shows honeycomb changes, traction bronchiectasis, and a reticular pattern that is predominantly in the periphery of the lower lobes (pg. 86, Presentation and Diagnosis).
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the method of treatment of the claims of the ‘859 application in a patient that is older than 55 years old. One would have understood in view of the claims of the ‘859 application that the composition is suitable to treat pulmonary fibrosis and in view of Glass that idiopathic pulmonary fibrosis has an average onset at about age 65. It would have been obvious that a patient receiving treatment for pulmonary fibrosis is likely about 65 years old. One of ordinary skill in the art would have been motivated to utilize the treatment method of the claims of the ‘859 application in a patient older than 55 years old in order to treat a patient that is likely to have been diagnosed with pulmonary fibrosis. The artisan of ordinary skill in the art would have had reasonable expectation of success because Glass teaches that idiopathic pulmonary fibrosis has an average onset at about age 65.
It would have been prima facie obvious to one of ordinary skill in the art of filing that the method of the claims of the ‘859 application may be used to treat a patient diagnosed with bronchiectasis. One would have understood in view of Glass that a patient diagnosed with idiopathic pulmonary fibrosis may also show traction bronchiectasis via CT imaging. It would have been obvious that a patient diagnosed with pulmonary fibrosis may also be diagnosed with traction bronchiectasis. One of ordinary skill in the art of filing would have been motivated to utilize the treatment method of the claims of the ‘859 application in a patient diagnosed with bronchiectasis in order to treat idiopathic pulmonary fibrosis that is diagnosed along with the bronchiectasis. The artisan of ordinary skill would have had reasonable expectation of success because the claims of the ‘859 application teaches that the method may be used to treat pulmonary fibrosis and Glass teaches that a patient diagnosed with idiopathic pulmonary fibrosis may also show traction bronchiectasis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5-10 and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application no. 19/688,859, as applied to claims 1, 3, 13-14, and 19 above, and further in view of McCarthy et. al. (Journal of Personalized Medicine, pg. 1-22, publication year: 2020), as evidenced by Cohen (U.S. Patent Application No. 2021/0260144, publication year: 2021) and Smyth (Expert Opinion on Drug Delivery, pg. 53-74; publication year: 2005).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘859 application render obvious the relevant limitations above. The claims of the ‘859 application do not teach the administration of the composition for inhalation via nebulizer or inhaler. However, this deficiency is cured by McCarthy. McCarthy teaches that aerosol therapy improves therapeutic effects by directly targeting diseased lung regions for rapid onset of action, requiring smaller doses than oral or intravenous delivery and minimizing systemic side effects (pg. 1 Abstract). Nebulized drugs may be used to tread COPD and cystic fibrosis (pg. 1-2, Introduction). Nebulizers are generally used to deliver inhalational therapy in patient populations that cannot effectively used pressurized metered dose inhalers or dry powder inhalers, such as pediatric, geriatric and critically ill patients where difficulties with synchronization of inhalation and device actuation are likely (issues relate to coordination, age, cognitive status, dexterity, and strength), leading to reduced lung delivery (pg. 2, Development of Nebulizers). Jet nebulizers are the standard and lowest cost device for inhaled medications while vibrating mesh nebulizers are quiet and portable which confers benefits in both home and ICU settings. Vibrating mesh nebulizers are associated with low residual drug volumes and greater inhaled mass. Ultrasonic nebulizers are also aerosol generating devices used to generate therapeutic nebulizers for ventilated patients (pg. 3, Vibrating Mesh Nebulizers). Cohen teaches that jet nebulizers work on the mechanism of utilizing the gas flow from a compressor [0061], that ultrasonic nebulizers generate vibration via a piezo-electric crystal to generate droplets from a liquid formulation [0063], and that vibrating mesh nebulizers utilize the vibration mechanism to deliver liquid drug via the mesh with an annular piezo-element [0065]. McCarthy also teaches that pressurized metered dose inhalers (pMDI) may deliver respiratory drug and are highly portable and do not require electrical power or compressed gas to drive nebulization (pg. 1, Introduction). Smyth teaches that pMDI are propellant driven (pg. 53 Introduction).
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize aerosolized therapy such as a pressurized metered dose inhaler or nebulizer to deliver the inhaled therapy of the claims of the ‘859 application. One of ordinary skill in the art would have been capable of applying these known techniques (aerosolized therapy rendered by an inhaler or nebulizer) to a known method (the inhalation therapy of the claims of the ‘859 application to treat lung fibrosis) that was ready for improvement and the results would have been predictable to one of ordinary skill in the art (improved therapeutic effects rendered by directly targeting diseased lung tissue). The artisan of ordinary skill in the art would have had reasonable expectation of success because McCarthy teaches that nebulizers and inhalers may be utilized to treat lung diseases such as COPD. See MPEP 2143 (I)(D).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11, 12, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application no. 19/688,859, as applied to claims 1, 3, 13-14, and 19 above, and further in view of Lander (U.S. Patent Application No. 2012/0263680, publication year: 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘859 application render obvious the relevant limitations above. The claims of the ‘859 application do not embrace utilization of the treatment method in a patient diagnosed with a bacterial infection or administration of the composition in combination with a bronchodilator or antibiotic agent. However, this deficiency is cured by Lander. Lander teaches that pulmonary fibrosis can result from a bacterial infection [0149]. Lander also teaches that therapeutic agents used to treat fibrotic diseases such as COPD include bronchodilators [0064 and 0095]. Antibiotics may be administered in combination with therapeutic peptides to treat pulmonary fibrosis [0353].
It would have been prima facie obvious to one of ordinary skill in the art of filing that the method of the claims of the ‘859 application may be used to treat a patient diagnosed with a bacterial infection. One would have understood in view of Lander that pulmonary fibrosis can result from a bacterial infection. It would have been obvious that a patient diagnosed with pulmonary fibrosis may also be diagnosed with a bacterial infection. One of ordinary skill in the art of filing would have been motivated to utilize the treatment method of the claims of the ‘859 application in a patient diagnosed with a bacterial infection in order to treat the pulmonary fibrosis results from such an infection. The artisan of ordinary skill would have had reasonable expectation of success because the claims of the ‘859 application teaches that the method may be used to treat pulmonary fibrosis and Landers teaches that pulmonary fibrosis can result from a bacterial infection.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the composition of the claims of the ‘859 application and a bronchodilator or antibiotic for the purpose of treating COPD or pulmonary fibrosis), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application no. 19/688,859, as applied to claims 1, 3, 13-14, and 19 above, and further in view of Kahrs (U.S. 2019/0381023, publication year: 2019, cited in the IDS filed 11/20/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘859 application render obvious the relevant limitations above. The claims of the ‘859 application do not embrace administration with an anti-inflammatory agent. However, this deficiency is cured by Kahrs. Kahrs teaches a treatment or preventative measure to a patient having fibrosis such as lung fibrosis comprising a therapeutically effective amount of a combination of a PPAR gamma agonist and an Nrf2 activator [0161]. Dimethyl fumarate may be the Nrf2 activator [0110] and the PPAR gamma agonist may be non-steroidal anti-inflammatory drugs (NSAIDs) [0032]. The PPAR gamma agonist and Nrf2 activator may together be incorporated into pharmaceutical compositions to be administered by inhalation [0141].
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the composition of the claims of the ‘859 application and an anti-inflammatory drug for the purpose of treating pulmonary fibrosis), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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