DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The submission filed on 02/14/2023 has been entered. Claims 1-44 are pending in this application. Claims 3, 4, 12-23, 25-34, 41, and 42 are withdrawn. Claims 1, 2, 5-11, 24, 35-40, 43, and 44 are currently under examination.
Priority
This application is a 371 of PCT/TR2021/050630 filed on 06/18/2021 and claims foreign priority of TÜRKİYE 2020/12816 filed on 08/14/2020 and TÜRKİYE 2021/00552 filed on 01/14/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Note: The statement “Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference… Failure to provide a certified translation may result in no benefit being accorded for the non-English application”, as set forth on page 2 of the Requirement for Restriction/Election mailed on 10/07/2025, is withdrawn in view of translation filed on 02/06/2026.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. TÜRKİYE 2020/12816 or TÜRKİYE 2021/00552, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1, 2, 5-11, 24, 35-40, 43, and 44 recite “acute lung diseases… chronic lung diseases… active vibrating mesh technology nebulizer, or passive vibrating mesh technology nebulizer”, which is not disclosed or supported by the prior-filed Application No. TÜRKİYE 2020/12816. Claims 1, 2, 5-11, 24, 35-40, 43, and 44 also recite “soft mist inhaler”, which is not disclosed or supported by the prior-filed Application No. TÜRKİYE 2021/00552. Claims 5-11, 24, 35-40, and 43 further recite “water for injection, water for inhalation, physiological saline (0.9% NaCl), half physiological saline (0.45% NaCl), or phosphate buffer (pH 4.5-7.4)”, “4000-25000 IU (or 4000 IU, 6000 IU, 8000 IU, or 10000 IU; or 4000 IU/ml, 6000 IU/ml, 8000 IU/ml, or 10000 IU/ml) of heparin”, “at least one different active substance (or mannitol, acetyl cysteine, or hypertonic (3-20% NaCl, w/v) physiological saline, an anti-inflammatory corticosteroid, ascorbic acid, and/or ascorbic acid derivatives) or at least one excipient”, “dexamethasone, budesonide, beclomethasone dipropionate, fluticasone, and/or mometasone”, “a sterile isotonic saline solution”, “influenza, tuberculosis, cystic fibrosis, chronic obstructive pulmonary disease (COPD), asthma, acute pulmonary infection, bronchitis, acute respiratory distress syndrome (ARDS), hypoxemia, pulmonary embolism, pulmonary hypertension, idiopathic pulmonary fibrosis”, “sarcoidosis, and/or chronic pulmonary embolism”, “single-use or multi-use dosage”, “mass median aerodynamic diameter (MMAD) value is between the range of 1-6 μm (or is 5.3 μm)”, “fine particle fraction (FPF) value is between the range of 10-60% (or is 44%)”, and/or “the form of emulsion or suspension”, which are not disclosed or supported by the prior-filed Application No. TÜRKİYE 2020/12816 and TÜRKİYE 2021/00552. Thus, the priority date of claims 1, 2, 5-11, 24, 35-40, 43, and 44 is 06/18/2021.
Election/Restrictions
Applicant's election without traverse of Group I invention (claims 1-40, 43, and 44) and species ( A. low molecular weight heparin (LMWH), recited in claim 2, as the single disclosed species of heparin or derivative thereof; B. budesonide, as the single disclosed species of further active substance or excipient; and C. COVID-19, a viral lung disease) in the reply filed on 02/06/2026 is acknowledged. 3, 4, 12-23, 25-34, 41, and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1, 2, 5-11, 24, 35-40, 43, and 44 are currently under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/01/2023 has been considered.
Claim Objections
Claim 1 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 44. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 35, 36, and 43 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim . See MPEP § 608.01(n). Accordingly, the claims 35, 36, and 43 have not been further treated on the merits.
Claims 1, 2, 5-11, 24, 37-40, and 44 are objected to because of the following informalities: In claims 1 and 44, change the incorrect recitation “locally administer it to” (line 3) to “locally being administered to”; and replace the incorrect conjunction “and/or” (line 5) with “or” because acute and chronic lung diseases are not always coexist. In claim 2, change the incorrect recitation “, characterized in that, heparin” (lines 1 to 2) to proper dependent claim recitation “, wherein the heparin”. In claim 5, change the incorrect recitation “, characterized in that, the” (lines 1 to 2) to proper dependent claim recitation “, wherein the”; and insert the missing phrase “concentration of” immediately after the recitation “half” (line 3). In claim 6, change the incorrect recitation “, characterized in that, it comprises” (lines 1 to 2) to proper dependent claim recitation “, wherein the composition comprises”; and delete the excessive recitation “that is dissolved in the carrier solution” (lines 2 to 3). In claim 7, change the incorrect recitation “, characterized in that, a” (lines 1 to 2) to proper dependent claim recitation “, wherein a”; and delete the excessive recitation “used in the treatment,” (line 2). In claim 8, change the incorrect recitation “, characterized in that, a dose” (lines 1 to 2) to proper dependent claim recitation “, wherein the dose”; and delete the excessive recitation “used in the treatment,” (line 2). In claim 9, change the incorrect recitation “, characterized in that, it further” (lines 1 to 2) to proper dependent claim recitation “, wherein the composition further”. In claim 10, change the incorrect recitation “, characterized in that, the active substance can be selected” (lines 1 to 2) to proper dependent claim recitation “, wherein the active substance is selected”; and delete the excessive conjunction “or” (line 2). In claim 11, change the incorrect recitation “, characterized in that, it is corticosteroid” (lines 1 to 2) to proper dependent claim recitation “, wherein the corticosteroid is selected from”. In claim 24, change the incorrect recitation “, characterized in that, it comprises” (lines 1 to 2) to proper dependent claim recitation “, wherein the carrier solution comprises”. In claims 37-39, change the incorrect recitation “, characterized in that,” (line 1) to proper dependent claim recitation “, wherein a particle with”; and insert the clause “by mean of the inhaler or nebulizer” at the end of the claim to indicate how a particle of the recited MMAD or FPF is obtained. In claim 40, change the incorrect recitation “Claim 38, mean” (line 1) to proper dependent claim recitation “Claim 39, wherein the mean”; and insert the clause “by mean of the inhaler or nebulizer” at the end of the claim to indicate how a particle of the recited FPF is obtained. Appropriate correction is required.
Note: The recitation “A pharmaceutical composition” in the beginning of dependent claims 2, 5-11, 24, and 37-40 is suggested to be changed to “The pharmaceutical composition” according to MPEP 608.01(n) [R- 01.2024][IV. CLAIM FORM AND ARRANGEMENT].
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 1, 2, 5-11, 24, 37-40, and 44 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. Claims 2, 5, 9, 11, and 37-40 depend from claim 1.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 44 recite the broad recitation “viral lung diseases” (line 3), and the claim also recites “including COVID-19 disease” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 1, 6-8, 10, and 44 recite “derivative” or “derivatives”, which is not defined and thus the scopes or metes and bounds of the claims are not clear.
Claim 24 recites the limitation "the dosage form" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Taken together, Applicant is advised to change the recitation “including COVID-19” (line 4 of claims 1 and 44) to “selected from COVID-19”; to insert the word “structural” immediately before the “derivative” or “derivatives” in claims 1, 6-8, 10, and 44; and to change the recitation “the dosage form" in claim 24 to “a dosage form”.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim interpretation: The recitation “soft mist inhaler or active vibrating mesh technology nebulizer, or passive vibrating mesh technology nebulizer” in claims 1 and 44 are directed to an apparatus. Since claims 1, 2, 5-9, 24, 37-40, and 44 are directed to a pharmaceutical composition, the claims are interpreted as any pharmaceutical composition suitable for administration by the recited apparatus.
(I) Claims 1, 2, 5-9, 24, 37-40, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmed et al. (AM J RESPIR CRIT CARE MED 1999;160:576–581, hereinafter referred to as Ahmed ‘1999) as evidenced by Busti (October 2015, hereinafter referred to as Busti ‘2015).
With regard to structural limitations “a pharmaceutical composition comprising heparin (or low molecular weight heparin, LMWH, elected, or 4000-25000 IU; or 4000 IU/ml, 6000 IU/ml, 8000 IU/ml, or 10000 IU/ml) that is dissolved in a carrier solution (or water for injection; or a sterile isotonic saline solution) in order to locally being administered to the lungs for use in the treatment of viral, acute, or chronic lung disease through inhalation route (or further comprises at least one different active substance; or a particle with MMAD value of 1-6 or 5.3 µm or with mean FPF value, defined as percentage of particles with aerodynamic particle size less than 5 μm, of 10-60% or 44%)” (claims 1, 2, 5-9, 24, 37-40, and 44):
Ahmed ‘1999 disclosed that thirteen asthmatic subjects (age range 16 to 42 yr, mean 27) performed a standardized exercise challenge on a treadmill to document the presence of exercise-induced bronchoconstriction (EIB). On five different experiment days the subjects were pretreated with 4 ml of aerosolized heparin (80,000 units = 7.5 mg/kg), placebo, or 3 different doses of low-molecular-weight heparin (LMWH), enoxaparin (0.5 mg/kg, 1 mg/kg, 2 mg/kg) in a double-blind, randomized, crossover design, and exercise challenge was performed 45 min later. Bronchial provocation with methacholine was also performed in five subjects on two additional days after pretreatment with either placebo or inhaled enoxaparin (2 mg/kg). Solutions (4 ml) of heparin, enoxaparin, and placebo were administered as a constant-flow aerosol during tidal breathing, generated with a disposable raindrop medication nebulizer during a 15- to 20-min period. The mass median aerodynamic diameter of droplets discharged from the nebulizer was estimated at 4.5 µm (geometric SD 2.1). Enoxaparin (Rhône-Poulenc Rorer Pharmaceuticals, Inc., Collegeville, PA) solution (0.5 mg/kg, 1 mg/kg, 2 mg/kg) was reconstituted in 4 ml of bacteriostatic injection water. Dilutions of methacholine were prepared fresh daily, and diluted in phosphate-buffered isotonic saline solution. Methacholine was delivered through a DeVilbiss No. 644 nebulizer (page 576, Abstract; right col., para. 2; page 577, left col., para. 5; right col., para. 3 and 4). Busti ‘2015 (cited here as evidence only) disclosed that enoxaparin is able to be dosed in mg or mg per kg because of its easy conversion (1 mg inhibits 100 anti-Xa units). So instead of the dose being 100 anti-Xa units per kg for treatment doses of enoxaparin, clinicians can use 1 mg per kg (page 1/5).
Thus, these, teachings of Ahmed ‘1999 evidenced by Busti ‘2015 anticipate Applicant’s claims 1, 2, 5-9, 24, 37-40, and 44 because (a) the MMAD value of 4.5 ± 2.1 µm and the low-molecular-weight heparin (LMWH) enoxaparin solution of Ahmed ‘1999 read on claims 1, 2, 5, 9, 24, 37-40, and 44 of this Application, and (b) the 2 mg/kg (= 200 IU/kg) of enoxaparin would be equivalent to 16000 IU (or 4000IU/ml) for a subject with a body weight of 80 kg and 8000 IU for a subject with a body weight of 40 kg, which read on claims 6-8 of this Application and would also carry the same effectiveness for treating COVID-19 disease caused by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2), acute lung diseases, or chronic lung diseases.
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.
(II) Claims 1, 2, 5-11, 24, 37-40, and 44 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Mousa (US 10,993,909, published on May 4, 2021, filed on June 19, 2020, and benefitted by US PRO 62/992867 filed on March 20, 2020, hereinafter referred to as Mousa ‘909).
With regard to structural limitations “a pharmaceutical composition comprising heparin (or low molecular weight heparin, LMWH, elected, or 4000-25000 IU; or 4000 IU/ml, 6000 IU/ml, 8000 IU/ml, or 10000 IU/ml) that is dissolved in a carrier solution (or water for inhalation or physiological saline; or a sterile isotonic saline solution) in order to locally being administered to the lungs for use in the treatment of COVID-19 viral (elected), acute, or chronic lung disease through inhalation route (or further comprises at least one different active substance, an anti-inflammatory corticosteroid or budesonide, elected)” (claims 1, 2, 5-11, 24, and 44):
Mousa ‘909 disclosed a composition, comprising heparin, low molecular weight heparin (LMWH) or sulfated Non-anticoagulant LMWH (S-NACH) in combination with low dose corticosteroid along with carrier based aerosolized inhaler in the treatment of respiratory diseases, such as asthma, chronic obstructive pulmonary diseases, and infectious diseases. The physicochemical properties of both drugs and carriers have important effects on the fluidization, dispersion, delivery, and deposition of the formulations in the airways. The final formulation contained 100-20,000 USP U Heparin or LMWH per 1-200 mg of powder. In one embodiment, the heparin daily dose may be in a range of 10-200 mg, the corticosteroid (e.g., dexamethasone or betamethasone) daily dose may be 0.1-0.5 mg, In one embodiment, the composition comprises 10,000-40,000 IU of the pharmaceutically active agent. In one embodiment, the composition comprises a liquid selected from a solution that includes a solvent in which the microparticles and/or nanoparticles are dissolved and a suspension in which the microparticles and/or nanoparticles are suspended. In one embodiment, the solvent is water or buffered saline. In one embodiment, the apparatus comprises a nebulizer employing nebulization by air-jet, using vibrating mesh technology producing aerosol droplets generated from liquids. In one embodiment, the apparatus comprises a mouth mist spray. Spray-drying of a combination of molecules, to enable delivery by inhalation to the lung for COVID-related indications, may be used to counter upper respiratory tract and systemic complications (page 10/12, col. 9, lines 31-45; col. 10, lines 4-8, 32, 33, and 51-55; page 11/12, col. 11, lines 5, 10, 11, and 57-60; col. 12, lines 1-8). The average size of the microparticles ranged from 0.5-5 μm for pulmonary delivery and from 10-50 μm for nasal delivery. The range of microparticles sizes (i.e., diameters) that can be delivered in support of the pulmonary distribution is 1 to 10 μm (page 8/12, col. 6, lines 36-43).
Thus, these, teachings of Mousa ‘909 anticipate Applicant’s claims 1, 2, 5-11, 24, 37-40, and 44 because (a) the 10,000 IU and 20,000 IU of LMWH are specifically taught by Mousa ‘909, and (b) the nebulizer employing nebulization by air-jet, using vibrating mesh technology producing aerosol droplets generated from liquids or the mouth mist spray of Mousa ‘909 reads on the recited “soft mist inhaler or active vibrating mesh technology nebulizer, or passive vibrating mesh technology nebulizer” in claims 1 and 44, and would obtain the MMAD and FPF values of claims 37-40. Or, in an alternative, the IU/ml of LMWH, MMAD value, and FPF value are readily optimized to achieve the pulmonary delivery or distribution, as taught by Mousa ‘909.
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691