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 Application
Claims 1-20 are pending in this application.
No claim amendments have been submitted. All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on June 12, 2025 is acknowledged. A signed copy is attached to this office action.
Claim Objections
Claims 1-2, 11-13, 16. 18 and 20 are objected to because of the following informalities: the claims recite HFO-1234ze(E) for trans-1,3,3,3-tetrafluoropropane, when such an abbreviation is recited in the claims, it is appropriate to recite the full name, followed by the acronym in parenthesis, such as “trans-1,3,3,3-tetrafluoropropane (HFO-1234ze(E))” and then recite only the abbreviation in subsequent reiterations.
Appropriate correction is required.
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 11, 17, and 19-20 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.
Regarding claim 11, the claim recites “less than about 98% by weight” of HFO-1234ze(E) but also recites “greater than 2%” of ethanol. The recitation of “less than about” indicates an amount greater than 98% of HFO-1234ze(E). Since the minimum amount of ethanol is greater than 2%, this would result in an amount of greater than 100%, prior to any salbutamol being added.
Regarding claim 17, the claim depends from claim 15 which recites “further comprising from greater than 0.005% by weight to about 0.01% by weight oleic acid”, however claim 17 recites “further comprising oleic acid”. However, it is unclear if this is in addition to the amount recited in claim 15. Claims 19-20 are included in this rejection, as they do not remedy the indefinateness of claim 17.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim depends from claim 15, however, claim 15 already recites an amount of oleic acid. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-2 4-13, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Boldt et al. (Physical Stability of Salbutamol Sulfate Suspensions in HFA-134a and HFO-1234ze(E); Drug Deliver to the Lungs, Volume 34, 2023) in view of Mitchell et al. (Use of the Aerosizer Aerodynamic Particle Size Analyzer to Characterize Aerosols From Pressurized Metered-Dose Inhalers (pMDIs) for Medication Delivery, J. Aerosol Sci Vol 30, No 4, pp,467-477 (1999).
Boldt concludes Salbutamol sulfate suspensions in HFO-1234ze(E) are more physically stable than those in HFA-134a as measured by static multiple light scattering methods. The addition of ethanol to HFO-1234ze(E) increases suspension stability and reduces particle size variation (Key Message).
The composition comprises 0.16% w/w salbutamol sulfate and 5-10% ethanol, the remainder up to 10g is disclosed to be propellent (HFO-1234ze(E) ) (methods), which would be approximately 95%.
The addition of increasing amounts of ethanol reduces the particle size variation of salbutamol sulfate in HFO-1234ze(E), likely by weakening the hydrophilic intermolecular forces between salbutamol sulfate particles.
Regarding claims 2 and 13, the composition disclosed by Boldt does not disclose any additional components, therefore, it would “consist essentially of” the recited components.
Regarding claims 4-6, as noted above, the salbutamol is salbutamol sulfate.
Regarding claims 7-8, 10, 12, and 16, the claims recite amount of salbutamol contained in the delivery device and not dosages administered, therefore, the amount contained in the device would be dependent upon the size of the device used. Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
Regarding claim 9, the compostion is claimed to be a pMDI (Introduction).
Regarding claim 11, as noted above, the composition comprises 0.16% w/w salbutamol sulfate and 5-10% ethanol, the remainder up to 10g is disclosed to be propellent (HFO-1234ze(E) ) (methods), which would be approximately 95%, however, as discussed by Boldt the addition of ethanol reduced flocculation and sedimentation rate in HFO-1234ze(E), increasing the total stability over time. The addition of increasing amounts of ethanol reduces the particle size variation of salbutamol sulfate in HFO 1234ze(E), likely by weakening the hydrophilic intermolecular forces between salbutamol sulfate particles. Thereofre, the skilled artisan would be motivated to adjust the amount of ethanol in order to achieve the desired effects.
Regarding claim 18, as noted above, the composition comprises 0.16% w/w salbutamol sulfate and 5-10% ethanol, the remainder up to 10g is disclosed to be propellent (HFO-1234ze(E) ) (methods), which would be approximately 95%. Additionally, the composition is disclosed as being contained in a pMDI.
Boldt does not disclose the salbutamol sulfate is a fine particle.
Mitchell discloses aerosols from pMDIs typically comprise particles in the size range from about 0.3 to 10 m aerodynamic diameter to be efficacious at targeting lung delivery of medication. Particles in this size range are sampled and transported more efficiently than either finer or coarser particles (page 468).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have utilized particles in size in the range disclosed by Mitchell since it is disclosed to be efficacious at targeting lung delivery of the medication.
Claims 3, 14-15, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Boldt et al. (Physical Stability of Salbutamol Sulfate Suspensions in HFA-134a and HFO-1234ze(E); Drug Deliver to the Lungs, Volume 34, 2023) in view of Mitchell et al. (Use of the Aerosizer Aerodynamic Particle Size Analyzer to Characterize Aerosols From Pressurized Metered-Dose Inhalers (pMDIs) for Medication Delivery, J. Aerosol Sci Vol 30, No 4, pp,467-477 (1999) as applied to claims 1-2 4-13, 16, and 18 above, and further in view of Sawant et al. (US 2007/0286814).
The teachings of Boldt and Mitchell are discussed above.
The combination does not disclose the use of oleic acid.
Sawant discloses stable aerosol pharmaceutical composition. Active agnets include salbutamol.
Regarding claims 3, 14-15, 17, and 19-20, surfactants, including oleic acid is present in a finite group, in the pharmaceutical composition in the amount of 0.00001% to about 0.1% (paragraph 0017).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have selected to include a surfactant in the formulation of Boldt and Mitchell in order to maintain homogeneity of the suspension and also act as a lubricant for the smooth functioning of the valve in the pMDI.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Giffen et al. (The Nonclinical Assessment of Trans-1,3,3,3-tetrafluoroproene (HFO-1234ze(E), a Near Zero Global Warming Potential Propellent for Use in Metered Dose Inhalation Products, International Journal of Toxicology, 2024, Vol 43(1) 4-18).
Giffen dislcoes HFO-1234ze (E) is proposed as a near zero global warming propellant for use in metered dose inhaled (MDI) products (abstract).
In an effort to reduce its carbon footprint, create more sustainable MDIs, and comply with emerging environmental initiatives, the use of HFAs with HFO-1234ze(E), such a change will ensure that MDIs remain viable options to patients. HFO-1234ze (E) (also known as trans-1,3,3,3-tetrafluoropropene,R-1234ze(E), is a near zero GWP alternative with very similar physical properties toHFA-134a and has been shown to deliver comparable performance in MDI products (page 5, left column).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
Prosecution Insights