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 .
Claim Objections
Claims 19, 20, 22, 23, 27, 29, 30, 32, and 33 are objected to because of the following informalities:
Regarding claim 19, “an upper posterior region” should be “the upper posterior region”.
Regarding claim 20, “an upper posterior region” should be “the upper posterior region”.
Regarding claim 22, “about186 µg of fluticasone propionate BID” in lines 2-3 and 5. There is no space between “about” and “186”. Additionally, “an upper posterior region” should be “the upper posterior region”.
Regarding claim 23, “a subject” should be “the subject”.
Regarding claim 29, “an upper posterior region” should be “the upper posterior region”.
Regarding claim 30, “an upper posterior region” should be “the upper posterior region”.
Regarding claim 32, “of subjects with chronic rhinosinusitis” should be “of the subjects with chronic rhinosinusitis”.
Regarding claim 33, “an upper posterior region” should be “the upper posterior region”.
Appropriate correction is required.
Claim Rejection 35 U.S.C. § 112(b)
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.
Claims 17, 24-26, 27, and 34-36 are rejected under 35 U.S.C. 112(b), 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 claims 17 and 27, where it recites “causing the subject to exhale into the mouthpiece and produce the flow of exhalation breath, wherein exhalation by the subject causes the closure”. It is unclear whether the first “exhale” is the same breath as the “flow of exhalation breath”.
Regarding claims 24-26 and 34-36, where it recites “about 2.86%”, “about 7.26%”, and “about 10.53%”. It is unclear if “about” is to be considered as >/= value or +/- 10% of value in these recitations.
Additionally, without sufficient description of the values: 2.86%, 7.26%, and 10.53%, it is unclear whether these values are to be directed towards either 186 µg or 372 µg of fluticasone propionate.
Claim Rejection 35 U.S.C. § 102
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.
Claims 17-19, 21, 23, 27-29, 31, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JACI (1).
(https://www.jacionline.org/article/S0091-6749(18)30863-7/fulltext), hereinafter JACI.
Regarding claim 17, JACI discloses the method for treating chronic rhinosinusitis or sinusitis in a subject in need, (JACI Conclusion [04] lines 1-2; EDS-FLU (exhalation delivery system – fluticasone) delivers medication to targeted regions of chronic rhinosinusitis) comprising:
fitting a nosepiece of a delivery device to the nostril of a subject (Figure 1 below; nosepiece can be in the nostril of a subject);
fitting a mouthpiece of the delivery device to the mouth of a subject (Figure 1 below; mouthpiece can be in the mouth of a subject);
while the mouthpiece is fluidly connected to the nosepiece (Figure 1 below; mouthpiece and nose piece are connected);
and configured to direct the flow of exhalation breath from the subject to the nosepiece (Figure 1 below; flow of exhalation breath from mouthpiece goes through the channel to the nosepiece through a valve);
and the nosepiece is configured to direct the flow of the exhalation breath into a nasal airway of a subject (JACI Figure 1 Description; exhalation breath transfers pressure into the nose);
causing the subject to exhale into the mouthpiece and produce the flow of exhalation breath (JACI Figure 1 Description; flexible mouthpiece allowing the subject to exhale into the EDS (exhalation delivery device));
wherein exhalation by the subject causes closure of an oropharyngeal velum of the subject and permits a bi-directional flow of exhalation breath into one nostril of the subject and out of another nostril of the subject (JACI Figure 1 Description; pressure causes the soft palate (oropharyngeal velum) to close and air goes from one nostril and escapes out the other – creating bi-directional flow).
[AltContent: oval]manually actuating a delivery unit of the delivery device is to deliver a dose of about 186 µg of FP BID to an upper posterior region of the nasal airway of the subject to achieve a reduction in sinus opacification in the subject (JACI Methods line 1; 186 µg of FP BID, Objective; FP is capable of improving outcomes – an outcome could be sinus opacification improvement, Figure 1; dose delivery to an upper posterior region of the nasal airway).
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Figure 1: Annotated Figure 1 of JACI: delivery device.
Regarding claim 18, the method of JACI (paragraph 7 above), further discloses wherein delivering the dose of about 186 µg of FP BID includes manually actuating the delivery unit of the delivery device to deliver a first dose of about 93 µg of FP to the upper posterior region of the nasal airway of the subject via a first nostril and manually actuating the delivery unit of the delivery device to deliver a second dose of about 93 µg of FP to the upper posterior region of the nasal airway of the subject via a second nostril (JACI Methods lines 1-2; 93 µg FP BID from exhalation delivery system, Figure 1 above; where you can manually actuate the dose to different nostrils by taking it out and putting in the other and it is the upper posterior region).
Regarding claim 19, the method of JACI (paragraph 7 above), further discloses delivering a dose (JACI Objective; exhalation delivery system with fluticasone capable of drug deposition), comprising of:
of about 186 µg FP BID to an upper posterior region of the nasal airway of the subject (JACI Methods lines 1-2; 2x daily exhalation delivery system with fluticasone of 186 µg);
to achieve an improvement of one or more of facial pain, facial pressure, nasal congestion, nasal blockage, rhinorrhea, or loss of the sense of smell in a subject (JACI Figure 4; where facial pain, pressure, nasal congestion, rhinorrhea improved).
Regarding claim 21, the method of JACI (paragraph 7 above) further discloses, dose of about 186 µg FP BID that is administered for 24 weeks (JACI Methods lines 1-2; 186 µg FP BID for 24 weeks).
Regarding claim 27, the method of JACI, further discloses treating chronic rhinosinusitis or sinusitis in a subject in need, (JACI Conclusion [04] lines 1-2; EDS-FLU (exhalation delivery system – fluticasone) delivers medication to targeted regions of chronic rhinosinusitis) comprising:
fitting a nosepiece of a delivery device to the nostril of a subject (Figure 1 above; nosepiece can be in the nostril of a subject);
fitting a mouthpiece of the delivery device to the mouth of a subject (Figure 1 above; mouthpiece can be in the mouth of a subject);
while the mouthpiece is fluidly connected to the nosepiece (Figure 1 above; mouthpiece and nose piece are connected);
and configured to direct the flow of exhalation breath from the subject to the nosepiece (Figure 1 above; flow of exhalation breath from mouthpiece goes through the channel to the nosepiece through a valve);
and the nosepiece is configured to direct the flow of the exhalation breath into a nasal airway of a subject (JACI Figure 1 Description; exhalation breath transfers pressure into the nose);
causing the subject to exhale into the mouthpiece and produce the flow of exhalation breath (JACI Figure 1 Description; flexible mouthpiece allowing the subject to exhale into the EDS (exhalation delivery device));
wherein exhalation by the subject causes closure of an oropharyngeal velum of the subject and permits a bi-directional flow of exhalation breath into one nostril of the subject and out of another nostril of the subject (JACI Figure 1 Description; pressure causes the soft palate (oropharyngeal velum) to close and air goes from one nostril and escapes out the other – creating bi-directional flow).
manually actuating a delivery unit of the delivery device is to deliver a dose of about 372 µg of FP BID to an upper posterior region of the nasal airway of the subject to achieve a reduction in sinus opacification in the subject (JACI Methods lines 1-2; 372 µg of FP BID, Objective; see whether FP is capable of improving outcomes – an outcome could be sinus opacification improvement, Figure 1; delivery of dose to upper posterior region).
Regarding claim 28, the method of JACI (paragraph 7 above), further discloses wherein delivering the dose of about 372 µg of FP BID includes manually actuating the delivery unit of the delivery device to deliver a first dose of about 186 µg of FP to the upper posterior region of the nasal airway of the subject via a first nostril and manually actuating the delivery unit of the delivery device to deliver a second dose of about 186 µg of FP to the upper posterior region of the nasal airway of the subject via a second nostril (JACI Methods lines 1-2; 186 µg FP BID from exhalation delivery system, Figure 1 above; where you can manually actuate the dose to different nostrils by taking it out and putting in the other and it is the upper posterior region).
Regarding claim 29, the method of JACI (paragraph 7 above) further discloses delivering a dose of about 372 µg FP BID to an upper posterior region of the nasal airway of the subject to achieve an improvement of one or more of facial pain, pressure, nasal congestion, nasal blockage, rhinorrhea, or loss of sense of smell (JACI Figure 4; where facial pain, pressure, nasal congestion, rhinorrhea improved, and there is a dose of 372 µg FP BID, Figure 1; delivery of dose to upper posterior region).
Regarding claim 31, the method of JACI (paragraph 7 above) further discloses, wherein the dose of about 372 µg FP BID is administered for 24 weeks (JACI Methods lines 1-2; 372 µg FP BID for 24 weeks).
Claim Rejection 35 U.S.C. § 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.
Claims 20, 22, 24-26, 30, and 33-36 are rejected under 35 U.S.C. 103 as being obvious over JACI (1) in view of NHS.UK (2).
(https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/opn-flu-cs-3205/), hereinafter NHS.
Regarding claim 20, the method of JACI (paragraph 7 above) discloses the method of the delivery device (paragraph 7 above), but fails to disclose delivering a dose of about 186 µg FP BID to an upper posterior region to achieve a reduction of incidence of acute exacerbations of chronic rhinosinusitis, hereinafter AECRS.
The NHS discloses the method of JACI, (paragraph 7 above) discloses delivering a dose of about 186 µg FP BID to an upper posterior region of the nasal airway of the subject to achieve a reduction of incidence of AECRS (NHS Summary of Results [04] line 7; reduced incidents of acute disease exacerbations with an active treatment, where an active treatment can be 186 or 372 µg FP BID to an upper posterior region of nasal airway).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify JACI with a reduction of acute exacerbations analysis of NHS since the system is anticipated and has the same purpose to use FP for the of treatment of nasal inflammatory diseases (NHS Summary of research line 1; treatment of nasal inflammatory diseases intention to improve) and because the same technique is used (NHS Summary of Research line 1: “OptiNose has developed OPN-375” and JACI Figure 1; OPN-375 = EDS-FLU).
Regarding claim 22, the modified method of JACI (paragraph 17 above), further discloses the reduction of incidence of AECRS in patients with chronic rhinosinusitis or chronic sinusitis receiving a dose of about 186 µg FP BID in an upper posterior region of the nasal airway is approximately 56% relative to patients with chronic rhinosinusitis or chronic sinusitis not receiving about 186 µg FP BID in an upper posterior region of the nasal airway (NHS Summary of Results [04] line 7; reduced incidents of acute disease exacerbations with active treatment, where active treatment is 186 µg FP BID to an upper posterior region of nasal airway and JACI Table 1&2; where at 24 weeks a dose of 186 mg FP BID reduced the baseline incidence of chronic sinusitis (SNOT score) by 52% (48.1-22.89 = 25.21/48.1 = 52%).
Regarding claim 30, the method of JACI, (paragraph 7 above) further discloses delivering a dose of about 372 µg FP BID to an upper posterior region of the nasal airway of the subject to achieve a reduction of incidence of AECRS (NHS Summary of Results [04] line 7; reduced incidents of acute disease exacerbations with an active treatment, where an active treatment can be 186 or 372 µg FP BID to an upper posterior region of nasal airway).
Regarding claim 33, modified method of JACI (paragraph 17 above), further discloses the reduction of incidence of AECRS in patients with chronic rhinosinusitis or chronic sinusitis receiving a dose of about 372 µg FP BID in an upper posterior region of the nasal airway is approximately 66% relative to patients with chronic rhinosinusitis or chronic sinusitis not receiving about 372 µg FP BID in an upper posterior region of the nasal airway (NHS Summary of Results [04] line 7; reduced incidents of acute disease exacerbations with active treatment, where active treatment is 372 µg FP BID to an upper posterior region of nasal airway and JACI Table 2; at week 16, “much or very much improved” conditions, 68% and at 24 weeks, 68.1%).
Regarding claim 24, the modified method of JACI (paragraph 17 above), further discloses a reduction in sinus opacification is about 2.86% (NHS Summary of Results [03] line 4-5; treatment with OPN-375 = EDS-FLU resulted in greater improvements in APOV (sinus opacification analysis [02] line 3) at week 24 than placebo treatments, wherein 2.86%= minimally improved= an improvement).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify JACI with the reduction of sinus opacification analysis of NHS since the system is anticipated and has the same purpose to use FP for the of treatment of nasal inflammatory diseases (NHS Summary of research line 1; treatment of nasal inflammatory diseases intention to improve) and because the same technique is used to yield the same results (NHS Summary of Research line 1: “OptiNose has developed OPN-375” and JACI Figure 1; OPN-375 = EDS-FLU)
Regarding claim 25, the modified method of JACI (paragraph 17 above), further discloses a reduction in sinus opacification is about 7.26% (NHS Summary of Results [03] line 4-5; treatment with OPN-375 = EDS-FLU resulted in greater improvements in APOV (sinus opacification analysis [02] line 3) at week 24 than placebo treatments, wherein 7.26%= much improved= an improvement).
Regarding claim 26 the modified method of JACI (paragraph 17 above), further discloses a reduction in sinus opacification is about 10.53% (NHS Summary of Results [03] line 4-5; treatment with OPN-375 = EDS-FLU resulted in greater improvements in APOV (sinus opacification analysis [02] line 3) at week 24 than placebo treatments, wherein 10.53%= very much improved= an improvement).
Regarding claim 34, the modified method of JACI (paragraph 17 above), further discloses a reduction in sinus opacification is about 2.86% (NHS Summary of Results [03] line 4-5; treatment with OPN-375 = EDS-FLU resulted in greater improvements in APOV (sinus opacification analysis [02] line 3) at week 24 than placebo treatments, wherein 2.86%= minimally improved= an improvement).
Regarding claim 35 the modified method of JACI (paragraph 17 above), further discloses a reduction in sinus opacification is about 7.26% (NHS Summary of Results [03] line 4-5; treatment with OPN-375 = EDS-FLU resulted in greater improvements in APOV (sinus opacification analysis [02] line 3) at week 24 than placebo treatments, wherein 7.26%= much improved= an improvement).
Regarding claim 36, the modified method of JACI (paragraph 17 above), further discloses a reduction in sinus opacification is about 10.53% (NHS Summary of Results [03] line 4-5; treatment with OPN-375 = EDS-FLU resulted in greater improvements in APOV (sinus opacification analysis [02] line 3) at week 24 than placebo treatments, wherein 10.53%= very much improved= an improvement).
Claims 23 and 32 are rejected under 35 U.S.C. 103 as being obvious over JACI (1) in view of SEC.gov (3),
(https://www.sec.gov/Archives/edgar/data/1494650/000149465021000010/optn-20201231.htm), hereinafter SEC.
Regarding claim 23, the method of JACI (paragraph 17 above) discloses the method of receiving a dose of about 186 µg FP BID (paragraph 7 above), but fails to disclose the disease burden improving in approximately 44% of subjects with chronic rhinosinusitis or chronic sinusitis.
SEC discloses the disease burden of a subject configured to improve in 44% of subjects with chronic rhinosinusitis or chronic sinusitis (SEC Clinical Trials Highlights Bullet 3; complete response rates in at least 47.1-48% of patients; improvement of chronic rhinosinusitis with also nasal polyp elimination).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify JACI in view of SEC with the use of FP to treat rhinitis in SEC since the system is anticipated and has the same purpose to use FP for the treatment of nasal inflammatory diseases (SEC Note Regarding Forward-Looking Statements bullet 12; development for the treatment of chronic sinusitis) and because SEC performs the results of improving rhinitis with dosage changes of FP (SEC Clinical Trial Highlights bullet 6; 186 and 372 µg doses, Overview bullet 3; use of FP).
Regarding claim 32, the method of JACI (paragraph 11 above) in view of SEC (paragraph 26 above), further discloses wherein disease burden improves in approximately 54% of subjects with chronic rhinosinusitis or chronic sinusitis (SEC Clinical Trials Highlights Bullet 3; complete response rates in at least 47.1-48% of patients; improvement of chronic rhinosinusitis with also nasal polyp elimination).
References Cited
Leopold, D., et al., (2019, January). Navigate II: Randomized, double-blind trial of the exhalation delivery system with fluticasone for nasal polyposis - journal of allergy and clinical immunology. https://www.jacionline.org/article/S0091-6749(18)30863-7/fulltext
NHS. (2019, October 1). OPN-FLU-CS-3205. https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/opn-flu-cs-3205/
OPTN-20201231. (2020, December 31). https://www.sec.gov/Archives/edgar/data/1494650/000149465021000010/optn-20201231.htm
Conclusion
The following prior art were considered but not used on a 35 U.S.C. § 102 or 103 rejection: WO 9853869 A1, US 20160310683 A1, US 20150246194 A1, US 20150144129 A1, US 20150013677 A1, JP 2017164557 A, WO 2013124491 A1, (https://www.jacionline.org/article/S0091-6749(05)80069-7/pdf).
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785