DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 17, 19, 20, 22, 27, 29, 30, and 33 are currently amended, claims 18, 21, 24-26, 28, 31, and 34-36 are previously presented, claims 23 and 32 are cancelled. Therefore claims 17-22, 24-31 and 33-36 are pending in the instant application.
Per the amendments to the claims, the claim objections have been withdrawn.
Per the amendments to the claims, the 112(b) objections have been withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 17-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejection 35 U.S.C. § 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.
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 17-19, 21, 23, 27-29, 31, and 32 are rejected under 35 U.S.C. 102(a)(1) as anticipated by JACI (1) or, in the alternative, under 35 U.S.C. 103 as obvious over JACI (1) in view of Francois (WO 2012006599 A2), (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);
exhaling into the mouthpiece thereby producing 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 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 relative to sinus opacification in the subject before treating or in a subject treated with a placebo (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01]).
Per MPEP 2112.03 I., under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction in sinus opacification in the subject relative to sinus opacification in the subject before treating or in a subject treated with a placebo, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on. Logical reduction in opacification due to the treatment would result from the prior art device as claimed.
In the alternative:
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);
exhaling into the mouthpiece thereby producing 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 186 µg of FP BID to an upper posterior region of the nasal airway of the subject (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01]).
JACI doesn’t explicitly state achieving a reduction in sinus opacification in the subject relative to sinus opacification in the subject before treating or in a subject treated with a placebo.
Francois discloses a treatment of rhinosinusitis comprising:
actuating a dose of FP to achieve a reduction in sinus opacification in the subject relative to sinus opacification in the subject before treating or in a subject treated with a placebo (Francois [00165]; use of fluticasone propionate, [0042]; imaging studies such as computed tomography (CT), can be used for diagnosis, where the CT scan can reveal mucosal thickening, sinus opacification, and or air/ fluid level, [00158]; control subjects can receive a placebo, an improved outcome, e.g. a reduction in symptoms of CRS and/or nasal polyposis as determined by at least one clinical assessment is statistically significant – monitoring sinus opacity to determine how well a treatment works).
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 the method of JACI to include monitoring of sinus opacification through CT and determining how well a treatment works as taught by Francois, since, CT scanning can reveal mucosal thickening, sinus opacification, and or air/ fluid level, which can be used for diagnosis for a patient and to show how well the treatment is working (Francois [0042,00158]).
In addition, per MPEP 2145 II., and in re Wiseman, it is recognized that prior art teachings are not rebutted by recognizing advantages or latent properties of a device/ method that would be innately present in the prior art, even if the prior art itself does not expressly recognize the latent property.
In the present case, the latent property/ advantage of the drug is a reduction in sinus opacification. Just because the prior art does not explicitly say a reduction in sinus opacification, it would still be something that results/ stems from the applied references given that the device/ method language in the claims is present in the prior art disclosure. Merely claiming an advantage, while the prior art is silent does not in and of itself prove patentability of the device/ method per MPEP 2145 II.
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Figure 1: Annotated Figure 1 of JACI: delivery device.
Regarding claim 18, (under both the 102 and 103 rejection above) JACI further discloses the method of claim 17, 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, 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 19, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the method achieves 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, (under both the 102 and 103 rejection above) JACI further discloses, the method of claim 17, 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, 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);
exhaling into the mouthpiece thereby producing 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 relative to sinus opacification in the subject before treating or in a subject treated with a placebo (JACI Methods line 2; 372 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01]).
Per MPEP 2112.03 I., under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction in sinus opacification in the subject relative to sinus opacification in the subject before treating or in a subject treated with a placebo, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on. Logical reduction in opacification due to the treatment would result from the prior art device as claimed.
In the alternative:
Regarding claim 27, 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);
exhaling into the mouthpiece thereby producing 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 (JACI Methods line 2; 372 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01]).
JACI is silent to achieving a reduction in sinus opacification in the subject relative to sinus opacification in the subject before treating or in a subject treated with a placebo.
Francois discloses a treatment of rhinosinusitis comprising:
actuating a dose of FP to achieve a reduction in sinus opacification in the subject relative to sinus opacification in the subject before treating or in a subject treated with a placebo (Francois [00165]; use of fluticasone propionate, [0042]; imaging studies such as computed tomography (CT), can be used for diagnosis, where the CT scan can reveal mucosal thickening, sinus opacification, and or air/ fluid level, [00158]; control subjects can receive a placebo, an improved outcome, e.g. a reduction in symptoms of CRS and/or nasal polyposis as determined by at least one clinical assessment is statistically significant – monitoring sinus opacity to determine how well a treatment works).
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 the method of JACI to include monitoring of sinus opacification through CT and determining how well a treatment works as taught by Francois, since, CT scanning can reveal mucosal thickening, sinus opacification, and or air/ fluid level, which can be used for diagnosis for a patient and to show how well the treatment is working (Francois [0042,00158]).
In addition, per MPEP 2145 II., and in re Wiseman, it is recognized that prior art teachings are not rebutted by recognizing advantages or latent properties of a device/ method that would be innately present in the prior art, even if the prior art itself does not expressly recognize the latent property.
In the present case, the latent property/ advantage of the drug is a reduction in sinus opacification. Just because the prior art does not explicitly say a reduction in sinus opacification, it would still be something that results/ stems from the applied references given that the device/ method language in the claims is present in the prior art disclosure. Merely claiming an advantage, while the prior art is silent does not in and of itself prove patentability of the device/ method per MPEP 2145 II.
Regarding claim 28, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 27, 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, 372 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, (under both the 102 and 103 rejection above) JACI further discloses the method of claim 27, wherein the method achieves an improvement of one or more of facial pain, pressure, nasal congestion, nasal blockage, rhinorrhea, or loss of sense of smell in the subject (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, (under both the 102 and 103 rejection above) JACI further discloses, the method of claim 27, 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).
Claims 20, 22, 24-26, 30, and 33-36 are rejected under 35 U.S.C. 103 as being obvious over JACI (1) as evidenced by Wytske et al. (https://epos2020.com/Documents/supplement_29.pdf)(2), hereinafter Wytske, and EPOS2020 (https://epos2020.com/Documents/Hopkins-Burden-and-Prevention-of-ARS.pdf)(3), in the alternative obvious over JACI(1) in view of Francois, as evidenced by Wytske and EPOS2020.
Regarding claim 20, (under both the 102 and 103 rejection above) JACI further discloses the method of claim 17, wherein the method achieves a reduction of incidence of acute exacerbations of chronic rhinosinusitis (AECRS) in the subject (JACI Methods lines 1-2; 186 µg FP BID from exhalation delivery system, Figure 1 above; the upper posterior region where the dose is delivered).
Although JACI is silent to achieving a reduction of incidence of AECRS, as evidenced by Wytske, steroids are the main treatment of AECRS (Wytske pg.5, 1.2.6), where it would have been understood by one of ordinary skill in the art that fluticasone propionate is considered a steroid, specifically a corticosteroid, to help treat rhinitis, and another publication by the same journal EPOS2020 (slides 3-4), details that a reduction in the incidence of disease is done by reducing exposure to risk factors or triggers, early reduction of prevalence can help to prevent future exacerbations, where a logical conclusion of a reduction in AECRS if the symptoms are being controlled by the therapeutic treatment with the use of FP.
Further, as mentioned previously, per MPEP 2112.03 I., if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, where here the claimed process is to achieve a reduction of incidence of AECRS.
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction of incidence in AECRS, and other further recitations of a reduction of incidence, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on.
Regarding claim 22, (under both the 102 and 103 rejection above) JACI, and as evidenced by Wytske and EPOS2020, 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 the 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 the upper posterior region of the nasal airway (JACI Methods lines 1-2 where the patient receives a dose of 186 µg FP BID, Figure 1 above; where the dose is delivered to the upper posterior region of the nasal airway, JACI Figure 4 description; there is a population of the study that is the placebo, does not receive the 186 µg FP BID, explanation of reduction of incidence of AECRS as explained above previously, JACI conclusion; the device improves the quality of life in patients with chronic rhinosinusitis and the EDS-FLU system is clinically and statistically significant).
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction of incidence in AECRS, and other further recitations of a reduction of incidence, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on, where the claimed percentage of 66%, would necessarily be achieved due to the prior art structure being the same as claimed.
Regarding claim 30, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 27, wherein the method achieves a reduction of incidence of AECRS of acute exacerbations of chronic rhinosinusitis (AECRS) in the subject (JACI Methods lines 1-2; 186 µg FP BID from exhalation delivery system, Figure 1 above; the upper posterior region where the dose is delivered).
Although JACI is silent to achieving a reduction of incidence of AECRS, as evidenced by Wytske, steroids are the main treatment of AECRS (Wytske pg.5, 1.2.6), where it would have been understood by one of ordinary skill in the art that fluticasone propionate is considered a steroid, specifically a corticosteroid, to help treat rhinitis, and another publication by the same journal EPOS2020 (slides 3-4), details that a reduction in the incidence of disease is done by reducing exposure to risk factors or triggers, early reduction of prevalence can help to prevent future exacerbations, where a logical conclusion of a reduction in AECRS if the symptoms are being controlled by the therapeutic treatment with the use of FP.
Further, as mentioned previously, per MPEP 2112.03 I., if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, where here the claimed process is to achieve a reduction of incidence of AECRS.
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction of incidence in AECRS, and other further recitations of a reduction of incidence, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on.
Regarding claim 33, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 30, wherein the reduction of incidence of AECRS in patients with chronic rhinosinusitis or chronic sinusitis receiving a dose of about 372 µg FP BID in the 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 the upper posterior region of the nasal airway (JACI Methods lines 1-2 where the patient receives a dose of 372 µg FP BID, Figure 1 above; where the dose is delivered to the upper posterior region of the nasal airway, JACI Figure 4 description; there is a population of the study that is the placebo, does not receive the 372 µg FP BID, explanation of reduction of incidence of AECRS as explained above previously, JACI conclusion; the device improves the quality of life in patients with chronic rhinosinusitis and the EDS-FLU system is clinically and statistically significant).
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction of incidence in AECRS, and other further recitations of a reduction of incidence, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on, where the claimed percentage of 66%, would necessarily be achieved due to the prior art structure being the same as claimed.
Regarding claim 24, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the reduction in sinus opacification is about 2.86% (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01]).
Per MPEP 2112.03 I., if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, where the structure of the method of claim 17, would necessarily perform the treatment step of a reduction in sinus opacification at the claimed percentages of 2.86%, 7.26%, and 10.53%, because the structure is the same as claimed.
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction in sinus opacification percentage, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on. Logical reduction in opacification due to the treatment would result from the prior art device as claimed.
Regarding claim 25, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the reduction in sinus opacification is about 7.26% (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01], with the same logic as above for the sinus opacification reduction percentage).
Regarding claim 26 (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the reduction in sinus opacification is about 10.53% (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01], with the same logic as above for the sinus opacification reduction percentage).
Regarding claim 34, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the reduction in sinus opacification is about 2.86% (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01]).
Per MPEP 2112.03 I., if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process, where the structure of the method of claim 17, would necessarily perform the treatment step of a reduction in sinus opacification at the claimed percentages of 2.86%, 7.26%, and 10.53%, because the structure is the same as claimed.
In the present case, the prior art device, in its normal and usual operation, would necessarily perform the method claimed of achieving a reduction in sinus opacification percentage, because the device is the same as the device described in the Specification for carrying out the claimed method. Structurally, there is nothing in the method that differentiates method step-wise over the prior art relied on. Logical reduction in opacification due to the treatment would result from the prior art device as claimed.
Regarding claim 35 (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the reduction in sinus opacification is about 7.26% (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01], with the same logic as above for the sinus opacification reduction percentage).
Regarding claim 36, (under both the 102 and 103 rejection above) JACI, further discloses the method of claim 17, wherein the reduction in sinus opacification is about 10.53% (JACI Methods line 1; 186 µg of FP BID, Figure 1; manual actuation of a delivery unit of the delivery device to deliver a dose to an upper posterior region of the nasal airway, JACI conclusion; where the EDS-FLU device has clinically and statistically improved in all 4 diagnostically defining disease symptoms – under JACI abbreviations used [01], with the same logic as above for the sinus opacification reduction percentage).
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
Wytske. (2020, February). European Position Paper on Rhinosinusitis and Nasal Polyps 2020. https://epos2020.com/Documents/supplement_29.pdf
Hopkins Burden & Provention of Ars - EPOS 2020. (2020). https://epos2020.com/Documents/Hopkins-Burden-and-Prevention-of-ARS.pdf
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Djupesland (US 20160310683 A1): substantially the same delivery device.
Djupesland (20150246194 A1): substantially the same delivery device.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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