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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/233,661 filed August 16, 2021.
Status of Claims
Claims 1-22, filed August 16, 2022, are presently pending in this application.
Information Disclosure Statement
The information disclosure statement filed December 15, 2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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 2 and 10-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “wherein nebulized particles including the drug agent are delivered in an approximately equivalent surface concentration between the patient's nasal passages and lungs.”, ln 1-3 The term “approximately” is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of this Office Action “approximately equivalent surface concentration of the particles containing the drug agent” has been interpreted as a surface concentration of between about 10:1 and 1:10 between the patient's nasal passages and lungs.
Similar rational has been applied to claims 10-22.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Longest et al. (U.S. Pub. No. 2018/0043585; hereinafter: “Longest”) in view of Ingenito (U.S. Pub. No. 2008/005787).
Regarding Claim 1, Longest discloses a method of delivering particles of delivering nebulized particles of a drug agent to a patient's nasal passages, the method comprising: operating a nebulizer (¶¶ 0014, 0015, 0044, 0045, 0068; Claim 15; Examiner notes: Longest discloses the aerosol generator as being a nebulizer.) containing the drug agent to continuously form particles containing the drug agent (¶¶ 0014, 0068); holding the nebulizer in the mouth (¶¶ 0045, 0070, 0073, 0076) and repeatedly inhaling for 4 seconds or longer from the nebulizer through the mouth (¶ 0045; Examiner notes: Longest discloses a slow inhalation may be up to 5 seconds through the mouth.) followed by exhaling only through the nose for 3 seconds or less (¶¶ 0045, 0070, 0073, 0076; Examiner notes: Longest discloses the exhalation may be 3 seconds through the nose).
Longest does specifically disclose the method comprising holding a mouthpiece of the nebulizer in the mouth with lips sealed over the mouthpiece.
Ingenito teaches a method comprising holding a mouthpiece (3; Fig. 1A) of a nebulizer (1; Fig. 1A) in the mouth with lips sealed over the mouthpiece (¶ 0057) for the purpose of providing a substantially leak tight connection (¶¶ 0057, 0078).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Longest to include holding the mouthpiece of the nebulizer in the mouth with lips sealed over the mouthpiece as taught by Ingenito for the purpose of providing a substantially leak tight connection (See Ingenito: ¶¶ 0057, 0078).
Regarding Claim 2, the modified method of Longest discloses the method wherein nebulized particles including the drug agent are delivered in an approximately equivalent surface concentration between the patient's nasal passages and lungs (See Longest: ¶¶ 0045, 0070-0076; Examiner notes: Longest discloses the method ensures the particles or droplets to grow and deposit in desired target regions of the nasal cavity or other regions of the respiratory tract.).
Regarding Claim 3, the modified method of Longest discloses the method wherein inhaling for 4 seconds or longer comprises inhaling for between 4-10 seconds (See Longest: ¶ 0045; Examiner notes: Longest discloses a slow inhalation may be up to 5 seconds through the mouth.).
Regarding Claim 4, the modified method of Longest discloses the method wherein exhaling only through the nose for 3 seconds or less comprises exhaling only through the nose for 3 seconds (See Longest: ¶¶ 0045, 0070, 0073, 0076).
The modified device of Longest discloses the method wherein exhaling only through the nose is for 2 seconds or less.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method of Longest wherein exhaling only through the nose is for 2 seconds or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified method of Longest would not operate differently with the claimed exhalation time and since the exhalation time is intended to be short the method would function appropriately having the claimed exhalation time of 2 or less.
Regarding Claim 6, the modified device of Longest discloses the method wherein operating the nebulizer to continuously form particles containing the agent comprises forming particles of average particle or droplet size in the range from about 0.1 to about 200 microns (See Longest: ¶¶ 0011, 0022, 0048, 0049, 0070-0076).
Regarding Claim 7, the modified device of Longest discloses the method wherein operating the nebulizer to continuously form particles containing the agent comprises forming particles of average particle or droplet size in the range from about 2 to 7 microns (See Longest: ¶¶ 0011, 0022, 0048, 0049, 0070-0076).
Regarding Claim 10, Longest discloses a method of delivering an approximately equivalent surface concentration of nebulized particles of a drug agent between a patient's nasal passages and lungs, the method comprising: operating a nebulizer (¶¶ 0014, 0015, 0044, 0045, 0068; Claim 15; Examiner notes: Longest discloses the aerosol generator as being a nebulizer.) containing the drug agent to continuously form particles containing the drug agent (¶¶ 0014, 0068); holding the nebulizer in the mouth (¶¶ 0045, 0070, 0073, 0076); and repeating one or more cycles of: inhaling, for an inhalation period of 4 second or longer, particles containing the drug agent through the mouth for the inhalation period (¶ 0045; Examiner notes: Longest discloses a slow inhalation may be up to 5 seconds through the mouth.), and exhaling, for an exhalation period of 3 seconds or shorter, through the nose but not the mouth for the exhalation period (¶¶ 0045, 0070, 0073, 0076; Examiner notes: Longest discloses the exhalation may be 3 seconds through the nose), wherein an approximately equivalent surface concentration of the particles containing the drug agent is deposited between the patient's nasal passages and lungs (See Longest: ¶¶ 0045, 0070-0076; Examiner notes: Longest discloses the method ensures the particles or droplets to grow and deposit in desired target regions of the nasal cavity or other regions of the respiratory tract.).
Longest does specifically disclose the method comprising holding a mouthpiece of the nebulizer in the mouth with lips sealed over the mouthpiece.
Ingenito teaches a method comprising holding a mouthpiece (3; Fig. 1A) of a nebulizer (1; Fig. 1A) in the mouth with lips sealed over the mouthpiece (¶ 0057) for the purpose of providing a substantially leak tight connection (¶¶ 0057, 0078).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Longest to include holding the mouthpiece of the nebulizer in the mouth with lips sealed over the mouthpiece as taught by Ingenito for the purpose of providing a substantially leak tight connection (See Ingenito: ¶¶ 0057, 0078).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Longest in view of Ingenito as applied to claim 1 above, and further in view of Hillsman (U.S. Pat. No. 4,984,158).
Regarding Claim 5, the modified method of Longest discloses the method, shown above.
The modified method of Longest does not specifically discloses the method further comprising triggering a first indicator for the period of inhalation, wherein the first indicator is triggered for 4 seconds or longer and triggering a second indicator for the period of exhalation wherein the second indicator is triggered for 3 seconds or less.
Hillmans teaches a method comprising triggering a first indicator (46, 56; Fig. 6-8C) for the period of inhalation (col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17) and triggering a second indicator (47, 56; Fig. 6-8C) for the period of exhalation (col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17) for the purpose of indicating when user’s performance is deficient (col 9, ln 9 to col 10, ln 17).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Longest to include the triggering the first indicator for the period of inhalation, wherein the first indicator is triggered for 4 seconds or longer and triggering the second indicator for the period of exhalation wherein the second indicator is triggered for 3 seconds or less as taught by Hillmans for the purpose of indicating when user’s performance is deficient (See Hillsman: col 9, ln 9 to col 10, ln 17).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Longest in view of Ingenito as applied to claim 1 above, and further in view of Regeneron Pharmaceuticals Inc. (hereinafter "Regeneron").
Regarding Claims 8-9, the modified method of Longest discloses the method, shown above.
The modified method of Longest does not specifically discloses the method wherein the drug agent comprises a recombinant antibody comprising a human or humanized Fc region, wherein the recombinant antibody comprises a population of antibodies in which at least 40% comprise an oligosaccharide having a GO glycosylation pattern comprising a biantennary core glycan structure of Manal-6(Manal-3)Man 1-4GlcNAc3I -4GlcNAc3I with terminal N-acetylglucosamine on each branch that enhances the trapping potency of the recombinant antibody in mucus.
Regeneron discloses a population of antibodies in which at least 40% are glycosylated with a G0 glycosylation pattern comprising a biantennary core glycan structure of Man 1-6(Man -1-3)Man 4GlcNAc -1-4GlcNAc -1 (protein administered to subject, which can be a monoclonal antibody, can be 60-79% galactosylated glycans, wherein the core of a galatocyslated glycan comprises a biantennary core glycan structure of Man 1-6(Man -1-3)Man -1- 4GlcNAc -1-4GlcNAc -1 (¶¶ 0024, 0249) because G0 glycosylation pattern on greater than 40% of antibody, the lifetime of proteins is extended in the body (¶ 0026; Table 6-4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Longest to include the drug agent comprises a recombinant antibody comprising a human or humanized Fc region, wherein the recombinant antibody comprises a population of antibodies in which at least 40% comprise an oligosaccharide having a GO glycosylation pattern comprising a biantennary core glycan structure of Manal-6(Manal-3)Man 1-4GlcNAc3I -4GlcNAc3I with terminal N-acetylglucosamine on each branch that enhances the trapping potency of the recombinant antibody in mucus as taught by Regeneron because G0 glycosylation pattern on greater than 40% of antibody, the lifetime of proteins is extended in the body (See Regeneron: ¶ 0026; Table 6-4).
Claim(s) 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Longest in view of Ingenito in view of Hillsman.
Regarding Claim 11, Longest discloses a method of delivering an approximately equivalent surface concentration of nebulized particles of a drug agent between a patient's nasal passages and lungs, the method comprising: operating a nebulizer (¶¶ 0014, 0015, 0044, 0045, 0068; Claim 15; Examiner notes: Longest discloses the aerosol generator as being a nebulizer.) containing the drug agent to continuously form particles containing the drug agent (¶¶ 0014, 0068); holding the nebulizer in the mouth (¶¶ 0045, 0070, 0073, 0076); and repeating one or more cycles of: inhaling, for an inhalation period of 4 second or longer, particles containing the drug agent through the mouth for the inhalation period (¶ 0045; Examiner notes: Longest discloses a slow inhalation may be up to 5 seconds through the mouth.), and exhaling, for an exhalation period of 3 seconds or shorter, through the nose but not the mouth for the exhalation period (¶¶ 0045, 0070, 0073, 0076; Examiner notes: Longest discloses the exhalation may be 3 seconds through the nose), wherein an approximately equivalent surface concentration of the particles containing the drug agent is deposited between the patient's nasal passages and lungs (See Longest: ¶¶ 0045, 0070-0076; Examiner notes: Longest discloses the method ensures the particles or droplets to grow and deposit in desired target regions of the nasal cavity or other regions of the respiratory tract.).
Longest does specifically disclose the method comprising holding a mouthpiece of the nebulizer in the mouth with lips sealed over the mouthpiece and indicating, with a first indicator, the inhalation period of 4 second or longer, to guide the patient in inhaling particles containing the drug agent through the mouth for the inhalation period, and indicating with a second indicator, the exhalation period of 3 seconds or shorter, to guide the patient in exhaling through the nose but not the mouth for the exhalation period.
Ingenito teaches a method comprising holding a mouthpiece (3; Fig. 1A) of a nebulizer (1; Fig. 1A) in the mouth with lips sealed over the mouthpiece (¶ 0057) for the purpose of providing a substantially leak tight connection (¶¶ 0057, 0078).
Hillmans teaches a method comprising indicating with a first indicator (46, 56; Fig. 6-8C) for the period of inhalation (col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17) and indicating with a second indicator (47, 56; Fig. 6-8C) for the period of exhalation (col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17) for the purpose of indicating when user’s performance is deficient (col 9, ln 9 to col 10, ln 17).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Longest to include holding the mouthpiece of the nebulizer in the mouth with lips sealed over the mouthpiece as taught by Ingenito and indicating, with the first indicator, the inhalation period of 4 second or longer, to guide the patient in inhaling particles containing the drug agent through the mouth for the inhalation period, and indicating with the second indicator, the exhalation period of 3 seconds or shorter, to guide the patient in exhaling through the nose but not the mouth for the exhalation period as taught by Hillsman for the purpose of providing a substantially leak tight connection (See Ingenito: ¶¶ 0057, 0078) and indicating when user’s performance is deficient (See Hillsman: col 9, ln 9 to col 10, ln 17), respectively.
Regarding Claim 12, the modified method of Longest discloses the method wherein the approximately equivalent surface concentration of the particles containing the drug agent comprises a surface concentration of between about 10:1 and 1:10 between the patient's nasal passages and lungs (See Longest: ¶¶ 0045, 0070-0077).
Regarding Claim 13, the modified method of Longest discloses the method further comprising triggering the first indicator at a start of inhalation by the patient (See Hillsman: col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17).
Regarding Claim 14, the modified method of Longest discloses the method , further comprising triggering the second indicator at a start of exhalation by the patient (See Hillsman: col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17).
Regarding Claim 15, the modified method of Longest discloses the method wherein the first indicator comprises illuminating a first LED (See Hillsman: col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17).
Regarding Claim 16, the modified method of Longest discloses the method wherein the second indicator comprises illuminating a second LED (See Hillsman: col 2, ln 58 to col 4, ln 23; col 9, ln 9 to col 10, ln 17).
Regarding Claim 17, the modified method of Longest discloses the method wherein inhaling for 4 seconds or longer comprises inhaling for between 4-10 seconds (See Longest: ¶ 0045; Examiner notes: Longest discloses a slow inhalation may be up to 5 seconds through the mouth.).
Regarding Claim 18, the modified method of Longest discloses the method wherein exhaling only through the nose for 3 seconds or less comprises exhaling only through the nose for 3 seconds (See Longest: ¶¶ 0045, 0070, 0073, 0076).
The modified device of Longest discloses the method wherein exhaling only through the nose is for 2 seconds or less.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method of Longest wherein exhaling only through the nose is for 2 seconds or less since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified method of Longest would not operate differently with the claimed exhalation time and since the exhalation time is intended to be short the method would function appropriately having the claimed exhalation time of 2 or less.
Regarding Claim 19, the modified device of Longest discloses the method wherein operating the nebulizer to continuously form particles containing the agent comprises forming particles of average particle or droplet size in the range from about 0.1 to about 200 microns (See Longest: ¶¶ 0011, 0022, 0048, 0049, 0070-0076).
Regarding Claim 20, the modified device of Longest discloses the method wherein operating the nebulizer to continuously form particles containing the agent comprises forming particles of average particle or droplet size in the range from about 2 to 7 microns (See Longest: ¶¶ 0011, 0022, 0048, 0049, 0070-0076).
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Longest in view of Ingenito in view of Hillsman as applied to claim 11 above, and further in view of Regeneron Pharmaceuticals Inc. (hereinafter "Regeneron").
Regarding Claims 21-22, the modified method of Longest discloses the method, shown above.
The modified method of Longest does not specifically discloses the method wherein the drug agent comprises a recombinant antibody comprising a human or humanized Fc region, wherein the recombinant antibody comprises a population of antibodies in which at least 40% comprise an oligosaccharide having a GO glycosylation pattern comprising a biantennary core glycan structure of Manal-6(Manal-3)Man 1-4GlcNAc3I -4GlcNAc3I with terminal N-acetylglucosamine on each branch that enhances the trapping potency of the recombinant antibody in mucus.
Regeneron discloses a population of antibodies in which at least 40% are glycosylated with a G0 glycosylation pattern comprising a biantennary core glycan structure of Man 1-6(Man -1-3)Man 4GlcNAc -1-4GlcNAc -1 (protein administered to subject, which can be a monoclonal antibody, can be 60-79% galactosylated glycans, wherein the core of a galatocyslated glycan comprises a biantennary core glycan structure of Man 1-6(Man -1-3)Man -1- 4GlcNAc -1-4GlcNAc -1 (¶¶ 0024, 0249) because G0 glycosylation pattern on greater than 40% of antibody, the lifetime of proteins is extended in the body (¶ 0026; Table 6-4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified method of Longest to include the drug agent comprises a recombinant antibody comprising a human or humanized Fc region, wherein the recombinant antibody comprises a population of antibodies in which at least 40% comprise an oligosaccharide having a GO glycosylation pattern comprising a biantennary core glycan structure of Manal-6(Manal-3)Man 1-4GlcNAc3I -4GlcNAc3I with terminal N-acetylglucosamine on each branch that enhances the trapping potency of the recombinant antibody in mucus as taught by Regeneron because G0 glycosylation pattern on greater than 40% of antibody, the lifetime of proteins is extended in the body (See Regeneron: ¶ 0026; Table 6-4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785