DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I and the species of congestion for the condition, nasal cavity for the body location, and the mode of administration to be a liquid dropper in the reply filed on 05/13/2026 is acknowledged. The traversal is on the ground(s) that there is no serious burden. This is not found persuasive because as addressed in the prior action, the groups are directed to different composition forms (aqueous liquid, lozenge, syrup) which are to different classifications A61K 9/08 (solution), A61K 9/0056 (lozenge), A61K 9/0095 (syrup) establishing that the inventions have a separate status in the art and would be a serious search and/examination burden. As for the traversal for the election of species with the assertion that the Examiner did not establish serious burden would be involved in the different species, this is not persuasive as addressed in the prior action, the species have distinctly different etiologies/presentations including distinctly different areas as written the irritation is to any body area and congestion is to the nasal sinuses, and the means of administration require different components/equipment (i.e. a nebulizer requires machinery to create the mist, the liquid requires a dropper, the spray requires a pressure container with a nasal dispenser); wherein these species are not obvious variants of each other based on the current record.
The requirement is still deemed proper and is therefore made FINAL.
Upon review, the condition is expanded to include irritation of the nasal cavity, and the means of administration is expanded to include a nasal spray.
It is noted that the nonelected groups have been cancelled by Applicant.
Status of Application
Applicant has elected Group I in response to restriction requirement and elected the species of congestion for the condition, nasal cavity for the body location, and the mode of administration to be a liquid dropper for the examination. Upon review the condition is expanded to include irritation of the nasal cavity, and the means of administration is expanded to include a nasal spray.
Due to restriction, based on election of Group I, claims 10, 14, 16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-16, 21-23 are pending.
Claims 1-9, 11-13, 15, 21-23 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 02/07/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3, 11, 15, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims as written are to directing a dose (first/second/third, about 0.25ml-about 1ml) to a body location (i.e. nasal cavity) or through a nostril to the nasal cavity and retaining the dose in the nasal cavity for a period of time (i.e. at least 2 minutes); however the specification does not provide a written description on what steps must be done to be able to direct the doses to the desired body location such as the nasal cavity and to reside for a specified period of time that is different from general nasal administration of the composition by the specified modes of administration such as nasal sprays or nasal drops. The only description for a particular step for directing the composition to a throat, nasal passage, or pharynx is for passage through an irrigation tube which is not to the nasal cavity but to a nasal passage (through it), the pharynx and throat. Wherein there is inadequate written description to for steps to perform the recited means that is different from general nasal administration of the composition by the specified modes of administration such as nasal sprays or nasal drops. The issue of indefiniteness is addressed below.
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 3, 11, 15 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.
The claims as written are to directing a dose (first/second/third, about 0.25ml-about 1ml) to a body location (i.e. nasal cavity) or through a nostril to the nasal cavity and retaining the dose in the nasal cavity for a period of time (i.e. at least 2 minutes); which is unclear as to how this is accomplished or what steps must be done to be able to direct the doses to the desired body location such as the nasal cavity and to reside for a specified period of time that is different from general nasal administration of the composition by the specified modes of administration such as nasal sprays or nasal drops. The claim as written does not allow one to ascertain the metes or bounds of the claims. For purposes of examination, the claims are treated to where the composition flows through the nasal cavity as directed (i.e. through the nostril into the nasal cavity) upon nasal administration of the composition by the specified modes of administration such as nasal sprays or nasal drops
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.
Claims 1-9, 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lan (CN 108066401) in view of Belardinelli et al. (U.S. Pat. Pub. 2022/0226301).
Rejection:
Lan teaches treating nasal conditions like rhinitis and sinusitis, which presents with nasal congestion, with the administration of an aqueous composition comprising hyaluronic acid, panthenol, lavender essential oil, sea salt, sodium bicarbonate (0.1-10%=about 0.012mEq/ml-about 1.19mEq/ml, 84mg sodium bicarbonate=1mEq; abstract, [2, 4-5, 9, 12-13, 22]). Examples include the sodium bicarbonate at 10% (10%=about 1.19mEq/ml, Example 2 [31-33]), 1% (1%=about 0.119mEq/ml, Example 4 [41-43]), 6% (6%=about 0.714mEq/ml, example 5 [46-48]), and 4% (4%=about 0.48mEq/ml, Example 3 [36-38]; all falling within the instant independent claimed range). The composition can be administered as a nasal spray that can be sprayed directed into the nasal cavity 2-3 times/day with 2-4 sprays each time (each time a dose (each dose 2-4 sprays), 2-3 doses/day), or as nasal drops applied directed into the nasal cavity 1-3 times/day with 2-3 drops each time ((each time a dose (each dose 2-3 drops, 1-3 doses/day; abstract, [2, 4-5, 9, 12-13, 22], see full document specifically areas cited).
While Lan does not recite the exact claimed values of about 0.25mEq/ml of sodium bicarbonate, but it is embraced within the taught range and within the values of the exemplified examples (i.e. Example 4 =about 1.19mEq/ml and Example 3=about 0.48mEq/ml) wherein it would be prima facie obvious to one of ordinary skill in the art to optimize within the taught range and within the taught exemplified values to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value. While Lan does not recite the exact time frame between doses, it does overlap as Lan does recite the doses to be about 2-3 times a day and one does not generally administer the nasal composition during sleep (about 8 hours/day) wherein within a 16 hour day to administer 1-3x/day is about 5-8 hours, wherein it would be prima facie obvious to one of ordinary skill in the art to optimize the frequency between doses within the day (i.e. about 5-8 hours) depending on the severity of symptoms and convenience of the patient during the day to arrive at the desired therapeutic relief with a reasonable expectation of success.
Lan does not expressly teach the exact volume of the spray/drop dose administered, but does teach administration of a nasal spray or drops into the nasal cavity (spray is 2-3 times/day (each dose 2-4 sprays), 2-3 doses/day), nasal drops is 1-3 times/day ((each dose 2-3 drops).
Belardinelli et al. teaches that nasal spray devices for intranasal administration are known and are known to deliver volumes of about 50µl to about 800µl (about 0.05-0.8ml) per spray [158-159].
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to deliver the nasal dose in the claimed values as suggested by Belardinelli et al. and produce the claimed invention, as it is prima facie obvious to deliver the nasal spray in known nasal devices and volumes and to optimize the dose volume of composition delivered for each dose (first, second, third) within the taught range to attain the desired therapeutic profile with a reasonable expectation of success. As the structural components of the composition are met and administered for the treatment for the condition as claimed, the properties and therapeutic profile would be the same such as the lack of systemic effects on blood pH levels as any structural components or steps must be present in the claims to be commensurate in scope as written.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lan (CN 108066401) in view of Belardinelli et al. (U.S. Pat. Pub. 2022/0226301) as applied to claims 1-9, 11-12 above, further in view of Alliger (U.S. Pat. Pub. 2013/0108714) and Ray (U.S. Pat. Pub. 2020/0121795).
Rejection:
The teachings of Lan in view of Belardinelli et al. are addressed above.
Lan in view of Belardinelli et al. does not expressly teach the inclusion of guaifenesin, but teach treating rhinitis and sinusitis and nasal congestion with the composition comprising sodium bicarbonate.
Alliger teaches that mucus looseners (mucolytics) useful for the treatment of sinusitis like sodium bicarbonate and guaifenesin to loosen the mucus of exposed membranes [106].
Ray teaches that mucolytics like guaifenesin are known to be in intranasal formulations from about 15-about 400 mg (abstract, [31-32].
Wherein it is obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate guaifenesin in the composition as suggested by Alliger and Ray and produce the claimed invention; as the inclusion of an additional mucolytic for its additive effect for treating the condition and optimizing the guaifenesin within the known range to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lan (CN 108066401) in view of Belardinelli et al. (U.S. Pat. Pub. 2022/0226301) et al. and Alliger (U.S. Pat. Pub. 2013/0108714) and Ray (U.S. Pat. Pub. 2020/0121795) as applied to claim 21 above, further in view Park et al. (U.S. Pat. 2014/0199266)
Rejection:
The teachings of Lan in view of Belardinelli et al. and Alliger and Ray are addressed above.
Lan in view of Belardinelli et al. and Alliger and Ray does not expressly teach the inclusion of honey but does teach treatment of nasal conditions like sinusitis and rhinitis.
Park et al. teaches that honey is a useful component in the nasal treatment of nasal conditions like sinusitis and rhinitis (abstract) and compatible with sodium bicarbonate [52, 60].
Wherein it would be obvious to one of ordinary skill in the art to incorporate honey in the composition administered as suggested by Park et al. and produce the claimed invention; as the inclusion of an additional active for its additive effect for treating the condition is prima facie obvious with a reasonable expectation of success.
Claims 1-9, 11-13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lan (CN 108066401) in view of Frey, II et al. (U.S. Pat. Pub. 2019/0060414).
Rejection:
Lan teaches treating nasal conditions like rhinitis and sinusitis, which presents with nasal congestion, with the administration of an aqueous composition comprising hyaluronic acid, panthenol, lavender essential oil, sea salt, sodium bicarbonate (0.1-10%=about 0.012/ml-about 1.19mEq/ml, 84mg sodium bicarbonate=1mEq; abstract, [2, 4-5, 9, 12-13, 22]). Examples include the sodium bicarbonate at 10% (10%=about 1.19mEq/ml, Example 2 [31-33]), 1% (1%=about 0.119mEq/ml, Example 4 [41-43]) 6% (6%=about 0.714mEq/ml, example 5 [46-48]), and 4% (4%=about 0.48mEq/ml, Example 3 [36-38]; all falling within the instant independent claimed range). The composition can be administered as a nasal spray that can be sprayed directed into the nasal cavity 2-3 times/day with 2-4 sprays each time (each time a dose (each dose 2-4 sprays), 2-3 doses/day), or as nasal drops applied directed into the nasal cavity 1-3 times/day with 2-3 drops each time ((each time a dose (each dose 2-3 drops, 1-3 doses/day; abstract, [2, 4-5, 9, 12-13, 22], see full document specifically areas cited).
While Lan does not recite the exact claimed values of about 0.25mEq/ml of sodium bicarbonate, but it is embraced within the taught range and within the values of the exemplified examples (i.e. Example 4 =about 1.19mEq/ml and Example 3=about 0.48mEq/ml) wherein it would be prima facie obvious to one of ordinary skill in the art to optimize within the taught range and within the taught exemplified values to attain the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed value. While Lan does not recite the exact time frame between doses, it does overlap as Lan does recite the doses to be about 2-3 times a day and one does not generally administer the nasal composition during sleep (about 8 hours/day) wherein within a 16 hour day to administer 1-3x/day is about 5-8 hours, wherein it would be prima facie obvious to one of ordinary skill in the art to optimize the frequency between doses within the day (i.e. about 5-8 hours) depending on the severity of symptoms and convenience of the patient during the day to arrive at the desired therapeutic relief with a reasonable expectation of success.
Lan does not expressly teach the exact volume of the spray/drop dose administered, but does teach administration of a nasal spray or drops into the nasal cavity (spray is 2-3 times/day (each dose 2-4 sprays), 2-3 doses/day), nasal drops is 1-3 times/day ((each dose 2-3 drops).
Frey, II et al. teaches that nasal sprays and nasal drops are known to deliver a dosage volume ranging from 0.015ml-1.0ml [51].
Wherein it would be obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to deliver the nasal spray or nasal drop with a dosage volume in the claimed values as suggested by Frey, II et al. and produce the claimed invention, as it is prima facie obvious to deliver the nasal spray/drops in known volumes and to optimize the dosage volume of composition delivered for each dose (first, second, third) within the taught range to attain the desired therapeutic profile with a reasonable expectation of success. As the structural components of the composition are met and administered for the treatment for the condition as claimed, the properties and therapeutic profile would be the same such as the lack of systemic effects on blood pH levels as any structural components or steps must be present in the claims to be commensurate in scope as written.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Lan (CN 108066401) in view of Frey, II et al. (U.S. Pat. Pub. 2019/0060414) as applied to claims 1-9, 11-13, 15 above, further in view of Alliger (U.S. Pat. Pub. 2013/0108714) and Ray (U.S. Pat. Pub. 2020/0121795).
Rejection:
The teachings of Lan in view of Frey, II et al. are addressed above.
Lan in view of Frey, II et al. does not expressly teach the inclusion of guaifenesin, but teach treating rhinitis and sinusitis and nasal congestion with the composition comprising sodium bicarbonate.
Alliger teaches that mucus looseners (mucolytics) useful for the treatment of sinusitis like sodium bicarbonate and guaifenesin to loosen the mucus of exposed membranes [106].
Ray teaches that mucolytics like guaifenesin are known to be in intranasal formulations from about 15-about 400 mg (abstract, [31-32].
Wherein it is obvious to one of skill in the art before the effective filing date of the claimed invention to incorporate guaifenesin in the composition as suggested by Alliger and Ray and produce the claimed invention; as the inclusion of an additional mucolytic for its additive effect for treating the condition and optimizing the guaifenesin within the known range to attain the desired therapeutic profile is prima facie obvious with a reasonable expectation of success absent evidence of criticality for the claimed values.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lan (CN 108066401) in view of Frey, II et al. (U.S. Pat. Pub. 2019/0060414) and Alliger (U.S. Pat. Pub. 2013/0108714) and Ray (U.S. Pat. Pub. 2020/0121795) as applied to claim 21 above, further in view Park et al. (U.S. Pat. 2014/0199266)
Rejection:
The teachings of Lan in view of Frey, II et al. and Alliger and Ray are addressed above.
Lan in view of Frey, II et al. and Alliger and Ray does not expressly teach the inclusion of honey but does teach treatment of nasal conditions like sinusitis and rhinitis.
Park et al. teaches that honey is a useful component in the nasal treatment of nasal condition like sinusitis and rhinitis (abstract) and compatible with sodium bicarbonate [52, 60].
Wherein it would be obvious to one of ordinary skill in the art to incorporate honey in the composition administered as suggested by Park et al. and produce the claimed invention; as the inclusion of an additional active for its additive effect for treating the condition is prima facie obvious with a reasonable expectation of success.
Status of Claims with Regards to Prior Art
Claim 23 appears free of the prior art but is objected to as addressed above.
Conclusion
Claims 1-9, 11-13, 15, 21-22 are rejected.
Claim 23 is objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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