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
This office action is responsive to a preliminary amendment filed on 4/13/2026. As directed by the amendment, claim 1 was amended, no claims were cancelled nor added. Thus, claims 1-16 are presently pending in this application.
Election/Restrictions
Claims 6-7 and 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/13/2026.
Applicant's election with traverse of species I in the reply filed on 4/13/2026 is acknowledged. The traversal is on the ground(s) that Applicant believes that these species are not patentably distinct, as they all share the common inventive concept of an insertion element with a surface-applied inhibition agent specifically positioned to interact with nasal airflow and further argues that all the claims could easily be examined together and that restriction is not necessary. This is not found persuasive because as stated in the restriction requirement, the species are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species, the examiner further explained how the species have mutually exclusive characteristics. By merely stating that just because the shared feature is inventive does not overcome the fact that the different species have mutually exclusive characteristics, it is noted that the restriction did not rely on lack of unity. Since the applicant has not shown how the differences in the structures/characteristics make the species independent or distinct, the restriction requirement still stands. Furthermore, regarding the argument that the claims could easily be examined together, the argument is not persuasive because the applicant merely stated that the claims could easily be examined together without explaining how the differences between each species would make them be easily examined. As stated in the restriction requirement, the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter and the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Therefore, the restriction requirement still stands.
The requirement is still deemed proper and is therefore made FINAL.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, (i.e., the terms “comprising” in line 1 and “said” in line 2 of the abstract). Correction is required. See MPEP § 608.01(b).
The abstract of the disclosure is objected to because it is unclear if the term “Figure 1” at the bottom of the abstract is part of the abstract. See MPEP § 608.01(b).
Claim Objections
Claim 1, 3 and 4 are objected to because of the following informalities:
In claim 1, line 5, the limitation “said insertion element arranged to insert the surface into the nasal cavity” is suggested to be changed to --said insertion element is configured to insert the surface into the nasal cavity-- in order to clarify that the nasal cavity is not being positively claimed.
In claim 3, lines 1-2, the term “wherein the topical inhibitor is applied to the surface” is suggested to be changed to --further comprising the topical inhibitor, wherein the topical inhibitor is applied to the surface-- in order to clarify that the topical inhibitor is being positively claimed.
In claim 4, lines 1-2, the term “wherein the surface is formed from a material, said material being the topical inhibitor” is suggested to be changed to --further comprising the topical inhibitor, wherein the surface is formed from a material, said material being the topical inhibitor-- order to clarify that the topical inhibitor is being positively claimed.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Presently, no limitation(s) is/are being interpreted under 112(f).
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 4 and 8-9 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 pre-AIA the applicant regards as the invention.
Regarding claim 4, the limitation “wherein the surface is formed from a material, said material being the topical inhibitor” (lines 1-2) is unclear as to how to define the metes and bounds of the limitation in combination with claims 1-3, specifically, claim 1, lines 3-4 claims that “said insertion element having a surface having the inhibition agent”, however, claim 3 claims that the topical inhibitor which is the inhibition agent (see claim 2) is applied to the surface, which would imply that the topical inhibition is not the same as the surface, therefore, how can an agent applied to a surface is also the agent itself, the limitation “wherein the surface is formed from a material, said material being the topical inhibitor” in claim 4 is contradicting claims 1-3.
Regarding claim 8, the limitation “said surface of layer inhibitor” (lines 3-4) is unclear if the inhibitor is referring to the inhibitor agent or not, furthermore, it is unclear if the “said surface” of the layer of inhibitor is referring to the surface of the insertion element being claimed in claim 1, line 3.
Any remaining claims are rejected for their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Santin (2006/0085027).
Regarding claim 1, Santin discloses a device (1’’ in figs. 5A-5E and 10A-10B, see paragraphs 0095-0096 and 0101-0105) for providing an inhibition agent to a nasal cavity of a user (see paragraphs 0049 and 0103, Santin discloses that the devices can be used alone or in conjunction with decongestant and antihistamines powders, tablets or liquid medications, antihistamines are an inhibition agent, furthermore, see paragraphs 0124-0126 for different type of inhibitors), the device comprising: an insertion element (see 10 comprising medication carrier 80 in fig. 10A, paragraphs 0101-0103 and 0124-0126, Santin discloses that 80 can carry medicine such as antihistamine, furthermore, discloses in paragraph 0124-0126 that other biologically active agents can include inhibitors), said insertion element having a surface having the inhibition agent (see surface of 80 being provided with the inhibition agent, figs. 10A-10B and paragraphs 0101-0103 and 0124-0126); said insertion element arranged to insert the surface into the nasal cavity (see paragraphs 0096-0097), such that the inhibition agent is placed to receive an inhalation and/or exhalation airflow (see figs. 5A-5B and 10A-10B and paragraphs 0049, 0096-0097, 0101-0103, when 10 is worn inside the nose, the inhibition agent is placed to receive an inhalation and/or exhalation airflow).
Regarding claim 2, Santin discloses that the inhibition agent includes a pharmaceutical agent (see paragraphs 0101-0103 and 0124-0126, antihistamine or other inhibitor agent is a pharmaceutical agent).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. 102(b) as anticipated by Land (6,701,924) or, in the alternative, under 35 U.S.C. 103 as obvious over Land (6,701,924) in view of Binyamin (2021/0038508).
Regarding claim 1, Land discloses a device (10, fig. 1, col 5, line 27 to col 6, line 3) for providing an inhibition agent to a nasal cavity of a user (see col 4, lines 61-65 and col 5, lines 46-65, Land discloses that oxymetazoline is an agent that is beneficial in the treatment of nasal congestion, therefore, is an inhibitor agent), the device comprising: an insertion element (14, fig. 1, col 5, line 27 to col 6, line 3), said insertion element having a surface having the inhibition agent (surface that oxymetazoline is being positioned on, see col 5, lines 46-65); said insertion element arranged to insert the surface into the nasal cavity, such that the inhibition agent is placed to receive an inhalation and/or exhalation airflow (see abstract and col 5, lines 46-65 and fig. 1, the insertion element is arranged to insert the surface into the nasal cavity, furthermore, the since the filter material is being used to hold oxymetazoline to treat nasal congestion, the inhibition agent would be placed to receive an inhalation and/or exhalation airflow).
However, if there is any doubt that Oxymetazoline is an inhibitor agent. Land discloses that other medication can be used (see col 6, lines 45-60). Binyamin teaches a topical medication used to treat the nasal area, wherein the topical medication is an inhibitor agent (see paragraphs 0007 and 0010, Binyamin discloses antihistamines and antibiotics can be used to locally treat sinuses using foam that are position the nasal cavity (see paragraphs 0007-0009)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medication of Land to be an inhibitor agent as taught by Binyamin to locally treat sinuses of the patient, thereby, bringing comfort to the patient in need of such treatment (see paragraphs 0007-0010 of Binyamin).
Regarding claim 2, Land or the modified Land discloses that the inhibition agent includes a pharmaceutical agent (see abstract and col 5, lines 46-65, oxymetazoline is a pharmaceutical agent), alternatively, Land discloses that the inhibition agent is a topical agent (abstract and col 5, lines 46-65 of Land, Land discloses that the filter 14 is impregnated with oxymetazoline to treat nasal congestion, and further discloses in col 4, lines 60-65 of Land that “Lastly, it is an object of the present invention to provide a new and improved nasal filter which is treated with oxymetazoline. This allows further treatment of nasal congestion targeted at the exact area of the body where the symptoms are most prevalent”, therefore, is a topical agent, alternatively see the modification with Binyamin and paragraphs 0007-0010 of Binyamin).
Regarding claim 3, Land or the modified Land discloses that the topical inhibitor is applied to the surface (see abstract and col 5, lines 46-65 of Land with reference to oxymetazoline, alternatively, see the modification with Binyamin and paragraphs 0007-0010 of Binyamin).
Regarding claim 4, Land or the modified Land discloses that the surface is formed from a material, said material being the topical inhibitor (see abstract and col 5, lines 46-65 of Land, the oxymetazoline being impregnated into the filter would have a surface, the surface of the oxymetazoline and the surface that the oxymetazoline is being positioned are being interpreted as “the surface”, alternatively, see the modification with Binyamin and paragraphs 0007-0010 of Binyamin, the surface of the inhibition agent of Binyamin and the surface of the insertion element that the inhibition of Binyamin is place on are being interpreted as “the surface”).
Regarding claim 5, Land or the modified Land discloses that the insertion element includes scaffold of filaments, with the surface located on said filaments (see abstract and col 5, lines 46-65, Land discloses that the filter material is being impregnated with oxymetazoline, Land further discloses that the filter member 15 is made of medium grade cotton which has been rolled or formed into the oval configuration, which would comprise cotton fibers or filaments that are place one on top of another, therefore, would form a scaffold of filaments).
Claims 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kjellsson (2,162,583) and in view of Binyamin (2021/0038508).
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Regarding claim 1, Kjellsson discloses a device (entire device in fig. 12 with reference to figs. 8-11 and the medicine being placed onto the device, page 2, col 1, line 72 to page 2, col 2, line 53) for providing an agent to a nasal cavity of a user (see page 2, col 2, lines 20-26, Kjellsson discloses that the filtering material 36 may be saturated with a nasal oil or similar medicant if so desired for moistening and healing the skin and mucous membranes to alleviate a hay fever condition), the device comprising: an insertion element (36, 30, 35, 36a, 31a, 31b, 31, 32, see figs. 8-12 and the annotated-Kjellsson fig. 12 above, page 2, col 1, line 72 to page 2, col 2, line 53), said insertion element having a surface having the agent (see fig. 10 and page 2, col 2, lines 20-26, Kjellsson discloses that the filter material is saturated with an agent/medicine for the mucous membrane, therefore, the surface is the surface that the agent is positioned on); said insertion element arranged to insert the surface into the nasal cavity (see fig. 10), such that the inhibition agent is placed to receive an inhalation and/or exhalation airflow (see figs. 8-12, page 2, col 1, line 72 to page 2, col 2, line 53), but fails to disclose that the agent is an inhibition agent.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medication and the filter 36 and cloth covering 34 of Kjellsson to have an inhibitor agent as taught by Binyamin to locally treat sinuses of the patient, thereby, bringing comfort to the patient in need of such treatment (see paragraphs 0007-0010 of Binyamin).
Regarding claim 2, the modified Kjellsson discloses that the inhibition agent includes a pharmaceutical agent or a topical agent (see the modification with Binyamin and paragraphs 0007-0010 of Binyamin).
Regarding claim 3, the modified Kjellsson discloses that the topical inhibitor is applied to the surface (see the modification with Binyamin and paragraphs 0007-0010 of Binyamin).
Regarding claim 4, the modified Kjellsson discloses that the surface is formed from a material, said material being the topical inhibitor (see the modification with Binyamin and paragraphs 0007-0010 of Binyamin, the surface of the inhibition agent of Binyamin and the surface of the insertion element that the inhibition of Binyamin is place on are being interpreted as “the surface”).
Regarding claim 5, the modified Kjellsson discloses that the insertion element includes a scaffold of filaments, with the surface located on said filaments (figs. 8-12, page 2, col 1, line 72 to page 2, col 2, line 53 of Kjellsson, the scaffold of filaments are formed by filaments 31, cloth cover 34a, 36, 36a, 34b, 35, see the annotated-Kjellsson fig. 12 above, the filament 31 is constructed of fine wire or piano wire (see page 2, col 2, lines 1-19), while cloth cover 34 would be formed from filaments/fibers, 36, 36a and 35 are formed of stiches and cotton fibers, furthermore, after the modification with Binyamin, the surface of the agent would be located on said surface of said filaments because the covering 34 and filter 36 of Kjellsson will be saturated with the inhibitor agent).
Regarding claim 8, the modified Kjellsson discloses that said filaments comprise an outer sheave (34a, figs. 8-12, page 2, col 2, lines 10-19 of Kjellsson) and a core material of porous structures (core is made of 31, 34b, 35, 36 and 36a (page 2, col 2, lines 20-26)), figs. 8-12, page 2, col 1, line 72 to page 2, col 2, line 53 of Kjellsson), said porous structures (31, 34b, 35, 36 and 36a, see the annotated-Kjellsson fig. 12 above) comprising a matrix (matrix formed by ends of 31 (see 31a) and 34b and 35, see the annotated-Kjellsson fig. 12 above) separated by interstitial pores (pores of 36a which separates ends 31a of the matrix), said surface located on said matrix, said surface having a layer of inhibitor agent (figs. 8-12, page 2, col 1, line 72 to page 2, col 2, line 53 of Kjellsson, the surface of 34a that is located on the matrix is the surface that comprises a layer of inhibitor agent).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kjellsson (2,162,583) in view of Binyamin (2021/0038508) as applied to claim 8 above, and further in view of Santin (2006/0085027).
Regarding claim 9, the modified Kjellsson discloses that the matrix (matrix formed by ends of 31 (see 31a) and 34b and 35 of Kjellsson), but fails to disclose that the matrix includes a mineral layer.
However, Santin teaches a matrix comprising a mineral layer and medicaments (see paragraphs 0073 and 0121 for mineral layer, furthermore, Santin discloses matrix 80 comprising the medicament in paragraphs 0102-0103 and 0124-0126).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the matrix and the outer sheave of the modified Kjellsson to have a layer of mineral as taught by Santin for the purpose of providing treatment, prevention, diagnosis, cure or mitigation of disease or illness for patient who are in need of such substance (see paragraphs 0073 and 0121 of Santin).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Levin (2018/0256867) is cited to show a device for delivering medicament to the nasal area of the patient comprising an end made of a matrix of filaments.
Wang (5,417,205) is cited to show an air filter for the nose.
Weinzeweig (2017/0296759) is cited to show an intranasal device comprising a topical inhibitor agent.
MacDonald (2017/0273626) is cited to show a nasal insert comprising medication.
Ede (2015/0196420) is cited to show a nasal device for providing medicament to the user.
Miller (6,386,197) is cited to show a nasal air passageway opening device.
Brennan (1,804,670) is cited to show a nose pellet comprising a matrix of filaments.
Shaari (2013/0085472) is cited to show a nasal delivery device comprising an inhibitor agent.
Vanlandingham (WO 2023069126) is cited to show a device for topically treating the nasal area.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TU A VO/Primary Examiner, Art Unit 3785
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