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 in response to the amendment filed on 04/27/2026. As directed by the amendment, claims 12-14 were canceled, claims 10 and 16 were amended, and no claims were newly added. Thus, claims 1-11 and 15-17 are presently pending in this application.
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. In line 1, the word “comprising” should be removed as legal phraseology.
Claim Objections
Claims 1-2, 6, and 9-11 are objected to because of the following informalities:
Regarding claim 1 line 4, claim 2 line 2, claim 2 line 3-4, and claim 6 line 2, the term “the support member” should read --the rigid, elongated support member-- to remain consistent with language from claim 1 line 3.
Regarding claim 1 line 4, 5, 8, and 9, claim 6 line 1, claim 9 line 1, claim 10 lines 1 and 4, and claim 11 line 1, the term “the flexible member” should read --the at least one flexible member-- to remain consistent with language from claim 1 line 2.
Appropriate correction is required.
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 2-6, 10, and 15-17 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.
Regarding claim 2 line 1-2, the term “a set of flexible members” is unclear as to if the term is the same or different than “at least one flexible member” of claim 1 line 2. In claim 1 line 4, the term “the flexible member” is used to seemingly claim only one of the at least one flexible members, making it unclear how the claim 2 “set of flexible members” is the same or differs from one flexible member. In line 2, the term “a plurality of parallel plates” is unclear as to if the term is the same or different than “a plurality of plates” in claim 1 line 7. In line 3, the term “the extension” is indefinite because it lacks proper antecedent basis.
Regarding claim 2 line 3 and claim 4 line 1, the term “each plate” is unclear as to if the term refers to the plates in claim 1 or 2. Examiner suggests language --each plate of the plurality of parallel plates-- or --each plate of the plurality of plates-- depending on which term “each plate” refers back to, in order to provide clarity.
Regarding claim 3 line 1, the term “the plates” is unclear as to if the term refers to the plates in “a plurality of plates” of claim 1 or “a plurality of parallel plates” of claim 2. In line 2-3, the term “a nostril” is unclear as to if the term is the same or different than claim 1 line 5.
Regarding claim 4 line 2, the term “the periphery” is indefinite because it lacks proper antecedent basis. If the term is referring back to “differently sized peripheries” of claim 3 line 2, Examiner suggests language such as --each periphery of the differently sized peripheries-- for clarity.
Regarding claim 4 line 3, the term “the recesses” is indefinite because it lacks proper antecedent basis. In line 3, the term “no recess” and “a recess” are both unclear as to if there are new recesses being claimed or if the terms refer back to “one recess” from line 1-2. Specificity and consistency as to each individually claimed recess of the possible multiple recesses is needed. In line 3-4, the term “a previous or subsequent plate” is unclear as to if the term is a newly added plate to the structure, or refers to the plates in “a plurality of plates” of claim 1 or “a plurality of parallel plates” of claim 2 or “each plate” of claim 2 line 3.
Regarding claim 5 line 2, the term “every second plate” is unclear as to if the term is a newly added plate to the structure, or refers to the plates in “a plurality of plates” of claim 1 or “a plurality of parallel plates” of claim 2 or “each plate” of claim 2 line 3. In line 2 and 4-5, the term “the periphery” is indefinite because it lacks proper antecedent basis. In line 4, the term “every plate” is unclear as to if the term refers to the plates in claim 1 or 2. Examiner suggests language --every plate of the plurality of parallel plates-- or --every plate of the plurality of plates-- depending on which term “every plate” refers back to, in order to provide clarity.
Regarding claim 6 line 2, the term “a helically arranged band” is unclear as to if the term is the same or different than “a band” in claim 1 line 7.
Regarding claim 10 line 4 and claim 16 line 4, the term “the total material” is indefinite because it lacks proper antecedent basis.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
Claims 1-7, 9-11, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bergstrand Borjegren et al. (US 9,220,628; hereinafter “Bergstrand”) in view of Santelli, Jr. (US 9,776,025; hereinafter “Santelli”).
Regarding claim 1, Bergstrand discloses a nose plug (see Bergstrand nose plug 1), comprising:
at least one flexible member (see Bergstrand flexible member 2); and
one rigid, elongated support member (see Bergstrand rigid, elongated support member 3),
wherein the flexible member is arranged to surround the support member (see Bergstrand Col. 3 lines 14-16 “the flexible member 2 comprises parallel plates 4 surrounding the support member”),
wherein the flexible member is configured to be placed within a nostril to accurately fill an opening of the nostril (see Bergstrand Col. 3 lines 18-20 “When the nose plug is placed in a nose and the flexible plates accurately fill the openings of the nostrils”), and is provided with means for guiding the flow of air entering the nostril in a serpentine or spiral path by means of a plurality of plates or a band (see Bergstrand Col. 1 lines 57-60 “despite the plug filling the nostril, it is provided with means for guiding the flow of air entering the nostril in a serpentine or spiral like path by means of a plurality of plates or a band”).
Bergstrand discloses wherein the flexible member comprises a substance permanently immobilized in a material of the flexible member or on a surface of the flexible member (see Bergstrand Col. 4 lines 31-34 “The releasable substance dispersed in the flexible material or arranged on the surface of the flexible member 2 may be a fragrance, medicine, nicotine or any other releasable substance”), but is silent as to an anti-microbial substance. However, Santelli teaches the flexible member comprises an anti-microbial substance permanently immobilized in a material of the flexible member or on a surface of the flexible member (see Santelli nasal insets 10/50/60 have pads 11, 12 inserted into the nostrils, formed of plastic material comprising an antimicrobial agent; Col. 4 lines 54- 56 “Nasal inserts 10, 50 and 60 can be formed of a plastic and/or thermoplastic material including one or more additives. The additives can include antimicrobial agents”). 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 flexible member of Bergstrand with the addition of an anti-microbial substance permanently immobilized in a material of the flexible member or on a surface of the flexible member as taught by Santelli so as to reduce the undesirable microbes passing through the respiratory tract and kill and/or inhibit growth of microbes (see Santelli Col. 1 lines 33-37).
Modified Bergstrand discloses wherein the anti-microbial substance is configured to significantly reduce a number of viable microbes in the flow of air passing through the serpentine or spiral path of the nose plug (see Bergstrand modified by Santelli, Santelli Abstract “A nasal insert including an antimicrobial agent is inserted into the nose to eliminate or reduce undesirable microbes in the area just inside the nose”), and
wherein the anti-microbial substance comprises metal ions selected from the group consisting of silver ions, zinc ions, copper ions, and iron ions (see Santelli Col. 3 lines 27- 29 “Suitable antimicrobial agents are metal antimicrobial agents including silver, gold, platinum, copper, zinc or palladium”).
Regarding claim 2, modified Bergstrand discloses a set of flexible members comprise a plurality of parallel plates arranged along the support member (see Bergstrand the flexible member 2 comprises parallel plates 4 surrounding the support member), and wherein each plate extends in a direction perpendicular to the extension of the support member (see Bergstrand Claim 1 “ each of the parallel plates (4) extends in a direction perpendicular to an extension of the rigid, elongated support member (3)”).
Regarding claim 3, modified Bergstrand discloses the plates have differently sized peripheries (see Bergstrand Col. 2 lines 15-16 “The plates may also have different sized peripheries”), in order to adapt the nose plug to a shape of the inside of a nostril (see Bergstrand ).
Regarding claim 4, modified Bergstrand discloses each plate has one recess at the periphery (see Bergstrand Col. 2 lines 8-9 each plate has one recess at the periphery), and wherein the recesses are arranged such that no recess overlaps a recess in a previous or subsequent plate (see Bergstrand Col. 2 lines 9-11 the recesses are arranged such that no recess overlaps a recess in a previous or subsequent plate).
Regarding claim 5, modified Bergstrand discloses a first set of recesses are arranged on every second plate on a position at the periphery at one end of a transverse diameter (see Bergstrand Col. 2 lines 18-20 a first set of recesses are arranged on every second plate on a position at the periphery at one end of the transverse diameter), and wherein a second set of recesses are arranged on every plate therebetween at the periphery at another end of the transverse diameter (see Bergstrand Col. 2 lines 21-23 a second set of recesses are arranged on every plate there between at the periphery at the other end of the transverse diameter).
Regarding claim 6, modified Bergstrand discloses the flexible member comprises a helically arranged band forming a spiral structure around the support member (see Bergstrand Col. 2 lines 25-26 the flexible member comprises a helically arranged band forming a spiral like structure around the support member).
Regarding claim 7, modified Bergstrand discloses the anti-microbial substance comprises silver ions (see Santelli Col. 3 lines 27- 29 “Suitable antimicrobial agents are metal antimicrobial agents including silver).
Regarding claim 9, modified Bergstrand discloses the flexible member is made of a thermoplastic elastomer (see Bergstrand flexible member 2 is made of a thermoplastic elastomer), and the anti-microbial substance is evenly dispersed therein (see Bergstrand modified by Santelli to include antimicrobial agent, wherein Santelli base is a plastic pre-polymer such as polyurethane and Col. 5 lines 41-43 the microbial agent is evenly distributed through the pre-polymer base compound).
Regarding claim 10, modified Bergstrand discloses the flexible member is made of a thermoplastic elastomer and the anti-microbial substance (see Bergstrand flexible member 2 is made of a thermoplastic elastomer, modified by Santelli to include antimicrobial agent), and wherein the anti-microbial substance constitutes a percentage in a range of 2% and 10% by weight of the total material in the flexible member (see Santelli Col. 5 lines 37-38 “The amount of microbial agent can be in the range of about 1% to about 25%”, of the base material).
Regarding claim 11, modified Bergstrand discloses the flexible member is coated with a coating comprising the anti-microbial substance (see Bergstrand in claim 1, the substance is arranged on the surface of the flexible member 2; modified to include anti-microbial substance of Santelli).
Regarding claim 15, modified Bergstrand discloses the set of flexible members are made of a thermoplastic elastomer (see Bergstrand flexible member 2, comprising parallel plates 4, is made of a thermoplastic elastomer), and the anti-microbial substance is evenly dispersed therein (see Bergstrand modified by Santelli to include antimicrobial agent, wherein Santelli base is a plastic pre-polymer such as polyurethane and Col. 5 lines 41-43 the microbial agent is evenly distributed through the pre-polymer base compound).
Regarding claim 16, modified Bergstrand discloses the set of flexible members are made of a thermoplastic elastomer and the anti-microbial substance (see Bergstrand flexible member 2 is made of a thermoplastic elastomer, modified by Santelli to include antimicrobial agent), and wherein the anti-microbial substance constitutes a percentage in a range of 2% and 10% by weight of the total material in the flexible member (see Santelli Col. 5 lines 37-38 “The amount of microbial agent can be in the range of about 1% to about 25%”, of the base material).
Regarding claim 17, modified Bergstrand discloses the set of flexible members are coated with a coating comprising the anti-microbial substance (see Bergstrand in claim 1, the substance is arranged on the surface of the flexible member 2; modified to include anti-microbial substance of Santelli).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bergstrand in view of Santelli as applied to claim 7 above, and further in view of Gandola et al. (US 2020/0276364; hereinafter “Gandola”).
Regarding claim 8, modified Bergstrand is silent as to the silver ions are encapsulated in glass. However, Gandola teaches the silver ions are encapsulated in glass (see Gandola [0033] viscoelastic foam, as a base layer, comprises an additional antimicrobial additive, where the antimicrobial silver ions are encapsulated in a glass particle). 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 antimicrobial substance particles of modified Bergstrand with the encapsulation of the antimicrobial particles in glass as taught by Gandola so as to extend the device durability and extend the efficiency of the antimicrobial effects.
Response to Arguments
The action is made as a non-final again due to Applicant’s arguments. The rejection has been modified. Since the modified rejection is presented to the Applicant for the first time, the rejection is a non-final rejection.
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1 on pages 5-7 of the remarks have been considered but are moot because the new ground of rejection does not rely solely on any one reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claim(s) 8, 10, and 16 on pages 6-7 of the remarks have been considered but are moot because the new ground of rejection does not rely solely on any one reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Zhan et al. (US 2019/0351170) is cited to show a nasal plug with tiered nose contact portions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
