Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. This office action is in response to the filing of the application on 06/20/2023. Since the initial
filing, claims 12-14 have been canceled. Thus, claims 1-11, and 15-17 are pending in the application.
Priority
3. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. SE2051529-2, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim(s) 10 and 16 are not supported by the above listed foreign application.
The non-supported limitations in these claims are listed below:
“the anti-microbial substance constitutes a percentage in a range of 2% and 10% of the total material in the flexible member” (claim 10, lin. 5).
“the anti-microbial substance constitutes a percentage in a range of 2% and 10% of the total material in the flexible member” (claim 16, lin. 3-4).
Therefore, the above listed claims 10 and 16 are given the effective filing date of the date
when the corresponding subject matter and claims were filed with the office: 12/16/2021.
Accordingly, claim(s) 10 and 16 are not entitled to the benefit of the prior application
SE2051529-2.
Claim Interpretation
4. 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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“means for guiding the flow of air entering the nostril in a serpentine or spiral path” (claim 1, lin. 7-8). “a plurality of plates or a band” provides sufficient structure to perform the function of “guiding the flow of air”.
“means of a plurality of plates or a band (claim 1, lin. 8-9). “a plurality of plates or a band” provides sufficient structure to perform the function of “guiding the flow of air”.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
At present, no claims are interpreted under 35 USC 112(f).
Claim Rejections - 35 USC § 112
5. 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.
Claim(s) 10 and 16 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(s) 10 and 16 recite the limitation “the anti-microbial substance constitutes a percentage in a range of 2% and 10% of the total material in the flexible member.” (claim 10, lin. 5 and claim 16, lin. 3-4). It is unclear whether the percentage of total material is by volume or weight.
For purposes of examination, it is being interpreted to mean either percentage of total material by weight or volume.
Claim Rejections - 35 USC § 103
6. 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.
7. Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergstrand et al. (US 9220628 B2) in view of Frank et al. (US 20200261751 A1)
Regarding clam 1, Bergstrand discloses a nose plug (Fig. 1, abs., nose plug 1), comprising: at least one flexible member (abs., one flexible member 2), and one rigid, elongated support member (abs. one rigid, elongated support member 3), wherein the flexible member is arranged to surround the support member (abs., The flexible member 2 is arranged to surround the support member 3), wherein the flexible member is configured to be placed within a nostril to accurately fill an opening of the nostril (abs., the flexible member 2 is adapted to be placed within a nostril to accurately fill the opening of the nostril), 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 (col. 1 lines 58-60, 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 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, wherein the anti-microbial substance is adapted configured to reduce a number of viable microbes in the flow of air passing through the serpentine or spiral path of the nose plug (col. 4 lines 31-34, Nicotine dispersed in the flexible material or arranged on the surface of the flexible member, which has antimicrobial properties); but is silent on the anti-microbial substance comprising metal ions selected from the group consisting of silver ions, zinc ions, copper ions, and iron ions.
However, Frank et al. teaches a nose plug (abs., 3-dimensional (3D) nasal pod structure) which includes a membrane (configured to be inserted into a user’s nostril, para. 15) comprising silver ions (para. 27).
Therefore, it would be 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 to comprise silver ions as taught by Frank to increase the antimicrobial effect against bacteria and viruses.
Regarding claim 2, the modified nose plug of Bergstrand has a set of flexible members comprising a plurality of parallel plates arranged along the support member (Bergstrand, col 2 lin. 2-3, a plurality of parallel plates arranged along the support member), wherein each plate extends in a direction perpendicular to the extension of the support member (Bergstrand, col 2 lin. 3-4, wherein each plate extends in a direction perpendicular to the extension of the support member).
Regarding claim 3, the modified nose plug of Bergstrand has the plates having differently sized peripheries (Bergstrand, col. 2 lin. 14-15, the plates have differently sized peripheries), in order to adapt the nose plug to a shape of the inside of a nostril (Bergstrand, col. 2 lin. 15-16, nose plug to properly adapt within a nostril).
Regarding claim 4, the modified nose plug of Bergstrand has each plate having one recess at the periphery (Bergstrand, col. 2 lin. 9, one recess at the periphery), and wherein the recesses are arranged such that no recess overlaps a recess in a previous or subsequent plate (Bergstrand, col. 2 lin. 8-11, the recesses are arranged such that no recess overlaps a recess in a previous or subsequent plate).
Regarding claim 5, the modified nose plug of Bergstrand has a first set of recesses are arranged on every second plate on a position at the periphery at one end of a transverse diameter (Bergstrand, col. 2 lin. 17-19, 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 there between there between at the periphery at the other another end of the transverse diameter (Bergstrand, col. 2 lin. 19-22, 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, the modified nose plug of Bergstrand has the flexible member comprising a helically arranged band forming a spiral structure around the support member (Bergstrand, col. 2 lin. 25-27, flexible member comprises a helically arranged band forming a spiral like structure around the support member).
Regarding claim 7, the modified nose plug of Bergstrand has the anti-microbial substance comprising silver ions (Frank para. 27, silver ions).
8. Claim(s) 8, 10 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergstrand et al. (US 9220628 B2), in view of Frank et al. (US 20200261751 A1), and further in view of Gandola et al. (US 20200276364 A1)
Regarding claim 8, the modified nose plug of Bergstrand is silent on the silver ions being encapsulated in glass.
However, Gandola teaches a material for contact between an appliance and living tissue (abs.), which includes a viscoelastic foam comprising an antimicrobial additive with active ingredients such as silver ions encapsulated in a glass particle ([0033]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the silver ions in the flexible member of Bergstrand to be silver ions encapsulated in glass particles, as taught by Gandola, in order to extend device durability and limit environmental leaching.
Regarding claim 10, the modified nose plug of Bergstrand has the flexible member made of a thermoplastic elastomer (Bergstrand, col. 4, lines 11-12, flexible member is preferably made of a thermoplastic elastomer) and the anti-microbial substance (Frank et al., [0027], silver ions), but is silent on the anti-microbial substance constitutes a percentage in a range of 2% and 10% of the total material in the flexible member.
However, Gandola teaches a material for contact between an appliance and living tissue (abs.), which includes a ([0033], viscoelastic foam comprising an antimicrobial additive with active ingredients such as silver ions), wherein the ([0031], percentage by weight of the foaming agent additive to the elastomeric component will preferably be 1 to 10%, and more preferably 1 to 5%, and most preferably 1.5 to 3%).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition of the flexible member of the modified nose plug of Bergstrand with the percentages taught in Gandola to make an antimicrobial flexible member that provides high-efficacy pathogen reduction while maintaining material integrity.
Regarding claim 16, the modified nose plug of Bergstrand has the set of flexibles member made of a thermoplastic elastomer (Bergstrand, col. 4, lines 11-12, flexible member is preferably made of a thermoplastic elastomer) and the anti-microbial substance (Frank et al., [0027], silver ions), but is silent on the anti-microbial substance constitutes a percentage in a range of 2% and 10% of the total material in the flexible member.
However, Gandola teaches a material for contact between an appliance and living tissue (abs.), which includes a ([0033], viscoelastic foam comprising an antimicrobial additive with active ingredients such as silver ions), wherein the ([0031], percentage by weight of the foaming agent additive to the elastomeric component will preferably be 1 to 10%, and more preferably 1 to 5%, and most preferably 1.5 to 3%.).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition of the flexible member of the modified nose plug of Bergstrand with the percentages taught in Gandola to make an antimicrobial flexible member that provides high-efficacy pathogen reduction while maintaining material integrity.
9. Claim(s) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergstrand et al. (US 9220628 B2), in view of Frank et al. (US 20200261751 A1), and further in view of Barone (US 20220142272 A1)
Regarding claim 11, the modified nose plug of Bergstrand is silent on the flexible member is being coated with a coating comprising the anti-microbial substance.
However, Barone teaches a nasal strip mask for filtering out airborne viruses (abs.), wherein the nostril insert is a semi-rigid material with an anti-microbial coating ([0027]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the flexible member of Bergstrand to be coated in an anti-microbial, as taught by Barone, instead of dispersed throughout the flexible member to lower device manufacturing cost, due to coating needing lower concentrations of expensive anti-microbial materials like silver or copper ions than dispersing.
Regarding claim 17, the modified nose plug of Bergstrand is silent on the set of flexible members being coated with a coating comprising the anti-microbial substance.
However, Barone teaches a nasal strip mask for filtering out airborne viruses (abs.), wherein the nostril insert is a semi-rigid material with an anti-microbial coating ([0027]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the flexible member of Bergstrand to be coated in an anti-microbial, as taught by Barone, instead of dispersed throughout the flexible member to lower device manufacturing cost, due to coating needing lower concentrations of expensive anti-microbial materials like silver or copper ions than dispersing the ions throughout the material of the nose plug.
10. Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bergstrand et al. (US 9220628 B2), in view of Frank et al. (US 20200261751 A1), and further in view of Reddy et al. (US 20220089105 A1)
Regarding claim 9, the modified nose plug of Bergstrand has the flexible member made of a thermoplastic elastomer (Bergstrand, col. 4, lines 11-12, flexible member is preferably made of a thermoplastic elastomer), and the anti-microbial substance ([0027], Frank et al., silver ions), but is silent on the anti-microbial substance evenly dispersed therein.
However, Reddy et al. teaches an anti-viral polymer to limit viruses such as Coronavirus 2 (abs., para. 4, Reddy et al.) which includes (Reddy et al., [0006], metal oxide particles 316 dispersed therein, [0089], metal oxide particles 316 are individually uniformly dispersed throughout the polymeric matrix), and includes a (Reddy et al., [0006], thermoplastic elastomer).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the flexible member of Bergstrand with the uniform distribution of anti-microbial particles, as taught by Reddy, to increase product durability.
Regarding claim 15, the modified nose plug of Bergstrand has the set of flexibles members being made of a thermoplastic elastomer (Bergstrand, col. 4, lines 11-12, flexible member is preferably made of a thermoplastic elastomer), and the anti-microbial substance ([0027], Frank et al., silver ions), but is silent on the anti-microbial substance evenly dispersed therein.
However, Reddy et al. teaches an anti-viral polymer to limit viruses such as Coronavirus 2 (abs., para. 4, Reddy et al.) which includes (Reddy et al., [0006], metal oxide particles 316 dispersed therein, [0089], metal oxide particles 316 are individually uniformly dispersed throughout the polymeric matrix), and includes a (Reddy et al., [0006], thermoplastic elastomer).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the flexible member of Bergstrand with the uniform distribution of anti-microbial particles, as taught by Reddy, to increase product durability.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure are Frey (US 20150047641 A1) and Curtis (US 20180304108 A1). These prior art are various nasal filtration devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC ROBERT WAHL whose telephone number is (571)272-9880. The examiner can normally be reached Monday - Friday 8:30 a.m. to 6:00 p.m..
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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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/A.R.W./Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785