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 arguments filed on 01/09/2026. As directed by the amendment, claims 11-18 were withdrawn, claims 25-28 were canceled, claims 1-10 were amended, and no claims were newly added. Thus, claims 1-10 and 19-24 are presently pending in this application.
Election/Restrictions
Applicant's election with traverse of Group I, claims 6-10 in the reply filed on 2/15/2024 is acknowledged. The traversal is on the ground(s) that “(1) there are overlapping or related technical features among the two groups of claims and (2) there would be no undue burden on the Examiner to examine both groups of claims”. This is not found persuasive because the Groups I and II are drawn to two separate inventions. Group I, claims 6-10 apply to a breathable mask used to administer the composite particle, whereas Group II, claims 11-17 apply to a sheet portion of a medical drive inserted into the nasal cavity to administer the composite particle.
The requirement is still deemed proper and is therefore made FINAL.
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 1-5, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Okazaki (Okazaki et al. (2016) “ An Analysis of the Clinical Benefits of Hydroxyl Ag Titan Sheet (HATS) in 12 Adults with Hay Fever” Public Health Research Vol. 6, No. 6, pp. 168-176 ; hereinafter referred to solely as “Okazaki”) in view of Sakurada et al (US 2014/0044801; hereinafter referred to solely as “Sakurada”) and Kaskel (US 2011/0010826).
Regarding claim 1, Okazaki discloses a method for preventing or treating allergic conjunctivitis (see Okazaki Title “An Analysis of the Clinical Benefits of Hydroxyl Ag Titan Sheet (HATS) in 12 Adults with Hay Fever”), comprising: administering to an intranasal mucosa (see Okazaki Abstract Lines 8-11 “additive-free non-woven fabric not treated with HATS were made into string shapes 1 cm wide x 5 cm and inserted intranasally… non-woven fabric containing henceforth HATS using group was used in the same manner as with the control group”), a pharmaceutical preparation comprising a composite particle containing titanium oxide particles, metal particles, and calcium phosphate particles (see Okazaki Abstract Lines 3-5 “The purpose of this study is to verify the clinical efficacy of composite Hydroxyl Ag Titan Sheet (HATS), a new, proprietary treatment for hay fever, developed by adding silver to the photocatalytic effect of titanium oxide and by using hydroxyapatite”).
Okazaki is silent as to wherein the content of the titanium oxide particles is 10 parts by mass to 300 parts by mass relative to 1 part by mass of the metal particles, and the content of the calcium phosphate particles is 1 part by mass to 100 parts by mass relative to 1 part by mass of the metal particles. However, Sakurada teaches a face mask (see Sakurada Fig. 6 [0054] textile can be used in face masks 24) made of a textile with a content of more titanium oxide particles than metal particles (see Sakurada [0029] “a combination of TiO.sub.2 and silver is preferred… the weight ratio of the ceramic to the metal is preferred to be 100:0.01-30, and 100:0.05-15”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to specifically make the content of the titanium oxide particles is 10 parts by mass to 300 parts by mass relative to 1 part by mass of the metal particles, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Additionally, Sakurada teaches the content of the calcium phosphate particles is 1 part by mass to 100 parts by mass relative to 1 part by mass of the metal particles (see Sakurada [0030] “The weight ratio of the mixture of the ceramic with the metal bonded thereto and the Hydroxyapatite (i.e. the adsorptive material) is preferred to be 100:1-50, and 100:1-30 in particular”; as evidenced by [0029] above the amount of metal in the mixture of the ceramic and metal is as small as 0.01 relative to 100 parts ceramic, meaning if the hydroxyapatite was even 50 parts to the 100 parts of the combined ceramic and metal, there would be more hydroxyapatite than silver). It would have been obvious to one having ordinary skill in the art at the time the invention was made to specifically make the content of the calcium phosphate particles is 1 part by mass to 100 parts by mass relative to 1 part by mass of the metal particles, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Modified Okazaki discloses the claimed invention except for the particle size of the composite particles is 250 to 350 nm, but rather discloses a particle size of 600 nm (see Sakurada [0029] “The size of the agent comprising the metal bonded to the ceramic is from 0.3 to 100 µm” = 300nm, meaning the TiO and metal as a whole can be 300nm in size. Then, [0030] “particle size of the Hydroxyapatite of the present invention is preferred to be 0.3 to 50 µm in particular” = 300nm, meaning the calcium phosphate as a whole can be 300nm in size. As a whole, the composite particle would be 600nm in size). However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the composite particle size to including 250 to 350 nm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Modified Okazaki is silent as to measuring by dynamic light scattering. However, Kaskel teaches a filter material (see Kaskel [0020] sorption/adsorption filter material treated with a sorbent/adsorbent) measured by dynamic light scattering (see Kaskel [0028] sorbent in particulate form with an average particle diameter; wherein particle diameter can be determined “by means of other conventional methods, e.g. dynamic light scattering”). 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 particle sizing method of modified Okazaki with the measuring particle size by dynamic light scattering as taught by Kaskel so as to ensure correct particle size, and as this would have been an obvious substitution for one known type of measuring to achieve a particular particle size for another and would yield predictable results, i.e. measure particle size.
Regarding claim 2, modified Okazaki discloses the method according to claim 1, wherein in the composite particle, the titanium oxide particles, the metal particles, and the calcium phosphate particles are arranged three-dimensionally and randomly (see Okazaki pg. 3 Section 2.2 paragraph 2, all three particles are mixed). The particles being arranged three-dimensionally and randomly is inherent because all three particles are mixed together, and the particles, both separately and together, have a three-dimensional shape.
Even if Okazaki does not discloses the three-dimensional and random arrangement as claimed, however, the feature of mixing the titanium oxide particles, the metal particles, and the calcium phosphate particles being three-dimensional and random is considered an obvious design choice since the particles have a natural three-dimensional shape and it is easy to mix these materials.
Regarding claim 3, modified Okazaki discloses at least one metal particle of the metal particles is fixedly attached to at least one titanium oxide particle of the titanium oxide particles (see Okazaki pg 3 Section 2.2 Lines 2-4 “an independently developed composite photocatalytic material sheet using silver added to the photocatalytic effects of titanium oxide” and Lines 16-18 “HATS used in this study was made by thermally bonding 10g of hydrated silver titanium into every square meter of 100% unwoven fabric”).
Regarding claim 4, modified Okazaki discloses the metal particles are selected from the group consisting of a silver particle (see Okazaki silver particle above).
Regarding claim 5, modified Okazaki discloses the metal particles comprise a silver particle and the calcium phosphate particles comprise a hydroxyapatite particle (see Okazaki silver particle and hydroxyapatite particle in claim 1 above).
Regarding claim 19, modified Okazaki discloses the claimed invention except for the particle size of the composite particles is 100 to 500 nm, but rather discloses a particle size of 600 nm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the composite particle size to including 100 to 500 nm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 6-10, 21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Okazaki in view of Conlon (US 2016/0015098), Sakurada, and Kaskel.
Regarding claim 6, Okazaki discloses a method for preventing or treating allergic conjunctivitis (see Okazaki Title “An Analysis of the Clinical Benefits of Hydroxyl Ag Titan Sheet (HATS) in 12 Adults with Hay Fever”) and the composite particle comprises titanium oxide particles, metal particles, and calcium phosphate particles (see Okazaki Abstract Lines 3-5 “The purpose of this study is to verify the clinical efficacy of composite Hydroxyl Ag Titan Sheet (HATS), a new, proprietary treatment for hay fever, developed by adding silver to the photocatalytic effect of titanium oxide and by using hydroxyapatite”).
Okazaki discloses using the composite particle on non-woven fabric (see Okazaki Abstract Lines 10-11 non-woven fabric containing henceforth HATS) and that the method of prevention or treatment of allergic conjunctivitis can be used on a wearable mask (see Okazaki pg. 2 Section 1 paragraph 6 lines 2-4 “The first of these methods is to avoid antigens through air purification and wearing a mask; physically removing allergen exposure from the body” and paragraph 7 lines 6-9 “HATS falls under the first treatment method mentioned above, as it controls the outbreak of hay fever by inhibiting bodily exposure to allergenic materials”). However, Okazaki is silent as to explicitly applying a breathable mask portion of a medical device over the nasal cavity of a subject in need of prevention or treatment of allergic conjunctivitis to cover the nasal cavity of the subject, and placing an ear loop portion provided on the breathable mask portion over the ears of the subject, wherein, the breathable mask portion includes a breathable sheet member and a composite particle is detachably attached to the breathable sheet member via a binder resin.
However, Conlon teaches applying a breathable mask portion of a medical device over the nasal cavity of a subject (see Conlon Abstract lines 14-15 “the facemask is configured to cover at least the nose and mouth of the wearer”), and placing an ear loop portion provided on the breathable mask portion over the ears of the subject (see Conlon ear loops 28, 30), wherein the breathable mask portion includes a breathable sheet member (see Conlon [0041] “the middle layer comprises nanofiber material that is coated onto either the outer side of the inner layer or the inner side of the outer layer”) and a composite particle is detachably attached to the breathable sheet member via a binder resin, so that the composite particle is administered to the intranasal mucosa of the subject (see Conlon [0069] “the nanofiber can be modified with silver, copper, or gold nanoparticles for antimicrobial functionality”; [0091] “binder chemicals may be added to the materials prior to formation of the mask”; additionally nanoparticles would enter the airway, and thus the intranasal mucosa, when the subject inhales through the nanofiber due to their particulate size). 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 non-woven fabric comprising the composite particle of Okazaki with the layer of a facemask comprising a silver particle as taught by Conlon so as to administer the protection of the composite particle in a direct way by being attached to the face.
Modified Okazaki is silent as to the content of the titanium oxide particles is 10 parts by mass to 300 parts by mass relative to 1 part by mass of the metal particles, and the content of the calcium phosphate particles is 1 part by mass to 100 parts by mass relative to 1 part by mass of the metal particles. However, Sakurada teaches a face mask (see Sakurada Fig. 6 [0054] textile can be used in face masks 24) made of a textile with a content of more titanium oxide particles than metal particles (see Sakurada [0029] “a combination of TiO.sub.2 and silver is preferred… the weight ratio of the ceramic to the metal is preferred to be 100:0.01-30, and 100:0.05-15”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to specifically make the content of the titanium oxide particles is 10 parts by mass to 300 parts by mass relative to 1 part by mass of the metal particles, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Additionally, Sakurada teaches the content of the calcium phosphate particles is 1 part by mass to 100 parts by mass relative to 1 part by mass of the metal particles (see Sakurada [0030] “The weight ratio of the mixture of the ceramic with the metal bonded thereto and the Hydroxyapatite (i.e. the adsorptive material) is preferred to be 100:1-50, and 100:1-30 in particular”; as evidenced by [0029] above the amount of metal in the mixture of the ceramic and metal is as small as 0.01 relative to 100 parts ceramic, meaning if the hydroxyapatite was even 50 parts to the 100 parts of the combined ceramic and metal, there would be more hydroxyapatite than silver). It would have been obvious to one having ordinary skill in the art at the time the invention was made to specifically make the content of the calcium phosphate particles is 1 part by mass to 100 parts by mass relative to 1 part by mass of the metal particles, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Modified Okazaki discloses the claimed invention except for the particle size of the composite particles is 250 to 350 nm, but rather discloses a particle size of 600 nm (see Sakurada [0029] “The size of the agent comprising the metal bonded to the ceramic is from 0.3 to 100 µm” = 300nm, meaning the TiO and metal as a whole can be 300nm in size. Then, [0030] “particle size of the Hydroxyapatite of the present invention is preferred to be 0.3 to 50 µm in particular” = 300nm, meaning the calcium phosphate as a whole can be 300nm in size. As a whole, the composite particle would be 600nm in size). However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the composite particle size to including 250 to 350 nm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Modified Okazaki is silent as to measuring by dynamic light scattering. However, Kaskel teaches a filter material (see Kaskel [0020] sorption/adsorption filter material treated with a sorbent/adsorbent) measured by dynamic light scattering (see Kaskel [0028] sorbent in particulate form with an average particle diameter; wherein particle diameter can be determined “by means of other conventional methods, e.g. dynamic light scattering”). 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 particle sizing method of modified Okazaki with the measuring particle size by dynamic light scattering as taught by Kaskel so as to ensure correct particle size, and as this would have been an obvious substitution for one known type of measuring to achieve a particular particle size for another and would yield predictable results, i.e. measure particle size.
Regarding claims 7, modified Okazaki discloses in the composite particle, the titanium oxide particles, the metal particles, and the calcium phosphate particles are arranged in a three-dimensionally and randomly (see Okazaki pg. 3 Section 2.2 paragraph 2, all three particles are mixed). The particles being arranged three-dimensionally and randomly is inherent because all three particles are mixed together, and the particles, both separately and together, have a three-dimensional shape.
Even if Okazaki does not discloses the three-dimensional and random arrangement as claimed, however, the feature of mixing the titanium oxide particles, the metal particles, and the calcium phosphate particles being three-dimensional and random is considered an obvious design choice since the particles have a natural three-dimensional shape and it is easy to mix these materials.
Regarding claims 8, modified Okazaki discloses at least one metal particle of the metal particles is fixedly attached to at least one titanium oxide particle of the titanium oxide particles (see Okazaki pg 3 Section 2.2 Lines 2-4 “an independently developed composite photocatalytic material sheet using silver added to the photocatalytic effects of titanium oxide” and Lines 16-18 “HATS used in this study was made by thermally bonding 10g of hydrated silver titanium into every square meter of 100% unwoven fabric”).
Regarding claims 9, modified Okazaki discloses the metal particles are selected from the group consisting of a silver particle (see Okazaki silver particle in claim 1 above).
Regarding claims 10, modified Okazaki discloses the metal particles comprise a silver particle and the calcium phosphate particles comprise a hydroxyapatite particle (see Okazaki silver particle and hydroxyapatite particle in claim 1 above).
Regarding claim 21, modified Okazaki discloses a total amount of the composite particles attached to the breathable sheet member per unit area of the breathable sheet member is 1 to 20 g/m2 (see Conlon [0116] “The nanofiber coating can have a thickness from between 0.03 grams per square meter (gsm) to about 1.0 gsm, or 1-60 gsm”).
Regarding claim 23, modified Okazaki discloses the binder resin, but is silent as to the binder resin is urethane resin. However, Sakurada teaches the binder resin is urethane resin (see Sakurada teaches bonding a composite particle agent to many surfaces, see Fig. 6 including face masks 22, and [0015] “the agent can be mixed with a variety of carriers… which can be applied to the human body and/or other surfaces” [0036] “As carriers… resins… urethane resin”). 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 binder resin of modified Okazaki with the urethane resin as taught by Sakurada as this would have been an obvious substitution for one known type of resin for another and would yield predictable results, i.e. function as a binder resin.
Regarding claim 24, modified Okazaki discloses the claimed invention except for the particle size of the composite particles is 100 to 500 nm, but rather discloses a particle size of 600 nm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the composite particle size to including 100 to 500 nm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Okazaki in view of Sakurada as applied to claim 1 above, and further in view of AAFA (2015, “Nasal Allergies (Rhinitis)” from Asthma and Allergy Foundation of America, hereinafter referred to solely as “AAFA”).
Regarding claim 20, modified Okazaki is silent as to explicitly saying a subject to which the pharmaceutical preparation is applied has inflammation of occurring to the conjunctive and as at least one symptom selected from eye itching, hyperemia, foreign body sensation, eye discharge and easy-to-appear tears. However, Okazaki discloses “Hay Fever” (see rejection to claim 1 above). AAFA teaches hay fever, also called allergic rhinitis (see AAFA page 2 “What are types of rhinitis?” lists “seasonal allergic rhinitis is sometimes called “hay fever””), causes cold-like symptoms, such as itchy eyes (see AAFA bottom of page 2 and top of page 3, “What are the symptoms of rhinitis? Itching in the nose and eyes”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the invention able to treat hay fever of Okazaki, with the teachings of itchy eyes being a symptom of hay fever as taught by AAFA, would be able to treat a subject to which the pharmaceutical preparation is applied has inflammation of occurring to the conjunctive and at least one symptom of eye itching.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Okazaki in view of Conlon and Sakurada as applied to claim 6 above, and further in view of Potnis et al. (US 2019/0069611; hereinafter referred to solely as “Potnis”).
Regarding claim 22, modified Okazaki discloses a total amount of the composite particles and the binder resin attached to the breathable sheet member, but is silent as to a total amount of the composite particles and the binder resin attached to the breathable sheet member per unit area of the breathable sheet member is 2 to 30g/m2 . However, Potnis teaches a total amount of the composite particles and the binder resin attached to the breathable sheet member per unit area of the breathable sheet member is 2 to 30g/m2 (see Potnis [0106] “the basis weight of the three-dimensional spacer layer, which includes the encapsulated PCM and binder (in various ratios of encapsulated PCM and binder holding it in place) disposed on a nonwoven material can range from about 20 gsm to about 300 gsm”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the total amount of the composite particles and binder resin attached to the breathable sheet member per unit are be 2-30 g/m2, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
Applicant argues, on page 7-8 of the remarks, that “that it is clear from the working Examples how to make such the composite particle (e.g., paragraphs [0166] to [0175] of the instant specification), and it becomes clearer upon entry of the amendments to claims 1 and 6 as explained above (since the claimed invention is more commensurate in scope with the working Examples)” and the amendments overcome the Okazaki reference even in view of secondary art under 35 USC 103. However, Examiner disagrees. The cited section of the present specification includes in paragraph [0169] a table that discloses the particle size dimensions of the components. Titanium oxide is 30-100nm; hydroxyapatite is 100-200nm; and silver is 1100-1900nm in this table. The overall size of the composite particle (the combination of these three elements) is only 250-350nm in size. Examiner is unclear as to how that large of components makes a smaller size composite particle. Regardless of this, the amendments presented are not persuasive, as discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Therefore, the rejection still stands.
Conclusion
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