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 .
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.
Claim Objections
Claims 4, 5, 9, 10, 16 and 17 are objected to because of the following informalities: The claims recite “exothermic substance” and should recite --exothermic material--. 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.
Claim 20 is 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 20 recites “maintaining the normal secretion of exosomes against infections” and claim 13 recites “applying the nose strip device to the nose of the user to warm the tissue of the nose in order to maintain normal exosome production.” It is unclear if this is an additional step or merely the result of the application of the warming provided by application of the nose strip device as in claim 13. For the purpose of the application of prior art, this limitation has been interpreted as the result of the apply step in claim 13.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 5,890,486 to Mitra et al. (Mitra).
Regarding claim 1, Mitra teaches a nose strip device (Fig. 6), comprising a first and second sections (see annotated Fig. 6 below) that are discrete and spaced apart from one another both including an exothermic material (36) contained therein and an adhesive substance (26) disposed on at least a portion of the first and second sections for engaging the nose strip device to a nose of a user, and a bridge (see annotated Fig. 6 below) having first and second end portions (Fig. 6), the first end portion bonded to at least a portion of the first section (Fig. 6), the second end portion bonded to at least a portion of the seconds section (Fig. 6).
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Regarding claim 2, Mitra teaches the device of claim 1 as well as wherein the first and second sections each further include a first layer (41) and a second layer (21) with at least one cavity positioned there between and the exothermic material disposed in the at least one cavity (Fig. 6).
Regarding claim 3, Mitra teaches the device of claim 2 as well as wherein the first layer (41) of the first and second sections includes a porous film/semi-porous/pad/fabric/non-woven material (Col. 7, lines 46-62), and the second layer (21) of the first and second sections includes non-porous fabric/film (Col. 6, lines 11-44), the second layer having an external surface (24) on which is disposed the adhesive substance (Fig. 6).
Regarding claim 4, Mitra teaches the device of claim 1 as well as wherein the exothermic material is positioned in an envelope that is flexible or non-flexible (Col. 11, lines 13-30).
Regarding claim 5, Mitra teaches the device of claim 1 as well as wherein the exothermic substance is tabletized or freely moveable (Col. 8, line 29-Col. 10, line 58).
Regarding claim 6, Mitra teaches a method of warming the tissues of a nose of a user (title), comprising using a nose strip device (Fig. 6), including a first and second sections (see annotated Fig. 6 above) that are discrete and spaced apart from one another both including an exothermic material (36) contained therein and an adhesive substance (26) disposed on at least a portion of the first and second sections for engaging the nose strip device to a nose of a user, and a bridge (see annotated Fig. 6 below) having first and second end portions (Fig. 6), the first end portion bonded to at least a portion of the first section (Fig. 6), the second end portion bonded to at least a portion of the seconds section (Fig. 6), activating the exothermic material to give off heat (Col. 12, lines 30-40), and applying the nose strip device to the nose of the user (Col. 12, lines 41-55).
Regarding claim 7, Mitra teaches the method of claim 6 as well as wherein the first and second sections each further include a first layer (41) and a second layer (21) with at least one cavity positioned there between and the exothermic material disposed in the at least one cavity (Fig. 6).
Regarding claim 8, Mitra teaches the method of claim 7 as well as wherein the first layer (41) of the first and second sections includes a porous film/semi-porous/pad/fabric/non-woven material (Col. 7, lines 46-62), and the second layer (21) of the first and second sections includes non-porous fabric/film (Col. 6, lines 11-44), the second layer having an external surface (24) on which is disposed the adhesive substance (Fig. 6).
Regarding claim 9, Mitra teaches the method of claim 6 as well as wherein the exothermic material is positioned in an envelope that is flexible or non-flexible (Col. 11, lines 13-30).
Regarding claim 10, Mitra teaches the method of claim 6 as well as wherein the exothermic substance is tabletized or freely moveable (Col. 8, line 29-Col. 10, line 58).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra in view of US 2019/0328575 A1 to Draper (Draper).
Regarding claim 11, Mitra teaches the method of claim 6, but not specifically wherein the exothermic material maintains the normal body temperature of the nose where the nose is exposed to colder than room temperature. Draper teaches that the common cold is a viral infections disease of the upper respiratory tract that primarily affects the nose, and that this type of virus is specifically reproduced in the nasal mucosa at temperatures below the normal body temperature ([0004]). Draper goes on to teach that laboratory evidence suggests that the cold virus may be sensitive to heat and devices that generate heat to the nasal cavity have been suggested for years to sure the common cold ([0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitra to maintain the normal body temperature of the nose as Draper teaches that colder than normal body temperatures of the nasal mucosa increases viral reproduction.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra.
Regarding claim 12, Mitra teaches the method of claim 6 as well as applying the first section of the nose strip device to one side of the nose and applying the second section of the nose strip device to the other side of the nose to warm the tissues of the nose (Col. 12, lines 44-55). However, Mitra is silent with respect to the distance between the first and second sections of the nose strip device from an adjacent nostril thereto is from about 0.5 cm to about 1.5 cm. It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitra to located the first and second sections of the nose strip device adjacent the nostril as claimed as an obvious matter of engineering design choice since Applicant has not disclosed that locating the first and second sections as claimed solves any stated problem or is for any particular purpose.
Claim(s) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mitra in view of Draper as evidenced by “Cold exposure impairs extracellular vesicle swarm-mediated nasal antiviral immunity” to Huang et al. (Huang) which was cited by Applicant.
Regarding claims 13, 18 and 20, Mitra teaches a method of warming the tissues of a nose of a user (title), comprising using a nose strip device (Fig. 6), including a first and second sections (see annotated Fig. 6 below) that are discrete and spaced apart from one another both including an exothermic material (36) contained therein and an adhesive substance (26) disposed on at least a portion of the first and second sections for engaging the nose strip device to a nose of a user, and a bridge (see annotated Fig. 6 abive) having first and second end portions (Fig. 6), the first end portion bonded to at least a portion of the first section (Fig. 6), the second end portion bonded to at least a portion of the seconds section (Fig. 6), activating the exothermic material to give off heat (Col. 12, lines 30-40), and applying the nose strip device to the nose of the user (Col. 12, lines 41-55).
However, Mitra does not specifically teach warming the tissue of the nose in order to maintain normal exosome production.
Draper teaches that the common cold is a viral infections disease of the upper respiratory tract that primarily affects the nose, and that this type of virus is specifically reproduced in the nasal mucosa at temperatures below the normal body temperature ([0004]). Draper goes on to teach that laboratory evidence suggests that the cold virus may be sensitive to heat and devices that generate heat to the nasal cavity have been suggested for years to sure the common cold ([0004]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitra to maintain the normal body temperature of the nose as Draper teaches that colder than normal body temperatures of the nasal mucosa increases viral reproduction. While, Draper does not specifically teach that warming to normal body temperature maintains normal exosome production, this is a natural consequence of maintaining the nasal cavity at a normal body temperature. This is evidenced by Huang teaching that cold exposure impairs extracellular vesicle swarm-mediated nasal antiviral immunity (title) which teaches that TLR3-stimulated EV surface receptor-virus interactions contributed to the antiviral activity and prevented virus entry into hose cells. Huang teaches that TLR3-stimulated siNC EV’s exhibited significantly enhanced antiviral activities when produced at 37oC relative to 32oC (pg. 15 paragraph before the Discussion). The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.
Regarding claim 14, the combination teaches the method of claim 13 as well as wherein the first and second sections each further include a first layer (41) and a second layer (21) with at least one cavity positioned there between and the exothermic material disposed in the at least one cavity (Fig. 6).
Regarding claim 15, the combination teaches the method of claim 14 as well as wherein the first layer (41) of the first and second sections includes a porous film/semi-porous/pad/fabric/non-woven material (Col. 7, lines 46-62), and the second layer (21) of the first and second sections includes non-porous fabric/film (Col. 6, lines 11-44), the second layer having an external surface (24) on which is disposed the adhesive substance (Fig. 6).
Regarding claim 16, the combination teaches the method of claim 13 as well as wherein the exothermic material is positioned in an envelope that is flexible or non-flexible (Col. 11, lines 13-30).
Regarding claim 17, the combination teaches the method of claim 13 as well as wherein the exothermic material is tabletized or freely moveable (Col. 8, line 29-Col. 10, line 58).
Regarding claim 19, the combination teaches the method of claim 13 as well as applying the first section of the nose strip device to one side of the nose and applying the second section of the nose strip device to the other side of the nose to warm the tissues of the nose (Col. 12, lines 44-55). However, Mitra is silent with respect to the distance between the first and second sections of the nose strip device from an adjacent nostril thereto is from about 0.5 cm to about 1.5 cm. It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Mitra to located the first and second sections of the nose strip device adjacent the nostril as claimed as an obvious matter of engineering design choice since Applicant has not disclosed that locating the first and second sections as claimed solves any stated problem or is for any particular purpose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2009/0112299 A1 to Chapman teaches that the common cold replicate optimally at 33oC or colder and that nasal hyperthermia could improve the course of the common cold ([0002]). US 2016/0242960 A1 to Igaue teaches a disposable body warmer (title) where the exothermic conditions are controlled by adjusting the components of the exothermic composition (for example, the content of iron powder serving as an exothermic element, moisture content ration, or the like) and the like ([0004]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794