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 .
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: typographical errors.
Claim 1 recites “comprises two sheet, and the two sheets comprises…” The Examiner recommends amending the claim to recite “comprises two sheets, and….” Appropriate action is required.
Claim 7 recites “carrier comprises solvent of….” The Examiner recommends amending the claim to recite “carrier comprises a solvent of…” as is proper when introducing a new limitation/establishing primary antecedent basis. 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 1-10 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 1, the phrase “comprises two sheet, and the two sheets” renders the claim indefinite because it is unclear whether each sheet has a first and second segment or whether the two sheets, as a whole, have the first and second segments. Furthermore, it is unclear how the arch portion is configured on one of the two sheets if the two sheets both comprises the arch portion. Under the broadest reasonable interpretation, the examiner interprets that the two sheets collectively comprise of a first and second segment.
Additionally independent Claim 8, incorporates the operation method of Claim 1 which renders the claim indefinite as recited above.
All remaining claims are also rejected as they depend from the rejected independent claims.
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.
Claims 1-2 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beaudry (US 7008392 B2, herein, Beaudry).
Regarding claim 1, Beaudry discloses a pharmaceuticals carrier (cleansing swab 10, see Fig.1), comprising a holding portion (stick 12, see Fig.1) and an absorbing portion (treating element 20, see Fig. 1), wherein the holding portion comprises two sheets (corresponding to first and second segments in annotated 4 below), and the two sheets comprises:
a first segment (see annotated Fig.4 below);
a second segment, connected with the first segment (see annotated Fig.4 below); and
an arch portion (overlap between first and second segments, see annotated Fig.4 below), configured on one of the two sheets and connected with the second segment;
wherein the absorbing portion is configured on the first segment of the holding portion (“cleansing element 22…. is attached over distal end 17 of stick 12”, see Col.2 lines 56-58), and the absorbing portion absorbs a medicament (under broadest reasonable interpretation, examiner interprets the absorbing portion to comprise an absorbable material (“materials for the wound cleansing element include woven fabrics, nonwoven fabrics, gauze, foams, sponges, and the like”), see Col.3 lines 60-63);
wherein the two sheets form a channel (“once frangible seal 28 is broken, the liquid in reservoir 26 can flow into wound cleansing element 22”, see Col.3 lines 27-28) via the arch portion (see annotated Fig.4 below).
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Regarding claim 2, Beaudry discloses the pharmaceuticals carrier as recited above, when one of the two sheets is formed by the first segment, the second segment and the arch portion simultaneously (see annotated Fig.4 above), the holding portion further comprises a third segment (distal portion 16, see Fig.2);
wherein the third segment is extended from the arch portion, and connected with the second segment (“stick 12 is generally elongated and has a…. distal portion 16”, see Col.2 lines 48-50).
Regarding claim 4, Beaudry discloses the pharmaceuticals carrier as recited above, wherein the first segment and the second segment form a first angle (see annotated Fig.3 below), and the second segment and the third segment form a second angle (see annotated Fig.3 below);
wherein the first angle is larger than or equal to the second angle (under broadest reasonable interpretation, examiner interprets the first angle larger than the second angle as the second angle may be squeezed or pressed by the user, hence forming a smaller angle than the open top of the first angle (“when stick 12 is manipulated, for example by squeezing with the fingers at the position indicated by the arrows in FIG. 3, frangible seal 28 will be broken”), see Col.3 lines 21-25).
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Regarding claim 5, Beaudry discloses the pharmaceuticals carrier as recited above, wherein the third segment is extended under a third angle, and the third angle is between 120 degree and 180 degrees (under broadest reasonable interpretation, examiner interprets the pressed portion of the stick 12 to be between the range of 120-180 degrees (“when stick 12 is manipulated, for example by squeezing with the fingers at the position indicated by the arrows in FIG. 3”), see Col.3 lines 21-25, Fig.3).
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.
Claims 3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Beaudry in view of Wang (US 20200306369 A1, herein Wang).
Regarding Claim 3, Beaudry discloses the pharmaceutical carrier (Beaudry, 10) as claimed in claim 1, recited above.
Beaudry does not appear to expressly disclose wherein the medicament comprises an allergen and a pharmaceutically acceptable carrier.
Wang teaches wherein the medicament comprises an allergen and a pharmaceutically acceptable carrier (“the addition of these anti-allergy drugs can prevent the allergy reaction induced by giving the allergen to the patient”, see para [0015]).
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 pharmaceutical carrier disclosed by Beaudry to comprise an allergen to aid the “prevention or reduction of undesired immune responses” (Wang, see para [0003]).
Regarding Claim 6, Beaudry discloses the pharmaceuticals carrier (Beaudry, 10) as claimed in claim 3, recited above.
Beaudry does not appear to expressly disclose wherein the allergen is dust mite extract.
Wang teaches wherein the allergen is dust mite extract (“allergen such as dust mite extract”, see para [0022]).
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 pharmaceutical carrier disclosed by Beaudry so that the allergen is dust mite extract to act as an “antigen causing allergy and immune activity enhancing agent” (Wang, see para [0021]).
Regarding Claim 7, Beaudry discloses the pharmaceuticals carrier (Beaudry, 10) as claimed in claim 3, recited above.
Beaudry does not appear to expressly disclose wherein the pharmaceutically acceptable carrier comprises solvent of glycerin, phenolic compounds, sodium chloride and sodium bicarbonate.
Wang teaches wherein the pharmaceutically acceptable carrier comprises solvent of glycerin, phenolic compounds, sodium chloride and sodium bicarbonate (“modifying agents include, for example, glycerin, propylene glycol, mannitol, glucose, dextrose, sorbitol, sodium chloride, potassium chloride, and other electrolytes”, see para [0047]).
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 pharmaceutical carrier disclosed Beaudry to comprise a solvent of glycerin, phenolic compounds, sodium chloride and sodium bicarbonate so that the carrier does not “diminish the desired effects of the composition” (Wang, see para [0047]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mathai et al. (US 20200306514 A1, herein Mathai), in view of Beaudry.
Regarding Claim 8, Mathai discloses a method of operating a pharmaceutical carrier (applicator 1- Fig.2) comprising:
immersing the absorbing portion into a container which contains the medicament (“applicator 1 can then be loaded or dipped into the reservoir 11 to load the applicator 1”, see para [0090]);
the absorbing portion is removed from the container after the absorbing portion is soaked by the medicament (“positioned on the surface of the applicator 1 so that when the device is inserted into the nasal passage of the individual, the naloxone containing formulation is transmitted or delivered to the surface of the nasal passage or nasal cavity”, see para [0081]);
the holding portion is operated via a hand, and the absorbing portion which is soaked is put into a nasal cavity (“the device can be operated by only one hand to deliver”, see para [0075]);
waiting for the medicament smearing the nasal cavity (under broadest reasonable interpretation, examiner interprets the operation duration and various application techniques of the applicator in the nasal cavity as waiting for smearing (“additional motion includes pressing the applicator against the nasal passage or nasal cavity, rotating the inserted applicator, rolling the applicator in a back-and-forth manner, rolling the applicator along the inside of the nasal passage or nasal cavity”, see para [0098)); and
removing the absorbing portion from the nasal cavity thereby the hand operating the holding portion (“manually inserting and rotating the applicator in the nasal cavity of the individual”, see para [0049]).
Mathai does not expressly disclose the pharmaceutical carrier of claim 1.
Beaudry teaches the pharmaceutical carrier of claim 1 as recited above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of operation as disclosed by Mathai with the pharmaceutical carrier of Beaudry, as claimed for claim 1 recited above, in order to cleanse a wound and effect hemostasis of the wound (Beaudry, Col. 1, lns 45-48).
Regarding Claim 9, Mathai in view of Beaudry discloses the operating method of the pharmaceutical carrier as claimed in claim 8, recited above,
wherein the step of the absorbing portion which is soaked is put into the nasal cavity (“inserting the delivery device into the nasal passage of the individual so that the surface of the applicator upon which the naloxone containing formulation is held contacts a surface of the nasal passage”, see Mathai, para [0009]) further comprises a step:
the holding portion is operated via the hand, resulting in the absorbing portion in the nasal cavity contacting wall of the nasal cavity (“the device can be operated by only one hand to deliver”, see Mathai, para [0075]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mathai in view of Beaudry, further in view of Yardley (US 20130184684 A1, herein, Yardley).
Regarding Claim 10, Mathai in view of Beaudry discloses an operating method of the pharmaceuticals carrier as claimed in claim 9, recited above.
Mathai does not appear to expressly disclose the pharmaceutical carrier wherein the medicament which is spilled over from the wall of the nasal cavity is guided to the channel, and the medicament is sustained in the channel after the absorbing portion has been contacted the wall of the nasal cavity.
However, Yardley teaches the pharmaceuticals carrier wherein the medicament which is spilled over from the wall of the nasal cavity is guided to the channel (“a hollow conical portion may be configured to help capture debris and/or other materials that may escape from a nostril onto the grip portion 710”, see para [0067], see Fig.7), and the medicament is sustained in the channel after the absorbing portion has been contacted the wall of the nasal cavity.
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 pharmaceuticals carrier disclosed by Mathai so that the applicator comprises a channel to capture spilled over medicament or debris, as taught by Yardley in order to “safely, efficiently and sanitarily removing debris and other materials from inside of a person's nose” (Yardley, see para [0007]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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