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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “inlet port passageways” (in plural, claim 1) and the “outlet port passageways” (in plural, claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1-22 is/are objected to because of the following informalities:
Claim 1, Ln. 6-7 recites “the inlet and outlet” which should read “an inlet and an outlet” as it is a first introduction
Claim 1, Ln. 8 recites “the mixing of inlet air and outlet air” which should read “a mixing of the inlet air and the outlet air”
Claim 6, Ln. 2 recites “the engagement” which should read “an engagement” as it is a first introduction
Claim 22, Ln. 1 recites “a filtering facepiece respirator” which should read “the filtering facepiece respirator” following after claim 3
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “inlet port passageways” and “outlet port passageways”. Each limitation is written in plural form (i.e. “passageways”). The written description and illustrations of the instant application only identify inlet port passageway 78 and outlet port passageway 80 in singular (e.g. Figs. 8-10). There is no discussion or illustration of how multiple inlet port passageways and outlet port passageways would be implemented into the diffuser. One of ordinary skill in the art would thus be left in doubt as to whether applicant was suitably in possession of the claimed invention at the time of the effective filing of the invention. There is thus lack of sufficient written description support for the full subject matter of claim 1.
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) 1-22 is/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 pre-AIA the applicant regards as the invention.
Claim 1 is recited as “A filtering facepiece respirator” but then fails to positively recite any filter structure and/or material. The claim is thus indefinite as it is unclear whether the word “filtering” is merely meant to be suggestive or is to be understood as structurally limiting on the claim. It appears the claim may be unfairly broad by attempting to claim a function without reciting a structure sufficient to perform the claimed function (see MPEP 2173.05(g)). The metes and bounds of the claim are thus unclear. Because the word “filtering” has been placed in the beginning of the claim it appears applicant is intending to require the facepiece respirator to perform a filtering function. The claim should thus be amended to positively recite a structure of the facepiece respirator which will perform filtering. Note for example the filter membrane recited in claims 16 and 18. For the purposes of examination the claim will be interpreted as requiring some filter structure and/or material.
Claim 6 recites the limitation “the inlet passageway” in Ln. 1. There is insufficient antecedent basis for this limitation in the claim. It appears the limitation may be referring to the same structure as the inlet port passageways of claim 1. For the purposes of examination the limitation will be interpreted as reading “the inlet port passageways”. The same change should additionally be made to Ln. 3 of the claim.
Claim 7 recites the limitation “an inlet port which provides an inlet passageway” in Ln. 2 which deems the claim indefinite. It appears the limitation may be referring to the same structure as the inlet port and the inlet port passageways of claim 1. For the purposes of examination the limitation will be interpreted as reading “the inlet port which provides the inlet port passageways”.
Claim 8 recites the limitation “the outlet passageway” in Ln. 1. There is insufficient antecedent basis for this limitation in the claim. It appears the limitation may be referring to the same structure as the outlet port passageways of claim 1. For the purposes of examination the limitation will be interpreted as reading “the outlet port passageways”.
Claim 8 recites the limitation “an outlet port” in Ln. 4 which deems the claim indefinite. It appears the limitation may be referring to the same structure as the outlet port of claim 1. For the purposes of examination the limitation will be interpreted as reading “the outlet port”.
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 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.
(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) 1-3 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al. (U.S. Pub. 2012/0260920).
Regarding claim 1, Choi discloses a filtering facepiece respirator (Fig. 1; ¶0026) comprising: a mask body (Fig. 2 #14) having an anterior side, a posterior side, a middle portion, a first side portion, a second side portion, a top side portion, a bottom side portion and outer edge portions; a port (Fig. 2 #53; ¶0037) positioned on the mask body; a diffuser (Fig. 2 #16; ¶0027) positioned over the port on the mask body, wherein the diffuser comprises an inlet port (Fig. 2 front of #34; ¶0027), inlet port passageways (Fig. 2 between #40 passing through #34; ¶0027), an outlet port (Fig. 2 front of #36; ¶0027) and outlet port passageways (Fig. 2 between #42 passing through #36; ¶0027) allowing for an inlet and an outlet of air, and wherein the inlet port passageways and outlet port passageways are separate and closed from each other preventing a mixing of the inlet air and the outlet air (Fig. 2 #34 and #36 provide two fully separate flow paths). The cited “portions” of the mask body can be somewhat arbitrarily defined within the locational adjective parameters recited.
Regarding claim 2, Choi discloses the diffuser comprises a base portion (Figs. 1-2 #16) and a top portion (Fig. 1 #24) which are engaged to each other (¶0027). It is noted that other possible base and top portions are readable from Choi, such as a front half of central portion 16 as the “top portion” and a rear half of central portion 16 as the “bottom portion” (Fig. 2).
Regarding claim 3, Choi discloses, when applying the alternate reading from claim 2 above, the base portion of the diffuser comprises a first conduit (Fig. 2 #39 is a conduit shape) which extends upward from the base portion (Fig. 2 #39 extends upward relative to the rear half of #16) and a second conduit (Fig. 2 #44 is a conduit shape) positioned within the first conduit which extends upward from the base portion (Fig. 2 #44 extends upward relative to the rear half of #16).
Regarding claim 20, Choi discloses a method of using the filtering facepiece respirator of claim 1 (see above) comprising: providing the filtering facepiece respirator (Fig. 1); and applying the filtering facepiece respirator over a face of a patient (Fig. 1).
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 1-3 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Magidson et al. (U.S. Pub. 2023/0241424) in view of Choi et al. (U.S. Pub. 2012/0260920).
Regarding claim 1, Magidson discloses a filtering facepiece respirator (Fig. 1; ¶0041) comprising: a mask body (Fig. 9 #102) having an anterior side, a posterior side, a middle portion, a first side portion, a second side portion, a top side portion, a bottom side portion and outer edge portions; a port (Fig. 9 #106; ¶0041) positioned on the mask body; a diffuser (Fig. 9 #108; ¶0041) positioned over the port on the mask body, wherein the diffuser comprises an inlet port (Fig. 9 #112; ¶0043), inlet port passageway (Fig. 9 through #112), an outlet port (Fig. 9 #114; ¶0043) and outlet port passageways (Fig. 9 #136; ¶0043) allowing for an inlet and an outlet of air, and wherein the inlet port passageways and outlet port passageways are separate and closed from each other preventing a mixing of the inlet air and the outlet air (Fig. 9 #112 and #114 provide two fully separate flow paths). The cited “portions” of the mask body can be somewhat arbitrarily defined within the locational adjective parameters recited.
Magidson fails to explicitly disclose the inlet port passageway includes multiple inlet port passageways.
Choi teaches a filtering facepiece respirator (Fig. 1; ¶0026) including a diffuser (Fig. 2 #16; ¶0027) comprising an inlet port (Fig. 2 front of #34; ¶0027) and inlet port passageways (Fig. 2 between #40 passing through #34; ¶0027). Choi teaches multiple inlet port passageways as providing the benefit of using a series of spokes to support a valve flap or diaphragm (¶0027).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Magidson the inlet port passageway includes multiple inlet port passageways in order to provide the benefit of using a series of spokes to support a valve flap or diaphragm (which Magidson teaches at Fig. 9 #116; ¶0043) in view of Choi.
Regarding claim 2, Magidson teaches the invention as modified above and further teaches the diffuser comprises a base portion (Fig. 9 #108) and a top portion (Fig. 9 #124) which are engaged to each other. It is noted that other possible base and top portions are readable from Magidson.
Regarding claim 3, Magidson teaches the invention as modified above and further teaches the base portion of the diffuser comprises a first conduit (Fig. 9 exterior surface of #114 is a conduit shape) which extends upward from the base portion (Fig. 9 #114 extends upward from a main surface of #108) and a second conduit (Fig. 9 central hub within #114 is a conduit shape) positioned within the first conduit which extends upward from the base portion (Fig. 9 #114 extends upward from a main surface of #108).
Regarding claim 20, Magidson teaches the invention as modified above and further teaches a method of using the filtering facepiece respirator of claim 1 (see above) comprising: providing the filtering facepiece respirator (Fig. 1); and applying the filtering facepiece respirator over a face of a patient (¶0041).
Allowable Subject Matter
Claim(s) 4-19 and 21-22 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 4, neither Choi nor Magidson teaches or suggests the top portion of the diffuser comprises a head portion and a bottom portion, a receiving conduit which extends upward towards the head portion of the top portion of the diffuser and a receiving flange integrated within the receiving conduit which extends downward from the head portion of the top portion of the diffuser. Particular note is made of how the receiving flange is recited as integrated within the receiving conduit and extending downward from the head portion.
Note is made that the allowability of the claim is in part based upon the claim language identified in claim 1 as lacking sufficient written description support (i.e. multiple inlet port passageways and outlet port passageways) as well as the interpretation applied to claim 1 in response to the 35 U.S.C. 112(b) rejection of that claim (i.e. requiring some filter structure and/or material). Applicant is cautioned that amendments to claim 1 which broaden that claim may lead to a necessity for new prior art rejections.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 14, neither Choi nor Magidson teaches or suggests the top portion and the base portion of the diffuser are rotatable with respect to each other and wherein the base portion of the diffuser is rotatable within the mask body. In each of Choi and Magidson the cited diffuser fits into a non-circular opening with the mask body and thus would not be rotatable therein.
Note is made that the allowability of the claim is in part based upon the claim language identified in claim 1 as lacking sufficient written description support (i.e. multiple inlet port passageways and outlet port passageways) as well as the interpretation applied to claim 1 in response to the 35 U.S.C. 112(b) rejection of that claim (i.e. requiring some filter structure and/or material). Applicant is cautioned that amendments to claim 1 which broaden that claim may lead to a necessity for new prior art rejections.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 15, neither Choi nor Magidson teaches or suggests the base portion of the diffuser is positioned under the port on the posterior side of the mask body and wherein the first conduit of the base portion of the diffuser extends upward from the posterior side of the mask body through the port to the anterior side of the mask body. In each of Choi and Magidson there is not a sufficiently readable first conduit, in accordance with both the instant claim and claim 3, which would extend upward from the posterior side of the mask body through the port to the anterior side of the mask body.
Note is made that the allowability of the claim is in part based upon the claim language identified in claim 1 as lacking sufficient written description support (i.e. multiple inlet port passageways and outlet port passageways) as well as the interpretation applied to claim 1 in response to the 35 U.S.C. 112(b) rejection of that claim (i.e. requiring some filter structure and/or material). Applicant is cautioned that amendments to claim 1 which broaden that claim may lead to a necessity for new prior art rejections.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 19, neither Choi nor Magidson teaches or suggests the mask body comprises strap hooks. In each of Choi and Magidson strap connections are provided on the structure cited as the diffuser and not on a structure readable as the mask body (Choi – Figs. 1-2; Magidson – Figs. 1 & 9).
Note is made that the allowability of the claim is in part based upon the claim language identified in claim 1 as lacking sufficient written description support (i.e. multiple inlet port passageways and outlet port passageways) as well as the interpretation applied to claim 1 in response to the 35 U.S.C. 112(b) rejection of that claim (i.e. requiring some filter structure and/or material). Applicant is cautioned that amendments to claim 1 which broaden that claim may lead to a necessity for new prior art rejections.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 21, neither Choi nor Magidson teaches or suggests a method of assembling the filtering facepiece respirator as claimed. The claim is found allowable for the same general reasons discussed above in regard to claim 15.
Note is made that the allowability of the claim is in part based upon the claim language identified in claim 1 as lacking sufficient written description support (i.e. multiple inlet port passageways and outlet port passageways) as well as the interpretation applied to claim 1 in response to the 35 U.S.C. 112(b) rejection of that claim (i.e. requiring some filter structure and/or material). Applicant is cautioned that amendments to claim 1 which broaden that claim may lead to a necessity for new prior art rejections.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 22, neither Choi nor Magidson teaches or suggests a method of making the filtering facepiece respirator as claimed. The claim is found allowable for the same general reasons discussed above in regard to claim 15.
Note is made that the allowability of the claim is in part based upon the claim language identified in claim 1 as lacking sufficient written description support (i.e. multiple inlet port passageways and outlet port passageways) as well as the interpretation applied to claim 1 in response to the 35 U.S.C. 112(b) rejection of that claim (i.e. requiring some filter structure and/or material). Applicant is cautioned that amendments to claim 1 which broaden that claim may lead to a necessity for new prior art rejections.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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