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 .
Status of Claims
The present office action is in response to the Remarks and Amendment filed 01/22/2024. As directed by the amendment, claims 1-13 have been amended. Thus, claims 1-13 are presenting pending in this application.
Specification
The disclosure is objected to because of the following informalities:
Amended ¶0001, lines 1-4 of the Specification filed 01/22/2024, recites “The present disclosure is a §371 of international PCT Application No. PCT/1B2022/056335, filed July 8, 2022, which claims priority to Italian Application No. 102021000019430, filed on July 22, 2021, the entire contents of each of which are incorporated herein by reference in their entirety.”
Examiner suggest replacing this paragraph with --The present disclosure is a §371 of international PCT Application No. PCT/1B2022/056335, filed July 8, 2022, which claims priority to Italian Application No. 102021000019430, filed on July 22, 2021.--
Examiner notes that the filing date of the PCT is the filing date for the national stage application. Therefore, any amendment that comes in with or after the filing of the national stage application in the US is not part of the original disclosure. Per MPEP 608.01(p)(I)(B) states that to be effective an incorporation by reference statement must be filing at time of filing and cannot be added after an application’s filing date. Since a 371 application’s filing date is the date the PCT was filed, an amendment in the 371 application to add an incorporation by reference is not effective and improper as new matter.
Appropriate correction is required.
Claim Objections
Claim objected to because of the following informalities:
Claim 1 recites, “solid and liquid hazardous and toxic dust particles, metal fumes, mist and micro-organisms, bacteria or viruses or a gas and particulate protective facemask/respirator” in ln 1-3 which Examiner interprets as a description of a facemask similarly to claim 13. The language may be confusing due to the arrangement of “or” and “and” in between as it may read into having suitability to individual limitation such as particles, fumes, mists, and etc. other than the facemask. Thus, Examiner suggest amending to read --a particulate or gas protection facemask-- similarly to claim 13.
Claim 1 recites, “facemask/respirator” in ln 3 which Examiner suggest amending to read --facemask-- similar to claim 13.
Claim 1 recites, “with said exhalation valve” in ln 6, and “through the exhalation valve” in ln 9 which Examiner suggest amending to read --with a selected exhalation valve of said at least one exhalation valve-- in ln 6 and --through the selected exhalation valve of said at least one exhalation valve-- in ln 9.
Examiner suggest amending the limitation, “the exhalation valve” to read --the at least one exhalation valve-- or -- the selected exhalation valve of the at least one exhalation-- through dependent claims for consistency with claim 1, ln 4 as the adaptor is used on a single valve at a time during the testing while the facemask may have one or more exhalation valves.
Claim 1 recites, “the air” in ln 10 which Examiner suggest amending to read --an air--
Claim 3 recites, “cylindrical and cup-shaped” in ln 2 which Examiner suggest amending to read --a cylindrical and cup-shaped--
Claim 3 recites, “the facemask body” in ln 5-6 which Examiner suggest amending to read --a facemask body--
Claim 4 recites, “and facemask body” in ln 3 which Examiner suggest amending to read --and a facemask body--
Claim 5 recites, “the opening” in ln 3 which Examiner suggest amending to read --the through opening-- for consistency with claim 3, ln 4.
Claim 9 recites, “is positioned at” in ln 2 which Examiner suggest amending to read --configured to be positioned at-- to avoid possible positively reciting the human organism.
Claim 9 recites, “his/her” in ln 3 which Examiner suggest amending to read --the user’s--
Claim 12 recites, “a facemask” in ln 2 which Examiner suggest amending to read --the facemask--
Claim 13 recites, “being of the” in ln 2 which Examiner suggest amending to read --is a-- similar to amendments in claim 6
Appropriate correction is required.
Claim Interpretation
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.
The following limitation is interpreted under 35 U.S.C. 112(f) in accordance with the above presumptions:
fastening means in claim 4
The following is considered the corresponding structure for the above limitation:
a projecting ring or annular portion and a recess for a snap fitting as described in ¶0034 and Fig 3
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(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.
Claims 1-8, 10-11 and 13 are rejected under 35 U.S.C. 102(1) as being anticipated by Busch (US Pat 4832011; cited in IDS filed 01/22/2024).
Regarding claim 1, Busch discloses, an adaptor (an attachment 40, Fig 3) to allow fit testing the suitability of solid and liquid hazardous and toxic dust particles, metal fumes, mist and micro-organisms, bacteria or viruses or a gas and particulate protective facemask (a respirator 10, Fig 2; Examiner notes that the limitation, “solid and liquid hazardous… or a gas and particulate protective” is understood as an intended use of said mask that does not further limit the claimed invention), the facemask having at least one exhalation valve (exhalation valve/port 22 as shown in Figs 1-2; Col 4, ln 55-59, “The respirator is further provided with…an exhalation port 22 which is fitted with a one-way valve), said adaptor comprising:
an adaptor body (a housing 44, Fig 3) adapted to sealingly couple with a selected exhalation valve of said at least one exhalation valve of the facemask (said housing affixed to the exhalation valve as shown in Fig 5; Col 5, ln 31-Col 6, ln 22, implies that the attachment is affixed to the exhalation valve of the facemask),
said adaptor body including a first sampling tube (an outboard end of the tubing 62 as shown in Figs 2-3) protruding from said body (Col 5, ln 63-Col 6, ln 22, “The outboard end 62 of the tubing 50 is adapted to receive thereon a conduit 32 for withdrawing gas from the interior of the chamber 54 for analysis”) and connected to a second sampling tube (an interior end 64, Figs 5-6; Col 5, ln 63-Col 6, ln 22, implies that the tubing 50 are two pieces where the interior end 64 at location 55 as shown in Figs 5-6 can be removed if needed depending on analyzing location on the inboard side or on the outboard side of the flap valve) which passes through the selected exhalation valve of the facemask and ends inside such said facemask (Col 5, ln 63-Col 6, ln 22, “the interior end 64 of the tubing 50 is of sufficient length to bypass the conventional flap valve (not shown) of the exhalation port 22 to terminate just slightly interiorly of such flap valve….the end 64 of the tubing 50 defeats the seal of the flap valve”) and configured to allow an air inside to the facemask to be sampled (Col 5, ln 63-Col 6, ln 22, “The outboard end 62 of the tubing 50 is adapted to receive thereon a conduit 32 for withdrawing gas from the interior of the chamber 54 for analysis”), the suitability of the facemask being tested through the first sampling tube (Col 5, ln 63-Col 6, ln 22, implies that the gas from the respirator is withdrawn via the inward end which passes through the flap of the exhalation valve and to outboard end which is connected to the analyzer).
Regarding claim 2, Busch discloses the adaptor of claim 1 as discussed above.
Busch recognized that the adaptor can be employed in the testing and can be readily affixed to a “working” respirator, the respirator tested, the adaptor removed, and the respirator would be placed in service (Col 4, ln 29-42) and also notes that method involving wherein the user is removed from the environment and the present attachment is removed from the respirator (Col 7, ln 7-14) by the annual seal and the annual shoulder which allows the valve to snap-fit and sealed against the flow of gas between these element (Col 5, ln 31-62 and in view of Fig 5). Thus, it could have reasonably be reused as long as it is not contaminated with prior testing in purpose of saving cost without unexpected result. Looking at other consideration, Examiner notes that the Busch does not specifically disclose that the device has to be disposed of after a single use.
Regarding claim 3, Busch discloses the adaptor of claim 1 as discussed above.
Busch further discloses, wherein said adaptor body is a cylindrical and cup-shaped (as shown in Fig 2-5; Examiner notes that the shape of cups are broad, so Examiner interprets to --any shape having a recess--) and includes a first end (an open end 46 of the housing 40, Fig 6) and a second opposite end (an open end 48 of the housing 40, Fig 6) opposite the first end, the second end comprising a through opening (the opening 48 with an edge as shown in Fig 6) delimited by an edge and configured to cooperate directly with said exhalation valve and with a facemask body (Col 5, ln 31-62, “…the housing 44 is provided at its open end 48 with a series of locking lugs 56 about the interior circumferential rim 58 of the opening 48 that are adapted to engage an existing annular shoulder provided on the exterior periphery of the exhalation valve 22 of a conventional respirator”; implies that the second end is configured to engage the respirator via the exhalation valve of the respirator), said first end having a through hole (as shown in Fig 6; Col 6, ln 23-44, implies the opening serving allows the air movement to the atmosphere via the flap 78).
Regarding claim 4, Busch discloses the adaptor of claim 1 as discussed above.
Busch further discloses, said adaptor body comprises fastening means (an open end 48 with a series of locking lugs 56 as shown in Fig 5) configured to cooperate with the selected exhalation valve and the facemask body to fasten said adaptor to said exhalation valve (Col 5, ln 31-62, implies that the open end is configured to engage the exhalation valve of the respirator).
Regarding claim 5, Busch discloses the adaptor of claim 3 as discussed above.
Busch further discloses, wherein said fastening means are include an annular portion (a series of locking lugs 56 which are projecting close to the edge and delimiting the through opening of the second end 48 as shown in Fig 5) inside the adaptor body and projecting close to the edge and delimiting the through opening of the second end of said adaptor body and adapted to snap-fit to the exhalation valve (Col 5, ln 31-62, implies that the fastening means is configured to snap-fit to the exhalation valve as an annular reduced wall 60 permits the distortion and the rim 58 resiliently returns to its position after affixing the housing to the valve), a recess (a space above the lugs 56 which receives the annual shoulder on the exhalation valve as shown in Fig 5) being provided inside said second end adapted to receive a free end of said selected exhalation valve (Col 5, ln 31-62, implies that annular shoulder of the exhalation valve is received within the recess)
Regarding claim 6, Busch discloses the adaptor of claim 3 as discussed above.
Busch further discloses, wherein, at the through hole, the first end of the adaptor body comprises a radial structure (a spider 66 which has multiple arms 68 and 70, Figs 4-5), and a diaphragm (a flap valve 76, Fig 5) is placed in said radial structure and is fixed to the adaptor body (as shown in Fig 5; Col 6, ln 23-36, implies the flap valve arrangement on said radial structure within the housing of the adaptor).
Regarding claim 7, Busch discloses the adaptor of claim 6 as discussed above.
Busch further discloses, wherein the radial structure has a central hole (a central receptacle 72 receiving a central body 74, as shown in Figs 4-5) in which a tail (a tip 79, Fig 9) of the diaphragm (76, Fig 5) is placed so as to constrain the latter to the adaptor body (Col 6, ln 37-44, “the flap valve 76 is provided with a tip 79 interiorly of the chamber 54 intended to be an aid in inserting the body member 74 within the receptacle 72”).
Regarding claim 8, Busch discloses the adaptor of claim 1 as discussed above.
Busch further discloses, wherein the second sampling tube passes through a diaphragm of the selected exhalation valve (Col 5, ln 63-Col 6, ln 22, “the interior end 64 of the tubing 50 is of sufficient length to bypass the conventional flap valve (not shown) of the exhalation port 22 to terminate just slightly interiorly of such flap valve….the end 64 of the tubing 50 defeats the seal of the flap valve”).
Regarding claim 10, Busch discloses the adaptor of claim 1 as discussed above.
Busch further discloses, wherein the first sampling tube projects laterally to the adaptor body (as shown in Figs 2-3).
Regarding claim 11, Busch discloses the adaptor of claim 1 as discussed above.
Busch further discloses, wherein said first adaptor sampling tube is L-shaped (as shown in Fig 5).
Regarding claim 13, Busch discloses, an assembly (an assembly shown in Fig 2) of a particulate or gas and particulate protection facemask (10, Fig 2) and an adaptor (40, Fig 2) according to claim 1 (see claim 1 as discussed above),
said facemask is a half-face or full-face type (a half-face type mask as shown in Fig 2) and comprising an exhalation valve, wherein the adaptor body (a housing 44, Fig 3) is adapted to be fixed directly to the exhalation valve (exhalation valve/port 22 as shown in Figs 1-2; Col 4, ln 55-59, “The respirator is further provided with…an exhalation port 22 which is fitted with a one-way valve), to perform a functionality test of the facemask (Col 1, ln 5-8, attachment for use in testing; Col 5, ln 63-Col 6, ln 22),
said adaptor comprising a second sampling tube (an interior end 64, Figs 5-6; Col 5, ln 63-Col 6, ln 22, implies that the tubing 50 are two pieces where the interior end 64 at location 55 as shown in Figs 5-6 can be removed if needed depending on analyzing location on the inboard side or on the outboard side of the flap valve) which passes through the exhalation valve (Col 5, ln 63-Col 6, ln 22, “the interior end 64 of the tubing 50 is of sufficient length to bypass the conventional flap valve (not shown) of the exhalation port 22 to terminate just slightly interiorly of such flap valve….the end 64 of the tubing 50 defeats the seal of the flap valve”) and coupled to a first sampling tube (an outboard end of the tubing 62 as shown in Figs 2-3) protruding from said adaptor body and connected to a machine for fit testing the suitability of the facemask for each user (Col 1, ln 5-8; Col 5, ln 63-Col 6, ln 22, “The outboard end 62 of the tubing 50 is adapted to receive thereon a conduit 32 for withdrawing gas from the interior of the chamber 54 for analysis”).
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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Busch (US Pat 4832011; cited in IDS filed 01/22/2024) applied to claims 1 and 8 above in further view of Church et al. (WO 2020109915 A1).
Regarding claim 9, Busch discloses the adaptor of claim 8 as discussed above.
While the Fig 2 in view of Fig 5 of Busch shows the arrangement of the adaptor to the mask and the second sampling tube protruding into the exhalation valve of the mask, Busch is silent on a distance between the user’s face, in between his/her mouth and nose and the tube.
However, Church et al. which is analogous art to the claimed invention for a breath indicator for providing an indication of an inhalation and/or exhalation state of a user such as sampling the gas (abstract) and a method of protruding through a valve in order to sample gas (¶0596), teaches a distance between the user’s face, in between his/her mouth and nose and the tube (¶0597, “…can be about 1 mm to about 15 mm away from the nose and mouth of the patient. It should be understood proximate is about 1 mm to about 20 mm, but may be about 1 mm to about 10 mm away” in order to receive a suitable gas sample without contacting a patient (¶0598).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the adaptor of Busch to include wherein the second sampling tube is configured to be positioned at 10 mm from a user's face, in between the user’s mouth and nose as taught by Church et al. in order to receive a suitable gas sample without contacting a patient (¶0598).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 12, the closest identified prior art of the record is Busch (US Pat 4832011).
Busch discloses main components of the limitations of independent claim 1 as discussed above, but the prior art does not teach or suggest, wherein the adaptor is coupled to the facemask comprising lateral suction filters, and wherein the adaptor includes lateral bodies, provided with grids, projecting from the adaptor body configured to cover said lateral filters, said lateral bodies provided with grids being connected to buckles for straps of the facemask.
No other prior arts have been found that teaches or suggest all the claimed feature of claim 12.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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/J.J./Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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