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 .
Priority
Acknowledgment is made of applicant’s claim for Foreign Priority to Application No. (DE102022112288.3) filed on the May 17, 2022.
Claim Objections
Claims 1, 3-7, 9-10, 12-15, and 17-20 are objected to because of the following informalities:
Regarding Claim 1, line 7, “at least nose and mouth of the user” should read –
at least a nose and a mouth of the user—
Claims 3-6, 15, 17, 18, 19, and 20, “the filter element” should read as –at least one filter element—
Claim 7 recites the limitation "the mask wings" in line 2. In claim 1, where claim 7 is depended on, there is only “at least one mask wing”. Examiner suggests to amend and have claim 7 depend off of claim 2 which positively recites two mask wings each having a filter or to amend the claim to say –wherein the mask body, the mask bead, and the at least one mask wing with the at least one filter element—.
Claim 9 recites the limitation "the mask wings" in line 2. In claim 1, where claim 9 is depended on, there is “at least one mask wing”. Examiner suggests to amend and have claim 9 depend off of claim 2 which positively recites two mask wings each having a filter or to amend the claim to say – wherein at least the mask body and the at least one mask wing are integrally manufactured, and the at least one filter element are reversibly connected to the at least one mask wing.—.
Similarly, Claims 10, 12, 13, 14, “the mask wings” should read as –at least one mask wing—.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 7 and 8, by dependency, are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 7 positively recites “in which mouth and nose of the user are located, a respiratory gas flow away from the mouth and nose of the user and toward the mouth and nose of the user being exclusively possible through the filter material” in lines 3-5. It is suggested that the language be amended to read --… in which the mouth and the nose of the user are located, a respiratory gas configured to be flown away from the mouth and the nose of the user and toward the mouth and the nose of the user being exclusively possible through the filter material.—to overcome the rejection.
Claim Rejections - 35 USC § 112
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are: “wherein the mask bead is formed at least in sections thereof for contact on skin of a user, and presses against the skin of the user during use of the breathing mask in such a way that the breathing mask terminates essentially respiratory gas-tight,” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the “terminates essentially respiratory gas-tight” is best understood as the mask seals to the patient face when in use. In applicant instant specification, page 9 last paragraph, applicant recites that “the sealing lip 130 during use, terminates essentially respiratory gas-tight against the facial skin of the user”.
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 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. 4
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 7, 9, 13-15, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hine et al. (US 20090217926 A1), hereafter as Hine.
Regarding Claim 1, Hine discloses a breathing mask (Fig. 1-5), wherein the mask comprises a mask body (Fig. 1-5; mainly 4), a mask bead (Fig. 1-5; oro-nasal mask 2, 21, 22), at least one mask wing (Fig. 1-3; filter support element 3) and at least one filter element (Fig. 1; filter section 1, 5), the mask bead being connected to the mask body (Fig. 1-5; 2 is connected to 4), and the mask wing being connected to the mask body and/or the mask bead (Fig. 1-5; the wings 3 is connected to the 4 and 2; para. 0047), wherein the mask bead is formed at least in sections thereof for contact on skin of a user (para. 0031), and presses against the skin of the user during use of the breathing mask in such a way that the breathing mask terminates essentially respiratory gas-tight (para. 0031; Examiner notes: the periphery of the air guide seals to the wearer's face. This is desirable to prevent leakage of hot, moist exhaled air into the hood, which could create fogging), wherein the mask bead (2) includes a receptacle opening (Fig. 1; 22), which is designed and configured to receive at least nose and mouth of the user during use of the breathing mask (Examiner notes; This limitation is functional; para. 0049), and wherein the filter element (Fig. 1; 5) is connected to the mask wing (Fig. 1; 3), the filter element being configured and designed in such a way that respiratory gas can flow through it at least in some areas (Examiner notes: this limitation is functional; para. 0050-0051).
Regarding Claim 2, Hine discloses the breathing mask of claim 1, wherein the breathing mask (Figs. 1-5) comprises at least two mask wings (Fig. 1; 3 which is on either side of the mask; para. 0059), which are each connected to at least one filter element (Figs. 1-5; 5; para. 0050).
Regarding Claim 3, Hine discloses the breathing mask of claim 1, wherein the filter element (Figs. 1-5; 5; para. 0050) is a filter material and/or comprises a filter material (para.
Regarding Claim 7, Hine discloses the breathing mask of claim 1, wherein the mask body (Figs. 1-5), the mask bead (Fig. 1-5; oro-nasal mask 2, 21, 22), and the mask wings (Fig. 1-3; filter support element 3) with the filter elements (Fig. 1-3; 5), during use of the breathing mask, define a respiratory gas space in which mouth and nose of the user are located(Fig. 2; in 22), a respiratory gas flow away from the mouth and nose of the user and toward the mouth and nose of the user being exclusively possible through the filter material (para. 0022, 0025).
Regarding Claim 9, Hine discloses the breathing mask of claim 1, wherein at least the mask body (Fig. 1-5; 4) and the mask wings (Fig. 1-5; 3) are integrally manufactured (Examiner notes: BRI of “integrally manufactured” is interpretated to mean “connected together so as to make up a piece or unit”) and the filter elements (Fig. 1-5; 5) are reversibly connected to the mask wings (Examiner notes: The filter (5) could be reversed on either one of the wings as there are able to be mounted and unmounted; Fig. 1; claim 14).
Regarding Claim 13, Hine discloses the breathing mask of claim 1, wherein the mask wings (Fig. 1-3; filter support element 3) comprise at least one wing duct having a lumen (Fig. 1; 31; para. 0048).
Regarding Claim 14, Hine discloses the breathing mask of claim 1, wherein the mask wings (Fig. 1-3; filter support element 3) comprise at least one receptacle device (Fig. 1; 31; para. 0048) for receiving the filter element (Fig. 1-5; 5), the receptacle device being made substantially complementary in shape to the filter element (Examiner notes: the space “substantially” fits the filter element 5).
Regarding Claim 15, Hine discloses the breathing mask of claim 14, wherein the receptacle device (Fig. 1; 31; para. 0048) and the filter element (Fig. 1-5; 5) essentially have a polygonal basic shape (Examiner notes: they are both rectangular; para. 0048). The prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125)).
Regarding Claim 17, Hine discloses the breathing mask of claim 14, wherein the filter element(Fig. 1-5; 5), after being received in the receptacle device(Fig. 1; 31; para. 0048), is at least partially enclosed by a receptacle side wall and is fixed by it in the receptacle device (Fig. 1-3).
Regarding Claim 18, Hine discloses the breathing mask of claim 1, wherein the filter element (Fig. 1-5; 5) comprises a front part (front of 5) and a rear part (Fig. 1, 32) and the filter material (inside 5), the filter material being arranged between the front part and the rear part (Fig. 1-2; para. 0048).
Regarding Claim 19, Hine discloses the breathing mask of claim 1, wherein the filter element (Fig. 1-5; 5) comprises at least one duct having a lumen (Fig. 4-5).
Regarding Claim 20, Hine discloses the breathing mask of claim 1, wherein the filter element (Fig. 1-5; 5) comprises a tunnel element having a lumen (Examiner notes: the BRI of tunnel is just a hole open on both ends, air flows in and out of the filter element, Fig. 1, 4-5).
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, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine, as applied to claim 1, in view of Dolezal et al. (US 20090007919 A1), hereafter as Dolezal.
Regarding Claim 4, Hine discloses the breathing mask of claim 1,
Hine does not disclose wherein the filter material is manufactured from polymer fibers.
However, Dolezal teaches filter material are manufactured from polymer fibers (164, 166; para. 0079).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the filters of Hine to be manufactured from polymer fibers as taught by Dolezal for the purpose of filtering finer particles (para. 0079).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine and Dolezal, as applied to claim 4, in view of Rekow et al. (US 20010013347 A1), hereafter as Rekow.
Regarding Claim 5, Modified Hine discloses the breathing mask of claim 1,
Modified Hine does not specifically disclose wherein the filter material has an area of from 35 cm2 to 55 cm2.
However, Rekow teaches that the filter material has cross-sectional area of from 10cm2 to 200 cm2 (para. 0025).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the area of Modified Hine to include a filter material has an area of from 10 cm2 to 200 cm2 as taught by Rekow as these are normal ranges for fluid flow of a non-compressed condition of a filter element, one would want the filter element to be of a certain area to form an interference fit with the retainer or receptable so it can exerts a compressive stress upon the filter element (para. 0024-0025).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine, as applied to claim 1, in view of Viner et al. (US 20040055604 A1), hereafter as Viner.
Regarding Claim 6, Hine discloses the breathing mask of claim 1,
Hine does not specifically disclose wherein the filter material is exchangeable (para. 0020; Examiner notes that filters are mounted meaning they can be unmounted).
However, Viner teaches that is well known in the art that the filter materials are exchangeable (para. 0002).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the that filters of Hine to be exchangeable as taught by Viner for the purpose of replacing the filter when the useful life ends (para. 0002).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine, as applied to claim 7, in view of Tovey (US 20100087749 A1).
Regarding Claim 8, Hine discloses the breathing mask of claim 7,
Hine does not disclose specifically wherein the respiratory gas space has a volume of at most 200 ml.
However, Tovey teaches wherein the respiratory gas space has a volume of about 100 ml (para. 0079).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mask of Hine to include that the respiratory gas space has a volume of about 100 ml as taught by Tovey because it is anticipated that this space within the support member will provide an opportunity for exhaled air to mix within the mask and what will be exhaled will be diluted with previously inhaled air from the dead space. It will also allow for condensation on the inner surface. These may reduce the sampling efficiency of the collection device (para. 0079).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine, as applied to claim 1, in view of Veliss et al. (US 20100313891 A1), Veliss.
Regarding Claim 10, Hine discloses the breathing mask of claim 1, wherein the mask bead is manufactured from a silicone (claim 18, para. 0047).
Hine does not specifically disclose the mask body, the mask wings are essentially manufactured from a silicone.
However, Veliss teaches the mask could essentially manufactured from a silicone and it is transparent (para. 0131, 0206).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mask of Hine to be manufactured from a silicone as taught by Veliss for the purpose of being comfortable for the patient and it can allow the clinician to view the nares of the patient (para. 0206).
Regarding Claim 11, Modified Hine discloses the breathing mask of claim 10, wherein the silicone is transparent (para. 0131, 0206; Veliss).
Modified Hine does not specifically disclose having a light transmission of at least 50%.
However, it would have been obvious to one of the ordinary skill in the art before the effective filling date of the claimed invention to modify the device of Modified Hine to have a light transmission of at least 50% since it has been held that “what the only difference between the prior art and the claims was a recitation of relative percentage of the claimed device and a device having the claimed relative percentage of light transmission would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Applicant has not disclosed that the 50% light transmission provides criticality as evidenced by the Applicant' s specification which recites “wherein the silicone has a light transmission of at least about 50%, preferably of at least about 80%, particularly preferably of at least about 90%.” (page 11, lines 20-22). In the instant case, the device of Modified Hine teaches that the mask is made of transparent silicone. One could reasonably conclude that such a mask would allow at least 50% of light transmission for the purpose of the patient's nares can be inspected through the cushion (para. 0025, 0131, 0206) and particularly important in the case of children to ensure that there are no physical obstructions to nasal breathing (para. 0131).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine, as applied to claim 1, in view of Heimbuch et al. (US 20210023326 A1), hereafter as Heimbuch.
Regarding Claim 12, Hine discloses the breathing mask of claim 1,
Hine does not specifically teach wherein at least the mask body, the mask bead, and the mask wings can be autoclaved (Examiner note: this limitation is functional, “can be” can also be read on as “cannot” as this limitation is not positively recited).
However, Heimbuch teaches wherein at least masks, filters can be sterilized using autoclaved (para. 0040, 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the mask of Hine to be autoclaved as taught by Heimbuch for the purpose of longer shelf life and lower cost for the user (para. 0094).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine, as applied to claim 14, in view of Skov et al. (US 20150217144 A1), hereafter as Skov.
Regarding Claim 16, Hine discloses the breathing mask of claim 14,
Hine does not specifically teach that the receptacle device comprises at least one receptacle side wall, which is elastically deformable.
However, Skov teaches that the receptacle device (Fig. 3-4; 19) comprises at least one receptacle side wall (19), which is elastically deformable (para. 0009-0010, 0018, 0034).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the locking means of Hine to include the that the receptacle device comprises at least one receptacle side wall, which is elastically deformable as taught by Skov for the purpose of achieve a self-retention of the locking mechanism (para. 0034) and provides a spring force which can be used to safely lock the filter module in place by means of the coupling elements (para. 0018).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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/MAAP ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785