DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of species I in the reply filed on October 19, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 19, 2025.
Information Disclosure Statement
4. The information disclosure statement filed July 24, 2023 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the documents that are crossed out, as indicated on the IDS form, are not considered. The information disclosure statement filed on July 24, 2023 includes references Braun et al. (US 5,033,485) and Greer et al. (US 2006/0196957) which are not considered due to discrepancies between author names in the IDS and in the cited documents.
Drawings
5. The drawings are objected to because, for example:
Applicant used the English alphabet, i.e., “B”, “F”, “D”, and “R” in figure 1 to represent structures. The English alphabet must be used as letters. See 37 CFR 1.84(p)(2). Applicant is suggested to use numbers instead of the English alphabet to represent drawing structures. In addition, the English alphabet in figures 1 and 2 are missing lead lines. See 37 CFR 1.84(q).
Figs. 3A, 4, 5A, 6A, 9, 9B, 10, and 11 are objected to due to the filter element having hatch lines which suggests it is a solid body which contradicts a normal filter structure which allows air to pass through.
Figs. 1-11 are objected to due to an improper legend being placed underneath each figure label. See 37 C.F.R. 1.84(o). It is suggested to instead provide these short descriptions in the brief description of embodiments, see the arrangement and content of the specification provided in the specification objections below.
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.
Specification
6. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The phrase “Methods of use” in line 9 of the abstract is unclear as to what is being referred to.
7. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
8. The disclosure is objected to because of the following informalities:
Beginning on page 18 of the specification, pages and figures are cited in reference to the appendices of previous applications. However, the page and figure references are unclear because the referenced figure is not provided in the drawings and the figure/page numbers being referenced are the same as those in the provided disclosure.
Appropriate correction is required.
Claim Objections
9. Claims 1 and 11 are objected to because of the following informalities:
Claim 1 recites the phrase “its inlet side” in line 8, it is suggested to change this to –the inlet side—to clarify what is being referred to.
the phrase “See FIG. 10.” in line 5 is improper. It is suggested to remove the reference to a figure, see MPEP 2173.05(s).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 1-11 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 term “can” in line 7 is unclear if the filtration device can or cannot be mounted by the adhesive layer since the term “can” can be defined as providing possibility.
Regarding claim 6, the term “type” in line 2 is unclear because there are no metes and bounds to the limitation due to the relative nature of the term “type”. Therefore, the structure of the filter is indefinite as it could be a pad filter or some other structure.
Claim(s) 2-5 and 7-11 is/are rejected due to being dependent on a rejected claim.
Claim Rejections - 35 USC § 102
12. 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.
13. 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.
14. Claim(s) 1-2, 4, and 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (WO 9401199).
Regarding claim 1, Smith discloses a filtration device (figs. 1-3 show a filter 2 meant for filtering air breathed through a tracheostoma) suitable to be mounted to a facemask (fig. 3, shows use of adhesive 18 which is used to affix the filter to the user, due to the adhesive, it could be similarly mounted to an opening on a respiratory mask) having a port (fig. 2, cover layers 4 and 6 have perforations which are interpreted as a port) comprising:
a plastic sheet (fig. 2, cover layer 4) having an inlet port (page 15, lines 7-13 states option 1 can be used for the cover layers 4 and 6, page 12, lines 11-19 state the cover layer can be perforated, see fig. 2, where a single perforation is being interpreted as an inlet port);
a sponge element (fig. 2, intermediate layer 10, page 12, lines 20-26 state that the intermediate layers acts as a pre-filter with a relatively large filter size that can exchange heat and moisture and therefore acts as a sponge) disposed behind the plastic sheet (fig. 2, when considering cover layer 4 as the innermost layer, intermediate layer 10 is behind it);
a filter element (fig. 2, central layer 8) disposed behind the sponge element (fig. 2, central layer 8 is behind intermediate layer 10 and cover layer 4);
an adhesive layer (fig. 3, adhesive 18) disposed on the plastic sheet about the inlet port (see annotated fig. 3 below, adhesive 18 is positioned on the peripheral portions thereby not interfering with the perforations);
wherein the filtration device has an inlet side (fig. 3, the side with the adhesive opposite of cover layer 6) and an outlet side (fig. 3, the side with cover layer 6) and can be mounted at is inlet side by the adhesive layer (fig. 3, adhesive 18 allows mounting) to the facemask with the inlet port of the filtration device aligned with the mask port (fig. 3, the adhesive 18 around the perforations allows for mounting on various surfaces including an opening on a respiratory mask).
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Regarding claim 2, the device of Smith discloses the limitations of claim 1 and further discloses a flexible substrate disposed between the plastic sheet and the adhesive layer (fig. 3, backing sheet 16 is between a cover layer and adhesive 18) and having an opening aligned with the inlet port of the filtration device (fig. 3, the shape of backing sheet 16 matches that of the adhesive 18 meaning it similarly aligns with the openings on the cover layers).
Regarding claim 4, the device of Smith discloses the limitations of claim 1 and further discloses the plastic sheet comprises polyethylene (fig. 2, cover layer 4 can be made of polypropylene and polyethylene, see page 15, lines 7-18).
Regarding claim 7, the device of Smith discloses the limitations of claim 1 and further discloses a protective cover (fig. 2, cover layer 6) disposed over the filter element on the outlet side of the filtration device (fig. 3, cover layer 6 is shown to be on the outside relative to adhesive 18) to protect the filter element from contamination (page 7, lines 24-27 state that the cover layers can protect the filter in use).
Regarding claim 8, the device of Smith discloses the limitations of claim 7 and further discloses perforations in the protective cover (page 12, lines 11-19 states the cover layer is perforated) to allow air exhaled by a patient to exit the filtration device (fig. 2, the perforated cover layers 4, 6 allow air the flow through the filter device).
Regarding claim 9, the device of Smith discloses the limitations of claim 7 and further discloses a second sponge element (fig. 2, intermediate layer 12, has the same structure as intermediate layer 10, see page 15, lines 1-6) disposed between the filter element and the protective cover (fig. 2, intermediate layer 12 is between the central layer 8 which is the filter element and cover layer 6 which is the protective cover).
Regarding claim 10, the device of Smith discloses the limitations of claim 7 and further discloses the protective cover comprises an additional plastic sheet (fig. 2, cover layer 6 is shown to be an additional plastic sheet).
Regarding claim 11, the device of Smith discloses the limitations of claim 1 and further discloses a cutout (fig. 2, the pores in intermediate layer 10 are defined as the cutout, see page 15, lines 1-6 which states that the intermediate layers are made of a non-woven fabric, page 12, lines 20-26 state that the central layer is where particulate matter is filtered meaning they can pass through the intermediate layers due to a relatively large pore size) extending into the sponge element (fig. 2, intermediate layer 10 has pores that are a part of the layer) from the inlet side of the filtration device, at least partially through the sponge element towards the outlet side of the filtration device (fig. 3, intermediate layer 10 has pores extending in a direction from the inlet side to the outlet side to allow air to pass through) to allow a flap of a non-rebreather facemask to move outward when a patient wearing the facemask exhales (fig. 3, the intermediate layer 10 is shown to be elevated away from a surface due to the adhesive 18 meaning a flap could open without being impacted by the intermediate layer 10).
Claim Rejections - 35 USC § 103
15. 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.
16. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith as evidenced by Bach et al. (US 2010/0191201).
Regarding claim 3, the device of Smith discloses the limitations of claim 1, and further discloses that the adhesive allows disguising of the filter under normal clothes (Smith page 9, lines 9-13) and can be a hydrocolloid composition (Smith page 9, lines 18-24) which is known to be pressure-sensitive (see Bach paragraph [0007]). Smith does not expressly disclose the thickness of the adhesive layer.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the thickness of the adhesive in the Smith device to be approximately 2 mil because Applicant has not provided criticality that the specific thickness of the adhesive provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating the adhesive layer may comprise a thickness of 2 mil on the first paragraph of page 8 in the specification. Further, it appears the filter of Smith would perform equally well with the recited thickness.
17. Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith.
Regarding claim 5, the device of Smith discloses the limitations of claim 1, but is silent on the thickness of the plastic sheet (fig. 2, cover layer 4).
However, it would have been an obvious matter of design choice to one of ordinary skill before the effective filing date of the claimed invention to modify the thickness of the cover layer of the Smith device to have a thickness of approximately 6 mil since such a modification would have involved a mere change in the form or shape of a component. A change in shape or form is generally recognized as being within the level of ordinary skill in the art. Further, Applicant has not provided criticality that the thickness of the sheet provides and advantage, is used for a particular purpose, or solves a stated problem. It appears the modified device of Smith would perform equally well with the recited thickness.
Regarding claim 6, the device of Smith discloses the limitations of claim 1, and further discloses that the filter element (fig. 2, central layer 8) has a thickness between 0.5-1.0 mm (page 14, lines 21-31). Smith does not disclose that the central layer has a thickness of approximately 1.1 mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the thickness of the filter element of the device of Smith to have a thickness of approximately 1 .1 mm, for the purpose of providing a thickness that would be capable of filtering particulate matter, pollutants, and micro-organisms (Smith page 12, paragraph 7), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the thickness of the filter element provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the filter element may be 1.1 mm thick, see the 4th paragraph of page 9 in the specification. Further it appears the central layer of Smith would perform equally well with the recited thickness. MPEP 2144.05(II).
Double Patenting
18. Claims 1-2 of this application is patentably indistinct from claims 12 and 19 of Application No. 17/734,133. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Application 18/225,175
Copending Application 17/734,133
Claim 1: A filtration device (FD) suitable to be mounted to a facemask (M) having a port (P), comprising:
Claim 7: An exhalation filtration device (FD) comprising:
a plastic sheet (PS) having an inlet port (IP);
a plastic sheet (PS) having a periphery and an inlet port (IP);
a filter element (FE) disposed behind the sponge element (SE); and
a filter element (FE) disposed behind the plastic sheet; and
a sponge element (SE) disposed behind the plastic sheet (PS);
an aerosol separator (AS) disposed behind the plastic sheet, between the plastic sheet and the filter element; Claim 12/19: The filtration device of claim 7, wherein: the aerosol separator comprises a sponge element (SE).
an adhesive layer (AL) disposed on the plastic sheet (PS) about the inlet port (IP); wherein the filtration device (FD) has an inlet side and an outlet side and can be mounted at its inlet side by the adhesive layer (AL) to the facemask with the inlet port (IP) of the filtration device (FD) aligned with the mask port (P).
wherein the filtration device is adapted for mounting to a respiratory mask (M) having a port (P); an adhesive layer (AL) disposed on a front surface of the plastic sheet (PS) for mounting the filtration device to the mask with the inlet port of the filtration device aligned with the port (P) of the mask (M);
Claim 2: The filtration device (FD) of claim 1, further comprising: a flexible substrate (FS) disposed between the plastic sheet (PS) and the adhesive layer (AL) and having an opening aligned with the inlet port (IP) of the filtration device (FD).
a flexible substrate (FS) disposed between the adhesive layer and the front surface of the plastic sheet and having an opening aligned with the inlet port of the filtration device.
Claim 12 and 19 of Copending Application 17/734,133 fails to disclose that the filtration device has an inlet side and an outlet side. However, an inlet side and an outlet side are inherently in a filtering device with an inlet port and inherent outlet port as presented in copending claim 12 and 19.
Claim 12 and 19 of Copending Application 17/734,133 fails to disclose the plastic sheet having a periphery. However, a periphery, is inherent in a plastic sheet with any shape.
Thus, it is apparent, for the broadening aspect, that copending claims 12 and 19 include features that are not in application claims 1 and 2, see the underlined limitations. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
19. Claims 1-7 and 10-11 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 7, 12, 5, 16, 17, 18, 20, 20, and 12 respectively, of Application No. 17/734,133 hereinafter ‘133 in view of Cerbini et al. (US 2005/0034728).
Although the claims are not identical, they are not patentably distinct from one another. The application claims are broader in at least one aspect and also recite additional features not claimed in the patent claims.
For claim 1:
Regarding the broadening aspect of the application claims, the following comparison between the patent claims and the application claims highlights (see underlined features in the patent claims) what elements have been excluded in the presentation of the application claims.
Application 18/225,175
Copending Application 17/734,133
Claim 1:
A filtration device (FD) suitable to be mounted to a facemask (M) having a port (P), comprising:
a plastic sheet (PS) having an inlet port (IP);
a filter element (FE) disposed behind the sponge element (SE); and
a sponge element (SE) disposed behind the plastic sheet (PS);
an adhesive layer (AL) disposed on the plastic sheet (PS) about the inlet port (IP); wherein the filtration device (FD) has an inlet side and an outlet side and can be mounted at its inlet side by the adhesive layer (AL) to the facemask with the inlet port (IP) of the filtration device (FD) aligned with the mask port (P).
Claim 7:
An exhalation filtration device (FD) comprising:
a plastic sheet (PS) having a periphery and an inlet port (IP);
a filter element (FE) disposed behind the plastic sheet; and
an aerosol separator (AS) disposed behind the plastic sheet, between the plastic sheet and the filter element;
wherein the filtration device is adapted for mounting to a respiratory mask (M) having a port (P);further comprising:
an adhesive layer (AL) disposed on a front surface of the plastic sheet (PS) for mounting the filtration device to the mask with the inlet port of the filtration device aligned with the port (P) of the mask (M);
further comprising: a flexible substrate (FS) disposed between the adhesive layer and the front surface of the plastic sheet and having an opening aligned with the inlet port of the filtration device.
Thus, it is apparent, for the broadening aspect, that copending claim 7 includes features that are not in application claim 1, see the underlined limitations. Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Since application claim 1 is anticipated by copending claim 7, with respect to the broadening aspect, and since anticipation is the epitome of obviousness, then application claim 1 is obvious over copending claim 7 with respect to the broadening aspect.
With respect to the additional features recited in application claim 1,
Claim 7 of Copending Application ‘133 fails to disclose that the filtration device has an inlet side and an outlet side. However, an inlet side and an outlet side are inherently in a filtering device with an inlet port and inherent outlet port as presented in copending claim 7.
Claim 7 of Copending Application ‘133 fails to disclose the plastic sheet having a periphery. However, a periphery, is inherent in a plastic sheet with any shape.
Claim 7 of Copending Application ‘133 recites an aerosol separator but fails to recite a sponge element. However, Cerbini teaches of a filter which can absorb liquids and therefore acts as a sponge when contacted by liquids contaminated by bacteria and viruses ([0049]). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the aerosol separator of ‘133 with the filter as taught by Cerbini as a simple substitution of one known element for another to obtain a predictable result of being able to capturing aerosols from the inlet of the filter device.
For dependent claims 2-6, the recited limitations are contained in ‘133 claims 7, 5, 16, 17, and 18 respectively.
For dependent claim 7, the recited limitations are contained in ‘133 claim 20
Application 18/225,175
Copending Application 17/734,133
Claim 7:
The filtration device (FD) of claim 1, further comprising:
a protective cover (PC)
disposed over the filter element (FE), on the outlet side of the filtration device (FD),
to protect the filter element (FE) from contamination.
Claim 20:
The filtration device of claim 7, further comprising:
a second plastic sheet (PS2)
disposed on a back side of the filtration device,
behind the filter element.
For dependent claim 10, the recited limitations are contained in ‘133 claim 20
Application 18/225,175
Copending Application 17/734,133
Claim 10:
The filtration device (FD) of claim 7, wherein:
the protective cover (PC) comprises an additional plastic sheet or a folded-over extension of the (first) plastic sheet.
Claim 20:
The filtration device of claim 7, further comprising:
a second plastic sheet (PS2)
disposed on a back side of the filtration device,
behind the filter element.
Where the underlined portion indicates an alternative structure which makes the instant application claim broader than the copending claim 20 of ‘133.
For dependent claim 11, the recited limitations are contained in ‘133 claim 12 where the sponge element has pores (the cutout that extends into the sponge) which allow a flap of a non-rebreather mask to move outward when a patient exhales (the pores do not impact movement of a non-rebreather mask).
20. Claims 8-9 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 7 of ‘133 in view of Cerbini and Smith.
For dependent claim 8¸ ‘133 claim 7 fails to disclose perforations in the protective cover to allow air exhaled by a patient to exit the filtration device.
However, Smith teaches of a cover layer with perforations (page 12, lines 11-19 states the cover layer is perforated).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the protective cover of ‘133 with the perforated cover layer of Smith as a simple substitution of one known element for another to obtain a predictable result of allowing exhaled gas to exit the device.
For dependent claim 9, ‘133 claim 7 fails to disclose a second sponge element between the filter element and the protective cover.
However, Smith teaches of a sponge element (fig. 2, intermediate layer 12, has the same structure as intermediate layer 10, see page 15, lines 1-6) for exchanging heat and moisture (page 12, lines 20-26).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of ‘133 with the intermediate layer of Smith for the purpose of improving heat and moisture exchange in the filter device (Smith page 12, lines 20-26).
Conclusion
21. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Groth et al. (US 2021/0106937) discloses a filter cartridge that has a filter media (fig. 2, 54) and a plenum 74 encapsulated by a fluid inlet 44 which allows gas to pass through ([0051]). Hacke et al. (US 2009/0250060) discloses a disposable mask with a disc valve (figs. 10-13) which extends during exhalation ([0053]). Xu et al. (US 2004/0226563) discloses a face mask with an exhalation device (fig. 2, 108) with filter 120 that comprises a moisture protection layer 120b and a filter 120a within housing 118, the exhalation device further includes a filter cap 122 with an inlet port that holds the filter in place ([0067]). Hanuka et al. (US 2016/0166424) discloses a gas filter for an ostomy applicant with a sealing element (fig. 1b, 115) that creates a space between the ostomy wafer 120 and the gas filter 160. Haughey et al. (US 5,140,980) discloses a filter system for a hood mask (fig. 1) that uses a holder 24 and flange member 25 to seal a screen 21, aerosol filter layer 22, and porous separator 23 against a mask opening 19.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Thursday (Every other Friday) 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at (571)272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TU A VO/Primary Examiner, Art Unit 3785