Prosecution Insights
Last updated: April 19, 2026
Application No. 18/786,021

A MASK WITH A VALVE

Final Rejection §103§112
Filed
Jul 26, 2024
Examiner
RUDDIE, ELLIOT S
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Dcstar Inc.
OA Round
4 (Final)
65%
Grant Probability
Favorable
5-6
OA Rounds
3y 9m
To Grant
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allow Rate
303 granted / 464 resolved
-4.7% vs TC avg
Strong +43% interview lift
Without
With
+42.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
36 currently pending
Career history
500
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
48.3%
+8.3% vs TC avg
§102
17.6%
-22.4% vs TC avg
§112
24.9%
-15.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 464 resolved cases

Office Action

§103 §112
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 This Office Action is responsive to the amendment filed on May 9, 2025. As directed by the amendment: claims 1, 7, 13, and 18 have been amended; and claims 8-9 have been cancelled. Thus, claims 1-7, 10-16 and 18-23 are presently pending in this application. Claim(s) 1-5 and 7-23 were previously rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al (U.S. Pub. No. 2009/0187113). Claim(s) 6 was previously rejected under 35 U.S.C. 103 as being unpatentable over Friedman et al. in view of Denyer et al. (U.S. Pat. No. 6,192,876). Applicant's amendments necessitated the application of new grounds of rejection in light of prior art, shown below. Information Disclosure Statement Acknowledgement is made to Applicant's lack of an Information Disclosure Statement submission. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim 19 is 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. Claim 19 recites “wherein the plurality of slits are provided”, ln 1-2. There is insufficient antecedent basis for “the plurality of slits” limitation in the claim. Examiner believes an amendment error occurred. Therefore, claim 19 for the purpose of this Office Action has been interpreted as --wherein the valve assembly includes a plurality of slits provided--. 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. Claim(s) 1-4, 6-7, 10-16, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (U.S. Pat. No. 3,777,757; hereinafter: “Gray”) in view of He (U.S. Pat. No. 11,478,575). Regarding Claim 1, Gray discloses a mask with a valve, configured to provide protection for a device with the mask in multiple fields, the mask comprising: a mask body (A, Fig. A annotated below), having a first end (B, Fig. A annotated below) configured to be in contact with a face of a user and a second end (C, Fig. A annotated below) opposite the first end, wherein the first end of the mask body is configured to at least partially cover an entrance of a nasal and/or oral airway of the user (Fig. 4); a connecting part (D, Fig. A annotated below), having a third end (E, Fig. A annotated below) adjacent to the second end and a fourth end (F, Fig. A annotated below) opposite the third end, wherein the connecting part forms a through passage (G, Fig. A annotated below) that is at least formed by sides of the connecting part that extend between the third end and the fourth end (Fig. 4) and that is configured to expel airflow from the mask body (col 5, ln 53 to col 6, ln 16); and a valve assembly (H and I, Fig. A annotated below), wherein the valve assembly is provided at least partially on the through passage (Fig. 4; col 5, ln 53 to col 6, ln 16), and wherein the valve assembly comprises the valve (Fig. 4; col 5, ln 53 to col 6, ln 16) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (Fig. 4; col 5, ln 53 to col 6, ln 16) and prevents the airflow in an opposite direction through the connecting part (Fig. 4; col 5, ln 53 to col 6, ln 16). PNG media_image1.png 427 665 media_image1.png Greyscale Figure A, Adapted from Figure 4 of Gray. Gray does not specifically disclose the mask wherein the valve assembly includes a plurality of slits to allow the valve assembly to open when airflow is permitted in the direction of the airflow. He teaches a valve assembly (21, 212, 2121, 26; Fig. 3-4) is provided at least partially on a through passage (26; Fig. 3-4; col 6, ln 51 to col 7, ln 18), and wherein the valve assembly comprises a valve (21, Fig. 3-4; col 6, ln 51 to col 7, ln 18) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) and prevents the airflow in an opposite direction through the connecting part (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), wherein the valve assembly includes a plurality of slits (2121; Fig. 3) to allow the valve assembly to open when airflow is permitted in the direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (col 8, ln 40-48). 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 valve assembly of Gray to include the valve assembly being provided at least partially on the through passage, and wherein the valve assembly comprises the valve and is the one-way valve that is configured to allow the airflow to pass through the connecting part only in the direction of the airflow and prevents the airflow in the opposite direction through the connecting part, wherein the valve assembly includes the plurality of slits to allow the valve assembly to open when airflow is permitted in the direction of the airflow as taught by He for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (See He: col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (See He: col 8, ln 40-48). Regarding Claim 2, the modified device of Gray discloses the mask wherein at least one cross-section of the connecting part has a shape of a circle (See Gray: Fig. 4, See He: Fig. 3; col 6, ln 53-55). Regarding Claim 3, the modified device of Gray discloses the mask wherein at least part of the connecting part has an unbent shape (See Gray: Fig. 4, See He: Fig. 3; col 6, ln 53-55). Regarding Claim 4, the modified device of Gray discloses the mask wherein the valve assembly has two ends, and when there is no airflow, an area of one end differs from an area of another end (See He: Fig. 3; col 6, ln 51 to col 7, ln 18; col 8, ln 40-63). Regarding Claim 6, the modified device of Gray discloses the mask wherein the first end of the mask body further comprises a flexible pad (See Gray: 106; Fig. 4), and the flexible pad is configured to form a seal with the face of the user (See Gray: col 5, ln 61-62). Regarding Claim 7, Gray discloses a mask with a valve, configured to provide protection for a device with the mask in multiple fields, the mask comprising: a mask body (A, Fig. A annotated above), having a first end (B, Fig. A annotated above) configured to be in contact with a face of a user and a second end (C, Fig. A annotated above) opposite the first end, wherein the mask body is configured to at least partially cover an entrance of a nasal and/or oral airway of the user (Fig. 4); a connecting part (D, Fig. A annotated above), having a third end (E, Fig. A annotated above) adjacent to the second end and a fourth end (F, Fig. A annotated below) opposite the third end, wherein the connecting part forms a through passage (G, Fig. A annotated above) that is at least formed by sides of the connecting part that extend between the third end and the fourth end (Fig. 4) and that is configured to expel airflow from the mask body (col 5, ln 53 to col 6, ln 16); and a valve assembly (H and I, Fig. A annotated above), wherein the valve assembly is provided at least partially on the through passage (Fig. 4; col 5, ln 53 to col 6, ln 16), and wherein the valve assembly comprises the valve (Fig. 4; col 5, ln 53 to col 6, ln 16) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (Fig. 4; col 5, ln 53 to col 6, ln 16) and prevents the airflow in an opposite direction through the connecting part (Fig. 4; col 5, ln 53 to col 6, ln 16), and wherein an opening (at C, Fig. A annotated above where the connecting part is connected to the mask body.) is provided on the second end of the mask body. Gray does not specifically disclose the mask wherein the one-way valve is provided on top of the fourth end of the connecting part, and wherein a projected area of the valve assembly on the horizontal plane is greater than 30% of an area of the opening. He teaches a valve assembly (21, 212, 2121, 26; Fig. 3-4) is provided at least partially on a through passage (26; Fig. 3-4; col 6, ln 51 to col 7, ln 18), and wherein the valve assembly comprises a valve (21, Fig. 3-4; col 6, ln 51 to col 7, ln 18) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) and prevents the airflow in an opposite direction through the connecting part (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), wherein the valve assembly includes a plurality of slits (2121; Fig. 3) to allow the valve assembly to open when airflow is permitted in the direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), wherein the one-way valve is provided on top of a fourth end (A, Fig. B annotated below) of the connecting part and a projected area (B, Fig. B annotated below) of the valve assembly on a horizontal plane (C, Fig. B annotated below) is greater than 30% of an area (D, Fig. B annotated below) of the opening (Fig. 3; col 6, ln 51 to col 7, ln 18; col 8, ln 40-63; Examiner notes: He clearly depicts the projected area of the valve assembly as seen from the horizontal plane would cover the entirety of the area of the opening to ensure the closure of the opening when there is no flow through the through passage.) for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (col 8, ln 40-48). PNG media_image2.png 283 800 media_image2.png Greyscale Figure B, Adapted from Figure 3 of He. 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 valve assembly of Gray to include the one-way valve is provided on top of the fourth end of the connecting part, and wherein the projected area of the valve assembly on the horizontal plane is greater than 30% of the area of the opening as taught by He for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (See He: col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (See He: col 8, ln 40-48). Regarding Claim 10, the modified device of Gray discloses the mask wherein the valve assembly is configured to allow the airflow to flow from the first end towards the fourth end only (See He: col 6, ln 51 to col 7, ln 18; col 8, ln 40-63). Regarding Claim 11, the modified device of Gray discloses the mask wherein at least part of the valve assembly is connectable and secured to the connecting part (See He: col 9, ln 7-14). Regarding Claim 12, the modified device of Gray discloses the mask wherein a connection of at least part of the valve assembly to the connecting part is achieved through one or more of the following: adhesive bonding, welding, or mechanical structural connection (See He: col 9, ln 7-14). Regarding Claim 13, Gray discloses a mask with a valve, configured to provide protection for a device with the mask in multiple fields, the mask comprising: a mask body (A, Fig. A annotated above), having a first end (B, Fig. A annotated above) configured to be in contact with a face of a user and a second end (C, Fig. A annotated above) opposite the first end, wherein the mask body is configured to at least partially cover an entrance of a nasal and/or oral airway of the user (Fig. 4); a connecting part (D, Fig. A annotated above), having a third end (E, Fig. A annotated above) adjacent to the second end and a fourth end (F, Fig. A annotated below) opposite the third end, wherein the connecting part forms a through passage (G, Fig. A annotated above) that is at least formed by sides of the connecting part that extend between the third end and the fourth end (Fig. 4) and that is configured to expel airflow from the mask body (col 5, ln 53 to col 6, ln 16); and a valve assembly (H and I, Fig. A annotated above), wherein the valve assembly is provided at least partially on the through passage (Fig. 4; col 5, ln 53 to col 6, ln 16), and wherein the valve assembly comprises the valve (Fig. 4; col 5, ln 53 to col 6, ln 16) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (Fig. 4; col 5, ln 53 to col 6, ln 16) and prevents the airflow in an opposite direction through the connecting part (Fig. 4; col 5, ln 53 to col 6, ln 16. Gray does not specifically disclose the mask wherein the valve assembly includes a plurality of slits to allow the valve assembly to open when airflow is permitted in the direction of the airflow; and wherein, during a process of unidirectional airflow, a maximum area of the at least one airflow port is less than or equal to 38.485 cm2. He teaches a valve assembly (21, 212, 2121, 26; Fig. 3-4) is provided at least partially on a through passage (26; Fig. 3-4; col 6, ln 51 to col 7, ln 18), and wherein the valve assembly comprises a valve (21, Fig. 3-4; col 6, ln 51 to col 7, ln 18) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) and prevents the airflow in an opposite direction through the connecting part (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), wherein the valve assembly includes a plurality of slits (2121; Fig. 3) to allow the valve assembly to open when airflow is permitted in the direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (col 8, ln 40-48). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valve assembly of Gray to include the valve assembly being provided at least partially on the through passage, and wherein the valve assembly comprises the valve and is the one-way valve that is configured to allow the airflow to pass through the connecting part only in the direction of the airflow and prevents the airflow in the opposite direction through the connecting part, wherein the valve assembly includes the plurality of slits to allow the valve assembly to open when airflow is permitted in the direction of the airflow as taught by He for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (See He: col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (See He: col 8, ln 40-48). The modified device of Gray does not explicitly disclose the mask wherein, during a process of unidirectional airflow, a maximum area of the at least one airflow port is less than or equal to 38.485 cm2. There is no evidence of record that establishes that changing the maximum area of the at least one airflow port would result in a difference in function of the modified device of Gray. Further, a person having ordinary skill in the art, being faced with modifying, during a process of unidirectional airflow, a maximum area of the at least one airflow port to be less than or equal to 38.485 cm2 of the modified device of Gray, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the maximum area. Lastly, applicant has not disclosed that the claimed range solves any stated problem (Pg. 12, ln 9-10) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. 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 modified device of Gray to, during a process of unidirectional airflow, a maximum area of the at least one airflow port is less than or equal to 38.485 cm2 as an obvious matter of design choice within the skill of the art. Regarding Claim 14, the modified device of Gray discloses the mask wherein a central axis of the valve assembly (A, Fig. C annotated below) coincides with or is parallel to a central axis of the connecting part (B, Fig. C annotated below; See He: Fig. 3). PNG media_image3.png 232 790 media_image3.png Greyscale Figure C, Adapted from Figure 3 of He. Regarding Claim 15, the modified device of Gray discloses the mask of claim 13, shown above. The modified device of Gray does not specifically disclose the mask wherein a distance (A, Fig. D annotated below) from the valve assembly to the first end of the mask body is greater than one-tenth of a distance (B, Fig. D annotated below) from the second end of the mask body to the first end. PNG media_image4.png 742 826 media_image4.png Greyscale Figure D, Adapted from Figure 4 of Gray. Though prior art drawings are not interpreted as depicting scale, unless specified, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125.) In this case the modified device of Gray clearly depicts the distance (A, Fig. D annotated above) from the valve assembly to the first side of the mask body is greater than one-tenth of the distance (B, Fig. D annotated above) from the second side of the mask body to the first side. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distance from the valve assembly to the first side of the mask body to be greater than one-tenth of the distance from the second side of the mask body to the first side for the benefit of forming a compact mask with valve. Regarding Claim 16, the modified device of Gray discloses the mask of claim 13, shown above. The modified device of Gray does not specifically disclose the mask wherein a distance (C, Fig. F annotated above) between the valve assembly and the fourth end of the connecting part is less than or equal to a distance (D, Fig. F annotated above) between the first end of the mask body and the fourth end of the connecting part. Though prior art drawings are not interpreted as depicting scale, unless specified, the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). In this case the modified device of Gray clearly depicts the distance (C, Fig. F annotated above) between the valve assembly and the fourth end of the connecting part is less than or equal to the distance (D, Fig. F annotated above) between the first end of the mask body and the fourth end of the connecting part. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distance between the valve assembly and the fourth end of the connecting part to be less than or equal to the distance between the first end of the mask body and the fourth end of the connecting part for the benefit of forming a compact mask with valve. Regarding Claim 18, Gray discloses a mask with a valve, configured to provide protection for a device with the mask in multiple fields, the mask comprising: a mask body (A, Fig. A annotated above), having a first end (B, Fig. A annotated above) configured to be in contact with a face of a user and a second end (C, Fig. A annotated above) opposite the first end, wherein the mask body is configured to at least partially cover an entrance of a nasal and/or oral airway of the user (Fig. 4); a connecting part (D, Fig. A annotated above), having a third end (E, Fig. A annotated above) adjacent to the second end and a fourth end (F, Fig. A annotated below) opposite the third end, wherein the connecting part forms a through passage (G, Fig. A annotated above) that is at least formed by sides of the connecting part that extend between the third end and the fourth end (Fig. 4) and that is configured to expel airflow from the mask body (col 5, ln 53 to col 6, ln 16); and a valve assembly (H and I, Fig. A annotated above), wherein the valve assembly is provided at least partially on the through passage (Fig. 4; col 5, ln 53 to col 6, ln 16), and wherein the valve assembly comprises the valve (Fig. 4; col 5, ln 53 to col 6, ln 16) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (Fig. 4; col 5, ln 53 to col 6, ln 16) and prevents the airflow in an opposite direction through the connecting part (Fig. 4; col 5, ln 53 to col 6, ln 16), and wherein an opening (at C, Fig. A annotated above where the connecting part is connected to the mask body.) is provided on the second end of the mask body. Gray does not specifically disclose the mask wherein the one-way valve is provided on top of the fourth end of the connecting part, wherein the valve assembly comprises at least one thin region, wherein the at least one thin region has a thickness thinner than other parts of the valve assembly, and is configured to deform to allow unidirectional airflow through the valve assembly; and wherein a thickness of at least part of the at least one thin region is less than or equal to 5 mm. He teaches a valve assembly (21, 212, 2121, 26; Fig. 3-4) is provided at least partially on a through passage (26; Fig. 3-4; col 6, ln 51 to col 7, ln 18), and wherein the valve assembly comprises a valve (21, Fig. 3-4; col 6, ln 51 to col 7, ln 18) and is a one-way valve that is configured to allow the airflow to pass through the connecting part only in a direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) and prevents the airflow in an opposite direction through the connecting part (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), wherein the valve assembly includes a plurality of slits (2121; Fig. 3) to allow the valve assembly to open when airflow is permitted in the direction of the airflow (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), wherein the one-way valve is provided on top of a fourth end (A, Fig. B annotated above) of the connecting part wherein the valve assembly comprises at least one thin region (A, Fig. E annotated below), wherein the at least one thin region has a thickness thinner than other parts of the valve assembly (Fig. 4; col 6, ln 51 to col 7, ln 18; col 8, ln 40-63), and is configured to deform to allow unidirectional airflow through the valve assembly (col 6, ln 51 to col 7, ln 18; col 8, ln 40-63) for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (col 8, ln 40-48). PNG media_image5.png 343 563 media_image5.png Greyscale Figure E, Adapted from Figure 4 of He. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the valve assembly of Gray to include the one-way valve is provided on top of the fourth end of the connecting part, wherein the valve assembly comprises at least one thin region, wherein the at least one thin region has the thickness thinner than other parts of the valve assembly, and is configured to deform to allow unidirectional airflow through the valve assembly as taught by He for the purpose of being easier to open (compared with other valve), and is conducive to extracting out obstructions in the respiratory tract of the patient (See He: col 8, ln 57-63) and when pressure is applied in the opposite direction of the permitted airflow the valve is closed more tightly (See He: col 8, ln 40-48). The modified device of Gray does not explicitly disclose the mask wherein a thickness of at least part of the at least one thin region is less than or equal to 5 mm. There is no evidence of record that establishes that changing thickness of at least part of the at least one thin region would result in a difference in function of the modified device of Gray. Further, a person having ordinary skill in the art, being faced with modifying the thickness of at least part of the at least one thin region to be less than or equal to 5 mm of the modified device of Gray, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness of at least part of the at least one thin region. Lastly, applicant has not disclosed that the claimed range solves any stated problem and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. 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 modified device of Gray to form the thickness of at least part of the at least one thin region is less than or equal to 5 mm as an obvious matter of design choice within the skill of the art Regarding claim 19, the modified device of Gray discloses the mask wherein the valve assembly includes a plurality of slits (See He: 2121; Fig. 3; Examiner notes: See claim interpretation in 112b rejection, above.) provided on a middle of the at least one thin region and/or at a joining area of multiple thin regions (See He: col 6, ln 51 to col 7, ln 18; col 8, ln 40-63). Regarding claim 20, the modified device of Gray discloses the mask wherein the at least one thin region is configured so that it does not damage its material or performance during deformation (See He: col 6, ln 51 to col 7, ln 18; col 8, ln 40-63). Regarding claim 21, the modified device of Gray discloses the mask wherein at least part of the at least one thin region includes a flexible material (See He: col 6, ln 53-62; Examiner notes: He discloses the valve assembly is made from an elastic material.). Regarding claim 22, the modified device of Gray discloses the mask, shown above. The modified device of Gray does not specifically disclose the mask wherein the valve assembly and the connecting part are not integrally formed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form the valve assembly and the connecting part as not integrally, since it has been held by the courts making an integral structure separable (e.g. in a plurality of pieces), if so is desired, would require only ordinary skill. In re Dulberg, 129 USPQ 348, 349 (CCPA 1961) See MPEP 2144.04 V Regarding claim 23, the modified device of Gray discloses the mask wherein the valve assembly and the connecting part are integrally formed (See He: col 9, ln 7-11). Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gray in view of He as applied to claim 1 above, and further in view of Friedman et al (U.S. Pub. No. 2009/0187113; hereinafter: “Friedman”). Regarding Claim 5, the modified device of Gray discloses the mask wherein the valve of the valve assembly is made from an elastic material (See He: col 6, ln 53-62). The modified device of Gray does not specifically disclose the mask wherein the valve assembly includes one or more of the following materials: silicone, plastic, or metal. Friedman teaches a mask (102; Fig. 1, 2, 16, 22, 26) with a valve assembly (104; Fig. 1); wherein the valve assembly includes a valve (806; Fig. 9-15) with the material of silicone (¶ 0061) for the purpose of utilizing a flexible and deformable material (¶ 0061). 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 modified device of Gray to include the valve assembly including the material of silicone as taught by Friedman for the purpose of utilizing a flexible and deformable material (See Friedman: ¶ 0061). Response to Arguments Applicant’s arguments with respect to claim(s) 1, 7, 13, and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached on (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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Prosecution Timeline

Jul 26, 2024
Application Filed
Oct 18, 2024
Non-Final Rejection — §103, §112
Jan 23, 2025
Response Filed
Mar 06, 2025
Final Rejection — §103, §112
May 09, 2025
Response after Non-Final Action
Jun 09, 2025
Request for Continued Examination
Jun 11, 2025
Response after Non-Final Action
Aug 22, 2025
Non-Final Rejection — §103, §112
Nov 20, 2025
Response Filed
Mar 18, 2026
Final Rejection — §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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2y 5m to grant Granted Apr 14, 2026
Patent 12594390
CONTROL OF FLOW AND/OR PRESSURE PROVIDED BY BREATHING APPARATUS
2y 5m to grant Granted Apr 07, 2026
Patent 12594388
DEVICE TO DELIVER A PREDETERMINED AMOUNT OF A SUBSTANCE TO A NATURAL ORIFICE OF THE BODY
2y 5m to grant Granted Apr 07, 2026
Patent 12582783
DRY POWDER INHALERS AND INTERFACES FOR IMPROVED AEROSOL DELIVERY TO CHILDREN
2y 5m to grant Granted Mar 24, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
65%
Grant Probability
99%
With Interview (+42.7%)
3y 9m
Median Time to Grant
High
PTA Risk
Based on 464 resolved cases by this examiner. Grant probability derived from career allow rate.

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