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 .
This office action is in response to the election filed 5/13/26 and the claims filed 7/5/23. Claims 1-20 are pending in the instant application.
Election/Restrictions
Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 5/13/26.
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.
Claims 1-5 and 7-20 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 language “the second lock features” (line 7) is unclear as it is not sure if this is referring to the same “plurality of second lock features” set forth in line 4-5 or some particular subset thereof. Examiner suggests amending to read –the plurality of second lock features--.
Regarding claim 1, the language “the first lock features” (line 7) is unclear as it is not sure if this is referring to the same “plurality of first lock features” set forth in line 2 or some particular subset thereof. Examiner suggests amending to read –the plurality of first lock features--.
Regarding claim 2, the language “the first lock features” (line 1) is unclear as it is not sure if this is referring to the same “plurality of first lock features” set forth in claim 1 line 2 or some particular subset thereof. Examiner suggests amending to read –the plurality of first lock features--.
Regarding claim 2, the language “the second lock features” (line 2) is unclear as it is not sure if this is referring to the same “plurality of second lock features” set forth in claim 1 line 4-5 or some particular subset thereof. Examiner suggests amending to read –the plurality of second lock features--.
Regarding claim 2, the language “second lock features include pegs that extend axially from a surface of the second ring” (line 2-3, emphasis added) is unclear in light of the disclosure which shows pegs (28 Fig. 18-19, 528 Fig. 20, 628 Fig. 23, 728 Fig. 27) which extend radially from the second ring rather than axially, thus the metes and bounds of the claim are unclear as they appear to contradict the disclosure.
Regarding claim 4, the language “the end wall” (line 2) is unclear as it is not known if this is referring to the end wall of the second ring (claim 4 line 1) or the end wall of the first ring (claim 3 line 1).
Regarding claim 5, the language “the first lock features” (line 1 and 2, two instances) is unclear as it is not sure if this is referring to the same “plurality of first lock features” set forth in claim 1 line 2 or some particular subset thereof. Examiner suggests amending to read –the plurality of first lock features--.
Regarding claim 5, the language “the second lock features” (line 2) is unclear as it is not sure if this is referring to the same “plurality of second lock features” set forth in claim 1 line 4-5 or some particular subset thereof. Examiner suggests amending to read –the plurality of second lock features--.
Regarding claim 10, the language “the seal” (line 8, 10, 13) is unclear as the language “at least one seal” (line 5) sets forth the possibility of plural seals and it is not known if the language is referring back to the potential plural seals or referring to a particular one thereof. Examiner suggests amending to read –the at least one seal--.
Regarding claim 10, the language “the concentric rings” (line 10, 13) is unclear as it is not sure if this is referring to the same “plurality of concentric rings” set forth in line 7 or some particular subset thereof. Examiner suggests amending to read –the plurality of concentric rings--.
Regarding claim 10, the language “a flexible member …” (line 12) is unclear as line 7 has already set forth a flexible member for the seal and it is unclear if Applicant is intending to set forth an additional flexible member for the seal.
Regarding claim 10, the language “the flexible member” (line 14) is unclear because as discussed above, it is not known if Applicant is intending to claim one of or plural flexible members, and therefore it is unclear which, if plural exist, flexible member the language in line 14 is referring to.
Regarding claim 10, the language “the passage” (line 14 and 15-16, two instances) is unclear as the language “at least one passage” in line 2-3 sets forth the possibility of plural passages and it is therefore unclear which of the possible plural passages this language refers to. Examiner suggests amending to read –the at least one passage--.
Regarding claim 12, the language “the passage” (line 2) is unclear as the language “at least one passage” in claim 10 line 2-3 sets forth the possibility of plural passages and it is therefore unclear which of the possible plural passages this language refers to. Examiner suggests amending to read –the at least one passage--.
Regarding claim 13, the language “the flexible member” (line 1) is unclear because as discussed above, it is not known if Applicant is intending to claim one of or plural flexible members, and therefore it is unclear which, if plural exist, flexible member the language in line 1 is referring to.
Regarding claim 14, the language “the lock features” (line 3) is unclear as it is not sure if this is referring to the same “plurality of lock features” set forth in claim 10 line 9 or some particular subset thereof. Examiner suggests amending to read –the plurality of lock features--.
Regarding claim 14, the language “the circumferential wall” (line 3) is unclear as the language in line 1-2 sets forth plural circumferential walls, one for each of the concentric rings, and it is therefore unclear which of the plural circumferential walls the language in line 3 is referring to.
Regarding claim 15, the language “the lock features” (line 2) is unclear as it is not sure if this is referring to the same “plurality of lock features” set forth in claim 10 line 9 or some particular subset thereof. Examiner suggests amending to read –the plurality of lock features--.
Regarding claim 15, the language “the circumferential wall” (line 1) is unclear as the language in line 1-2 sets forth plural circumferential walls, one for each of the concentric rings, and it is therefore unclear which of the plural circumferential walls the language in line 1 is referring to.
Regarding claim 16, the language “the concentric rings” (line 3, 6, 7, 8, and 10) is unclear as it is not sure if this is referring to the same “plurality of concentric rings” set forth in line 2-3 or some particular subset thereof. Examiner suggests amending to read –the plurality of concentric rings--.
Regarding claim 17, the language “the lock features” (line 1) is unclear as it is not sure if this is referring to the same “plurality of lock features” set forth in claim 16 line 5 or some particular subset thereof. Examiner suggests amending to read –the plurality of lock features--.
Regarding claim 17, the language “the concentric rings” (line 3) is unclear as it is not sure if this is referring to the same “plurality of concentric rings” set forth in claim 16 line 2-3 or some particular subset thereof. Examiner suggests amending to read –the plurality of concentric rings--.
Regarding claim 18, the language “the lock features” (line 1) is unclear as it is not sure if this is referring to the same “plurality of lock features” set forth in claim 16 line 5 or some particular subset thereof. Examiner suggests amending to read –the plurality of lock features--.
Regarding claim 20, the language “the passage” (line 2) is unclear as the language “at least one passage” in claim 19 line 3 sets forth the possibility of plural passages and it is therefore unclear which of the possible plural passages this language refers to. Examiner suggests amending to read –the at least one passage--.
Claims 3, 7-9, 11, and 18-19 are rejected based on dependency on a rejected claim.
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.
Claim(s) 1-5, 7, and 9 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Beckman et al. (2008/0221389).
Regarding claim 1, Beckman discloses an adjustable seal (see Fig. 1-10 and abstract for example) which includes a first ring extending about an axis (see Fig. 3, first ring 32, axis being vertical axis running through the center of the rings, para. 0035-0036) and including a plurality of first lock features (see Fig. 3 and 8, first lock features 66, see para. 0046-0047), wherein the first ring is a single piece (see Fig. 3, ring 32 is a single piece as shown); a second ring extending about the axis (see Fig. 3, second ring 28 extending about axis being the vertical axis running through the center of the rings, see para. 0035-0036) and including a plurality of second lock features (see Fig. 3 and 8, second lock features 70, para. 0046 which discloses plural “spring fastener(s) 70” and “spring fasteners 70”), wherein the second ring is a single piece (see Fig. 3), the first and second rings cooperatively defining a passage extending along the axis (see Fig. 1-3 and 6-7 for example showing passage), wherein the adjustable seal has a locked configuration in which the second lock features engage the first lock features and prevent movement of the first ring relative to the second ring (see Fig. 8 and para. 0039, 0046-0048 and 0050, interaction between locking features 66 and 70 provides for resistance to unwanted relative rotation of the rings and thus a lock configuration), and an unlocked configuration in which the first ring is able to rotate relative to the second ring (see Fig. 4-5 showing the rings rotated relative to each other in an unlocked configuration to open the seal member 16, see para. 0043); and a flexible member attached to the first ring and the second ring (see Fig. 1, 3, and 6, flexible member 16, para. 0031, 0041-0042 for example), wherein rotation of the first ring relative to the second ring in the unlocked configuration causes the flexible member to extend across at least a portion of the passage defined by the first and second rings (see Figs. 4-5 and para. 0039, 0043).
Regarding claim 2, the Beckman device’s first lock features include protrusions that define grooves that extend about the axis (see Fig. 8, protrusions defined by teeth 66 and which define grooves therebetween, see para. 0046-0048) and the second lock features include pegs that extend axially from a surface of the second ring (see Fig. 8, peg 92 of 70, of which there are plural per para. 0046), the grooves sized and shaped to receive the pegs when the adjustable seal is in the locked configuration (see Fig. 8, para. 0046-0048).
Regarding claim 3, the Beckman device’s first ring includes an end wall and a circumferential wall protruding axially from the end wall with the protrusions extending radially away from and circumferentially along the circumferential wall (see annotated Fig. 6 below and Fig. 8).
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Regarding claim 4, the Beckman device’s second ring includes an end wall and a circumferential wall protruding axially from the end wall with the pegs extending radially from the circumferential wall of the second ring (see annotated Fig. 6 above and Fig. 8).
Regarding claim 5, the Beckman device’s first ring includes a circumferential wall that extends axially beyond the first lock features to guide the second lock features of the second ring into engagement with the first lock features of the first ring (Beckman can be read such that the first ring is ring 28 with first locking features 70 and second ring 32 with second locking features 66; circumferential wall being the wall labeled ‘2nd circumferential wall’ in above annotated Fig. 6 and which extends axially beyond the lock features 70 to guide the second ring and lock features into engagement).
Regarding claim 7, the Beckman device’s first and second rings are circular (see Fig. 3 for example).
Regarding claim 9, the Beckman device’s flexible member includes an elastic sleeve that is attached around circumferences of the first and second rings (see Fig. 6 and para. 0031, 0041-0042 for example).
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.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beckman in view of Willoughby et al. (8,512,303).
Regarding claim 8, the Beckman device is silent as to the first and second rings being constructed of a rigid material; however, Willoughby discloses a similar seal element which includes rigid rings (see Willoughby col. 6 ln. 65 through col. 7 ln. 5). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Beckman device’s rings to be constructed of a rigid material, as taught by Willoughby, in order to provide that the rings maintain their shape during application of forces during use (Willoughby col. 6 ln. 65 through col. 7 ln. 5).
Claim(s) 10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (6,792,943) in view of Beckman.
Regarding claim 10, Kumar discloses an airway management system (see Fig. 1-8 and abstract for example) which includes a mask sized to cover a nose and mouth of a person (see Fig. 1 and 3-6, mask 20, col. 5 ln. 18-26), the mask defines at least one passage sized to receive an instrument and extending along an axis (see Fig. 1 and 8, passage 40, col. 5 ln. 35-52, Fig. 4-6, passage 214 for instrument 280 being an endotracheal tube, col. 6 ln. 46-57, col. 7 ln. 16-30); at least one seal attached to the mask for selectively sealing the at least one passage (seal 46 Fig. 1). Kumar is silent as to the seal including the structural elements as claimed. However, Beckman discloses an adjustable seal (see Beckman Fig. 1-10 and abstract for example) which includes a plurality of concentric rings and a flexible member attached to the concentric rings (see Beckman Fig. 3 and 6, concentric rings 32 and 28 for example, flexible member 16 shown in Fig. 1 for example, see para. 0035-0036 and 0031, 0041-0042) the adjustable seal having a locked configuration and an unlocked configuration (see Beckman Fig. 8 and para. 0046-0048 and 0050, interaction between locking features 66 and 70 provides for resistance to unwanted relative rotation of the rings and thus a lock configuration), each concentric ring including a plurality of lock features that engage each other to lock rotational movement of the rings when in the locked configuration (Beckman: plural lock features 66 and 70, see para. 0046-0047; para. 0046-0048 and 0050, interaction between locking features 66 and 70 provides for resistance to unwanted relative rotation of the rings and thus a lock configuration); and a flexible member attached to the concentric rings (see Beckman Fig. 1, 3, and 6, flexible member 16, para. 0031, 0041-0042 for example), wherein rotation of the concentric rings in the unlocked configuration causes the flexible member to extend across at least a portion of the passage defined by the first and second rings and seal against an instrument if the instrument is positioned in the passage (see Beckman Figs. 4-5 and para. 0039, 0043, Beckman Fig. 7 shows an instrument 26 therein; Fig. 6 of Kumar showing an instrument/endotracheal tube sealed in the passage, col. 7 ln. 30-45). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Kumar system to include the adjustable seal, as taught by Beckman, as this would have been obvious substitution of one known element for another and one would expect the modified Kumar device to perform equally as well.
Regarding claim 12, the modified Kumar system further includes an endotracheal tube extending through the passage (see Kumar Fig. 6 and col. 7 ln. 30-45, endotracheal tube 280).
Regarding claim 13, the modified Kumar system’s flexible member includes an elastic sleeve that is attached around circumferences of the first and second rings (see Beckman Fig. 6 and para. 0031, 0041-0042 for example).
Regarding claim 14, the modified Kumar system is such that each of the plurality of concentric rings includes an end wall and a circumferential wall that protrudes axially from the end wall with the lock features extending radially from the circumferential wall (see above annotated Fig. 6 of Beckman and Beckman Fig. 3 and 8).
Regarding claim 15, the modified Kumar system’s circumferential wall extends axially beyond the lock features (see above annotated Fig. 6 of Beckman).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar and Beckman as applied to claim 10 above, and further in view of Resto et al. (2022/0023573).
Regarding claim 11, the modified Kumar system is silent as to the mask with the at least one passage including first and second passages with first and second seals therein for selective sealing; however, Resto teaches a similar face mask which includes first and second sealable passages (see Resto Fig. 1, passages 110 and 120, see para. 0012, 0014). Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Kumar system to include first and second sealable passages, as taught by Resto (with the adjustable seal of Beckman in each passage), in order to provide ports for both the oral and nasal cavity (Resto para. 0012 and 0014).
Allowable Subject Matter
Claims 16-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Reasons for Allowance
When read in light of the limitations of the claimed method of sealing a passage, the prior art does not disclose, either alone or suggest in combination, a method including positioning an adjustable seal in a passage, the seal including plural concentric rings and a flexible member attached thereto, the seal having a locked and unlocked configuration, each ring including plural locking features that engage each other to lock rotational movement of the concentric rings when the seal is in the locked configuration; moving at least one concentric ring in an axial direction relative to another of the concentric ring to switch the seal from the locked configuration and the unlocked configuration; and rotating at least one concentric ring when the seal is in the unlocked configuration to cause the flexible member to extend across at least a portion of the passage as set forth in independent claim 16.
The closest prior art references of record are those mentioned above in the prior art rejections and below in the conclusion citation of pertinent art section. While the prior art references of record are related to the claimed invention, they do not disclose, either alone or suggest in combination, the limitations discussed above and set forth in independent claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Chun (2013/0197303) and Tylka et al. (2017/0197052) disclose masks/airway management systems which include sealable instrument ports similar to the claimed/disclosed invention; Beckman et al. (2008/0146884), Beckman et al. (2008/0208175), and Voegele (2009/0082632) disclose adjustable seals similar to the claimed/disclosed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN W STUART whose telephone number is (571)270-7490. The examiner can normally be reached M-F: 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
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