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 .
Response to Amendment and Arguments
In view of the amendment filed February 24, 2026, claim 1 has been amended and claim 7 has been added. Accordingly, claims 1-7 are pending and under examination.
The amendment to claim 2 overcome the objection in the Office action issued December 5, 2025. Therefore the objection is hereby withdrawn.
The amendment to claim 1 overcome the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Noble (US 5,176,705, hereinafter “Noble”) in view of Lev et al. (US 2003/0034031, which is cited in the IDS filed June 13, 2024, hereinafter “Lev”). Examiner acknowledges the combination of Noble/Lev fails to disclose the new limitation of “the at least one filter device has a particulate cut-off in a range of 0.1-10 micrometers.”
In the Remarks filed February 24, 2026, applicant argues that “Applicants respectfully disagree that the motivation "to prevent foreign bodies [from getting] into the lung of the child" is an obvious result of the combination. More specifically, the motivation relies on the Examiner's hindsight rationale, which imputes a problem of Lev (i.e., "foreign bodies" traversing the nipple 22 to exit out of the first aperture 32) that is not supported by the evidence as being a problem in Noble, as Noble does not have the same type of aperture as included in Lev (see MPEP 2142 ("impermissible hindsight must be avoided and the legal conclusion must be reach on the basis of the facts gleaned from the prior art.")). More specifically, Noble appears to rely on a liquid permeable material, and does not appear to suffer from the same susceptibility to foreign bodies that the structure of Lev does.” Examiner respectfully traverses applicant’s remarks.
Examiner notes that the issue of inhale of foreign particles when using a non-liquid pacifier and liquid pacifier is well known. Lev teaches a non-liquid pacifier with a filter to prevent foreign particulate enter the lung. Lau (US 2018/0211558) a feeding bottle that can be used as a pacifier (para. [0121]) includes air filter 113 to prevent foreign particles from entering the entrance aperture 112 (para. [0155] discloses “coarse, replaceable particle filter 113 is provided in the flowstream near the entrance aperture 112 to screen out large particulates, dust, etc. The coarse filter can have a pore size of about 5-10 microns, for example.” Thus, provide an air filter to the pacifier improve safety to the child.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev et al. (US 2003/0034031, which is cited in the IDS filed June 13, 2024, hereinafter “Lev”) in view of Lau (US 2018/0211558, hereinafter “Lau”).
Referring to claim 1, Lev discloses a pacifier (Figs. 4a-4b) comprising:
a suction part 22 (Fig. 4a, which is reproduced below; paras. [0027]-[0028]) comprising a nipple 22 and a shield 46 connected to each other; and
a housing part (the portion at lead line 24 as shown in Fig. 4a; para. [0027]) connected to said suction part 22, wherein said suction part defines a passageway through which a fluid can pass from outside the pacifier to inside a mouth of a user of the pacifier such that the pacifier is configured as a breath-through pacifier,
wherein said housing part 24 comprises a housing,
wherein said housing comprises, in an interior space of the housing at least one filter device comprising a bacterial and/or particulate filter, and
wherein the housing defines at least one air opening (aperture 30 as shown in Fig. 4a and Fig. 4b; para. [0027]: “Nipple 22 is hollow and includes an interior volume 28 which serves as a first channel 34 of fluid communication between at least one first aperture 32 and at least one second aperture 30.”) through which air can pass such that the air passing between the at least one air opening of the housing and the passageway of the suction part has to pass through the at least one filter device.
Lev discloses the invention substantially as claimed except for disclosing wherein the at least one filter device has a particulate cut-off in a range of 0.1-10 micrometers.
However, Lau discloses air filter of a feeding bottle can be used as a pacifier has a pore size of about 5-10 microns (para [0155]: “coarse, replaceable particle filter 113 is provided in the flowstream near the entrance aperture 112 to screen out large particulates, dust, etc. The coarse filter can have a pore size of about 5-10 microns, for example.”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have provided an air filter with a pore size of about 0.1-10 microns prevent foreign particle from entering the lung of the child.
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Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noble (US 5,176,705, hereinafter “Noble”) in view of Lev et al. (US 2003/0034031, which is cited in the IDS filed June 13, 2024, hereinafter “Lev”) and further in view of Lau (US 2018/0211558, hereinafter “Lau”).
Referring to claim 1, Noble discloses a pacifier (FIGS. 1-6) comprising:
a suction part 10 (FIG. 1, which is reproduced below; col. 3, ln 7-12) comprising a nipple 12 and a shield 19 connected to each other; and
a housing part (cap 26 as shown in FIG. 1; col. 3, ln 1-58) connected to said suction part, wherein said suction part defines a passageway through which a fluid can pass from outside the pacifier to inside a mouth of a user of the pacifier such that the pacifier is configured as a breath-through pacifier (Noble discloses the pacifier is for delivering a medication to the child. Noble further discloses cap 26 includes a closure panel 30, wherein the closure panel 30 includes a hole and a valve for controlling amounts of air into the cap (col. 3, ln 45-58). Examiner contends that the medication pacifier of Noble is capable as a breath-through pacifier when there is no medication inside the pacifier),
wherein said housing part comprises a housing (cap 26 as shown in FIGS. 1-2 and 5; col. 3, ln 28 and ln 50-58),
wherein said housing comprises, in an interior space of the housing,
wherein the housing 26 defines at least one air opening through which air can pass such that the air passing between the at least one air opening of the housing and the passageway of the suction part has to pass through (Noble further discloses cap 26 includes a closure panel 30, wherein the closure panel 30 includes a hole and a valve for controlling amounts of air into the cap (col. 3, ln 45-58: “Closure panel 30 spans sidewall 27 at rear extremity 29, and may contain a perforation and associated valve mechanism 33 for passage of controlled amounts of air. One type of valve mechanism that may be used is a slit rubber sheet. Another type of valve is a ball-type check valve. Still other types of valves may be employed.”))
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Referring again to claim 1, Noble discloses the invention substantially as claimed except for disclosing at least one filter device comprising a bacterial and/or particulate filter in the housing and wherein the filter device has a particulate cut-off in range of 0.1-1.0 microns. However, in the same field of endeavor, which is a pacifier in which a fluid can pass from outside the pacifier to inside a mouth of a user of the pacifier, Lev discloses pacifier 20 includes a filter 48 to prevent the entry of foreign bodies get into the channel (Figs. 1a-1b; para. [0028]). Furthermore, Lau discloses air filter of a feeding bottle can be used as a pacifier has a pore size of about 5-10 microns (para [0155]: “coarse, replaceable particle filter 113 is provided in the flowstream near the entrance aperture 112 to screen out large particulates, dust, etc. The coarse filter can have a pore size of about 5-10 microns, for example.”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have provided an air filter with a pore size of about 0.1-10 microns at the ceiling of closure panel 30 (FIG. 6) of cap 26 of Noble pacifier to prevent foreign bodies get into the lung of the child, thereby improve safety of the pacifier.
Referring to claim 2, the modified pacifier of Noble discloses the pacifier according to claim 1, wherein said passageway comprises a first end and a second end between which the fluid can pass (FIG. 1 shows passageway for fluid extends from lead line 11 to the tip of nipple 12), wherein the first end is at a first connection interface (male thread on the outside surface of sleeve 21 as shown in FIG. 1) of the suction part configured for mating with a second connection interface of the housing part (FIG. 6 shows cap 26 includes thread for mating with thread on sleeve 21; col. 3, ln 34-50), and the second end of the passageway is in a part of the nipple which is configured to be positioned within the mouth of the user during use of the pacifier, such that the fluid can pass through the passageway between the first connection interface of the suction part and to the inside of the mouth of the user during use of the pacifier.
Referring to claim 3, the modified pacifier of Noble discloses the pacifier according to claim 1, wherein the housing (cap 26) of the housing part comprises: a lid (FIG. 6 shows cap 26 includes a closure panel 30 or a ceiling 30), surrounding walls connected to the lid, and a second connection interface (thread on the inner wall surface of cap 26 as shown in FIG. 6) provided opposite to the lid, wherein the lid, the surrounding walls, and the second connection interface define the interior space, wherein said second connection interface is at least partly open into the interior space of the housing and is configured to mate with a first connection interface (thread on sleeve 21 as shown in FIG. 1) of the suction part.
Referring to claim 4, the modified pacifier of Noble discloses the pacifier according to claim 3, wherein the lid (closure panel 30 or ceiling 30 of cap 26 as shown in FIG. 6) comprises the at least one air opening through which air can pass (Noble further discloses the closure panel 30 or ceiling 30 includes a hole and a valve for controlling amounts of air into the cap (col. 3, ln 45-58: “Closure panel 30 spans sidewall 27 at rear extremity 29, and may contain a perforation and associated valve mechanism 33 for passage of controlled amounts of air. One type of valve mechanism that may be used is a slit rubber sheet. Another type of valve is a ball-type check valve. Still other types of valves may be employed.”)), and wherein the at least one filter device are provided within the interior space of the housing such that the air passing between the at least one air opening in the lid and the second connection interface of the housing has to pass the at least one filter device.
Referring to claim 6, the modified pacifier of Noble discloses the pacifier according claim 1, further comprising: at least one recess in one of the housing part or the suction part, and at least one protruding part in the other of the housing part or the suction part, whereby the at least one recess is configured to receive the at least one protruding part when the suction part and the housing part are connected (examiner notes that Noble discloses the cap 26 includes thread for mating with thread on sleeve 21. FIGS. 1 and 6 show thread on sleeve 21 and cap 26 have peak and valley. Thus, the peak on the thread of cap 26 will mate will the valley on the thread on the sleeve 21 or vice versa).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noble in view of Lev et al. and Lau as applied to claim 1 and further in view of Hesselmar et al. (US 2016/0256649, which is cited in IDS filed June 13, 2024, hereinafter “Hesselmar”).
Referring to claim 5, the modified pacifier of Noble discloses the pacifier according to claim 1, wherein the at least one filter device is secured within the interior space of the housing (see rejection of claim 1 above). Noble/Lev/Lau, especially, Lev fails to disclose the filter is attached to the proximal end of the pacifier by at least one grating welded to a surrounding wall.
Referring again to claim 5, however, Hesselmar discloses a breathing protector for individuals with tracheotomy tubes. Hesselmar discloses a heat and moisture exchanging filter device 205 (Figs. 4-5) is arrange between grids (¶ [0027]). Apparently, the function of the grids is for allowing outside air flows into tracheal then into the lungs. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provide a grids as suggested by Hesselmar to fixedly attach the air filter of Lev to the closure panel 30 or ceiling 30 of cap 26 of Noble.
Referring still to claim 5, as to the limitation of welded to the surrounding wall, examiner contends that one of ordinary skill in the art will appreciate that there are many ways to attach one component to another component, for example, by interference fit, glue, adhesive, ultrasonic weld or mechanical interface, such as, thread or snap fit or bayonet fit, etc. Thus, using ultrasonic weld for attaching the grids to the wall of the cap 26 of Noble is within the skill of an ordinary skill in the art. The technique of attaching the grating to the wall of the housing as required in the claim does not require a leap of inventiveness.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,036,184 (hereinafter “the patent”) in view of Lau (US 2018/0211558, hereinafter “Lau”).
Claims 2 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 4, respectively, of U.S. Patent No. 12,036,184 (hereinafter “the patent”) in view of Lau (US 2018/0211558, hereinafter “Lau”).
The claims match-up with respect to one another as listed below:
Application No. 18/742,558
U.S. Patent No. 12,036,184
Claim 1. A pacifier comprising: a suction part comprising a nipple and a shield connected to each other; and a housing part connected to said suction part, wherein said suction part defines a passageway through which a fluid can pass from outside the pacifier to inside a mouth of a user of the pacifier such that the pacifier is configured as a breath-through pacifier, wherein said housing part comprises a housing, wherein said housing comprises, in an interior space of the housing, at least one heat and moisture exchanger (HME) device and/or at least one filter device comprising a bacterial and/or particulate filter, and wherein the housing defines at least one air opening through which air can pass such that the air passing between the at least one air opening of the housing and the passageway of the suction part has to pass through the at least one HME device and/or the at least one filter device;
and wherein the at least one filter device has a particulate cut-off in a range of 0.1-10 micrometers
Claim 3. A pacifier according to claim 1, wherein the housing of the housing part comprises: a lid, surrounding walls connected to the lid, and a second connection interface provided opposite to the lid, wherein the lid, the surrounding walls, and the second connection interface define the interior space, wherein said second connection interface is at least partly open into the interior space of the housing and is configured to mate with a first connection interface of the suction part.
Claim 4. A pacifier according to claim 3, wherein the lid comprises the at least one air opening through which air can pass, and wherein the at least one HME device and/or the at least one filter device are provided within the interior space of the housing such that the air passing between the at least one air opening in the lid and the second connection interface of the housing has to pass the at least one HME device and/or the at least one filter device.
Claim 1. A pacifier comprising a reusable suction part and at least one exchangeable housing part which are releasably connectable to each other, wherein said suction part comprises a nipple and a shield connected to each other, wherein said suction part comprises a passageway through which a fluid can pass from outside the pacifier to inside a mouth of a user of the pacifier such that the pacifier is configured as a breath-through pacifier, wherein said suction part comprises at least one first connection device, wherein said housing part comprises a housing and at least one second connection device which is releasably connectable to the at least one first connection device, wherein said housing comprises at least one heat and moisture exchanger (HME) device and/or at least one filter device comprising a bacterial and/or particulate filter,
Lau discloses air filter of a feeding bottle can be used as a pacifier has a pore size of about 5-10 microns (para [0155]: “coarse, replaceable particle filter 113 is provided in the flowstream near the entrance aperture 112 to screen out large particulates, dust, etc. The coarse filter can have a pore size of about 5-10 microns, for example.”). Therefore, it would have been obvious to have provided an air filter with a pore size of about 0.1-10 microns to prevent foreign particles enter the lung.
wherein the housing, of said housing part, comprises an interior space which is defined by a lid, surrounding walls connected to the lid and a second connection interface which is provided opposite the lid, wherein said second connection interface is at least partly open into the interior space of the housing and is configured for mating with a first connection interface of the suction part, and
wherein the lid comprises air openings through which air can pass and wherein the HME device and/or the filter device are provided within the interior space of the housing such that air passing between the air openings in the lid and the second connection interface of the housing also has to pass the HME device and/or the filter device.
Claim 2. A Pacifier according to claim 1, wherein said passageway comprises a first end and a second end between which the fluid can pass, wherein the first end is at a first connection interface of the suction part configured for mating with a second connection interface of the housing part, and the second end of the passageway is in a part of the nipple which is configured to be positioned within the mouth of the user during use of the pacifier, such that the fluid can pass through the passageway between the first connection interface of the suction part and to the inside of the mouth of the user during use of the pacifier.
Claim 2. A pacifier according to claim 1, wherein said passageway comprises a first end and a second end between which a fluid can pass, which first end is provided at a first connection interface of the suction part configured for mating with a second connection interface of the housing part and which second end of the passageway is provided in a part of the nipple which is configured to be positioned within a user's mouth during use of the pacifier, whereby a fluid can pass through the passageway between the first connection interface of the suction part and the inside of a user's mouth during use of the pacifier.
Claim 6. A pacifier according claim 1, further comprising: at least one recess in one of the housing part or the suction part, and at least one protruding part in the other of the housing part or the suction part, whereby the at least one recess is configured to receive the at least one protruding part when the suction part and the housing part are connected.
Claim 4. Pacifier according to claim 1, wherein the first or the second connection device comprises at least one recess and wherein the other one of the first or the second connection device comprises at least one protruding part whereby the at least one recess is configured to receive the at least one protruding part when the suction part and the housing part are connected.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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