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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/24/2026 has been entered.
Response to Arguments
Applicant's arguments filed 6/8/2026, with regards to the amended limitations of claims 1 and 2, have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that Ripich (US 2019/0223896 A1)(previously of record) does not expressly disclose or adequately suggest the amended limitations of “said body flow path channel having an inside diameter with no flow path openings in communication with an exterior of the body between the suction lumen and said reusable suction tubing line, such that the body flow path channel forms a closed system when suction is applied” on the grounds that the flow path 16 of Ripich comprises an opening (i.e., vacuum control opening(s) 20/21) along the length thereof to allow a user to modulate the vacuum pressure applied through said flow path 16. The presence of these two openings thus prohibit the flow path 16 of Ripich from having “no flow path openings in communication with an exterior of the body between the suction lumen and said reusable suction tubing line”.
The Examiner first notes that the above-cited amended limitations do not have sufficient written support within the specification and therefore fail to comply with the written description requirement, resulting in a 35 U.S.C. 112(a) rejection (see below). Additionally, in combatting Applicant’s arguments on the merits, while the intended meaning of the contention is understood, the Examiner respectfully disagrees that the current claim language is not reasonably disclosed or suggested by Ripich. Firstly, the secondary vacuum control opening 21 is an optional feature (see Para. [0038]-[0039] and [0045] mentioning wherein the secondary vacuum opening “can” be provided), and is thus not viewed as a mandatory feature. Additionally, Para. [0038] mentions wherein a user may selectively cover a portion of the vacuum control opening 20 to modulate the amount of vacuum pressure within the flow channel 16. The examiner contends that, should a user elect to cover the entirety of the vacuum control opening 20 and/or the secondary control opening 21, the flow channel 16 would, in this case, have no openings along the length thereof. The Examiner notes that Ripich discloses wherein a vacuum-seal is an undesirable state for the device to operate in (see Para. [0038]); however, the Examiner additionally notes that this state would only occur in the “unlikely scenario that head is pushed down to where it could vacuum seal to the tongue” (see Para. [0038]). So long as the head 6 has as least some space between the tongue and a portion thereof, a user is free to cover the vacuum control opening(s) without rendering the device non-functional or dangerous.
Regarding claim 2, Applicant contends that Ripich does not expressly disclose or adequately suggest the amended limitations of wherein the scraping edge element… includes a backside curvature configured to funnel and direct the scraped oral biofilm into the suction lumen”.
The Examiner respectfully disagrees. Fig. 5 and Para. [0047] of Ripich both show and discuss wherein the working edge 50 comprises a curve along a length thereof and may additionally comprise a tapered edge surface. Due to the curved, tapered edge of the working edge 50 (see Fig. 5), the working edge is understood to funnel and direct scraped oral biofilm into the suction lumen by directing debris radially-inward toward inlet 40.
Applicant’s arguments with respect to claim(s) 5 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. Specifically, Ripich is not relied upon to disclose the amended limitations of “wherein the scraping edge element tapers into an angled edge completely surrounding the bottom side of the scraper head portion such that the scraped oral biofilm is retained within the bottom side and inhibited from dribbling down the body”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Amended claim 1 recites, in part, “said body flow path channel having an inside diameter with no flow path openings in communication with an exterior of the body between the suction lumen and said reusable suction tubing line, such that the body flow path channel forms a closed system when suction is applied”. There is not sufficient support for this amendment in the disclosure as filed. While Applicant cites to Para. [0024]-[0025] of the specification in the submitted arguments (see “Remarks”, filed 6/8/2026), these paragraphs merely recite a “close aspiration suctioning” which is not sufficiently narrow enough to require a flow path channel with no flow path openings in communication with an exterior of the body, as claimed. A closed aspiration suctioning system does not require or imply the absence of any ports as, even if ports art present along a given flow path channel, so long as a user is covering the flow path ports (i.e., with a finger or other occluding element), the functional result would be a “closed aspiration suctioning system”. Additionally, the drawings do not provide adequate support for this limitation. Figs. 4 and 8 do not show all sides of the flow path channel to reasonably suggest wherein the flow path is free from any path openings. With the limited reference views, one of ordinary skill in the relevant art cannot make a conclusive determination that no flow path ports are present along the length of the flow path channel. Therefore, the amended claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one of ordinary skill in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
Claims 2-16 are also rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement due to their dependency from and further modification of claim 1.
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) 1-4, 6-14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ripich (US 2019/0223896 A1)(previously of record).
Regarding claim 1 (see 112(a) rejection above), Ripich discloses:
A tongue scraper (device 2, see Fig. 1 and Para. [0035]-[0036]) for use with a reusable suction tubing line (vacuum tube 14, see Fig. 1 and Para. [0036]-[0038]; the vacuum tube is understood to be repeatedly reusable per Para. [0036] reciting wherein, after a single use, the device may either be discarded or cleaned for further use) for removing scraped oral biofilm from a patient’s tongue (see Para. [0035]-[0038] and [0047]), the scraper comprising:
a body having a distal end and a proximal end (see Examiner’s Diagram of Fig. 1 below designating a “proximal end” and a “distal end” of the device);
said body including a flow path suction channel (flow path 16, see Fig. 3 and Para. [0046] and [0050]) transversing between said distal end and said proximal end (see Fig. 3);
said distal end configured with a scraper head portion (head 6, see Figs. 2-3) with a suction lumen accessing said body flow path channel for removing said scraped oral biofilm (see Para. [0046], [0048] and [0051] mentioning wherein a portion of flow path 16 extends into the distal head portion, defined to be trough 60 and inlet 40 as shown in Figs. 3 and 5);
said body flow path channel having an inside diameter (see Fig. 3) with no flow path openings in communication with an exterior of the body between the suction lumen and said reuseable suction tubing line, that that the body flow path channel forms a closed system when suction is applied (see Para. [0038] mentioning wherein vacuum control opening(s) 20/21 allows a user to modulate the vacuum pressure within the flow path 16 by selectively covering portions thereof; when the vacuum opening(s) 20/21 are completely covered, no openings along the flow path 16 are present and a strong vacuum force is applied therethrough).
wherein said scraper head portion further comprises a scraping edge element (working edge 50, see Fig. 3 and Para. [0047]);
said scraping edge element configured to direct said scraped oral biofilm into said scraper head suction lumen when said scraper is manually operated and said scraped (see Para. [0047]) and said oral biofilm is removeable through said flow path suction channel when the suction is applied to the proximal end of said tongue scraper body (see Para. [0047] mentioning wherein debris and saliva are scraped from the tongue by the working edge and accumulate thereon; thereafter, the vacuum is applied to suction and remove saliva and debris therefrom through the vacuum passage as recited in Para. [0037] and [0048]) by connection to said reusable suction tubing line (see Para. [0047]; the debris/saliva are only able to be aspirated by the vacuum source upon connection of the scraper device thereto via the vacuum tubing 14 per Para. [0036]-[0037]); and
wherein said reusable suction tubing line is flushable and cleanable by submersion of said scraper head portion in a fluid filled container while the suction is applied (as these limitations are recited as functional language, the device of Ripich merely needs to be reasonably capable of being utilized to perform the recited function (see MPEP 2114); as fluid/material entering the fluid path of the scraper device of Ripich are aspirated/transported through the vacuum tube (see Para. [0036]-[0037]), should a user place the scraper device into a container filled with cleaning fluid, the aspiration pressure would transport said cleaning fluid through the vacuum tube, resulting in the vacuum tube being cleaned), permitting said reusable suction tubing line to be repeatedly reused and reconnected to new replacement scrapers after disconnection and disposed of the scraper (see Para. [0036] mentioning wherein the scraper device may either be cleaned and reused, or disposed of after a number of uses; the vacuum source is disclosed to be useable with either different scraper devices or the same scraper device; as the vacuum tubing is part of the scraper system, the vacuum tube is also understood to be either cleaned and reused, or discarded after a number of uses).
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Examiner’s Diagram of Fig. 1
Regarding claim 2, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraping edge element is positioned in front of the scraper head suction lumen (see Figs 3 and 5 showing wherein working edge 50 is positioned distally of the vacuum trough 60 and inlet 40) and includes a backside curvature configured to funnel and direct the scraped oral biofilm into the suction lumen (see Fig. 5 showing wherein the working edge 50 comprises a curvature along the length thereof configured to funnel material towards the center thereof).
Regarding claim 3, Ripich discloses the invention of claim 1, Ripich further discloses wherein the suction is configured to be applied to the patient’s oral cavity (see Para. [0035]-[0036] mentioning wherein the device is configured to be used to clean a patient’s tongue) utilizing hospital supplied suction through the reusable suction tubing line (see Para. [0005] mentioning wherein the device may be used in a hospital room and is thus seen to be fully capable of utilizing a hospital-supplied tube as the vacuum tube 14 shown in Fig. 1).
Regarding claim 4, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is connectable at its proximal end to any type of external suction source (see Para. [0036] mentioning wherein any vacuum source known in the art may be used as the designated vacuum source).
Regarding claim 6, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper head portion has a top side (shown in Fig. 1) and a bottom side (shown in Fig. 5), said bottom side having the suction lumen (see Fig. 5 showing wherein the trough 60 and inlet 40 are disposed on the “bottom side” of the head).
Regarding claim 7, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper head portion is configured to remove oral secretions from the patient’s tongue (see Para. [0035]-[0038] and [0047]-[0048]).
Regarding claim 8, Ripich discloses the invention of claim 1, Ripich further discloses wherein the patient is intubated (see Para. [0047]-[0048]; as the device of Ripich is disclosed to remove saliva and other debris from a patient’s tongue, the device may be utilized to remove debris from the tongue of an intubated patient).
Regarding claim 9, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is plastic molded in one piece (see Para. [0035] mentioning wherein the device may be molded from rigid plastics to form the single piece tongue scraper device, further reinforced by Para. [0046] mentioning wherein the head and handle portions are integrally formed with one-another).
Regarding claim 10, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is disposable after use (see Para. [0036], [0053] and [0057] mentioning wherein the scraper may either be cleaned and reused, or disposed of after a number of uses).
Regarding claim 11, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is utilized in a hospital, home health, dental, nursing home, or home setting (see Para. [0005] and [0036]).
Regarding claim 12, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraping edge element has a curved scraper configuration edge (see Para. [0047] and Fig. 5) that tapers back into the body of the scraper (see Fig. 5 showing wherein the working edge 50 curves and tapers back into the body of the scraper).
Regarding claim 13, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is a single procedure use product disposable of after each use (see Para. [0036], [0053] and [0057] mentioning wherein the scraper may either be cleaned and reused, or disposed of after a number of uses).
Regarding claim 14, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is molded in one piece of a rigid plastic (see Para. [0035] mentioning wherein the device may be molded from rigid plastics to form the single piece tongue scraper device, further reinforced by Para. [0046] mentioning wherein the head and handle portions are integrally formed with one-another).
Regarding claim 16, Ripich discloses the invention of claim 1, Ripich further discloses wherein the scraper is flushable, cleanable, and storable to permit repeated single use procedures (see Para. [0036], [0053] and [0057] mentioning wherein the scraper may either be cleaned and reused, or disposed of after a number of uses; should the device be cleaned and reused, the scraped of Ripich is fully capable of being cleaned by flushing and stored for later, repeated used).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ripich (US 2019/0223896 A1)(previously of record) in view of Teed (US 2005/0197665 A1).
Regarding claim 5, Ripich discloses all of the limitations of the invention of claim 1, Ripich further discloses wherein the scraper head portion has a topside (shown in Fig. 1) and a bottom side (shown in Fig. 5), said bottom side having said scraping edge element (see Fig. 5); wherein the scraping edge element tapers into an angled edge (see Fig. 5 and Para. [0047] mentioning wherein the working edge is curved/angled).
However, while Ripich provides a disclosure of wherein the scraping edge is “stepped-down” from the head to allow the working edge to engage the tongue free of interference from the head (see Para. [0047] and Fig. 4), Ripich does not expressly disclose wherein the scraping edge element completely surrounding the bottom side of the scraper head portion such that the scraped oral biofilm is retained within the bottom side and inhibited from dribbling down the body.
In the same field of endeavor, namely tongue scraper devices, Teed teaches a tongue scraping device (see Fig. 1) comprising: A body (body 10, see Fig. 1) having a distal end comprising a scraper head portion (reservoir cup 12, see Fig. 1); wherein said scrap head further comprises a scraping edge element (edge 34, see Figs. 1 and 3) configured to direct scraped oral biofilm into said scraper head (see Para. [0032]-[0033]); wherein the scraping edge element completely surrounding the bottom side of the scraper head portion such that the scraped oral biofilm is retained within the bottom side and inhibited from dribbling down the body (see Figs. 1 and 3; see also Para. [0032]-[0033] mentioning wherein the edge 34 is a wall that completely surrounds the concave bottom wall 27 of the cup 12).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known tongue scraper edge element for another (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of modifying the working edge 50 of Ripich to extend around the circumference of the head 6, as shown to be an alternative scraping edge configuration by the disclosure of Teed. Since the only criticality imparted to the working edge 50 of Ripich pertains to wherein the working edge is “stepped-down” from the head 6 to allow the working edge 50 to engage the tongue free of interference from head 6 and handle 4 (see Ripich Para. [0047]), one of ordinary skill in the art would have expected the device of Ripich to function equally well with either the semi-circular working edge configuration shown in Ripich Fig. 5, or the circumferential working edge configuration shown in Teed Figs. 1 and 3. Since both configurations have the respective scraper edge element “stepped-down” away from the internal capture wall/portion of the head portion and are configured to scrape and remove oral biofilm from a patient’s tongue, one of ordinary skill in the art would have had a reasonable expectation of success in interchanging the two known alternative scraper edge configurations.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ripich (US 2019/0223896 A1)(previously of record) in view of Prendergast (US 2021/0330432 A1) (previously of record).
Regarding claim 15, Ripich discloses all of the limitations of the invention of claim 1.
However, while Ripich further discloses wherein the reusable suction tuning line connects to the proximal end of the scraper device (see Para. [0036]-[0037] and Fig. 1 showing vacuum tube connecting to the suction device), Ripich does not expressly disclose a specific type of connection aside from a “friction fit” and thus does not expressly disclose wherein the proximal end of the body includes a barbed fitting for connection to said reusable suction tubing line.
In the same field of endeavor, namely vacuum-assisted oral cleaning devices comprising a scraper and associated vacuum tube, Prendergast teaches a tongue cleaning device (toothbrush 10, see Fig. 1A) connected to a vacuum source (suction device 20, see Fig. 1A and Para. [0054]) via a suction tube (tube extending distally from suction device 20 towards connection 42, see Fig. 1A) at the proximal end thereof (see Fig. 1A; the suction tube of the suction device connects to the vacuum tube 16 of the toothbrush device at the proximal end thereof); wherein the proximal end of the tongue cleaning device includes a barbed fitting for connecting to said suction tube (see Para. [0054] mentioning wherein the connection 42 between the suction tube extending distally from the suction device and the vacuum lumen 16 of the toothbrush may be either a smooth or barbed fitting, allowing the two device to be fitted together as friction fit couplings).
Since Ripich is silent regarding a specific type of friction connection utilized to connect the vacuum tube to the scraper device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for known friction-fit connection types to secure a vacuum tube to a vacuum-assisted tongue cleaning device. Since both Ripich and Prendergast disclose wherein the connections between the oral cleaning devices and associated vacuum tubes are friction fit, one of ordinary skill in the art would have expected the device of Ripich to function normally should the connection between the vacuum tube and the scraper device be a barbed connection, as disclosed to be a known fitting type within the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2006/0085932 A1 to Santos and US 10813718 B2 to Gordon disclose oral cleaning devices comprising an oral biofilm capture had and tapered scraping surface surrounding the circumference thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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