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 .
Terminal Disclaimer
The terminal disclaimer filed on 1/8/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending application 18/957,405 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 1/8/2026 with regards to the rejection of claim 1 over Ripich (US 2019/0223896 A1)(previously of record) have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that Ripich does not expressly or adequately disclose or suggest the amended limitations of “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, permitting said reusable suction tubing line to be repeatedly reused and reconnected to new replacement scrapers after disconnection and disposal of the scraper” on the grounds that Ripich does not provide written disclosure to suggest or state that the vacuum tube (i.e., vacuum tube 14) is reuseable and cleanable by submersion of the scraper head portion in a fluid filled container while suction is applied, permitting said vacuum tube to be repeatedly used and reconnected to replacement scrapers. Without an express disclosure of the ability to use the vacuum tube in the claimed manner, Applicant contends that Ripich does not disclose or suggest the cited amended limitations.
While the Examiner concedes that Ripich does not provide an express disclosure of submerging the scraper in a fluid filler container with suction applied thereto, permitting said vacuum tube to be cleaned and repeatedly reused with addition scraper head portions, the Examiner notes that the amended limitations are recited as functional language (as opposed to express, required method steps due to claim 1 being designated as an apparatus-type claim) and the device of Ripich therefore need only be reasonably capable of being utilized to perform the recited functional steps (see MPEP 2114). Further, the reusable suction tubing line is not positively recited as a component of the tongue scraper device within the limitations of claim 1. Rather, the tongue scraper recited to be configured for use with a reusable suction tubing line, lacking a positive and express recitation that the reusable suction tubing line is part of the claimed invention.
Ripich provides a disclosure that the scraper portion may be either cleaned and reused, or disposed of after a number of uses (see Ripich Para. [0036]). Further, Ripich provides a disclosure that fluid entering the scraper device passes through the vacuum tube (see Para. [0036]-[0037]) and therefore is understood to pass any fluid aspirated through the suction head through the vacuum tube. The Examiner contends that, should a user place the scraper device of Ripich into a container filled with cleaning fluid, the aspiration pressure would transport said cleaning fluid from the scraper head and through the vacuum tube, resulting in the vacuum tube being cleaned and reuseable with additional scraper heads, should a user decide to discard the currently scraper head portion. Therefore, Ripich is understood to provide adequate disclosure in allowing the disclosed device to be reasonably capable of performing the amended functional language.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the objection to claim 1 for containing an errant semi-colon (“;”) marking have been fully considered and are persuasive in light of Applicant’s amendment to replace the cited semi-colon with a colon (“:”), placing the language in better grammatical form. This objection of claim 1 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the objection to claim 1 for the recitation of “said scraping edge element directing scraped oral biofilm into”, which introduced functional language in a manner inconsistent with claim 1’s designation as an apparatus claim, have been fully considered and are persuasive in light of Applicant’s amendment to have the cited language now recite “said scraping edge element configured to direct scraped oral biofilm into” which places the claim language in better form to comply with claim 1’s designation as an apparatus claim. This objection of claim 1 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the objection to claim 1 for reciting “and oral biofilm removed through said flow path suction”, which recited a functional step limitation in a manner inconsistent with claim 1’s designation as an apparatus claim, have been fully considered and are persuasive in light of Applicant’s amendment to have the cited language now recite “…oral biofilm is removeable through…” which places the language in better form in complying with claim 1’s designation as an apparatus claim. This objection of claim 1 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the objection to claim 3 for reciting “wherein suction is applied to a hospital patient’s oral cavity utilizing hospital supplied suction through suction tubing”, which recited a functional step limitation in a manner inconsistent with claim 3’s designation as an apparatus claim, have been fully considered and are persuasive in light of Applicant’s amendment to have the cited language now recite “wherein the suction is configured to be applied to a hospital patient’s oral cavity utilizing hospital supplied suction through suction tubing” which places the language in better form in complying with claim 3’s designation as an apparatus claim. The objection of claim 3 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the objection to claim 7 for reciting “wherein the scraper head portion removes oral secretions from a patient’s tongue”, which recited a functional step limitation in a manner inconsistent with claim 7’s designation as an apparatus claim, have been fully considered and are persuasive in light of Applicant’s amendment to have the cited language now recite “wherein the scraper head portion is configured to remove oral secretions from a patient’s tongue” which places the language in better form in complying with claim 7’s designation as an apparatus claim. The objection of claim 7 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the objection to claim 8 for reciting “herein the scraper head portion removes oral secretions from an intubated patient’s tongue”, which recited a functional step limitation in a manner inconsistent with claim 8’s designation as an apparatus claim, have been fully considered and are persuasive in light of Applicant’s amendment to remove the previously-cited claim language from claim 8. The objection of claim 8 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see “Remarks”, filed 1/8/2026, with respect to the 35 USC 112(b) rejection of claim 6 for reciting “said bottom side having a suction lumen”, which was unclear as to whether the cited “suction lumen” was a new and separate lumen from the “suction lumen” previously defined in claim 1, or whether this recitation had sought to further modify the previously-defined “suction lumen”, have been fully considered and are persuasive in light of Applicant’s amendment to have the previously-cited indefinite phrase now recite “the suction lumen” which provides a clear recitation in further modifying the suction lumen previously-defined in claim 1. The 35 USC 112(b) rejection of claim 6 has been withdrawn.
Double Patenting
Applicant’s filing of a terminal disclaimer (TD), see filing on 1/8/2026, with respect to the provisional non-statutory double patenting rejection of claims 1-15 in view of co-pending application 18/957,104 has been fully considered and obviates the double patenting rejection over co-pending application 18/957,104. The provisional non-statutory double patenting rejection of claims 1-15 has been withdrawn.
Election/Restrictions
Newly submitted claims 17-20 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 1-16 are drawn to a tongue scraper device configured for use with a reusable suction tubing line.
Newly amended claims 17-20 are drawn to a method of removing biofilm from a patient’s tongue with an accompanying method of cleaning a reusable suction tubing line.
The two inventions are related as a product and process of using said product. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product can be used in a materially different process of using said product in that the tongue scraper of the apparatus claims (Claims 1-16) does not require use of a reusable suction line connected thereto for removing scraped biofilm. As the tongue scraper of claims 1-16 is only configured to be used with a reusable suction tubing line (i.e., in the recitation of “for use with a reusable suction tubing line”), the reusable suction tubing line is not positively recited as a component of the tongue scraper system. The office contends that the tongue scraper of the apparatus claims can be used to scrape biofilm from a patient’s tongue without the aid of a suction tubing line connected thereto and the scraped biofilm may be removed by either a vacuum source that is separate from the tongue scraper device, or said scraped film may be washed off with a cleaning fluid without the need of a reusable suction tubing line. Further, reusable suction tubing line recited for use with the tongue scraper of claim 1 can be cleaned by other means than “submerging said distal end of said tongue scraper in a fluid filler container while the suction is applied to flush and clean said reusable suction tubing line” as recited in claim 17. For example, the reusable suction tubing line may be submerged with a suction applied therethrough without the need for a tongue scraper connected thereto. Additionally, the reusable suction tubing line may be cleaned without a suction force applied thereto at all via submersion within a container filled with cleaning fluid.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 17-20 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 1-14 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, 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 scraper head portion further having 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 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]);
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 recited 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 scraper 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).
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 5, Ripich discloses 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 scraper edge element (see Fig. 5).
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 scraper 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) 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).
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 11622841 B2 to Prendergast, US 11399924 B2 to Fritsch, US 20090136285 A1 to Hall and US 20090017426 A1 to Higgins all disclose tongue cleaning devices comprising a vacuum and scraper functions.
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 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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