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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Claim amendments filed 18 June 2026 are acknowledged. Claims 1-9, 11-12, 15-18, 21, 33-43, 45, and 47-49 are pending with claims 10, 13-14, 19-20, 22-32, 44, and 46 being cancelled.
The applicant’s amendments to the drawings and specification filed 18 June 2026 are sufficient to overcome the each and every previously presented objection.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 34 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.
The 35 U.S.C. 102(a)(1) rejections of claims 1 and 34 are withdrawn. However, after further consideration, new grounds of rejections are made in view of 35 U.S.C. 102(a)(1) with respect to Alemana (WO 2020077406 A1). Alemana teaches a method for cleaning the interior of a lumen (cleaning apparatus for a medical device having one or more internal channels, abstract) by mixing a liquid with a powder (viscoelastic liquid comprises dissolved chemicals including abrasive particles, paragraph [0072]), apportioning the slurry into a plurality of discrete portions (pump an individual and predetermined amount of viscoelastic liquid through each supply line, paragraph [00111]), and applying at least one flow of fluid to each discrete portion (water is pumped to push up against the viscoelastic liquid so that it can continue flowing, paragraph [00113]).
Following the above logic, the 35 U.S.C. 102(a)(1) rejections of claims 2, 4-6, 15, 34-35, 37-38, 41-43, and 49 with respect to Spargo are withdrawn. However, after further consideration, new grounds of rejections are made in view of 35 U.S.C. 102(a)(1) with respect to Alemana (WO 2020077406 A1). Similarly, the 35 U.S.C. 102(a)(1) rejections of claims 7-9 and 11-12 with respect to Spargo are withdrawn. However, after further consideration, new grounds of rejections are made in view of 35 U.S.C. 103 with respect to Alemana in view of Spargo. The 35 U.S.C. 103 rejections of claims 3 and 39-40 are withdrawn, but new ground of rejections are made in view of 35 U.S.C. 103 with respect to Alemana in view of Coughlin. The 35 U.S.C. 103 rejections of claims 33 are withdrawn, but new grounds of rejections are made in view of 35 U.S.C. 102(a)(1) with respect to Alemana.
The rejection of claim 44 has been withdrawn due to the claim being cancelled.
Applicant’s arguments, see page 14 of the applicant’s response, filed 18 June 2026, with respect to claims 16-18, 21, 36, 45 and 47-48 have been fully considered and are persuasive. The 35 U.S.C. 103 rejections of 16-18, 21, 36, 45 and 47-48 has been withdrawn.
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.
Claims 1-2, 4-6, 15, 33-35, 37-38, 41-43, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alemana (WO 2020077406 A1).
Regarding claim 1, Alemana teaches a method for cleaning at least one interior lumen of a medical device (abstract) comprising: mixing a liquid with a powder to form a slurry (viscoelastic liquid comprises dissolved chemicals including abrasive particles, paragraph [0072]); apportioning the slurry into a plurality of discrete portions (pump an individual and predetermined amount of viscoelastic liquid through each supply line, paragraph [00111]); and applying at least one flow of fluid to each of the plurality of discrete portions to individually propel each of the plurality of discrete portions through the eat least one interior lumen of the medical device (water is pumped to push up against the viscoelastic liquid so that it can continue flowing, paragraph [00113], and viscoelastic liquid reaches inlet apertures of the endoscope by being pushed by water, paragraph [00116]).
Regarding claim 2, Alemana teaches apportioning the slurry into the plurality of discrete portions based at least on a fluidic resistance of at least a proximal section of the at least one interior lumen (the amount of viscoelastic liquid pumped by the active cleaning pumps will depend on the operational parameters in the cleaning apparatus, paragraph [00111], and smaller internal channels have larger fluidic resistance so the flow rate through these channels will be lower, paragraph [00119]).
Regarding claim 4, Alemana teaches providing one of the plurality of discrete portions to a delivery chamber (viscoelastic liquid is pumped though primary and secondary conduits, paragraph [00111], and delivers viscoelastic liquid to the start of each internal channel whereby viscoelastic liquid is primed, paragraph [00112]); and applying the at least one flow of fluid in the delivery chamber to accelerate the one of the plurality of discrete portions prior to delivery of the one of the plurality of discrete portions to the at least one interior lumen (one predetermined amount of viscoelastic liquid has been pumped through cleaning pump the viscoelastic liquid supply is replaced with mains water to continue priming so the liquid can continue flowing, paragraph [00113]).
Regarding claim 5, Alemana teaches applying different flows of fluid in the delivery chamber (flow rate of the water through each of cleaning pumps is individually adjusted to the required flow rate of the viscoelastic liquid through the respective internal channel, paragraph [00113]).
Regarding claim 6, Alemana teaches delivering a fluid flow through the at least one interior lumen without any portion of the slurry (first step in cleaning process is a warm water flush, paragraph [00103], and warm water passes through each of the internal channels. Paragraph [00106]).
Regrading claim 15, Alemana teaches wherein the at least one interior lumen is a fluidically complex lumen having at least a first section with a first internal dimension and a second section fluidically connected with the first section (all endoscopes have internal channels, come channels bifurcate while others join from two into one, paragraph [0005]), and wherein the second section has a second internal dimension that is smaller than the first internal dimension (suction biopsy lumens are larger while air/water channels are smaller, paragraph [0009]).
Regarding claim 33, Alemana teaches wherein at least one of the plurality of discrete portions is delivered to the first section with a first configuration, and wherein the method comprises: modifying the at least one of the plurality of discrete portions to a second configuration at a transition from the first section of the at least one interior lumen to the second section of the at least one interior lumen (cleaning apparatus may be provided with several combined primary and secondary transfer conduit assemblies, paragraph [0082], and flow rate is individually altered to correspond to the ideal volumetric flow and pressure for the respective internal channel, paragraph [00116]).
Regarding claim 34, Alemana teaches a system comprising: at least one delivery chamber fluidically connected to at least one interior lumen of an apparatus (viscoelastic liquid is pumped though primary and secondary conduits, paragraph [00111], and delivers viscoelastic liquid to the start of each internal channel whereby viscoelastic liquid is primed, paragraph [00112]); at least one of a valve or pump configured to individually provide each of a plurality of discrete amounts of a liquid-powder mixture to the at least one delivery chamber (pump an individual and predetermined amount of viscoelastic liquid through each supply line, paragraph [00111], and viscoelastic liquid comprises dissolved chemicals including abrasive particles, paragraph [0072]); and a delivery mechanism configured to apply at least one flow of fluid to each of the plurality of discrete amounts of the liquid-powder mixture in the at least one delivery chamber to propel each of the plurality of discrete amounts of the liquid-powder mixture through the at least one interior lumen (water is pumped to push up against the viscoelastic liquid so that it can continue flowing, paragraph [00113], and viscoelastic liquid reaches inlet apertures of the endoscope by being pushed by water, paragraph [00116]).
Regarding claim 35, Alemana teaches a control sub-system configured to determine the plurality of discrete amounts of the liquid-powder mixture based on a fluidic resistance of at least a proximal sections of the at least one interior lumen (the amount of viscoelastic liquid pumped by the active cleaning pumps will depend on the operational parameters in the cleaning apparatus, paragraph [00111], and smaller internal channels have larger fluidic resistance so the flow rate through these channels will be lower, paragraph [00119], and cleaning apparatus includes a control computer to operate the programmed cleaning sequence based on the operational parameters of the selected endoscope, paragraph [0091]).
Regarding claim 37, Alemana teaches wherein the delivery mechanism is configured to apply a first flow of fluid in the at least one delivery chamber and a second flow of fluid in the at least one delivery chamber to entrain each of the plurality of discrete amounts of the liquid-powder mixture with the first flow of fluid and the second flow of fluid and propel each of the plurality of discrete amounts (water is pumped by primary and secondary cleaning pumps to push up against the viscoelastic liquid so that it can continue flowing and flow rate of water through each cleaning pump is individually adjusted to the required flow rate of the viscoelastic liquid through the respective internal channel, paragraph [00113], and flow rate for primary pump will be relatively higher than secondary cleaning pump, paragraph [0084]).
Regarding claim 38, Alemana teaches a holding chamber, wherein the holding chamber is a consumable component that his configured to mechanically decoupled from the system (consumable unit being connectable to the cleaning apparatus, paragraph [0042]).
Regarding claim 41, Alemana teaches wherein the system is configured to create a pressure difference between a holding chamber and the at least one delivery chamber to draw each of the plurality of discrete amounts of the liquid-powder mixture from the holding chamber to the at least one delivery chamber (booster pump may also be a peristaltic or diaphragm type pump to draw viscoelastic liquid from the consumable reservoir, paragraph [0098]).
Regarding claim 42, Alemana teaches a distribution manifold fluidly connected between the at least one delivery chamber and the at least interior lumen (connection to the endoscope is facilitated by the primary and secondary transfer conduit assembly, paragraph [0081]).
Regarding claim 43, Alemana teaches wherein the delivery mechanism is configured to apply a flow of at least one of compressed air or water to each apportioned amount of the plurality of discrete amounts of the liquid-powder mixture in the at least one delivery chamber (water is pumped by primary and secondary cleaning pumps to push up against the viscoelastic liquid so that it can continue flowing and flow rate of water through each cleaning pump is individually adjusted to the required flow rate of the viscoelastic liquid through the respective internal channel, paragraph [00113]).
Regarding claim 49, Alemana teaches wherein at least one delivery chamber comprises first and second delivery chambers each separately fluidically connected to a holding chamber (exit manifold is fluidly connected to a primary and secondary coupling interface, paragraph [0081]).
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.
Claims 3 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Alemana in view of Coughlin (US 20030121532 A1).
Regarding claim 3, Alemana teaches all aspects of the current invention as described above except wherein mixing the liquid with the powder to form the slurry comprises: introducing the liquid into a consumable holding the powder. However, Coughlin teaches introducing the liquid into a container holding the powder (Figure 3 water is supplied "30" into container "12" for slurry "44" and mixed with stir bar "14"), and Alemana teaches a consumable container (consumable unit being connectable to the cleaning apparatus, paragraph [0042]).
Alemana and Coughlin are considered analogous to the current invention because all are in the field of biofilm removal methods. Therefore, it would have been obvious to one of ordinary skill in the art to combine the paste cartridge taught by Alemana with the introduction of liquid into the powder taught by Coughlin because Coughlin teaches that flowing water into the compartment will allow the slurry to be conveyed through the tubing connecting the container and the instrument (paragraph [0085]).
Regarding claim 39, Alemana teaches all aspects of the current invention including a holding chamber (consumable unit being connectable to the cleaning apparatus, paragraph [0042]), but does not teach wherein the holding chamber is configured to retain a powder, and wherein the system is configured to deliver a fluid to the holding chamber for mixing with the powder to form the liquid-powder mixture. However, Coughlin teaches wherein the holding chamber is configured to retain a powder, and wherein the system is configured to deliver a fluid to the holding chamber for mixing with the powder to form the liquid-powder mixture (Figure 3 water is supplied "30" into container "12" for slurry "44" and mixed with stir bar "14").
Alemana and Coughlin are considered analogous to the current invention as discussed above. Therefore, it would have been obvious to one of ordinary skill in the art to combine the paste cartridge taught by Alemana with the introduction of liquid into the powder taught by Coughlin because Coughlin teaches that flowing water into the compartment will allow the slurry to be conveyed through the tubing connecting the container and the instrument (paragraph [0085]).
Regarding claim 40, the combination of Spargo and Coughlin teaches all aspects of the current invention including a motor for use in mixing the fluid with the powder to form the liquid-powder mixture (container is agitated by magnetic stirring bar driven by magnetic stirrer, paragraph [0079], Coughlin).
Claims 7-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Alemana in view of Spargo (WO 2019113634 A1).
Regarding claim 7, Alemana teaches all aspects of the current invention except mixing the powder with the liquid in at least one holding chamber, wherein the at least one holding chamber is in fluid communication with one or more delivery chambers. However Spargo teaches mixing the powder with the liquid in at least one holding chamber (paste is premixed in a cartridge, page 8 paragraph 5), wherein the at least one holding chamber is in fluid communication with one or more delivery chambers (Figure 2 cartridges "101" and "102" flow paste to valve "109" through line "108").
Alemana and Spargo are considered analogous to the current invention because all are in the field of lumen cleaning methods. Therefore, it would have been obvious to one of ordinary skill in the art to combine the lumen cleaning method taught by Alemana with the mixing of the powder and liquid in the holding chamber taught by Spargo because Spargo teaches the mixed paste allows for the selection of the paste thickness as desired (page 8 paragraph 6).
Regarding claim 8, the combination of Alemana and Spargo teaches all aspects of the current invention including individually drawing each of the plurality of discrete portions from the at least one holding chamber to at least one of the one or more delivery chambers (booster pump may also be a peristaltic or diaphragm type pump to draw viscoelastic liquid from the consumable reservoir, paragraph [0098], Alemana).
Regarding claim 9, the combination of Alemana and Spargo teaches all aspects of the current invention including individually pumping each of the plurality of discrete portions from the at least one holding chamber to at least one of the one or more delivery chambers (consumable unit includes a booster pump for pumping the viscoelastic unit housing the viscoelastic liquid, paragraph [0029], Alemana).
Regarding claim 11, Alemana teaches all aspects of the current invention except wherein mixing powder with the liquid to form the slurry comprises; providing excessive powder relative to the liquid such undissolved powder is suspended in the slurry. However, Spargo teaches except wherein mixing powder with the liquid to form the slurry comprises; providing excessive powder relative to the liquid such undissolved powder is suspended in the slurry (carrier fluid is selected to not dissolve or only provide minimal dissolution of solid particles page 7 paragraph 2).
Alemana and Spargo are considered analogous to the current invention as described above. Therefore, it would have been obvious to combine the lumen cleaning method taught by Alemana with the liquid powder mixing taught by Spargo because Spargo teaches such a mixture will provide a stable suspension of solid particles (page 7 paragraph 2).
Regarding claim 12, Alemana teaches all aspects of the current invention except wherein mixing the powder with the liquid to form the slurry comprises; mixing sodium bicarbonate with water. However, Spargo teaches wherein mixing the powder with the liquid to form the slurry comprises; mixing sodium bicarbonate with water (solid particles are crystals of sodium bicarbonate, page 5 paragraph 5, and one useful paste is 1/3 water, page 5 paragraph 10).
Alemana and Spargo are considered analogous to the current invention as described above. Therefore, it would have been obvious to combine the lumen cleaning method taught by Alemana with the liquid powder mixing taught by Spargo because Spargo teaches the nature of the particles have been shown to contribute to the cleaning effect (page 7 paragraph 4).
Allowable Subject Matter
Claims 16-18, 21, 36, 45 and 47-48 are 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 16, the closest prior art is Alemana in view of Spargo as identified above. However, a combination of Alemana and Spargo fails to teach changing at least one attribute of at least one of the plurality of discrete portions within the at least one interior lumen at a transition from the first section of the at least one interior lumen to the second section of the at least one interior lumen.
Claims 17-18 are considered allowable due to their dependence on claim 16.
Regarding claims 21 and 36, the closest prior art is Alemana in view of Spargo and Miller as identified in the Non-Final Rejection mailed 20 March 2026. However, the combination of Alemana, Spargo, and Miller fails to teach causing the one of the plurality of discrete portions to rotate along the frustoconical shaped interior surface.
Regarding claim 45, the closest prior art is Alemana in view of Spargo as identified above. However, a combination of Alemana and Spargo fails to teach delivering a fluid at a transition within the interior lumen between the first internal dimension to the second internal dimension.
Claims 47-48- are considered allowable due to their dependence on claim 45.
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 KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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