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 .
In light of the amendments to the claims filed 12/02/2025 in which claims 1, 3-4, 12, 16 were amended, claims 2, 14-15, 17, and 20 were cancelled, and claims 21-23 were added, claims 1, 3-13, 16, 18-19, and 21-23 are pending in the instant application and are examined on the merits herein.
Priority
The instant application claims priority to Foreign Application no. DE/10/2022120056.6 filed on 08/09/2022.
Claims 1, 3-13, 16, 18-19, and 21-23 receive priority to the prior-filed application, filed on 08/09/2022.
Response to Arguments
Objections to the Claims
The objections to the claims are withdrawn in view of the amendments to the claims filed 12/02/2025.
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claim 1, the applicant asserts that Huang fails to disclose that the liquid line is held on the applicator housing and the rotor can be placed against the deformable section when the pump is inserted into the drive receptacle, because Huang discloses a disposable container with a liquid line for a medication while the drive/pump is held in the applicator housing that is wearable like a wrist watch.
In response to the applicant’s argument, the examiner respectfully disagrees. In the previous Office Action filed 09/02/2025, Huang was used as a teaching reference to Thiessies to teach the specific drive arrangement as claimed. While it may be conceded that Huang holds the drive/pump in a housing, Huang was used to substitute the reusable and associated disposable drive structure of Thiessies with the reusable and associated disposable drive structure of Huang. Any disposable drive structure that is associated with the applicator housing of Thiessies would be substituted with any disposable drive structure of Huang; therefore, the rejection of the claim is maintained.
Further, the amendments to the claims have necessitated new grounds of rejection.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 7-13, 16, 18-19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over US/2020/0345925 A1 to Thiessies in view of US/2006/0271020 A1 to Huang.
Regarding claims 1, 3-5, 16, 18-19, and 23, Thiessies discloses (Claim 1) a lavage arrangement (Fig. 8-14), comprising:
an applicator housing having a body (Fig. 10, housing 1 comprising body 12), a handle (Claim 23) extending from the body (Fig. 10, grip part 11 extending from body 12) and (Claim 1) an application opening for dispensing a rinsing liquid (Fig. 10, holder 13 for connection to attachment comprising application opening), the applicator housing enclosing a drive receptacle which is accessible via a housing opening (para. 0042; Fig. 8, recess 41 as a drive receptacle accessible by opening 14);
a liquid line connecting the application opening to a reservoir of the rinsing liquid (para. 0032; para. 0040; para. 0044; Fig. 10, hoses 9); and
a drive unit of a pump that can be inserted into the drive receptacle for conveying the rinsing liquid from the reservoir to the application opening (para. 0040; Fig. 10, drive unit 3 of pump 3/6), the drive unit of the pump having a motor and a power supply device (para. 0034; para. 0036),
wherein the drive unit can be inserted interchangeably in the drive receptacle (para. 0042),
wherein the liquid line is held on the applicator housing (para. 0040; Fig. 10, hoses 9 held within housing 1), and
(Claim 23) wherein the claim elements may be in any of first, second, or third arbitrary directions (Fig. 8-14).
Thiessies differs from the instantly claimed invention in that Thiessies fails to disclose (Claims 1 and 23) a pump drive shaft which can be driven by the motor, wherein a rotor which can be driven by the pump drive shaft is provided with at least one displacement element (Claims 3-4 and 16) which may be at least three displacement elements held on the rotor and may be a roller, (Claim 1) the at least one displacement element, together with a deformable section of a liquid line (Claims 5 and 18-19) formed by a tube with a rounded cross section, (Claim 1) forming the pump in the form of a peristaltic pump, wherein the rotor is held with the at least one displacement element on the pump and can be inserted interchangeably with the pump in the drive receptacle, and (Claims 1, 5, and 18-19) wherein the liquid line is held on a correspondingly rounded concave contact area of a housing and (Claim 1) the rotor can be placed against the deformable section when the pump is inserted into the drive receptacle.
Huang teaches a reusable part of a medical pump system (Fig. 3, dispensing mechanism 2) comprising a pump for conveying a liquid from a reservoir (para. 0069-0070; Fig. 3), the pump having a motor (Fig. 3, motor 17; para 0069), a power supply device (Fig. 2, battery 6; para. 0061), and (Claims 1 and 23) a pump drive shaft which can be driven by the motor (para. 0069; para. 0103),
wherein a rotor which can be driven by the pump drive shaft is provided with at least one displacement element (Claims 3-4 and 16) which may be at least three displacement elements held on the rotor and may be a roller (Fig. 3, rotor 12 comprising rollers 15 [as displacement elements]; para. 0069; para. 0070), the at least one displacement element, together with a disposable part of a medical pump system (Fig. 2, disposable part 40) (Claims 5 and 18-19) formed by a deformable tube of a liquid line with a rounded cross section (Fig. 3, liquid line 13 with rounded cross section held in rounded concave contact surface 16A on housing 14) and a correspondingly rounded concave contact area of a housing which the tube can be placed against (Fig. 3, rollers 15 of rotor 12 configured to be placed against deformable section of liquid line 13 when dispensing mechanism 2 inserted into connection with receiving slot 16 of housing 14; para. 0070; Fig. 3, liquid line 13 with rounded cross section held in rounded concave contact surface 16A on housing 14), (Claim 1) forming the pump in the form of a peristaltic pump (Fig. 3 showing all elements of peristaltic pump comprised from reusable and disposable parts; para. 0070), and
wherein the rotor is held with the at least one displacement element on the pump (Fig. 3 showing rotor 12 with rollers 15 held in connection with motor 17 and drive shaft) and can be reused along with the pump with another disposable part (para. 0067-0071);
(Claims 1, 5, and 18-19) wherein the liquid line is held on the rounded concave contact area of the disposable part of the medical pump system and (Claim 1) the rotor can be placed against the deformable section when the reusable and disposable parts of the pump are brought together (Fig. 3, 13 liquid line held in rounded concave contact surface 16A on housing 14; Fig. 3, rollers 15 of rotor 12 configured to be placed against deformable section of liquid line 13 when dispensing mechanism 2 inserted into connection with receiving slot 16 of housing 14; para. 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the driving gear mechanism of the drive unit and the pump mechanism of Thiessies (para. 0040-0043) that drives lavage fluid through the system from the irrigation container connected to the hoses, for the drive shaft, rotor, displacement elements, deformable section of the liquid line, rounded concave contact area, and any other required structures to drive fluid through a hose and to allow for interchangeable connection as taught in Huang since these mechanisms perform the same functions of providing fluid through a pump mechanism and allowing for reusability of the drive unit (Thiessies: para. 0036-0037; para. 0040; Huang: para. 0066-0067; para. 0098). Simply substituting one drive and pump means for another would yield the predicable result of pumping fluid through a medical fluid system. See MPEP 2143.
Further, a vacuum or membrane pump with a reusable drive unit as disclosed in Thiessies and a peristaltic pump with a reusable drive unit as taught by Huang are functionally equivalent structures. According to MPEP 2183, "Factors that will support a conclusion that the prior art element is an equivalent are: (A) The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element " The device of Thiessies provides a usable irrigation pump that allows for removal and re-use of a drive unit from non-reusable pump parts (para. 0035-0047). The device of Huang, while having a different pump structure from Thiessies, also provides an irrigation pump that allows for removal and re-use of a drive unit from non-reusable pump parts (para. 0067-0071); therefore, the structure of Huang performs the identical function of that of Thiessies in substantially the same way.
Regarding claim 7, the cited prior art suggests the invention of claim 1. Thiessies further discloses: wherein the housing opening can be closed by a closing element held movably on a remainder of the applicator housing (para. 0033; Fig. 9, flap cover 16 closed by hinges 17 and provided on housing).
Regarding claim 8, the cited prior art suggests the invention of claim 7. Thiessies further discloses: wherein the closing element is formed by a hinged cover (para. 0033; Fig. 9, flap cover 16 closed by hinges 17 and provided on housing).
Regarding claim 9, the cited prior art suggests the invention of claim 7. Thiessies further discloses: wherein the applicator housing with the closing element is made of a single plastic material (para. 0047-0048).
Regarding claim 10, the cited prior art suggests the invention of claim 1. Thiessies further discloses: wherein a rinsing attachment can be attached exchangeably to the application opening (para. 0032; Fig. 10, attachment 5 connected to holder 13).
Regarding claim 11, the cited prior art suggests the invention of claim 1. Thiessies further discloses: wherein the reservoir of the rinsing liquid is formed by a separate container which can be connected to the applicator housing via the liquid line (para. 0040, one of hoses 9 connected with a supply container for the irrigation liquid).
Regarding claim 12, the cited prior art suggests the invention of claim 1. Thiessies further discloses: wherein the motor and the power supply device are received in a protected manner in a drive housing of the pump (para. 0046).
Regarding claim 13, the cited prior art suggests the invention of claim 1. Thiessies further discloses: wherein the power supply device is formed by a rechargeable battery (para. 0034).
Regarding claim 21, the cited prior art suggests the invention of claim 1. Thiessies further discloses: wherein the pump extends into the handle (Fig. 10, drive unit 3 extending into handle 11).
Regarding claim 22, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the pump comprises a drive housing, and wherein the pump drive shaft is perpendicular to the drive housing.
Another embodiment of Thiessies discloses a drive unit housing that is liquid-tight to protect the interior components that comprises the motor and rechargeable battery, and wherein a pump drive shaft is perpendicular to a part of the drive housing (Fig. 7, drive unit 3 comprised of drive unit housing; para. 0034-0036).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the current combination of Thiessies and Huang in view of the secondary embodiment of Thiessies, because Thiessies teaches that the drive unit housing is liquid-tight (para. 0034-0036), which would protect the interior electronic components during a lavage procedure.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Thiessies and Huang as applied above, and further in view of DE/10/2014004476 A1 to Zerle.
Regarding claim 6, the cited prior art suggests the invention of claim 1. Huang (as in the rejection of claim 1) further discloses: wherein the at least one displacement element has a contact surface that can be placed against the deformable section and has a rounded, transverse profile formed transversely to a conveying direction (Fig. 3, rollers 15 of rotor 12 configured to be placed against deformable section of liquid line 13 when dispensing mechanism 2 inserted into connection with receiving slot 16 of housing 14; Fig. 4 showing rounded, transverse profile of rollers 15 formed transversely to a conveying direction; para. 0070); however, the prior art differs from the instantly claimed invention in that they fail to disclose wherein the at least one displacement element has a rounded, concave transverse profile formed transversely to a conveying direction.
Zerle teaches a medical device for pumping a medical liquid comprising a peristaltic pump comprising rollers wherein the roller has a rounded, concave transverse profile formed transversely to a conveying direction to provide a more complete occlusion of the tube while avoiding high contact pressures (Fig. 5, rounded, concave recess 19 in concave contact area 3; para. 0008; para. 0020; para. 0061-0063, rounded, concave recess may be introduced in the surface of rollers 5).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the displacement elements and the contact area of the pump of Thiessies and Huang to comprise a partially concave profile as taught by Zerle, because Zerle teaches that this provides a greater contact pressure on the wide ends of the tube than on a central area of the tube, which leads to a better almost complete occlusion while avoiding high contact pressures (para. 0008; para. 0020; para. 0061-0063).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
11 March 2026