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 .
Election/Restrictions
Applicant’s election of Group I, claims 13-22, in the reply filed on June 16, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 23-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 13-22 will be examined on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 13-16, 18, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,552,163 to Biancalana et al. in view of U.S. Patent No. 5,275,668 to Dell et al. and U.S. Patent No. 5,265,628 to Sage et al.
As to claim 13, Biancalana discloses a method comprising: configuring a benchtop surgical (read as pathology) instrument contaminant removal device (see Biancalana Abstract; col. 1, lines 14-29) to receive an instrument in a wash chamber of the instrument contaminant removal device (see Biancalana Fig. 1, ref.#1, 2 and 5; col. 2, lines 28-34, col. 3, lines 7-26); based on receiving the instrument, convey water to a water spray system where pressurized water is sprayed on the instrument to clean contaminants from the instrument (see Biancalana col. 4, lines 53-64); while spraying the pressurized water on the instrument, continuously drain the water, comprising the contaminants, from the wash chamber (see Biancalana col. 2, line 55 – col. 3, line 6).
While Biancalana discloses that the pressurized water is supplied by water supply pipe 44 (see Biancalana col. 3, lines 61-64), Biancalana does not explicitly disclose that the water spray system comprises a pump and a corresponding motor. Dell discloses a similar cleaning apparatus wherein the water supply is via an external water source pump with corresponding motor (see Dell Fig. 8, ref.#3 and 14). It would have been obvious to one of ordinary skill in the art at the time of filing to have the water delivery activation device and water supply of Biancalana be in communication with an external water source pump and motor to pressurize the deliver water as disclosed by Dell and the results would have been predictable (supplying water to a cleaning device).
The combination of Biancalana and Dell does not explicitly disclose after removal of the instrument, flush, via the water spray system, the wash chamber to flush the contaminants dislodged from the instrument. Sage discloses a similar cleaning instrument comprising a self-clean cycle wherein after removal of the object to be cleaned, the chamber is flushed with cleaning solution to clean the chamber (see Sage col. 4, lines 51-60 and col. 7, lines 32-37). It would have been obvious to one of ordinary skill in the art at the time of filing to include a self-cleaning cycle as disclosed by Sage in order to prevent recontamination of the objects to be cleaned.
As to claim 14, the combination of Biancalana, Dell and Sage discloses that device is configured to spray the pressurized water via a plurality of jets positioned approximately equidistant around the wash tube (see Biancalana Fig. 1, ref.#10 where the two nozzles are on opposite sides).
As to claim 15, the combination Biancalana, Dell and Sage discloses that the plurality of jets can be disposed substantially flush with an inner surface of the wash tube (see Biancalana Fig. 1, ref.#10 where the nozzles 10 appear to be substantially flush with an inner surface of the wash tube).
As to claim 16, the combination of Biancalana, Dell and Sage discloses that the device can be further configured to deliver the water to the plurality of jets via a manifold connected to the pump (see Biancalana col. 3, lines 27-56 disclosing manifolds 23 and 24 configured to deliver the water to the plurality of jets; Dell Fig. 8, ref.#3 and 14 disclosing the pump and motor).
As to claim 18, the combination of Biancalana, Dell and Sage discloses that the device is configured to continuously drain via a drain basin wherein the drain basin comprises a conical shape that can prevent stasis of water comprising the contaminants and to support flow of the water comprising the contaminants from the wash chamber (see Biancalana Fig. 1, ref.#15 and 6d and col. 2, line 55 – col. 3, line 6 disclosing a drain basin with a conical shape between ref.#15 and ref.#6d).
As to claim 20, the combination of Biancalana, Dell and Sage discloses that the device can be further configured to sense the received instrument and based on sensing the received instrument, automatically conveying water to the water spray system (see Biancalana col. 4, lines 53-64); and sense removal of the instrument from the wash chamber wherein the water spray system can automatically flush the wash chamber based on the sensed removal of the instrument (see Sage col. 4, lines 51-60 and col. 7, lines 32-37).
As to claim 21, the combination of Biancalana, Dell and Sage discloses that the device is configured to sense the instrument via a proximity sensor (see Biancalana col. 4, lines 53-64).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,552,163 to Biancalana et al. in view of U.S. Patent No. 5,275,668 to Dell et al. and U.S. Patent No. 5,265,628 to Sage et al. as applied to claim 13 above, and further in view of U.S. Patent App. Pub. No. 2017/0095316 to Wiek.
Biancalana, Dell and Sage are relied upon as discussed above with respect to the rejection of claim 13.
As to claim 17, while the combination of Biancalana, Dell and Sage disclose using air and water, the use of jets capable of supplying water-only is known in the art (see, e.g., Wiek disclosing the use of a water-only without the need of pressurized air – see Fig. 1, Step III), and it would have been well within the skill of one of ordinary skill in the art to use only water (without pressurized air) in the combination of Biancalana, Dell and Sage. Furthermore, Wiek discloses that it is known in the art to clean instruments by use of a cleaning agent and then rinsing off the cleaning agent with only water (see Wiek Abstract and Fig. 1, Step I-III disclosing rinsing with water only). It would have been obvious to one of ordinary skill in the art at the time of filing to modify Biancalana/Dell/Sage to include the cleaning steps of Wiek in order to optimize the cleaning of the instrument where said cleaning steps of Wiek disclose use of “water-only” jets.]
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,552,163 to Biancalana et al. in view of U.S. Patent No. 5,275,668 to Dell et al. and U.S. Patent No. 5,265,628 to Sage et al. as applied to claim 13 above, and further in view of U.S. Patent App. Pub. No. 2003/0196289 to Schwab et al.
Biancalana, Dell and Sage are relied upon as discussed above with respect to the rejection of claim 13.
As to claim 19, regarding the recitation that “the instrument inlet comprises a first substantially round funnel shape, and a second funnel shape different from the substantially round funnel shape,” the combination of Biancalana, Dell and Sage discloses that the first diameter of the instrument inlet can be greater than the second diameter as indicated by the annotated Fig. 4 of Biancalana below disclosing a tapered opening of mouth pipe 8:
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(see also Biancalana Fig. 3 where the opening to mouth pipe 8 is larger than the outer diameter of tubular body 6 and also element 7 (not labeled in Fig. 4, but can be seen in Fig. 2 as being smaller than the opening of 8)). Thus, the combination of Biancalana, Dell and Sage is understood to disclose that the first end of the instrument inlet is greater than the second diameter of the instrument inlet and that the inlet is a substantially round funnel-shape. With respect to the recitation that the second funnel shape is different from the substantially round funnel shape, changes in shape are prima facie obvious and does not provide patentable significance absent secondary considerations (see MPEP 2144.04(IV)(B) where changes in shape are prima facie obvious).
The combination of Biancalana, Dell and Sage does not explicitly disclose that the inlet is disposed at an angle of approximately 45-60 degrees from horizontal. Schwab discloses a similar instrument cleaning device wherein the cleaning device is at an angled orientation from horizontal in the range of 30-70 degrees from horizontal (see Schwab paragraph [0015] and claim 12). It would have been obvious to one of ordinary skill in the art at the time of filing to modify Biancalana such that the linear alignment is approximately 45-60 degrees from horizontal in order to offer visual and mechanical access to the cleaning portal and so that it is relatively easy to insert the instrument into the cleaning unit (see Schwab paragraph [0015] and claim 12; see also MPEP 2144.05(I) where in the case the claimed range overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 4,552,163 to Biancalana et al. in view of U.S. Patent No. 5,275,668 to Dell et al. and U.S. Patent No. 5,265,628 to Sage et al. as applied to claim 13 above, and further in view of U.S. Patent No. 4,433,698 to Blaul.
Biancalana, Dell and Sage are relied upon as discussed above with respect to the rejection of claim 13.
As to claim 22, the combination of Biancalana, Dell and Sage does not explicitly disclose activating the water delivery system comprises depressing a foot pedal. Use of foot pedals to activate a cleaning spray is known in the art and does not provide patentable significance (see Blaul col. 4, lines 3-17). It would have been obvious to one of ordinary skill in the art at the time of filing to use a foot pedal to activate the water delivery system of Biancalana, Dell and Sage as disclosed by Blaul in order to free the hands of the operator by affording them foot control to start and stop the spray cleaning operation (see Blaul col. 4, lines 3-17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS LEE whose telephone number is (571)270-3296. The examiner can normally be reached M-F 7:30-4:30pm.
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/DOUGLAS LEE/Primary Examiner, Art Unit 1714
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