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 .
Applicant’s election with traverse of Group I, claims 1-13, in the reply filed on 5/6/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because "the injection of the first volume" and "the injection of the second fluid" lack positive antecedent basis. The examiner suggests "following the injecting of the first volume" and "following the injecting of the second fluid". Re claim 3, "the gas injection" lacks positive antecedent basis. The examiner suggests "wherein the injecting of the gas". Re claim 9, line 3, the examiner suggests amending to delete the term "of". Re claim 13, "the second fluid injection" and "the gas injection" lacks positive antecedent basis. The examiner suggests "the injecting of the second fluid" and "the injecting of the gas" instead of the term "injection" for proper antecedent basis.
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.
Claim(s) 1-3, 6-7, 9, and 13 is/are rejected under 35 U.S.C. 102a(1) as being anticipated by Yang et al. (10675118B2).
Yang et al. teach a method of cleaning a medical device (i.e. endoscope, abstract) comprising coupling the lumen (i.e. cavity) of the medical device to the cleaning machine (i.e. pump 32, Fig, 2; col. 4, lines 30-35); injecting a first volume of a first fluid for preliminary flushing the lumen, wherein the first fluid is a water rinse (pre-rinse cycle, col. 8-9 bridging), while the medical device is placed in a decontamination tank (14a of Fig. 2); following the injection of the first fluid, injecting a second fluid comprising a detergent solution 86 (col. 9, lines 10-25), through the lumen and into the tank, wherein the second fluid differs from the water used in the pre-rinse cycle, letting the second fluid sit in the lumen for a contact time period (col. 9, lines 30-35 teaches a couple of minutes, col. 21, lines 1-5 teaches a minimum dwell time); then injecting a second volume of the first fluid for rinsing the second fluid, as col. 9, lines 45-68 teaches after the detergent wash cycle, another rinse cycle is initiated, followed by injecting a sterile air for removing the fluid (col. 10, lines 10-20), wherein the injecting of the gas occurs after following the contact time period of the second fluid since the claim is opened ended to include intermediate steps because of the comprising language. The limitations of maintaining the medical device in a tank containing a mixture of the first and second fluids are met since Yang et al. teach after the pre-rinse cycle, the tank is filled with warm water followed by adding a detergent solution, therefore, during the soaking time, the medical device is exposed to a mixture containing a first fluid (warm water) and the second solution (i.e. detergent solution). Re claim 2, refer to col. 3, lines 55-65. Re claim 3, refer to col. 10, lines 1-20. Re claim 6, refer to col. 9, lines 25-35 which teaches a contact time of 3 min, and a soak time of a couple of minutes. Re claim 7, Yang et al. teach the first fluid comprising water. Re claim 9, the limitations are broadly interpreted as the ratio of second fluid to first fluid in the tank is zero (i.e. less than 66 percent). Therefore, filling the tank with warm water prior to adding the detergent solution inherently would result in the tank being 100 percent of the first fluid, and therefore, the limitations are met. Re claim 13, refer to Figs 1-2, and col. 4, lines 30-40 which teaches that internal channels (i.e. lumens; col. 3, lines 55-60) are connected with flush conduits (i.e. flush lines 30, col. 4, lines 30-40) in order to flush the plurality of fluids.
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) 4-5, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (10675118B2).
Re claim 4, Yang et al. do not teach the claimed pressures. Yang et al. do teach pumps 32 of Fig. 2 for delivery of fluids to clean the interior lumen of the endoscope. Absent of a showing of criticality and unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pressures at which the fluids are being injected depending upon such factors as the concentration, flowrate and temperature of the fluids, the type and amount of contaminants, as well as the orifice diameter of the lumen being cleaned. Re claim 5, Yang et al. do not teach the claimed temperature ranges. However, paragraph 5, lines 23-25 teaches an inline heater with temperature sensors to heat the liquid to optimum temperatures for cleaning and/or disinfection. Absent of a showing of criticality and/or unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the temperature at which the fluids are heated in order to achieve optimum temperatures needed for cleaning and/or disinfection. Re claim 12, Yang et al. do not specifically teach following the rinsing to place the medical device in an automated endoscope reprocessor. However, Fig. 1, components 10 and 12 of Yang et al. teach a reprocessing system comprising two stations 10 and 12, and absent of a showing of criticality and/or unexpected results, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the additional station of a reprocessing system if additional cleaning/disinfection are required.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (10675118B2) in view of Takashi et al. (JP2014014524A).
Yang et al. teach the invention substantially as claimed with the exception of brushing the exterior surface of the device. Takashi et al. teach washing the endoscope in a washing tank by brushing the outer peripheral surface. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yang et al. to include brushing the external surface of the endoscope, as taught by Takashi et al. for purposes of performing the same function of cleaning the endoscope.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (10675118B2) in view of Lin et al. (US6596232B1).
Yang et al. teach the invention substantially as claimed with the exception of the claimed diameter of the lumen. Lin et al. teach a method and apparatus for flowing the fluid through the lumen for purposes of cleaning and disinfecting the lumen (col. 3, lines 30-35), wherein the diameters of the lumen are 3mm (col. 6, lines 50-60). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified the method of Yang et al. to include lumens which are less than 6mm diameter for purposes of performing the same function of cleaning, sterilizing and disinfecting the endoscope.
Allowable Subject Matter
Claim 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: The prior art fails to teach the claimed composition as recited in claim 8.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Williams et al. teach a sterilization device. Parker et al. teach cleaning and disinfecting medical instruments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sharidan Carrillo whose telephone number is (571)272-1297. The examiner can normally be reached M-F, 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Barr can be reached at 571-272-1414. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Sharidan Carrillo
Primary Examiner
Art Unit 1711
/Sharidan Carrillo/Primary Examiner, Art Unit 1711 bsc
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