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 .
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) 1-7 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (11,730,457) in view of Yagi et al. (2025/0195741).
With respect to claim 1, Locke discloses a method of performing lavage, as shown in figure 1, comprising providing an irrigation fluid to a surgical site, as disclosed in column 4, lines 13-17, removing via a suction line the irrigation fluid and medical waste to generate a fluid stream in the suction line, as disclosed in column 4, lines 33-41, analyzing the fluid stream via a lateral flow test to generate a result, as disclosed in column 11, lines 43-50, and generating a feedback signal, as shown in figure 10B.
Locke discloses all aspects of the claimed invention with the exception of the feedback signal indicating whether the lavage has achieve a predetermined criteria and repeating the steps until the lavage has achieved the predetermined criteria or ending the lavage procedure if the predetermined criteria has been achieved. Yagi discloses a method of performing lavage including the step of analyzing the fluid stream to generate a feedback signal, as disclosed in paragraph [0057], and adjusting the number of irrigations based on the feedback signal, as disclosed in paragraph [0061]. Yagi further discloses performing the steps to remove bacteria, as disclosed in paragraph [0060], which suggests performing the steps until analysis of the fluid stream shows a reduction or elimination of bacteria. Setting a predetermined criteria, or threshold value, to meet is well-known in the art. It would therefore have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to perform the method of Locke wherein the feedback signal indicating whether the lavage has achieve a predetermined criteria and repeating the steps until the lavage has achieved the predetermined criteria or ending the lavage procedure if the predetermined criteria has been achieved, as taught by Yagi, to adjust the number of irrigations based on the feedback signal of the analysis of the fluid stream in order to achieve the predictable result of performing treatment until the surgical area is free of bacteria and sufficiently treated for infection.
With respect to claims 2-3, the lateral flow test of Locke is configured to test for a target material in the fluid stream, the target material being a microorganism, debris, or a non-endogenous protein, as disclosed in column 12, lines 4-24.
With respect to claim 4, the lateral flow test of Locke is performed in-line on at least one suction line, as disclosed in column 2, lines 3-11.
With respect to claim 5, the lateral flow test of Locke may be left in the sampling interface during the duration of the treatment, and therefore is considered to be continuously performed.
With respect to claim 6, the lateral flow test of Locke is performed at least once, as disclosed in column 11, lines 43-50.
With respect to claim 7, the feedback signal of Locke triggers a visual indication to a user, as shown in figure 10B.
With respect to claim 9, the visual indication is a symbol 1005 on the lateral flow test, as shown in figure 10B.
With respect to claim 10, Locke discloses the lateral flow test is separate from the sampling interface, as shown in figure 7, and further discloses obtaining a sample from the fluid stream, as disclosed in column 12, lines 45-51, and therefore is considered to anticipate the claim as presently written.
With respect to claim 11, Locke discloses a system for performing the steps of claim 1, as shown in figure 1.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (11,730,457) in view of Yagi et al. (2025/0195741), and further in view of Baker et al. (8,435,207).
With respect to claim 8, modified Locke discloses all aspects of the claimed invention with the exception of the visual indication being a light source. Baker discloses a method for irrigation comprising analyzing a fluid stream, and teaches using a light source as a visual indication operational purposes such as diagnostic purposes, as disclosed in column 13, lines 52-63. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the method of Locke with a light source as the visual indication, as taught by Baker, to achieve the predictable result of providing an easily identifiable indication of a diagnostic result to a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents 12,251,530; 11,980,352; and 11,006,879 disclose irrigation methods that analyze a fluid output.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNNE ANDERSON whose telephone number is (571)272-4932. The examiner can normally be reached Monday-Friday 10-6.
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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
