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 § 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) 1-9, 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krebs et al (Pub. No.: US 2019/0216559)
Regarding claims 1, 11, Krebs et al disclose a method of performing lavage comprising steps of:
(a) providing an irrigation fluid to a surgical area [see 0044];
(b) removing via at least one suction line the irrigation fluid and medical waste at the
surgical area to generate a fluid stream in the at least one suction line (suction tool) [see 0044, 0046, 0051];
(c) analyzing the fluid stream via ionizing radiation detection (fluorescent imaging system) to generate a result based on a predetermined criteria (a plan that is generated by the CAS system constitutes the criteria, emphasis added) [see 0053];
(b)generating a feedback signal based on the result, wherein the feedback signal indicates whether the lavage has achieved the predetermined criteria (a plan that is generated by the CAS system constitutes the criteria, emphasis added) [see 0053];
(e) based on the feedback signal, either (1) if the predetermined criteria has not been achieved, repeating steps (a) through (d) until the lavage has achieved the predetermined criteria, or (2) if the predetermined criteria has been achieved, ending the lavage procedure [see 0052-0053] by disclosing the CAS system 100 is able to monitor the debridement of the affected areas to confirm that the affected areas are completely debrided [see 0052]
Regarding claim 2, Krebs et al disclose wherein the ionizing radiation detection indicates a target
material (biofilm inhibiting agent) contained within the fluid stream [see 0053.
Regarding claim 3, Krebs et al disclose wherein the target material includes at least one of a microorganism, debris or non-endogenous protein [see 0044, 0051, 0053].
Regarding claim 4, Krebs et al disclose wherein the ionizing radiation detection is performed in-line on the at least one suction line (suction tool) [see 0044].
Regarding claim 5, Krebs et al disclose wherein the ionizing radiation detection is continuously performed on the fluid stream [see 0059] by disclosing guide the surgeon toward sections of the irrigation area that need additional debridement [see 0059].
Regarding claim 6, Krebs et al disclose wherein the ionizing radiation detection is performed periodically on the fluid stream [see 0059].
Regarding claim 7, Krebs et al disclose wherein the feedback signal triggers a visual indication to a User [see 0053] by disclosing the imaging agent is illuminated using a fluorescent imaging system to label the infected areas, allowing the physician to visualize the infected areas [see 0053].
Regarding claim 8, Krebs et al disclose wherein the visual indication is a light source [see 0053] by disclosing the imaging agent is illuminated using a fluorescent imaging system to label the infected areas, allowing the physician to visualize the infected areas [see 0053].
Regarding claim 9, Krebs et al disclose wherein the visual indication is a symbol on the ionizing radiation detection [see 0053] by disclosing biofilms may be stained using solutions or dyes (for example, methylene blue, congo red, etc.) which can also allow the physician to visualize the area [see 0053].
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) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Krebs et al (Pub. No.: US 2019/0216559) in view of Leighton et al (Pub. No.: 2020/0164194)
Regarding claim 10, Krebs et al don’t disclose wherein the ionizing radiation detection is performed remotely by obtaining a sample from the fluid stream.
Nonetheless, Leighton et al disclose the ionizing radiation detection performed remotely by obtaining a sample from the fluid stream [see 0038].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Krebs et al and Leighton et al by having the ionizing radiation detection performed remotely by obtaining a sample from the fluid stream; so further analysis can be performed in different locations such as overseas.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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