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
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.
Claims 1-6 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mollstam (US 20070249993).
Regarding claim 1, Mollstam discloses a method of performing lavage (paras. [0011]-[0012]) comprising steps of: (a) providing an irrigation fluid to a surgical area (Figs. 1-2: surgical site 1 and fluid from containers 10 and 11; para. [0053]); (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 (Figs. 1-2: outflow suction line 16; para. [0049], last two sentences and para. [0050], first sentence); (c) analyzing the fluid stream via a spectroscopy test to generate a result based on a predetermined criteria (Fig. 1: spectroscopy including sensors 21 and 22 and detectors 25 and 26; para. [0051]; the absorbance spectroscopy described in para. [0028] and para. [0024]); (d) generating a feedback signal based on the result, wherein the feedback signal indicates whether the lavage has achieved the predetermined criteria (the feedback signal result being the detected light absorption of the fluid/the amount of debris in the fluid: para. [0028], the predetermined criteria being the calibrated minimum absorbance of the clear fluid and the trigger level e in para. [0063]; paras. [0031]-[0032]: the results create feedback to control the rinsing of the cavity); and (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 (Figs. 5-6; para. [0063], the flow is controlled to continue the rinsing cycle as long as the optical density readings are above trigger level e), or (2) if the predetermined criteria has been achieved, ending the lavage procedure (Figs. 5-6; para. [0063], the rinsing cycle automated to stop when the criteria of the minimum optical density is reached at trigger level i).
Regarding claim 2, Mollstam discloses the method of claim 1, wherein the spectroscopy test is configured to test for a target material contained within the fluid stream (para. [0028], last sentence, the absorbance spectroscopy tests for a target material of debris).
Regarding claim 3, Mollstam discloses the method of claim 2, wherein the target material includes at least one of a microorganism, debris or non-endogenous protein (para. [0028], last sentence, the absorbance spectroscopy tests for a target material of debris; Fig. 5).
Regarding claim 4, Mollstam discloses the method of claim 1, wherein the spectroscopy test is performed in-line on the at least one suction line (Figs. 1 and 3: optical sensors 21 and 22 are located along suction line 16, and directly connected to/communicating with readers 25 and 26).
Regarding claim 5, Mollstam discloses the method of claim 4, wherein the spectroscopy test is continuously performed on the fluid stream (para. [0063] and Fig. 5: the optical density curve along the x-axis of time shows continuous detection of the debris via the spectroscopy).
Regarding claim 6, Mollstam discloses the method of claim 4, wherein the spectroscopy test is performed at least once and, if necessary, periodically thereafter on the fluid stream (para. [0063] and Fig. 5: the optical density curve along the x-axis of time shows continuous detection of the debris via the spectroscopy).
Regarding claim 11, Mollstam discloses a system for performing the steps of claim 1 (Figs. 1-3: physical system which executes disclosed steps).
Claim Rejections - 35 USC § 103
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 7, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mollstam (US 20070249993) in view of Kaczmarek (US 20170167997).
Regarding claim 7, Mollstam discloses the method of claim 1, that has a visual display, but fails to explicitly disclose that the feedback signal triggers a visual indicator.
Kaczmarek teaches an analogous method of delivering fluid through an optical density detection device, wherein the feedback signal triggers a visual indication to a user (para. [0049], last two sentences; para. [0071], sentence 3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Mollstam method by incorporating the visual indication of the fluid detection taught by Kaczmarek, in order to indicate to the user what level of debris is detected in the waste fluid so that the user can easily determine how much washing likely remains and when the fluid is clear and the washing will terminate.
Regarding claim 8, Mollstam in view of Kaczmarek teaches the method of claim 7, wherein the visual indication is a light source (Kaczmarek: para. [0049], second-to-last sentence, the LED screen being a light source).
Regarding claim 10, Mollstam discloses the method of claim 1, but fails to explicitly disclose what type of light emission is used in the spectroscopy.
Kaczmarek teaches an analogous method of delivering fluid through an optical density detection device, wherein the spectroscopy test is performed by at least one of an ultraviolet measurement, a multiangle light scattering, or a fluorescence emission (para. [0016], the optical density of the fluid is measured using ultraviolet light measurements). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Mollstam method of optical density detection by incorporating the specific technique of ultraviolet measurement used to measure the optical density of the fluid, as taught by Kaczmarek, for an effective and highly accurate method of detecting biological debris in the fluid.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mollstam (US 20070249993) in view of Nip (US 20130085462).
Regarding claim 9, Mollstam discloses the method of claim 1, but fails to disclose the spectroscopy test being performed at a remote location.
Nip teaches an analogous wound lavage method, wherein the test is performed remotely by obtaining a sample from the fluid stream (para. [0122], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the in-line spectroscopy testing in the Mollstam method by incorporating the step of obtaining a sample of the fluid stream and testing remotely, as taught by Nip, in order to reduce costs and complexity of the system by not requiring a separate spectroscopy testing device coupled to the system itself.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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