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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/2026 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over LaPointe (US 20170066020) in view of Tashiro (US 7947224) and Wang (CN 104928347). A machine translation of Wang is provided as an English equivalent and is used in the citations below.
Claims 1 and 9-10: LaPointe teaches a method for visualizing contamination on a solid surface (e.g. surface of piece of equipment)(abstract); it teaches that the contamination can be any kind of contamination [0031], and as shown in figure 1 said method comprising steps of: (a) providing a solid surface where at least a portion of the solid surface potentially is covered with contamination and which can have been previously been subject to the cleaning process [0039], which can include exposure to an aqueous medium (washing with water as the solution) [0100-0104] and (b) as shown in figure 1, maintaining the solid surface in a horizontal position in a horizontally positioned basin and covering the solid surface with a solution of a detection agent [0052-0056] which can be a dispersion of carbon particles [0059] where, as discussed above, water is a taught solvent for the process, (c) it further teaches embodiments where the substrate covered with the detection agent is tilted at an angle of 45 degrees from horizontal to allow excess aqueous dispersion of carbon particles to flow from the surface before detection [0168], (d) detecting any contamination present on the solid surface by determining whether there are areas not covered by aqueous dispersion of carbon particles [0072-0075].
Thus, it would have been obvious to a person of ordinary skill in the art at the time of invention to perform the process as claimed, including tilting the horizontal surface, such as to 45degrees to drain off excess liquid and detection agent, since it was a specifically taught treatment of the indicated surface to allow excess material to be removed and so produce contrast and since doing would produce no more than predictable results.
Regarding the requirement that the contamination be a “biofilm”, LaPointe teaches the contamination can be any kind [0031] which would include biocontamination, but LaPointe does not specifically identify the contamination as a biofilm.
Tashiro is also directed towards detecting contamination on a surface by imaging it, but teaches the need to detect a film of biological materials on the surface (biofilm) (col 1, lines 15-25), by exposing the surface to a detection agent (e.g. india ink, which is a carbon particle dispersion)(col 3, lines 4-10).
Thus, it would have been obvious to a person of ordinary skill in the art at the time of invention to use the method of LaPointe using a carbon particle dispersion, such as india ink, as an indicator to detect biofilms, since such contamination was taught to be in need of detection and such indicators were taught by the prior art to be useful for that purpose and doing so would produce no more than predictable results.
Regarding the claim limitation “wherein said method has no permanent effect on the biofilm or on the solid surface”, the references do not discuss a permanent effect and the references suggest an india ink dispersion which is the same dispersion applied by applicant’s claimed method. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established, In re Best, 195 USPQ 430, 433 (CCPA 1977). With regard to the no permanent effect limitation, when the structure recited in the prior art is substantially identical to that of the claims, the claimed properties or function are presumed inherent. MPEP 2112. In this situation, the prior art exemplifies the applicant's claimed method, so the claimed no permanent effect relating to the method are present in the prior art. Absent an objective evidentiary showing to the contrary, the addition of the physical properties to the claim language fail to provide patentable distinction over the prior art of record (claim 1).
LaPointe teaches one or more cameras configured to capture cleanliness information in the form of one or more two-dimensional images. LaPointe teaches the images acquired in any electromagnetic spectra which may be conducive to the measurement or detection of cleanliness. LaPointe teaches images may be representative of reflected or scattered light or acquired by any other suitable means ([0040]). The combined references do not explicitly teach the solid surface illuminated from below by transmitted light or the detection is performed using a stereo microscope; however, Wang teaches observation of a biofilm using a stereo microscope with transmitted light (page 3 step 6). Wang teaches observing the thickness change, i.e. 3D visualization (abstract). It would have been prima facie obvious to one of ordinary skill in the art to modify the method of the combined references to include a stereo microscope for biofilm detection, as suggested in Wang, because it is a known observation method in the art and one of ordinary skill in the art would have had a reasonable expectation of predictably achieving the captured information of LaPointe with a stereo microscope, as in Wang.
Claim 2: Tashiro teaches that the solid surface can be a polymeric surface (resin film, col 14, lines 45-55). Thus, it would have been obvious to a person of ordinary skill in the art at the time of invention to use the method of LaPointe with a polymeric surface, since such surfaces were taught by the prior art to be in need of detection and doing so would produce no more than predictable results (claim 2).
Claim 3: as discussed above, Tashiro teaches aqueous dispersion of carbon particles is an India ink, which is obvious to use as the indicator.
Claims 4-5: LaPointe teaches producing a photographic image (of the biofilm comprising an aqueous dispersion of carbon particles) as the detected image, which can be digitally processed to be black and white (one-bit image) [0041].
Claim 6: as discussed above, the tilting angle of 45o is obvious, which is greater than 20o.
Claims 7-8: applicant claims a particular ranges for the concentration of the carbon dispersion used and the concentration of carbon particles in the dispersion.
MPEP 2144.05 (II) states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. '[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.'"
Thus, it would have been obvious to one of ordinary skill in the art at the time of invention to choose the instantly claimed ranges of at least 0.1nl/cm2 of dispersion and 0.5-10wt% carbon particles in the dispersion, since it has been held that when the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (claims 7-8).
Claim 11: Wang teaches 12 microns/pixel, i.e. approximately 10 microns (pg. 3 step 6).
Claim 12: Wang teaches the visual field range reaches 529 mm2 (pg. 3 step 6). The combined references do not explicitly teach the area of the sample captured with the camera is from 7.6 to 510.7 mm2; however, Wang teaches the visual field such that growth of the whole biological film can be observed (pg. 3 step 6). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05 II A. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to optimize the size of the visual field, as suggested in Wang, such that the entire biological field is observed, and in such an optimization one of ordinary skill in the art would have arrived at applicants’ claimed area.
Claims 13-14: LaPointe teaches producing a photographic image (of the biofilm comprising an aqueous dispersion of carbon particles) as the detected image, which can be digitally processed to be black and white (one-bit image) [0041]. LaPointe teaches each pixel classified as a “clean pixel” or “dirty pixel” ([0084]). LaPointe teaches a computer-based processing unit may assign cleanliness levels represented as a percentage based on the pixels ([0085]). LaPointe is silent as to the color of the pixels; and does not explicitly teach the color of the “dirty” pixels are white and “clean” pixels are black; however, whether the black and white image of LaPointe is as captured or inverted is an aesthetic design choice which cannot be relied upon to patentably distinguish the claimed invention from the combined references. MPEP 2144.04.
Claim(s) 2 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over LaPointe (US 20170066020) in view of Tashiro (US 7947224) and Wang (CN 104928347) as applied to claims 1-14 above, and further in view of Ishibashi (JP H10235393). A machine translation of Ishibashi has been provided as an English equivalent and is used in the citations below.
Claims 2 and 16-17: Tashiro teaches that the solid surface can be a polymeric surface (resin film, col 14, lines 45-55). Ishibashi also teaches cleaning and detecting a biofilm contamination on a surface, including imaging it (Figures and discussion thereof). Ishibashi teaches reverse osmosis applications ([0007]). Ishibashi teaches polyamide materials ([0030]). It would have been obvious to a person of ordinary skill in the art at the time of invention to use the method of LaPointe with a surface, as taught in Ishibashi, since such surfaces were taught by the prior art to be in need of detection and doing so would produce no more than predictable results.
Claim 15: Regarding the claim limitation “the polymeric surface has a lightness of at least 100 lux when illuminated from below”, the references suggest a polyamide membrane which is the same membrane applied by applicant’s claimed method. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established, In re Best, 195 USPQ 430, 433 (CCPA 1977). With regard to the lightness limitation, when the structure recited in the prior art is substantially identical to that of the claims, the claimed properties or function are presumed inherent. MPEP 2112. In this situation, the prior art exemplifies the applicant's claimed method, so the claimed no permanent effect relating to the method are present in the prior art. Absent an objective evidentiary showing to the contrary, the addition of the physical properties to the claim language fail to provide patentable distinction over the prior art of record.
Response to Arguments
Applicant's arguments filed 2/23/2026 have been fully considered but they are not persuasive.
Applicant argues LaPointe, Tashiro, and Wanq, when considered in combination with or without Ishibashi, provide no teaching or suggestion of the visualization by transmitted light that is a specifically recited feature of Applicant's claimed process. In response to applicant’s argument, Wang teaches observation of a biofilm using stereo microscope with transmitted light (pg. 3 step 6).
Applicant argues the Official Action does not articulate any reason why it would have been obvious to one of ordinary skill in the art to alter the processes described by LaPointe, Tashiro, Wang and Ishibashi by eliminating the use of reflected or emitted light in order to produce Applicant's claimed process, which requires that the biofilm be visualized by light transmitted through the sample. In response to applicant’s argument, LaPointe teaches images acquired by cameras in any electromagnetic spectra which may be conductive to the detection. Since Wang suggests that a suitable method of observation of a biofilm uses stereo microscope with transmitted light (pg. 3 step 6), one of ordinary skill in the art would have had a reasonable expectation of success in using a stereo microscope with transmitted light for the biofilm detection of LaPointe.
Applicant argues the Response to Arguments has failed to consider each of the cited references "as a whole, including portions that would lead away from the claimed invention,". In response to applicant’s argument, the absence of the claimed imaging method in LaPointe and Tashiro does not constitute a teaching away from the claimed invention. The absence of the specific biofilm material having fluorescence or a uniform structure of the biofilm in Wang also does not constitute a teaching away from the claimed invention. The absence of the claimed imaging method or a method of removing a biofilm in Ishibashi also does not constitute a teaching away from the claimed invention. In response to applicant's argument that claimed features are missing from the cited references when considered individually, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Tashiro teaches detecting contamination by imaging using a carbon particle dispersion. LaPointe teaches images acquired by cameras in any electromagnetic spectra which may be conductive to the detection and Wang teaches observation of a biofilm using stereo microscope with transmitted light (pg. 3 step 6).
Applicant further provides a reproduced statement of the arguments filed 2/28/2025. In response to applicant’s arguments, these arguments have been fully considered by the examiner and a response to the arguments is presented in the Final Office action of 4/23/2025.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TABATHA L PENNY/Primary Examiner, Art Unit 1712