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 .
Response to Amendment
Examiner acknowledges the amendment filed 03 February 2026 wherein: the specification is amended; claims 1, 8-9 are amended; claims 2 and 10 canceled; claims 1 and 3-9 are pending.
Response to Arguments
Applicant’s arguments, see Remarks (page 6, first line through page 11, last line), filed 03 February 2026, have been fully considered.
Examiner acknowledges: the prior drawing objection is overcome by amendment; claim 1 no longer invokes 35 U.S.C. § 112(f) due to amendment; the prior 35 U.S.C. § 112(b) rejections are overcome by amendment.
Applicant’s arguments with respect to the rejections of claims 1 and 3-9 under 35 U.S.C. §§ 102-103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections — 35 U.S.C. § 103
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 C.F.R. § 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1 (1966), that are applied 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.
Claims 1 and 3
Claims 1 and 3 are rejected under 35 U.S.C. § 103 as being unpatentable over Tautvydas (US 5,922,592 A) in view of Testa (US 2005/0281711 A1), Quintern (US 5,371,004 A), Hell (US 2005/0094261 A1), and Ponce (US 2005/0136508 A1).
Claim 1
Regarding claim 1, a copy of Figure 1 of Tautvydas annotated by Examiner is provided below.
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Figure 1 of Tautvydas, annotated by Examiner to show features of the claimed invention, including sprouting cavities (10) and carrier (28).
Tautvydas discloses a method for measuring two-dimensional distribution of an industrial irradiation (radiation process for sterilization; col. 2, ll. 36-46), comprising the following steps: manufacturing a film: spreading a layer of spore suspension (22) flat on a plane of a carrier (28), and evaporating a suspension solvent to fix a layer of spore pixel surface on the plane of the carrier (28); providing a sprouting cavity (10) to cover the spore pixel surface within the sprouting cavity; and adding a sprouting agent germination/outgrowth medium), wherein the carrier is a tray having an agar layer, and the spore suspension is spread flat on the agar layer, and the agar layer includes agar; and measuring the irradiation dose using fluorescence measurements (col. 2, ll. 1-5, col. 3, l 24 - col. 7, l. 25, Figs. 1-2; agar layer specifically described in col. 6, l. 29-40).
Tautvydas does not expressly disclose covering the carrier with a glass lid to form a sprouting cavity to cover the spore pixel surface within the sprouting cavity and providing the glass lid with a filling hole configured to add the sprouting agent.
Testa discloses covering a carrier (slide) carrying a biological sample with a glass lid to cover the sample and providing the glass lid with a filling hole configured to add reagents or other liquids (¶¶ 68, 136).
It 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 to have modified the invention of Tautvydas in view of the teachings of Testa so include covering the carrier with a glass lid to form a sprouting cavity to cover the spore pixel surface within the sprouting cavity and providing the glass lid with a filling hole configured to add the sprouting agent.
One would have been motivated to do so to provide convenient means for sealing the spore pixel surface and adding the spouting agent.
Tautvydas modified does not expressly disclose obtaining a calibration curve: placing the film and directing irradiation of known intensity to the film with a parallel beam; and after irradiation, adding a sprouting solution containing the sprouting agent to the sprouting cavity, moving the film under a fluorescence microscope after the sprouting agent sufficiently makes contact with the spore pixel surface, monitoring fluorescence change of each spore pixel of the spore pixel surface, calculating sprouting lag time corresponding to each spore pixel and average sprouting lag time, and obtaining the calibration curve by plotting the average sprouting lag time of each sprout pixel point against the corresponding irradiation intensity; and the step of measuring the irradiation dose comprises placing the film under the irradiation device to receive irradiation; and after irradiation, adding the sprouting solution containing the sprouting agent to the sprouting cavity, moving the film under the fluorescence microscope after the sprouting agent sufficiently makes contact with the spore pixel surface, monitoring a fluorescence change curve of each spore pixel, calculating the sprouting lag time corresponding to each spore pixel, and inversely deducing the irradiation dose of each sprout pixel according to a plurality of known intensity calibration curves obtained in the calibration step, so as to obtain two-dimensional distribution of the industrial irradiation dose.
Quintern discloses obtaining a calibration curve: placing a film (sheet substrate formed of spores (microorganism) in a one-dimensional measurement array of pixels) under an irradiation device and directing irradiation of known intensity to the film; and after irradiation, adding a sprouting solution containing the sprouting agent to the sprouting cavity, moving the film under a fluorescence measuring device after the sprouting agent sufficiently makes contact with the spore pixel surface, monitoring fluorescence change of each spore pixel of the spore pixel surface, calculating sprouting lag time corresponding to each spore pixel and average sprouting lag time, and obtaining the calibration curve by plotting the average sprouting lag time of each sprout pixel point against the corresponding irradiation intensity; and the step of measuring the irradiation dose comprises placing the film under the irradiation device to receive irradiation; and after irradiation, adding the sprouting solution containing the sprouting agent to the sprouting cavity, moving the film under the fluorescence measuring device after the sprouting agent sufficiently makes contact with the spore pixel surface, monitoring a fluorescence change curve of each spore pixel, calculating the sprouting lag time corresponding to each spore pixel, and inversely deducing the irradiation dose of each sprout pixel according to a plurality of known intensity calibration curves obtained in the calibration step, so as to obtain two-dimensional distribution of the industrial irradiation dose (col. 2, l. 32 - col. 6, l. 45, Figure).
Hell discloses an irradiation device and a fluorescence measurement device are a fluorescence microscope (1) which emits a parallel beam (7) onto a sample (2; ¶ 28, Fig. 1).
It 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 to have further modified the invention of Tautvydas in view of the teachings of Quintern and Hell to include obtaining a calibration curve: placing the film and directing irradiation of known intensity to the film with a parallel beam; and after irradiation, adding a sprouting solution containing the sprouting agent to the sprouting cavity, moving the film under a fluorescence microscope after the sprouting agent sufficiently makes contact with the spore pixel surface, monitoring fluorescence change of each spore pixel of the spore pixel surface, calculating sprouting lag time corresponding to each spore pixel and average sprouting lag time, and obtaining the calibration curve by plotting the average sprouting lag time of each sprout pixel point against the corresponding irradiation intensity; and the step of measuring the irradiation dose comprises placing the film under the irradiation device to receive irradiation; and after irradiation, adding the sprouting solution containing the sprouting agent to the sprouting cavity, moving the film under the fluorescence microscope after the sprouting agent sufficiently makes contact with the spore pixel surface, monitoring a fluorescence change curve of each spore pixel, calculating the sprouting lag time corresponding to each spore pixel, and inversely deducing the irradiation dose of each sprout pixel according to a plurality of known intensity calibration curves obtained in the calibration step, so as to obtain two-dimensional distribution of the industrial irradiation dose.
One would have been motivated to do so to obtain more accurate measurements (via the calibration described by Quintern) using a well-known and routinely used irradiation device and fluorescent measurement device (a fluorescence microscope such as disclosed by Hell).
While Tautvydas modified teaches an agar layer as described above, Tautvydas modified does not expressly disclose the agar layer further includes TbCl3. However, doping agar with TbCl3 was well-known and routinely practiced in the art. For example, Ponce discloses a method for detecting and quantifying bacterial spores on a surface (¶ 18) using an agar layer doped with TbCl3 (¶¶ 36-37).
It 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 to have further modified the invention of Tautvydas in view of the teachings of Ponce so that the agar layer further includes TbCl3.
One would have been motivated to do so to take advantage of improved Tb luminescence, as recited in Ponce (¶¶ 36-37). The selection of a known material based on its suitability for its intended use is obvious. See MPEP § 2144.07.
Claim 3
Regarding claim 3, as best understood, Tautvydas modified teaches the method for measuring two-dimensional distribution of the industrial irradiation dose according to claim 1 m wherein the sprouting agent is L-alanine (Tautvydas, col. 6, l. 29-40).
Claim 4
Claim 4 is rejected under 35 U.S.C. § 103 as being unpatentable over Tautvydas (US 5,922,592 A) in view of Testa (US 2005/0281711 A1), Quintern (US 5,371,004 A), Hell (US 2005/0094261 A1), and Ponce as applied to claim 1 above, and further in view of Breen (US 2003/0015480 A1).
Regarding claim 4, as best understood, Tautvydas modified teaches the method for measuring two-dimensional distribution of the industrial irradiation dose according to claim 1, but does not expressly disclose a concentration of the sprouting agent in the sprouting solution is 1-100 mM.
Breen discloses a concentration of a sprouting agent (L-alanine) is 1 or 2.5 mM (¶ 148).
It 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 to have further modified the invention of Tautvydas in view of the teachings of Breen to include a concentration in the claimed range.
Where 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. See MPEP § 2144.05(II)(A). Further, a specific example in the prior art which is within the claimed range anticipates the range. See MPEP § 2131.03(I). One would have been motivated to use a concentration in the claimed range to achieve a desired amount of growth.
Claims 5-6
Claims 5-6 are rejected under 35 U.S.C. § 103 as being unpatentable over Tautvydas (US 5,922,592 A) in view of Testa (US 2005/0281711 A1), Quintern (US 5,371,004 A), Hell (US 2005/0094261 A1), and Ponce as applied to claim 1 above, and further in view of Maletzko (US 2023/0374221 A1).
Regarding claims 5-6, as best understood, Tautvydas modified teaches the method for measuring two-dimensional distribution of the industrial irradiation dose according to claim 1, but does not expressly disclose the sprouting solution is stored in a vessel, a rim of the vessel is provided with a pipe having a valve, and the pipe is communicated to the filling hole, wherein the vessel is disposed on an upper portion of the glass lid and is irradiated together with the film.
Maletzko discloses a solution is stored in a vessel, a rim of the vessel is provided with a pipe having a valve, and the pipe is communicated to a hole, wherein the vessel is disposed on an upper portion of a lid (¶ 155).
It 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 to have further modified the invention of Tautvydas in view of the teachings of Maletzko so that the sprouting solution is stored in a vessel, a rim of the vessel is provided with a pipe having a valve, and the pipe is communicated to the filling hole, wherein the vessel is disposed on an upper portion of the glass lid and is irradiated together with the film.
One would have been motivated to do so to provide a convenient means for adding the spouting solution.
Claim 7
Claim 7 is rejected under 35 U.S.C. § 103 as being unpatentable over Tautvydas (US 5,922,592 A) in view of Testa (US 2005/0281711 A1), Quintern (US 5,371,004 A), Hell (US 2005/0094261 A1), and Ponce as applied to claim 1 above, and further in view of Korenev (US 2003/0015480 A1).
Regarding claim 7, Tautvydas modified teaches the method for measuring two-dimensional distribution of the industrial irradiation dose according to claim 1, wherein the irradiation dose is for sterilization (col. 1, ll. 6-19), but does not expressly disclose wherein the irradiation dose is 10-100 kGy.
Korenev discloses an irradiation dose for sterilization is 60 kGy (¶ 36).
It 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 to have further modified the invention of Tautvydas in view of the teachings of Korenev to include a dose in the claimed range.
Where 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. See MPEP § 2144.05(II)(A). Further, a specific example in the prior art which is within the claimed range anticipates the range. See MPEP § 2131.03(I). One would have been motivated to use a concentration in the claimed range to achieve a desired amount of sterilization, such as described in Korenev (¶ 36).
Claims 8-9
Claims 8-9 are rejected under 35 U.S.C. § 103 as being unpatentable over Tautvydas (US 5,922,592 A) in view of Testa and Ponce as applied to claim 1 above.
Regarding claims 8-9, see the rejection of claim 1 above, mutatis mutandis (because claims 8 and 9 are not as detailed as claim 1, the teachings of Quintern and Hell are not needed for rejecting claims 8-9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Von Neubeck (US 8,002,466 B2) discloses an irradiation verification apparatus containing living cell material which is fixed in location on cell supports which are arranged between cell support holders, wherein for irradiation verification, the z co-ordinate of the irradiation verification apparatus is adjusted in the direction of the beam axis Z so that, after irradiation, regions having killed cell material can be demarcated in spatial co-ordinates, with reference to an irradiation scheme, from regions having cell material of the irradiation verification apparatus that is still active, wherein a container having an insert for the cell supports and also the cell support holders comprise a beam-transparent material, wherein the cell support holders have a base plate and a top plate, between which the cell supports are arranged orthogonally to the holding plates (Abstract).
Copeland (US 5,830,746 A) discloses an apparatus for growing anaerobic microorganisms is provided having a dish top that contains a sealing ring upon which the media surface in the dish bottom rests when the apparatus is inverted, wherein the contact between the sealing ring and the media surface forms a seal that traps the gas in the headspace between the media surface and the inside of the dish top (Abstract).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE RIDDICK whose telephone number is (571)270-1865. The examiner can normally be reached M - Th 6:30 am - 5:00 pm ET, with flexible scheduling.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-2995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Blake C. Riddick, Ph.D.
Primary Examiner
Art Unit 2884
/BLAKE C RIDDICK/Primary Examiner, Art Unit 2884