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 .
Priority
This application is a 371 of PCT/EP2022/000039, filed 4/26/2022. This application claims benefit to foreign applications EP 21 170 536.3, filed 4/26/2021 and EP 21 170 533.0, filed 4/26/2021. Claims 1-45 are pending.
Election/Restrictions
Claims 24-45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 2/3/2026.
Applicant's election with traverse of Group I, claims 1-23, in the reply filed on 2/3/2026 is acknowledged. The traversal is on the ground(s) that Applicant believes that it would not be unduly burdensome for the Examiner to search and examine all of the claims presented. This is not found persuasive because the application is a § 371 National stage entry of an International application; therefore, PCT rules regarding Lack of Unity apply. Search burden is not a factor in determination of lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-23 have been examined on the merits.
Claim Objections
Claims 8 and 19 are objected to because of the following informalities:
Claim 8, lines 6-8 recites “Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa or Kocuria rhizophila, Clostridium sporogenes or Bacteroides vulgatus, Candida albicans or Aspergillus niger” which should be “Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Kocuria rhizophila, Clostridium sporogenes, Bacteroides vulgatus, Candida albicans or Aspergillus niger” because taxonomic names are italicized and the extra “or” terms in the list of alternatives is unnecessary and confusing. Appropriate correction is required.
Claim 19, line 3, recites “wave lengths” which should be “wavelengths”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is a method claim which does not positively recite any method steps. Claim 1 recites “A method for sterility testing based on optically analyzing at least one test liquid, which test liquid is contained in a liquid container, wherein in an analyzing routine, image-related data representing at least one optical image of the test liquid are being generated by a sensor arrangement and that the contamination state of the test liquid is derived by a control arrangement from the image-related data based on the interrelation between the distribution characteristics of contaminants in the test liquid and the respective contamination state”; which does not provide any transitional phrase and only recites what the method is “based on”.
Claim 1 recites the limitation "the contamination state" in line 4. There is insufficient antecedent basis for this limitation in the claim. A contamination state is not previously described in the claim; hence, antecedent basis for the limitation is lacking.
Claim 1 recites the limitation "the distribution characteristics of contaminants in the test liquid" in line 6. There is insufficient antecedent basis for this limitation in the claim. Distribution characteristics of contaminants in the test liquid are not previously described in the claim; hence, antecedent basis for the limitation is lacking.
Claim 1 recites the limitation "the respective contamination state" in line 6-7. There is insufficient antecedent basis for this limitation in the claim. A respective contamination state is not previously described in the claim nor is it clear if the “respective contamination state” is the same as the “contamination state” recited in line 4; hence, antecedent basis for the limitation is lacking.
Claims 2-23 depend from claim 1 and do not resolve the indefiniteness of claim 1; hence, claims 1-23 are rejected under 35 U.S.C. 112(b) as being indefinite.
Hence, claim 1 requires amendment to include a transition phrase, to remove antecedent basis issues and to positively recite method steps. Amendment to “A method for sterility testing comprising optically analyzing at least one test liquid, wherein the test liquid is contained in a liquid container, wherein the optically analyzing the at least one test liquid comprises performing an analyzing routine comprising generating, with a sensor arrangement, image-related data representing at least one optical image of the test liquid and determining a contamination state of the test liquid, with a control arrangement, derived from an interrelation between one or more distribution characteristics of contaminants in the test liquid and a respective contamination state” or equivalent language would overcome the indefiniteness rejection.
Claim 3 recites the limitation "the distribution of the contaminants in the test liquid" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite a distribution of the contaminants in the test liquid; hence, the limitation lacks antecedent basis.
Claim 3 recites the limitation "the intensity of turbidity" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite an intensity of turbidity; hence, the limitation lacks antecedent basis.
Claim 3 recites the limitation "the spreading of turbidity" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite a spreading of turbidity; hence, the limitation lacks antecedent basis.
Claim 3 recites the limitation "the geometric structure of turbidity" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite a geometric structure of turbidity; hence, the limitation lacks antecedent basis.
Claim 3 recites the limitation "the occurrence of particle aggregates" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite an occurrence of particle aggregates; hence, the limitation lacks antecedent basis.
Claim 3 recites the limitation "the occurrence of sedimented particle aggregates" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Claim 3 depends from claim 1 and neither claim 1 nor claim 3 recite an occurrence of sedimented particle aggregates; hence, the limitation lacks antecedent basis.
If the “distribution of the contaminants in the test liquid” in claim 3 is meant to further define the “distribution characteristics of contaminants in the test liquid” in claim 1, then amendment of claim 3 to “The method according to claim 1, wherein the distribution characteristics of contaminants in the test liquid, which is detectable by the sensor arrangement, comprises an intensity of turbidity, spreading of turbidity, a geometric structure of turbidity, particle aggregates and/or sedimented particle aggregates in the test liquid” or equivalent language would overcome the indefiniteness rejection.
Claims 4-7 are rejected as being indefinite because claim 4 recites “The method according to claim 1, wherein in a prior analyzing routine preceding the analyzing routine...” wherein the “prior analyzing routine” does not appear to meet the limitations of the “analyzing routine” set forth in claim 1 because claim 5, dependent on claim 4, recites that the sensor components used by the “prior analyzing routine” are different from the sensor components used in the “analyzing routine” of claim 1; hence, claims 4-7 are indefinite because it is unclear whether the “analyzing routine” or “prior analyzing routine” of claim 4 or both or neither are the “analyzing routine” previously set forth in claim 1. Claims 5-7 depend from claim 4 and do not resolve the indefiniteness; hence, claims 4-7 are rejected as being indefinite.
For example, claim 4 could simply recite: The method according to claim 1, wherein at least one property of the test liquid is determined by the sensor arrangement before the analyzing routine. Claim 5 could recite: The method according to claim 4, wherein the at least one property of the test liquid is generated by different sensor(s) than the image-related data. Claim 6 could recite: The method according to claim 4, wherein the determination of the contamination state of the test liquid is determined by the control arrangement from the interrelation between the at least one property of the test liquid, the distribution characteristics of contaminants in the test liquid during the analyzing routine and the respective contamination state. Claim 7 could recite: The method according to claim 4, wherein a preliminary contamination state of the test liquid is determined by the control arrangement from the at least one property of the test liquid.
These are simply suggestions for wording claims 4-7 in such a way that the ambiguity of reciting two different, separate method steps with the same term “analyzing routine” can be avoided.
Claim 7 is indefinite because it is unclear if the terms “a preliminary contamination state of the test liquid” in line 2 is the same or different from “the respective preliminary contamination state” in line 4. Clarification or amendment is required.
Claim 15 recites the limitation "the training data set" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 15 depends from claim 10 which depends from claim 1 and none of claims 1, 10 or 15 recite a training data set; hence, the limitation lacks antecedent basis.
Claim 17 recites the limitation "the viewing direction" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from claim 1 and neither claim 1 nor 17 recite a viewing direction; hence, the limitation lacks antecedent basis.
Claim 17 recites the limitation "the camera unit" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 17 depends from claim 1 and neither claim 1 nor 17 recite a camera unit; hence, the limitation lacks antecedent basis.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19 recites the broad recitation “a light arrangement for illuminating the test liquid”, and the claim also recites “preferably, that the light arrangement illuminates the test liquid with the light of different wave lengths and/or different intensities.” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 8 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fradkin et al., US 2019/0011688 (cite A, attached PTO-892; herein “Fradkin”).
Fradkin teaches a system and method for characterizing particles, i.e., contaminants, within a fluid contained in a vessel, i.e., at least one test liquid which test liquid is contained in a liquid container, comprising determining the number and size of particles suspended in the fluid (Abst.) wherein the particles can be contaminants ([0003], [0019], wherein the analysis method, i.e., an analyzing routine, comprises optically imaging the entire volume of fluid in the vessel, i.e., optically analyzing the at least one test liquid in a liquid container, wherein the images of refracted light detected by the imager, i.e., sensor arrangement, is used to determine the presence of particles ([0005], [0019-22]), i.e., contaminants, in the at least one test liquid in a liquid container i.e., wherein the contamination state of the test liquid is derived by a control arrangement from the image-related data based on the interrelation between the distribution characteristics of contaminants in the test liquid and the respective contamination state, wherein the contamination state is either “contaminated”, i.e., the at least one test liquid in a liquid container comprises at least one particle, or “non-contaminated”, i.e., the at least one test liquid in a liquid container does not comprise any particles ([0019] - the number of particles in the vessel is counted) wherein the imaging and analysis are done autonomously by a control arrangement [0046-69] anticipating claims 1 and 8.
Fradkin teaches that the imager, i.e., sensor arrangement, can include a camera [0044] directed upwards with respect to gravity toward the test liquid ([0040], [0042]) anticipating claims 16-17.
Fradkin teaches that the imager can be configured to capture two or more images for the analysis [0043-44] anticipating claim 18.
Fradkin teaches that the sensor arrangement comprises a light arrangement for illuminating the test liquid [0040] anticipating claim 19.
Fradkin teaches that the method can comprise testing at least two liquids in separate vessels [0021], i.e., wherein at least two test liquids are provided, which are each contained in a separate liquid container, anticipating claim 20.
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.
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 1, 3-8 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fradkin.
The discussion of Fradkin regarding claims 1, 8 and 16-20 set forth in the rejection above is incorporated herein.
Fradkin does not specifically recite detecting turbidity; however, a person of ordinary skill in the art at the time of filing would have found it obvious for the distribution characteristics of contaminants in the test liquid to encompass the intensity, spreading and/or geometric structure of turbidity because Fradkin discloses that the method encompasses not only determining the count, movement, size, characteristics and classification of particles [0019], but also encompasses applying the same concepts to emulsions, i.e., turbidity, in the test liquid [0019]. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious for the detection in the method made obvious by Fradkin to comprise employing the sensor arrangement to gather image-related data regarding the intensity, spreading and/or geometric structure of turbidity, i.e., emulsions, in the test liquid; therefore, claim 3 is prima facie obvious.
Fradkin discloses that the sensor arrangement can comprise other sensing modalities such as infrared [0045]. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to use the other sensing modalities as a pre-screen for contaminants before the method made obvious by Fradkin set forth above, as a quick survey for contamination and to use the data from the other sensing modalities in combination with the camera-derived image-related data representing at least one optical image of the test liquid for the determination of contaminated or non-contaminated; therefore, claims 4-7 are prima facie obvious.
Regarding claim 21, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Fradkin wherein replicate samples of the same test liquid are analyzed together, i.e., wherein for at least two test liquids, which are each assigned to one and the same sample liquid, only one analyzing routine is performed based on the image-related data relating to those at least two different test liquids, because analyzing replicates will give greater statistical significance to the contamination determinations; therefore, claim 21 is prima facie obvious.
Fradkin teaches that the system comprises a plate holder [0076], i.e., container carrier, that the method comprises using a motorized manipulation system to control the relative movement of the liquid containers and the sensor arrangement for performing the analysis on each test liquid [0047], i.e., wherein a manipulation system is provided, via which a relative movement between the liquid containers and at least part of the sensor arrangement is being controlled by the control arrangement, such that for performing the analyzing routine, at least part of the sensor arrangement is being relatively moved to the respective liquid container. A person of ordinary skill in the art at the time of filing would have found it obvious that the relative movement of the liquid containers and the sensor arrangement for performing the analysis on each test liquid could be accomplished by moving the sensor arrangement on a motorized manipulator in the horizontal plane with regard to gravity because Fradkin teaches that the system can comprise motion actuators or motors to linearly move the components of the visual inspection system [0047]; therefore, claims 22-23 are prima facie obvious.
Claims 1-8 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fradkin in view of Bush et al., US Patent 4036698 (cite B, attached PTO-892; herein “Bush”).
The discussion of Fradkin regarding claims 1, 3-8 and 16-23 set forth in the rejection above is incorporated herein.
Fradkin does not teach that the test liquid comprises a nutrient solution or that the test liquid is prepared by filtering a sample liquid through a filter located within the liquid container followed by adding a nutrient solution to the liquid container; however, a person of ordinary skill in the art at the time of filing would have found it obvious for Fradkin’s method to further comprise filtering a sample liquid through a filter located within the liquid container followed by adding a nutrient solution to the liquid container in view of the disclosure of Bush.
Bush teaches methods of sterility testing comprising flowing a test solution, i.e., a sample liquid to be tested for sterility, through a liquid container having a membrane filter to strain microorganisms from the test solution followed by adding growth culture medium, i.e., a nutrient solution, to the liquid container wherein microorganisms in the original sample liquid are determined by optical observation of turbidity in the solution after an appropriate incubation period (Abst.)
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to incorporate Bush’s sample preparation routine into the method made obvious by Fradkin because it would amplify the contaminating microorganism facilitating detection of the contamination; therefore, claim 2 is prima facie obvious.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fradkin in view of Bush and Lu et al., US 2022/0170850 (cite C, attached PTO-892; herein “Lu”).
The discussion of Fradkin and Bush regarding claims 1-8 and 16-23 set forth in the rejection above is incorporated herein.
Fradkin discloses characterizing and classifying the contaminants detected in the test liquid [0019], but Fradkin does not disclose that the characterization and classification of the contaminants comprises training a neural network or other machine learning mechanism to classify the contaminants. However, a person of ordinary skill in the art at the time of filing would have found it obvious to characterize and classify the contaminants detected in the test liquid with a trained neural network in view of the disclosure of Lu.
Lu teaches optically characterizing fluids and determining the characteristics of the fluids by applying a machine learning model to the optical signals, i.e., image-related data, which have been obtained from optical sensor(s) (Abst.). Lu teaches that the machine learning model can be a neural network [0076]. Lu teaches that the machine learning model is trained with fluids having different characteristics ([0052], [0074], [0078], [0095]). Lu teaches that determining the characteristics of the fluids comprises classifying the target substance ([0008], [0016]). Lu teaches that determining the characteristics of the fluids comprises determining the turbidity of the fluid [0015].
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Fradkin in view of Bush wherein the analyzing routine is based on a machine learning mechanism, which is trained to derive the contamination state from the image-related data, wherein the machine learning mechanism is based on a trained neural network, wherein the analyzing routine comprises a classification step, in which the contamination class of the contamination state is derived by the machine learning mechanism from the image-related data, wherein the machine learning mechanism is being trained or has been trained in a training step, wherein the classification step in the analyzing routine is based on the training data set, wherein the analyzing routine is based on a machine learning mechanism, which is trained to derive the contamination state from the image-related data, from the distribution characteristics of the contaminants in the image-related data, and from the prior property data; therefore, claims 9-13 and 15 are prima facie obvious.
Regarding claim 14, Fradkin teaches reducing the size of the image data by subtracting a background image to filter out static images [0062-63]. Hence, a person of ordinary skill in the art at the time of filing would have found it obvious that an additional way to reduce the size of the image data would be to crop the image removing superfluous data outside a region of interest; therefore, claim 14 is prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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