Office Action Predictor
Application No. 18/263,809

METHODS OF SELECTIVELY PROMOTING ANIMAL WELFARE THROUGH MODULATION OF MICROBIOME

Non-Final OA §101§103§112
Filed
Aug 01, 2023
Examiner
MUKHOPADHYAY, BHASKAR
Art Unit
1792
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Novozymes A/S
OA Round
1 (Non-Final)
28%
Grant Probability
At Risk
1-2
OA Rounds
4y 7m
To Grant
47%
With Interview

Examiner Intelligence

28%
Career Allow Rate
195 granted / 699 resolved
Without
With
+18.9%
Interview Lift
avg trend
4y 7m
Avg Prosecution
53 pending
752
Total Applications
career history

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
64.3%
+24.3% vs TC avg
§102
6.3%
-33.7% vs TC avg
§112
24.3%
-15.7% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§101 §103 §112
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. DETAILED ACTION Status of the application 2. Claims 1-32 are pending in this office action. Claims 1-32 have been rejected. Claim Objections 3. Claims 1, 8, 10, 17,25 objected to because of the following informalities: Claims 1,8,17,25 recite in the first line the phrase “improving the health” . Ideally, it will be “ improving health ” . Claim 10 , 27 recite “ improving the welfare” . Ideally, it will be “ improving welfare ”. Claims 11, 12, 13, 28, 29 recite “ improv ement of welfare ” . Ideally, it will be “ improvement of the welfare ”. Claim 19 recites “ improving the performance” , “ improving the welfare”. Ideally, it will be “ improving performance” and “improving welfare”. Claim s 20-22 recite “ improving performance” , “improving welfare” respectively. Ideally it should be “ improving the performance” improving the welfare ” Appropriate correction is required. Use Claims Claim Rejections - 35 USC § 112 4 . The following is a quotation of the second paragraph of 35 U.S.C. 112 (b): 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. 5. Claim 32 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claim 32 provides for the use of feed enzymes, in particular N-acetyl- muramdase , and/or protease , in a diet for feeding to a group of animals for improving the health of animals. But since the claim does not set forth any steps involved in the method/ process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. 35 USC § 101 6 . 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. 7 . Claim 32 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki , 153 USPQ 678 ( Bd.App . 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Claim Rejections - 35 USC § 112 8 . 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 appl icant regards as his invention. 9 . Claims 1-32 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. Claims 1, 8, 17, 25 recite the term “preferably” and claim 32 recites the term “in particular” which render claims indefinite. Therefore, claims 2-7 which depend upon rejected claim 1 , claims 9-16 which depend upon rejected claim 8 , claims 18-24 which depend upon rejected claim 17 and claims 26-31 which depend upon rejected claim 25 are also rejected as they are depending upon a rejected claim. Therefore, all the claims have 112 second paragraph rejection. Claim Rejections - 35 USC § 103 10 . 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. 11 . 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. 12 . 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 non - obviousness. 1 3 . Claim(s) 1 , 3-8, 10-17, 19-25, 27 -32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aureli et al. (WO2020/058226) in view of Haahr et al. US 2020/0229463 A1 (1 6 / 630156 ) and as evidenced by ABSS Search Report posted 11/18/2025 ( 16 / 630156 SEQ ID #3 match #74 SEQ ID # 1 matches with SEQ ID # 74 protease of current application . SEE ABSS search result posted 11/18/2025 , 268 kb “Published Application). 14 . Regarding claim s 1, 8, 17 and 25, Aureli et al. discloses a method and an animal food composition having muramidase and protease enzymes used as food additives to enhance the nutritional potentiality of the feed composition (page 1, lines 5-8). Aureli et al. also discloses that SEQ ID # 1 is the sequence of a GH 25 muramidase from Acremonium alcalophilum (page 2 lines 3 2 -34 e.g. SEQ ID #1 has GH 25 muramidase activity) and it is identical to claimed SEQ ID # 1 of claim 1 (SEE ABSS Search Result posted 11/18/2025 , under “Published Appl. 377 kb : 17/276298-1 matches with SEQ ID of 17/276298 and it has identical SEQ ID #1. 17/276298 is under Result # 1, shows 100% match. This application number 17/276298 belongs to the patent family of WO 2020/058226 . Regarding protease, Aureli et al. discloses that a feed composition comprising a protease in combination with the disclosed muramidase which gives an additional performance benefit in animals (page 11, lines 12-15). However, Aureli et al. broadly discloses protease from various source s (Page 12 lines 13-30). Therefore, Aureli et al. is silent about specifically any protease which matches with anyone of SEQ ID #72-76 which represents protease as claimed in claim 1, 8, 17 and 25. Haahr et al. discloses that SEQ ID # 1 and SEQ ID #3( [0565], [0569], [0582], [0585]) match the claimed sequence ID # 74 and SEQ ID # 75 respectively (in PGPUB pages 55 and 56 for applicant’s SEQ ID #74 and #75 respectively). It is confirmed by ABSS search result (posted 11/18/2025) that the match has 100% identity. For example, Haahr et al. US 2020/0229463 A1 (16/630156) (16 / 630156 SEQ ID # 1 match #74 SEQ ID # 1 matches 100% with SEQ ID # 74 protease of current application. SEE ABSS search result posted 11/18/2025 , 268 kb “Published Application) . Haahr et al. discloses a method for increasing digestibility and/or solubility of protein and methods for improving the nutritional value of an animal feed using the animal feed additive and uses thereof can be used as animal feed additive which improves animal performance and the nutritional value of an animal feed (at least in Abstract, [0007], [0565] , [0569], [0582], [0585] ). One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Aureli et al. with the disclosed specific protease as taught by Haahr et al. to include in the feed composition of Aurelli et al. 1 5 . Regarding claim 32, it is to be noted that claim 32 is considered as ‘U se claim ’ and discussed above. However, the combined teaching of Aureli et al. in view of Haahr et al. can address the feed enzymes in a diet composition for feeding to a group of animals as claimed in claim 32. Regarding the kynurenine : tryptophan ratio , it is to be noted that the disclosed muramidase and protease have 100% identity with claimed muramidase and protease of claims 1,8,17, 25 and is used as feed enzymes for claim 32 as discussed above , therefore, it would have identical claimed property including the increased kynurenine : tryptophan ratio as claimed in claim 1 , serotonin: tryptophan ratio as claimed in claim 8, tryptamine: tryptophan ratio as claimed in claim 1 7 , and melatonin: tryptophan ratio as claimed in claim 25 and also will meet all the claimed use as claimed in claim 32 (a)-(d). 1 6 . Regarding claim s 3, 10, 19, 27, it is to be noted that the disclosed muramidase and protease have 100% identity with claimed muramidase and protease, therefore, it would have identical claimed property including the “improvement of the health of said group of production animals comprises providing one of more of the following benefits to said group of production animals: improving the welfare of said group of production animals, decreasing systemic inflammation of said group of production animals, decreasing local inflammation of said group of production animals, and reducing the light regimen into the daily circadian rhythm of said group of production animals” as claimed in claim 3. 1 7 . Regarding claim 4, 11, 21, 28, it is to be noted that the disclosed muramidase and protease have 100% identity with claimed muramidase and protease, therefore, it would have identical claimed property including the claimed property of “ improvement of welfare comprises reducing social disturbance among said group of production animals”. It is to be noted that it is within the skill of one of ordinary skill in the art to evaluate “reduction of social disturbance among said group of production animals”. 1 8 . Regarding claim s 5, 12, 22, 29, it is to be noted that the disclosed muramidase and protease have 100% identity with claimed muramidase and protease, therefore, it would have identical claimed property including the claimed property of the “improvement of welfare [which] comprises reducing feather pecking among said group of production animals”. It is to be noted that it is within the skill of one of ordinary skill in the art to evaluate “reduction of feather pecking among said group of production animals. 19 . Regarding claim s 6, 15, 23, 30, Aureli et al. discloses that the composition or animal feed is dosed so that the polypeptide having protease activity is at a level of 50 to 300 mg per kg animal feed, such as 80 to 250 mg, 100 to 200 mg per kg animal feed, or any combination of these intervals (at least in claim 15 of Aureli et al.). Aureli et al. also discloses that the composition or animal feed is dosed so that the polypeptide having muramidase activity is at a level of 100 to 1000 mg enzyme protein per kg animal feed, such as 200 to 900 mg, 300 to 800 mg, 400 to 700 mg or 500 to 600 mg enzyme protein per kg animal feed, or any combination of these intervals( at least in claim 16 of Aureli et al.). It is known that one ton is=1000kg (Approx) [any google search]. Therefore, if we consider a common value present for both the muramidase and protease, it is e.g. 200 mg /kg= 200gm/ton as claimed in claim s 6 , 15, 23, 30 . It is also to be noted that it is optimizable. One of ordinary skill in the art can optimize the concentration of either of them from within the disclosed range value which will meet the claimed range value in order to have desired benefits. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Additionally , a bsent showing of unexpected results, the specific amount of enzymes m uramidase or/and protease is not considered to confer patentability to the claims. As the age of the animal, health improvement related performances are variables that can be modified, among others, by adjusting the amount of said enzyme(s) muramidase or/and protease , the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount of said enzyme(s) cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of said enzyme(s) in Aureli et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. taste, texture etc (5). (In re Boesch , 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). 2 0 . Regarding claim s 7, 16, 24, 31, Aureli et al. discloses that it can be any animal including turkeys, ducks, piglets etc. ( at least on page 6) as claimed in claim 7. 2 1 . Regarding claim s 13, 14, as discussed above, the disclosed muramidase and protease have 100% identity with claimed muramidase and protease and is used as feed enzymes in the animal diet composition . T herefore, it would have identical claimed property including the increased kynurenine : tryptophan ratio which is within the skill of one of ordinary skill in the art who can confirm it by measuring the ratio of kynurenine : tryptophan in the feces or blood by using any standard method . Therefore, this will cause an obvious “improvement of welfare comprising rest o ration of the natural photoperiod of said group of production animals” as claimed in claim 13 which depends on claim 9 and the effect would have obvious been continued with the natural photoperiod time which can be maintained for “at least 8 hours of darkness’ as claimed in claim 14. The reason is, this is considered as inherent property . In this instance also, when the disclosed additives muramidase and protease is identical enzyme proteins of claimed muramidase and protease (e.g. derived from 100% SEQ Identity) in the feed composition, therefore, will have identical claimed property including the claimed property of an “ improvement of welfare comprising restoration of the natural photoperiod of said group of production animals” as claimed in claim 13 and the effect would have obvious been continued with the natural photoperiod time which can be maintained for “at least 8 hours of darkness’ as claimed in claim 14. 2 2 . Regarding claim 20, claim 20 depends on claim 19 and claim 19 ultimately depends on claim 17. As discussed above, the disclosed muramidase and protease have 100% identity with claimed muramidase and protease of claim 17 from which claim 20 ultimately depends. Therefore, it is to be noted that the disclosed muramidase and protease have 100% identity with claimed muramidase and protease, therefore, it would have identical claimed property including the “improvement of the performance of said group of production animals comprises providing one of more of the following benefits to said group of production animals: improving nutrient absorption, reduce gut peristaltic motility, improving vitamin absorption, and improving feed enzymatic processing” as claimed in claim 20. 23. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Aureli et al. (WO2020/058226) in view of Haahr et al. US 2020/0229463 A1 (16/630156) and (Alternatively), in view of Sandvang et al. US 2018/0296475 A1 and as evidenced by ABSS Search Report posted 11/18/2025 (16/630156 SEQ ID #3 match #74 SEQ ID # 1 matches with SEQ ID # 74 protease of current application. SEE ABSS search result posted 11/18/2025, 268 kb “Published Application) as applied to claims 1, 8,17, 25 and further in view of NPL Ohashi et al. (in International Journal of Tryptophan Research 2013:6 (Suppl. 1 ) 9-14) . 24 . Regarding claim 2 , Aureli et al. in view of Haahr et al. are silent about the method to m e asure kynurenine and tryptophan. NPL Ohashi et al. discloses the method of measuring Kynurenine , tryptophan in blood sample ( at least in page 10, col 2 under “Determination of tryptophan and Kynurenine ). One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Aureli et al. in view of Haahr et al. to include the teaching of NPL Ohashi et al. to measure the amount of kynurenine and tryptophan in blood sample ( at least in page 10, col 2 under “Determination of tryptophan and Kynurenine ) in order to determine their increased ratio which is a parameter to determine the effectiveness for improving the health of the animal in presence of the disclosed feed additives N- a cetyl muramidase and protease compared to non- treated group of individual as claimed in claimed invention. 25. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Aureli et al. (WO2020/058226) in view of Haahr et al. US 2020/0229463 A1 (16/630156) and as evidenced by ABSS Search Report posted 11/18/2025 (16/630156 SEQ ID #3 match #74 SEQ ID # 1 matches with SEQ ID # 74 protease of current application. SEE ABSS search result posted 11/18/2025, 268 kb “Published Application) as applied to claim 8 and further in view of R okutan et al. WO 2017 /047776 A1 . 2 6 . Regarding claim 9, Aureli et al. in view of Haahr et al. are silent about the method to measure tryptophan and serotonin. Rokutan et al. discloses the method of measurement of plasma tryptophan and stool serotonin using HPLC method (at least on page 5, under Example 1) . It is to be noted that it is within the skill of one of ordinary skill in the art to measure and optimize the measurement of tryptophan in stool also by using the same method used for bloo d plasma as both are the biological samples. One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Aureli et al. in view of Haahr et al. to include the teaching of Rokutan et al. to measure the amount of serotonin and tryptophan in blood (at least page 5, Example 1) in order to determine their increased ratio which is a parameter to determine the effectiveness for improving the health of the animal in presence of the disclosed feed additives N-acetyl muramidase and protease compared to non- treated group of individual as claimed in claimed invention. 27. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Aureli et al. (WO2020/058226) in view of Haahr et al. US 2020/0229463 A1 (16/630156) and as evidenced by ABSS Search Report posted 11/18/2025 (16/630156 SEQ ID #3 match #74 SEQ ID # 1 matches with SEQ ID # 74 protease of current application. SEE ABSS search result posted 11/18/2025, 268 kb “Published Application) as applied to claim 17 and further in view of NPL Ohashi et al. (in International Journal of Tryptophan Research 2013:6 (Suppl. 1 ) 9-14) and in view of O'BRIEN et al. CA 3077692 A1. 28. Regarding claim 18, Aureli et al. in view of Haahr et al. are silent about the method to measure tryptophan and tryptamine. NPL Ohashi et al. discloses the method of measuring tryptophan in blood sample (at least in page 10, col 2 under “Determination of tryptophan). O'BRIEN et al. discloses the method of measuring tryptamine in biological sample e.g. blood , stool etc. (Under “Methods of assaying tryptamine” , pages 29-30 ). One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Aureli et al. in view of Haahr et al. t o include the teaching of NPL Ohashi et al. to measure the amount of kynurenine and tryptophan in blood sample (at least in page 10, col 2 under “Determination of tryptophan and to include the teaching of to measure the amount of tryptophan as disclosed by NPL Ohashi et al. and tryptamine as disclosed by O'BRIEN et al. O'BRIEN et al. to measure tryptamine in biological sample e.g. blood (Under “Methods of assaying tryptamine”) in order to determine their increased ratio of tryptamine: tryptophan which is a parameter to determine the effectiveness for improving the health of the animal in presence of the disclosed feed additives N-acetyl muramidase and protease compared to non- treated group of individual as claimed in claimed invention. 29. Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Aureli et al. (WO2020/058226) in view of Haahr et al. US 2020/0229463 A1 (16/630156) and as evidenced by ABSS Search Report posted 11/18/2025 (16/630156 SEQ ID #3 match #74 SEQ ID # 1 matches with SEQ ID # 74 protease of current application. SEE ABSS search result posted 11/18/2025, 268 kb “Published Application) as applied to claim 17 and further in view of NPL Ohashi et al. (in International Journal of Tryptophan Research 2013:6 (Suppl. 1 ) 9-14) and in view of I deas et al. FR 3052063 A1 . 30. Regarding claim 26, Aureli et al. in view of Haahr et al. are silent about the method to measure tryptophan and tryptamine. NPL Ohashi et al. discloses the method of measuring Kynurenine , tryptophan in blood sample (at least in page 10, col 2 under “Determination of tryptophan and Kynurenine). Ideas et al. discloses the method of measuring melatonin in blood (Melatonin in blood , page 4, Under Ex 1 ). One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Aureli et al. in view of Haahr et al. to to include the teaching of NPL Ohashi et al. to measure the amount of tryptophan in blood sample (at least in page 10, col 2 under “Determination of tryptophan and Kynurenine) and to include the teaching of Ideas et al. to measure the amount of melatonin as disclosed by Ideas et al. in order to determine their increased ratio of melatonin : tryptophan which is a parameter to determine the effectiveness for improving the health of the animal in presence of the disclosed feed additives N-acetyl muramidase and protease compared to non- treated group of individual as claimed in claimed invention. Pertinent Note(s) 31 . Further notes on ABSS Search Report: The present invention further relates to methods of producing a polypeptide of the invention in a recombinant Bacillus host cell. he use of protease from Bacillus horneckiae (SEQ ID #1 [0565], [0569] of Haahr et al. has been prior published in WO 2015/091990). In result 1 of ABSS , there are 6 duplicates First one is 15/100842-3 which primarily used for detergent , therefore, not used. Second duplicate 16 -630-156-1 is used for animal feed and therefore, used as prior art (SEE ABSS search result posted 11/18/2025 , 268 kb “Published Application). It is also to be noted that Haahr et al. also discloses SEQ ID # 3 ([0581], [0585]) which matches with applicant’s SEQ ID # 75 (Bacillus spp.) . Also, Aureli et al. discloses that this SEQ ID #1 muramidase is published in the prior publication date of CLAWSON et al. WO2013/076253 SEQ ID # 4 as disclosed in page 2, lines 32-34 of Aureli et al.). I t is also to be noted that Sandvang et al. US 2018/0296475 A1 (15-580-081-27) has disclosed SEQ ID #27 ( matching from amino acid 6 Arg Ile…. Gly Asp) matching 100% with this claimed SEQ ID # 1 animal feed composition containing lysozyme (muramidase) in animal feed composition having GH25 family (0009], [0013]) SEQ ID #27 which matches 100% with the claimed SEQ ID # 1 (ABSS Search Report posted 11/18/2025 , under “Published Appl. 377 kb : 15-580-81-27 matches with claimed identical SEQ ID #1, SEE Result 2). Therefore, Sandvang et al. US 2018/0296475 A1 may be considered as primary prior art also. However, Aureli et al. discloses both muramidase and protease in animal feed composition. Therefore, Aureli et al. is used as primary prior art. Conclusion 32 . Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139. If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1000. /BHASKAR MUKHOPADHYAY/ Examiner, Art Unit 1792
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Prosecution Timeline

Aug 01, 2023
Application Filed
Nov 24, 2025
Non-Final Rejection — §101, §103, §112
Mar 20, 2026
Response Filed

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Prosecution Projections

1-2
Expected OA Rounds
28%
Grant Probability
47%
With Interview (+18.9%)
4y 7m
Median Time to Grant
Low
PTA Risk
Based on 699 resolved cases by this examiner