DETAILED ACTION
This office action is in response to applicant’s filling dated September 22, 2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 9, 2026 has been entered.
Notice of Change of Examiner
Please note that the Examiner prosecuting this application has been changed to Examiner Rayna B. Rodriguez of Art Unit 1628. Please address all future correspondences to Examiner Rodriguez.
Status of Claims
Claims 1, 3, 5-10, 12, and 13 are pending in the instant application. Acknowledgement is made of applicant’s remarks and amendments filed September 22, 2026. Acknowledgement is made of applicant’s amendment of claims 1 and 3; and addition of new claims 12 and 13. Claims 2, 4, and 11 were previously canceled.
Priority
The present application is a 371 of PCT/EP2021/072808 filed on August 17, 2021, which claims benefit of foreign priority to EP20191343.1 filed on August 17, 2020.
Withdrawn Objections and/or Rejections
Claim Rejections - 35 USC § 112(b)
Indefinite
The rejection of claims 1, 3, and 5-10 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 has been rendered moot in view of the amendment of claims 1 and 3. Thus, the rejection has been withdrawn.
Claim Objections
Claims 5 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 112(a)
Written Description
The rejection of claims 1, 3, and 5-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement has been rendered moot in view of the amendment of claims 1 and 3. Thus, the rejection has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12 and 13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 is directed to a crystalline form of 5-bromo-6-chloro-3-indoxyl caprylate characterized by having a powder X-ray diffraction pattern of claim 1. Claim 12 is directed to the crystalline form of claim 1 having the peaks provided in Table 1. Claim 12 describes X-ray powder diffraction pattern peaks of the identical compound cited in claim 1. Therefore, claims 12 is directed to inherent properties of the identical compound cited in claim 1. Thus, claim 12 does not further limit the limitations of claim 1.
Claim 3 is directed to a crystalline form of 5-bromo-6-chloro-3-indoxyl caprylate characterized by having a powder X-ray diffraction pattern of claim 3. Claim 13 is directed to the crystalline form of claim 3 having the peaks provided in Table 2. Claim 13 describes X-ray powder diffraction pattern peaks of the identical compound cited in claim 3. Therefore, claim 13 is directed to inherent properties of the identical compound cited in claim 3. Thus, claim 13 does not further limit the limitations of claim 3.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al (CN106986809 A, cited in the IDS filed February 14, 2023, machine translation obtained from WIPO Patentscope September 24, 2026).
Wu teaches 5-bromo-6-chloro-3-indolyl caprylate synthesis method (title); and crystallizing the crude product with ethanol-water in a refrigerator, filtering, washing with water, drying, and performing sufficient vacuum drying to obtain the desired target 5-bromo-6-chloro-3-indolyl octyl ester (page 4, 2nd paragraph). Thus, Wu teaches a crystalline form of 5-bromo-6-chloro-3-indolyl caprylate.
The prior art does not explicitly teach the disclosed composition has the claimed melting point of the instant claims. However, the above physical property depends, among other things, from the specific structure of the compound, which seems to be the same or very similar to the structure taught by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the 5-bromo-6-chloro-3-indolyl caprylate that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the crystalline form claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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, 6, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Moriyama et al (WO 2012/092181 A2, cited in the IDS filed February 14, 2023) in view of Wu et al (CN106986809 A, cited in the IDS filed February 14, 2023, machine translation obtained from WIPO Patentscope September 24, 2026).
Regarding claims 1, 3, 6, 7, 9, and 10, Moriyama teaches a method of detecting the presence or absence of a target microorganism, comprising: providing a culture device including a culture medium comprising ingredients selected to go facilitate growth of a predetermined indicator microorganism; a detection article comprising a first indicator system, the first indicator system selected to detect a target microorganism; and a sample (claim 1), wherein the first indicator system comprises a reagent to detect caprylate esterase enzyme activity (claims 8, 9, and 25), wherein the indicator is 5-bromo-6-chloro-3-indolyl caprylate (claim 26). Moriyama does not teach the 5-bromo-6-chloro-3-indolyl caprylate is in a crystalline form.
However, Wu teaches a crystalline form of 5-bromo-6-chloro-3-indolyl caprylate.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method of Moriyama to utilize the crystalline form of 5-bromo-6-chloro-3-indolyl caprylate taught by Wu with a reasonable expectation of success, since the cited art teach structurally similar compounds and that 5-bromo-6-chloro-3-indolyl caprylate is useful in a method of detecting an esterase.
The prior art does not explicitly teach the disclosed composition has the claimed melting point of the instant claims. However, the above physical property depends, among other things, from the specific structure of the compound, which seems to be the same or very similar to the structure taught by the prior art (see above rejection).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the 5-bromo-6-chloro-3-indolyl caprylate that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the crystalline form claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Taken together, all this would result in the practice of the method of claims 1, 3, 6, 7, 9, and 10 with a reasonable expectation of success.
Conclusion
Claims 1, 3, 6, 7, 9, 10, 12, and 13 are rejected.
Claims 5 and 8 are objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628
