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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/24/2026 has been entered.
Status of claims
Claims 1-5 and 7-18 as amended on 2/25/2026 are pending.
Claims 7-17 were been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention(s), there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 4/30/2025.
Claims 1-5 and 18 as amended on2/25/2026 are under examination in the instant office action.
Claim Objections
Claims 1-5 and 18 are objected to because of the following informalities:
Latin names of microorganisms should be italicized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-5 and 18 as amended 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 as amended is rendered indefinite by the newly inserted phrase “respectively” (claim1, lines 5) because it is unclear to what structural elements this phrase refers. The claim 1 recites one medium (by the virtue of language “A screening culture medium”); and the claimed medium includes 2 sugars that are raffinose and xylose as recited in the claim. However, the meaning of the phrase “respectively” is uncertain because this phrase creates confusion in the claim. Are two separate media are intended in one kit “respectively” to each separate well as, for example: in a multi-well plate? The specification example describes that raffinose and xylose are provided separately and they are not present in one medium but in separate wells or cupules of BioMeriux kit ID 32C API (par. 0078 of published application US 2023/0077422).
Claim 1 as amended is indefinite with respect to a concept of chromophores “undergoing a coupling reaction”. A coupling reaction is generally considered as a type of organic reaction where two hydrocarbon fragments are joined together to form a new, larger molecule. But the claim recites hydrolysis of enzyme substrates labeled by different chromogens in order to produce distinct colors upon hydrolysis. Thus, there is no “coupling reaction” but hydrolysis unless some generic mixing of distinct colors is intended.
Claim 1 as amended is rendered indefinite by the phrase “further” in the last newly inserted wherein clause. The phrase “further” extends the medium composition, thereby, it creates uncertainty about whether or not additional ingredients are required or not or optional.
Written description
Claims 1-5 and 18 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The nature of the invention relates to a screening method for identification of Candida auris as based on positive ability to degrade raffinose and negative ability to degrade xylose (par. 0051 of published application US 2023/0077422).
Claim 1 recites that a screening culture medium comprises raffinose and xylose as 2 enzyme substrates, that there is a chromogen which is covalently linked to each enzyme substrate and that the chromogen used for raffinose is different from a chromogen used for xylose. Claim 18 further recites that chromogen is indoxyl derivative.
The as-filed specification does not describe compounds that would be a raffinose covalently linked to a chromogen and a xylose covalently linked to a chromogen. The as-filed specification does not describe compounds that would be a raffinose covalently linked to indoxyl and a xylose covalently linked to indoxyl.
Although the generic description in the as-filed specification refers to the use of a generic indoxyl chromogen for labeling a generic enzyme substrate as intended to detect color upon hydrolysis of labeled enzyme substrate by a microbial enzyme, there are no description of a raffinose covalently linked to indoxyl and a xylose covalently linked to indoxyl. Although labeling of microbial enzyme substrates with chromogens is knonw in the art (see below the cited reference by Orenga), there is no description in the as-filed specification of a raffinose covalently linked to a chromogen and a xylose covalently linked to a chromogen including raffinose covalently linked to indoxyl and xylose covalently linked to indoxyl.
Particular embodiment (par. 0077-0079) describes the use of a prior art medium kit, wherein raffinose and xylose are present separately in different cups (see par. 0079, line 4), wherein raffinose and xylose are not labeled by chromogens, and wherein degradation of raffinose, xylose and other substrates determined by development of turbidity (opacity) but not by color or different colors resulting from microbial hydrolysis.
Thus, the claimed subject matter is not properly described in the application as filed. The claimed concept of the use of a screening culture medium comprising raffinose and xylose as 2 enzyme substrates, wherein raffinose and xylose are each labeled by a covalently linked chromogen, wherein the chromogen used for raffinose is different from a chromogen used for xylose is not satisfactorily resolved as disclosed in the as-filed specification.
Consequently, there is a reasonable doubt as to possession of the claimed invention at the time of filing.
Claim Rejections - 35 USC § 101
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.
Claims 1-5 and 18 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claims 1-5 recite a composition comprising nutrient compounds including raffinose and xylose, and further N-acetylglucosamine, potassium gluconate, glycerol and/or glucosamine. All claim-recited compounds are natural compounds. With regard to claim-recited limitations drawn to label, color and chromophores, that might develop or not upon potential degradation of nutrients, it is noted that the claim-recited terms are genetic and they fail to point out any specific characteristics that would distinguish labels or chromophores from natural compounds. The indoxyl and its derivatives recited in the claim 18 are found in nature and derived from plants like Isatis tinctoria or a plant glycoside called indican.
Thus, the final composition is a simple combination of natural products.
This judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed product, and the claimed product as a whole is nothing more than an attempt to generally link the product of nature to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Claim Rejections - 35 USC § 103
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.
Claims 1-5 and 18 as amended remain/are rejected under 35 U.S.C. 103 as being unpatentable over BioMerieux ID 32C identification system (IDS reference; BioMerieux “ID 32 C identification system for yeasts”. 2011/07, pages 1-9), US 4,450,238 (Vitobello et al) and Orenga et al (“Enzymatic substrates in microbiology”. Journal of Microbiological Methods. 2009, 79, pages 139-155).
The BioMerieux “ID 32 C identification system for yeasts” is a composition comprising a medium with carbohydrate substrates for potential assimilation by yeasts as intended for identification of various species of yeasts. The medium comprises raffinose, xylose, N-acetylglucosamine, potassium gluconate, glycerol and glucosamine (see table on page 1). The assimilation or degradation of each substrate is detected by a change in turbidity or opacity (page 2, col. 2).
Thus, the cited medium as disclosed is lacking a reagent or a label based on indoxyl that would manifest a color change when carbohydrate substrate is degraded.
However, it is a common microbiological practice to incorporate a reagent or a label that would manifest a color change when carbohydrate substrate is degraded.
For example, as applied to the claim-recited raffinose, it is well knonw that raffinose is hydrolyzed by alpha-galactosidase of yeasts including Saccharomyces cerevisiae (see abstract of US 4,450,238) and alpha-galactosidase substrate is commonly labeled with indoxyl (see table 2, line1, on page 145 of the reference by Orenga) for enzymatic tests and applications related to yeasts (YS) in commercial ID products (see table 3 on page 146 of the reference by Orenga) that are similar, if not the same, to the BioMerieux ID identification system discussed above.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to incorporate the enzyme-substrate associated labels/chromophores including indoxyl derivatives into the BioMerieux yeast identification product with a reasonably expectation in success for detecting developing colors upon enzymatic degradation of substrates because it is a common knowledge and routine practice in microbiological applications as evidenced by Orenga.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
With respect to limitation drawn to xylose, or to a potentially different label or color for xylose digestion, it is noted that pentose carbohydrates as xylose are not readily fermented by yeasts, for example: Saccharomyces cerevisiae (see page 2 at it. 3 by reference by Moyses). In the instant application xylose is not degraded by none of the yeasts of interest (see table 10 of as-filed specification) and no labels is disclosed for the claimed enzymatic substrates.
Response to Arguments
Applicant's arguments filed on 2/25/2026 have been fully considered but they are not found persuasive.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that the use of label provides for the structure to the claimed product that would distinguish it from the natural product.
This argument is not found persuasive. The claim-recited limitations drawn to label, color and chromophores, that might develop or not upon potential degradation of nutrients, are genetic; and they fail to point out any specific characteristics that would distinguish labels or chromophores from natural compounds. The indoxyl and its derivatives recited in new claim 18 are found in nature and derived from plants like Isatis tinctoria or a plant glycoside called indican.
With regard to the claim rejection under 35 USC § 103 Applicants’ arguments are drawn/based on a screening method for identification of yeast Candida auris as based on positive ability to degrade raffinose and negative ability to degrade xylose. In particular, with regard to primary reference by BioMerieux Applicants also argue that database of the cited BioMerieux system does not comprises information about detection of Candida auris.
However, the claimed invention is a composition matter or a culture medium with raffinose and xylose but not a method of using the medium for detection of Candida auris.
The cited BioMerieux “ID 32 C identification system for yeasts” is a composition comprising enzyme substrates including raffinose and xylose. Thus, it is a composition of matter with raffinose and xylose as required by the claims. In the cited medium system the detection of positive or negative degradation of raffinose and/or xylose is possible/done by development of turbidity which would be a visible change in a generic color from clear to opaque upon enzymatic degradation of enzymatic substrate. The cited BioMerieux medium does not comprise chromogens for detection of bright color changes. However, modifications of enzymatic substrates with chromogens for detection of bright color changes upon microbial enzymatic digestion of chromogenic enzymatic substrates have been knonw and used in the art of microbiology as clearly taught by the cited reference by Orenga. In particular, degradation of raffinose by yeasts is possible due to activity of enzyme alpha-galactosidase (abstract of US 4,450,238). The alpha-galactosidase substrates are commonly labeled with indoxyl (see table 2, line 1, on page 145 of the reference by Orenga) for enzymatic tests and applications related to yeasts (YS) in commercial ID products (see table 3 on page 146 of the reference by Orenga) that are similar, if not the same, to the BioMerieux ID identification system discussed above. Therefore, chromogenic modifications of enzymatic substrates are known and obvious to one of ordinary skill in the art.
Now turning to the claimed invention, the claimed subject matter is not properly described in the application as filed because there is no disclosure of chemical compounds that would be raffinose and/or xylose being each labeled by a covalently linked chromogen as recited in the claims. The disclosed detection medium does not comprise any chromogens for any substrates. Thus, in the absence of evidence to the contrary as based on applicants’ disclosure, the claimed invention as a whole is considered as clearly prima facie obvious because prior art clearly teaches and suggests chromogenic modifications of yeast alpha-glucosidase enzymatic substrates with indoxyl derivatives and because yeast alpha-glucosidase enzyme has ability to digest claimed raffinose.
With respect to limitation drawn to xylose, or to a potentially different label or color for xylose digestion, it is noted that pentose carbohydrates as xylose are not readily fermented by yeasts, for example: Saccharomyces cerevisiae (see page 2 at it. 3 by reference by Moyses). In the instant application xylose is not degraded by none of the yeasts of interest such as Candida auris (see table 10 of as-filed specification) and no labels is disclosed for the claimed enzymatic substrates. Thus, change of color is not even needed for xylose as substrate in the medium for detecting Candida auris as recited in claims since the medium will remain the same in the lack of xylose degradation.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Vera Afremova
April 15, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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