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 .
Status of the Claims
Applicant’s submission filed on April 17, 2026 has been entered and considered. Rejections and/or objections not reiterated from the previous action mailed November 11, 2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-3, 5-6, 10 and 13 have been amended. Claim 11 has been canceled.
Claims 1-10 and 12-13 are pending and examined on the merits.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/EP2021/085982, filed on December 15, 2021. The instant application claims foreign priority under 35 U.S.C. 119(a)-(d) to European Patent Application EP20215095.9, filed on December 17, 2020. A certified copy of the foreign patent application in the original language has been provided with the instant application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 17, 2025; April 1, 2026; April 17, 2026; and May 27, 2026 are in compliance with the provisions of 37 CFR 1.97 and are being considered by the examiner.
The information disclosure statements (IDS) submitted on June 15, 2023; July 27, 2023; and February 5, 2025 are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Withdrawn Objections to the Drawings
In view of Applicant’s submission of replacement Fig. 2 indicating the percentage of dehydration of tissue samples which matches those of the instant specification, the objection to drawings has been withdrawn.
Withdrawn Objections to the Specification
In view of Applicant’s amendment to the instant specification to remove the embedded hyperlink in Para. [0006], the objection to the specification has been withdrawn.
Withdrawn Claim Rejections - 35 USC § 112(b)
Claims 2-3, 5-6 and 13 were rejected under 35 U.S.C. 112(b) for being indefinite.
Claims 2-3 were previously rejected for use of the term “preferably”. In view of Applicant’s amendment to claims 2 and 3 to remove “preferably”, the rejection over the use of preferably has been withdrawn.
Claim 5 was previously rejected for reciting a broad range or limitation together with a narrow range or limitation for reciting both “dehydrating compositions composed of aqueous alcohol, ketone, or ether” and dehydrating compositions which were aqueous ethanol, for antecedent basis due to recitation of “the solvent”, for use of the term “preferably”, and for indefiniteness based on recitation of increasing concentrations of ethanol in a single mixture of ethanol. In view of Applicant’s amendments to claim 5, these rejections have been withdrawn.
Claim 6 was previously rejected for antecedent basis due to recitation of “the gradient” and for use of the relative term “small increments”. In view of Applicant’s amendments to claim 6, these rejections have been withdrawn.
Claim 13 was previously rejected for being indefinite based on reciting a method without method steps. In view of Applicant’s amendments to claim 13, this rejection has been withdrawn.
Withdrawn Claim Rejections - 35 USC § 112(d)
Claim 11, which depends from claim 10, was rejected under 35 U.S.C 112(d) for failing to further limit the subject matter of the claim from which it depends. Applicant has canceled claim 11 rendering the rejection to claim 11 moot.
Withdrawn Claim Rejections - 35 USC § 101
Claim 13 was rejected under 35 U.S.C. 101 for reciting both a product and a method. In view of Applicant’s amendment to claim 13, this rejection has been withdrawn.
Maintained Claim Rejections - 35 USC § 112(a)
Claims 1-9 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for clearing of tissue using 2-hydroxy-5-methoxybenzaldehyde (alternatively indicated as “m-Anisaldehyd” in the drawings) at concentrations of 100%, does not reasonably provide enablement for the full scope of benzaldehyde anisole ethers as instantly claimed at the full scope of concentrations of benzaldehyde anisole ethers as instantly claimed nor does the specification provide support for subsequent visualization by light microscopy. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Applicant’s disclosure does not provide enough information for any person skilled in the art to use any of the instantly claimed embedding mediums at any of the instantly claimed concentrations for clearing tissue for any subsequent visualization by light microscopy.
SCOPE OF THE INVENTION
The breadth of the claims encompasses a genus of benzaldehyde anisole ethers comprising 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, 2-hydroxy-5-methoxybenzaldehyde, and 4-ethoxybenzaldehyde which can be used at many concentrations for use in clearing tissue samples prior to subsequent visualization using light microscopy. As discussed supra, the specification fails to describe the full genus of compounds which can be used for tissue clearing and at which specific concentrations and would require undue experimentation to discover these compounds and concentrations. The specification only discloses and provides guidance for tissue clearing using 2-hydroxy-5-methoxybenzaldehyde at concentrations of 100%.
Independent claims 1 and 13, and dependent claim 4 encompass a genus of benzaldehyde anisole ethers comprising 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, 2-hydroxy-5-methoxybenzaldehyde, and 4-ethoxybenzaldehyde for use in clearing tissue samples while the working examples of the specification only discloses a single species, 2-hydroxy-5-methoxybenzaldehyde, of the claimed benzaldehyde anisole ether.
Dependent claims 2 and 3 encompass a genus of concentrations of benzaldehyde anisole ethers for use in clearing tissue.
Dependent claims 5-8 encompass a genus of dehydration steps.
Dependent claim 9 encompasses a genus of light microscopy techniques for visualizing internal tissue structure.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
The office has analyzed the specification in direct accordance to the factors outlined in In re Wands. MPEP 2164.04 states: "[W]hile the analysis and conclusion of a lack of enablement are based on factors discussed in MPEP 2164.01(a) and the evidence as whole, it is not necessary to discuss each factor in written enablement rejection." These factors will be analyzed, in turn, to demonstrate that one of ordinary skill in the art would have had to perform "undue experimentation" to make and/or use the invention and therefore, Applicant's claims are not enabled commensurate with the scope of the invention.
REDUCTION TO PRACTICE
The specification does not provide guidance for or a working example for the full scope of claimed benzaldehyde anisole ethers and claimed concentrations. The absence of working examples directed to several of the claimed benzaldehyde anisole ethers and use at a wide range of concentrations necessitates further experimentation. Additionally, no working examples were provided that utilize 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, or 4-ethoxybenzaldehyde nor were working examples provided that utilize concentrations of 2-hydroxy-5-methoxybenzaldehyde below 80%. Therefore, the specification does not provide sufficient guidance on how to make and use the full scope of the instantly claimed benzaldehyde anisole ethers at the full scope of the instantly claimed concentrations for tissue clearing and subsequent visualization of the internal structure of the tissue via light microscopy.
In regard to claims 1 and 4 encompassing a genus of benzaldehyde anisole ethers comprising 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, 2-hydroxy-5-methoxybenzaldehyde, and 4-ethoxybenzaldehyde; the specification shows a working examples to a single embodiment of 2-hydroxy-5-methoxybenzaldehyde (Examples 1-3).
In regard to dependent claims 2 and 3 encompassing a genus of concentrations at which the benzaldehyde anisole ethers can be used to clear tissue, Applicant discloses a fixed number of concentrations (100%) of only 2-hydroxy-5-methoxybenzaldehyde (Example 2).
In regard to dependent claims 5-8 encompassing a genus of dehydration steps; as stated above, the specification shows a working examples to a single embodiment of 2-hydroxy-5-methoxybenzaldehyde (Examples 1-3).
In regard to dependent claim 9, encompassing a genus a genus of light microscopy techniques for visualizing internal tissue structure, Applicant has provided images of tissue which appears clear in comparison to controls but no working examples of visualization of internal tissue structure using light microscopy.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
In fact, the state of the art teaches that tissue clearing has highly variable results based on the compound used and that each specific compound or combination of compounds requires optimization in order to generate results that are useful for subsequent visualization of tissue structural elements. Consequently, there is ample reason to conclude that there would be a high degree of unpredictability between embodiments of the instant invention.
Becker et al. (2012, Correction: Chemical clearing and dehydration of GFP expressing mouse brains. PLoS One, 7(8), 10-1371, found in IDS) teaches testing of many different compounds and their effectiveness for use in clearing of GFP positive tissues (Fig. 4). Becker et al. indicates that compounds comprising hydroxyl groups (for example, 2-hydroxy-5-methoxybenzaldehyde) are GFP-incompatible and greatly reduced the ability to visualize GFP positive samples (Pg. 4, left column) thus indicating there is an amount of unpredictability regarding use of various clearing compounds and also that some compounds, while being effective for clearing, may not be effective for specific types of subsequent visualization by light microscopy.
Chiang (US 6,472,216 B1) discloses an aqueous tissue clearing solution comprising dimethyl sulfoxide, diatrizoate acid, ethylenediaminetetraacetic acid, glucamine, β-nicotinamide adenine dinucleotide phosphate, sodium diatrizoate, and derivatives of polyoxyalkalene (Col. 2, lines 2-6)) which can be used without damaging tissue and without dehydration of tissue (Col. 1, lines 48-50). Chiang discloses that prior tissue clearing agents required solvent extraction which can distort tissue morphology (Col. 1, lines 36-38) and are not suitable for all uses.
Imai and Ke (US 9,933,342 B2) discloses a clearing reagent comprising fructose (Abstract) which does not cause swelling or shrinkage of biological material and thus prevents tissue deformation (Col. 7, lines 45-49) which is superior to other known clearing solutions which suffer from technical problems such as reduction of fluorescence due to use of an organic solvent (Col. 2, lines 25-30) or are not able to generate sufficient tissue transparency and also can cause tissue shrinkage (Col. 2, lines 31-32) which would obviously inhibit subsequent visualization of internal tissue structure.
Therefore the teachings of the prior art indicate that clearing of tissue is not one-size-fits-all and that a significant amount of optimization is necessary for each specific tissue clearing compound and also that the specific agent which is chosen for use should be optimized with the requirements of subsequent visualization in mind.
Since the prior art at the effective filing date of the present application did not provide guidance for using benzaldehyde anisole ethers comprising 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, 2-hydroxy-5-methoxybenzaldehyde, and 4-ethoxybenzaldehyde to clear tissue samples for further visualization using light microscopy, it is incumbent upon the instant specification to do so. As detailed above, the physiological art is recognized as unpredictable (MPEP 2164.03). As set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112, first paragraph requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.). In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to make and use the instant broadly claimed invention.
CONCLUSION
In conclusion, since the art teaches that success of said method is prone to influence by multiple factors, and is highly unpredictable with respect to tissue clearing, and the specification does not provide ample guidance with respect to achieving the unexpected results, one would be burdened with undue experimentation to use the claimed invention for clearing of tissue. Given the breadth of the claims and the limited scope of the specification, an undue quantity of experimentation is required to make and use the invention beyond the scope of the working embodiment of 2-hydroxy-5-methoxybenzaldehyde at concentrations of 100%.
Response to Arguments
Applicant's arguments filed April 17, 2026 have been fully considered but they are not persuasive.
First, with regard to the rejections of claims 1-9 and 13 under 35 U.S.C. 112(a) for lack of enablement over use of 2-hydroxy-5-methoxybenzaldehyde at the full range of instantly claimed concentrations, Applicant traverses on Pg. 10, 3rd para. that, based lack of English translation of the Fig. 2 of the drawings filed with the instant specification, the Office has misunderstood the instant disclosure of the drawings. Applicant asserts that a replacement Fig. 2 with English translation has been filed and that vol% values shown in Fig. 2 do not represent concentrations of 2-hydroxy-5-methoxybenzaldehyde used for tissue clearing, but instead indicate the residual water content in tissue samples based on various concentrations of ethanol in dehydration of tissue samples prior to placing tissues into the instantly claimed embedding media of 2-hydroxy-5-methoxybenzaldehyde (Pg. 10, 4th para.). Applicant further asserts that Para. [0022] of Applicant’s published U.S. patent application US 2024/0110853 A1 indicates the purity of each of the instantly claimed embedding media (Pg. 11, 2nd full para.) and that each claimed benzaldehyde anisole ether is disclosed along with respective CAS numbers (Pg. 11, 3rd full para.). Thus, Applicant traverses that the instant application discloses more than one working example of all benzaldehyde anisole ethers (Pg. 11, 4th full para.).
Applicant’s traversal has been fully considered but is not persuasive.
The Office appreciates Applicant’s clarification and submission of a replacement figure Fig. 2 with English translation regarding the working examples. Based on Applicant’s traversal and updated drawings, it appears that Applicant has reduced to practice clearing of tissue samples having residual water content between 0 and 20% in undiluted 2-hydroxy-5-methoxybenzaldehyde. This is supported by Para. [0016] of Applicant’s instant specification which states that, in the preferred embodiment, the benzaldehyde anisole ether is used as the “pure substance” having the technical available purity.
Instant claims 2 and 3 recite limitations wherein the embedding medium contains 10% to 100% by volume of the benzaldehyde anisole ether and 0 to 90% of an inert organic solvent. As claimed, claims 2 and 3 encompass embodiments of an embedding medium which has as little as 10% benzaldehyde anisole ether, as little as 0% of an inert organic solvent, and another undisclosed compound. Although Applicant has provided working examples that “pure” undiluted 2-hydroxy-5-methoxybenzaldehyde can be used for tissue clearing for tissues which have as much as 20% residual water content, Applicant has not provided evidence that as little as 10% of a benzaldehyde anisole ether could be used for tissue clearing for tissue samples which have not been dehydrated. Therefore, Applicant has not sufficiently disclosed the invention commensurate in scope with the breadth of the claims and therefore one of ordinary skill would not be able to use the invention as broadly as claimed for tissue clearing.
Second, with regard to the prior art of Becker et al., Applicant traverses on Pg. 12, 1st para. that Becker et al. is drawn to embedding media and influence on endogenous GFP signals which relates to only the subset of microscopic examination of GPF positive tissue, which was not used in the context of the instant application and therefore, the prior art is drawn to a different type of sample preparation. Applicant traverses on Pg. 12, 2nd para. that light microscopy is a well-established standard application known one of ordinary skill in the art.
Applicant’s traversal has been fully considered but is not persuasive.
In response to applicant's argument that Becker et al. is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Becker et al. is drawn to light microscopic examination of GFP positive tissues which is considered to be in the same field of endeavor and therefore pertinent art. Additionally, although Applicant traverses that no GFP positive tissue was utilized in the context of the patent application, Applicant’s instant claims recite use of the embedding medium for “a biological tissue” and thus do not limit the type of tissue which can be used in the method.
Third, regarding the prior art of Becker et al., Chiang, and Imai and Ke, Applicant traverses on Pg. 13, 1st para. that tissue clearing is not an unpredictable field and that optical clearing requires treating samples with reagents matching the refractive index of the tissue. Applicant points to para. [0056] of Applicant’s published U.S. patent application US 2024/0110853 A1 as detailing the refractive indices of various tissues and para. [0022] as detailing the CAS numbers of the instantly claimed benzaldehyde anisole ethers which can be used to determine the physicochemical properties. Applicant concludes that a skilled artisan would be able to select an embedding medium based on the tissue sample and implement the claimed method without undue experimentation.
Applicant’s traversal has been fully considered but is not persuasive.
While Applicant’s published U.S. patent application US 2024/0110853 A1 may provide information regarding the refractive indices of various tissues and physiochemical properties of the instantly claimed benzaldehyde anisole ethers, Applicant’s traversal indicates that tissue clearing involves selection of a reagent based on its physiochemical properties and the refractive index of a specific tissue. In other words, tissue clearing involves optimization of the specific reagent based on the tissue to be cleared. As detailed in the rejections under 35 U.S.C. 112(a), the prior art of Becker et al., Chiang, and Imai and Ke also support the need for optimization of tissue clearing compounds with those having hydroxy groups being unsuitable for GFP-related visualization and those involving solvent extraction causing tissue distortion. Use of the instantly claimed benzaldehyde anisole ethers is not well known nor predictable and while Applicant has reduced to practice clearing of tissue using undiluted 2-hydroxy-5-methoxybenzaldehyde in tissue samples having 20% or less residual water content, Applicant has claimed that as little as 10% of any of the claimed benzaldehyde anisole ethers could be used in order to produce a transparent tissue sample for light microscopic examination. Based on both the prior art and Applicant’s traversal, undue experimentation would be required in order to determine the various percentages by volume of the claimed benzaldehyde anisole ethers which could be mixed with various percentages of inert organic solvents as well as other compounds in order to produce the claimed tissue clearing effect.
Maintained Claim Rejections - 35 USC § 112(b)
Claims 2-3 stand 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 2 and 3 recite the term “optically suitable” in line 3 which is a relative term which renders the claim indefinite. The term “optically suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no guidance provided for what constitutes an “optically suitable” inert organic solvent, one having ordinary skill in the art would not be able to easily determine which inert organic solvent could be used in the instantly claimed method.
Response to Arguments
Applicant's arguments filed April 17, 2026 have been fully considered but they are not persuasive.
Applicant traverses on Pgs. 13, last para. and Pg. 14, 1st para. that the term “optically suitable” is clear to a skilled artisan in light of the specification and an knowledge of the art and that it is commonly known that “optically suitable” embedding media are selected based on the refractive index of the tissue to avoid light scattering.
Applicant’s arguments have been fully considered but are not persuasive.
Optically suitable does not appear to be a term of the art and is not defined by the instant specification. Applicant’s traversal does not further define what is to be considered “optically suitable” beyond that the refractive index of the organic solvent should match that of the tissue to be cleared. As instantly claimed, “optically suitable” is a relative term which is dependent on the type of tissue, the type of light microscopy, and the application for which the method is being performed. For example, the refractive index of acetone is approximately 1.36 at 20°C but is known to cause tissue shrinkage and to strip lipids (Pg. 2) and therefore would not be optically suitable for light microscopy of delicate tissues or those where maintaining lipid structure is of interest (BenchChem “Acetone in Tissue Fixation: A Detailed Guide for Histology and Immunohistochemistry”). Tetahydrofuran (THF) has a refractive index of approximately 1.4 at 20°C and methanol has a refractive index of approximately 1.3 at 20°C. However, Jing et al. (2018, Tissue clearing of both hard and soft tissue organs with the PEGASOS method. Cell Res., 28(8), 803-818) teaches that both THF and methanol are known to quench fluorescent proteins (Pg. 805, left col., 3rd para.) and therefore might not be suitable for clearing of tissues when detection of fluorescence was of interest. As Applicant has not defined a tissue type, a light microscopy type, or an application of the method, the scope of what is to be considered an optically suitable inert organic solvents is unclear. Note a claim may be rendered indefinite by reference to an object that is variable (see MPEP 2173.05(b), II). For example, the Board has held that a limitation in a claim to a bicycle that recited “said front and rear wheels so spaced as to give a wheelbase that is between 58 percent and 75 percent of the height of the rider that the bicycle was designed for” was indefinite because the relationship of parts was not based on any known standard for sizing a bicycle to a rider, but on a rider of unspecified build. Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989).
Maintained Claim Rejections - 35 USC § 102
Claims 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 103582475B (Espacenet translation attached, hereafter CN ‘475B).
Claims 10 and claim 12, which depends from claim 10 recite a kit with the intended use of “preparing biological tissue samples for light microscopy” comprising a solvent having the intended use of “dehydrating the tissue sample” and an embedding medium “for clearing the dehydrated tissue sample by placing the sample in the embedding medium”. The intended use of the kit, dehydrating solvent, and embedding medium as instantly claimed does not appear to impart any structural limitations on the instantly claimed components and is therefore not interpreted to be limiting. Further, claim 10 recites where in the “embedding medium is… 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, 2-hydroxy-5-methoxybenzaldehyde, and 4-ethoxybenzaldehyde” and is also therefore interpreted as indicating no structural difference between the instantly claimed compounds and the embedding medium.
With regard to claims 10 and 12, CN ‘475B discloses an oral composition for tooth whitening (Para. [0013]) which can be used in a kit (Para. [0087], line 6) wherein the oral composition comprises ethanol (Para. [0025]) and may comprise a flavoring (Para. [0051], line 5) wherein the flavoring may be anisaldehyde (Para. [0062], line 14).
Response to Arguments
Applicant's arguments filed April 17, 2026 have been fully considered but they are not persuasive.
Applicant traverses on Pg. 16 that the limitations of the instantly claimed kit claim a dehydrating solvent “for dehydrating a tissue sample” and an embedding medium “for clearing dehydrated tissue” which recite sufficient chemical and physical material which are beyond intended use. Applicant traverses on Pg. 16 that the claims require a dehydrating solvent for dehydrating the tissue sample and an embedding medium for clearing the dehydrated tissue which are not taught by the cited prior art and on Pg. 17 that the prior art does not disclose a kit for embedding tissue samples for light microscopy.
Applicant traverses on Pg. 17, last para. that the anisaldehyde of the cited prior art is not disclosed as an embedding medium nor in the context of tissue clearing not does the prior art disclose the instantly claimed selection of benzaldehyde anisole ethers or their use in combination with a dehydrating solvent.
Applicant traverses on Pg. 18, 1st para that there is no motivation for a person of ordinary skill in the art to modify the oral care composition to arrive at the presently claimed kit which is used for preparation of biological samples for light microscopy.
Applicants arguments have been fully considered but are not persuasive.
As claimed, Applicant’s kit comprises any concentration of a dehydrating solvent which is defined as being alcohol, ketone, or ether and any concentration of an embedding medium which is defined as being selected from 3-methoxybenzaldehyde, 4-methoxybenzaldehyde, 2-hydroxy-5-methoxybenzaldehyde (i.e, anisaldehyde), and 4-ethoxybenzaldehyde. The prior art discloses a composition which can be in a kit and comprises ethanol and anisaldehyde. Although the claimed intended use of the instantly claimed kit as well as the intended use of the solvent and benzaldehyde anisole ether is different from that of the prior art, the intended use is not considered to result in a structural difference between the claimed composition and that disclosed in the prior art.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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