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 .
Claim Interpretation
Claim 3 requires one or more of
A short-chain acetate compound
A short chain formate compound
A mixture of both
As it is only necessary to meet one of the aforementioned components to fully satisfy the requirement of claim 3, claim 5 will only be considered relevant if the prior art identifies a short chain organic formate compound to satisfy the requirements of claim 3. If the prior art identifies a short chain acetate compound, use of ethyl formate, propyl formate, butyl formate, or any isomer or combination thereof would fail to further specify and limit claim 3, as claim 3 would then teach use of a short-chain acetate compound.
Claim 12 requires the use of either a chaotropic agent, RNase inhibitor, or a combination thereof. As it is only necessary to meet one of the aforementioned components to fully satisfy the requirement of claim 12, claim 13 will only be considered relevant if the prior art identifies a RNase inhibitor to satisfy the requirements of claim 12. As claim 13 fails to further narrow use of a chaotropic agent, identification of a chaotropic agent in the prior art will render claim 13 irrelevant to claim 12, thus making the claim obsolete.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 11-16 and 41-47 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.
Claim 1 states use of a visualization fluid composition comprising a low molecular weight ester, ether, or formate moiety, a volatile organic liquid chemical component, a stabilization component, preservation component, and an image color adjusting moiety. The specification provides detailed information about the low molecular weight ester, ether, or formate moiety (0011), the volatile organic liquid chemical component (0012), the preservation component (0014), and an image color adjusting moiety. (0015). Furthermore, these components are well-known in the art and readily available. The specification does provide examples of certain hygroscopic salts to use in the invention (0013), but fails to actually define what, other than a hygroscopic salt, constitutes a stabilization component and the benefit or role it has in successful use of the invention.
Regarding use in the prior art, hygroscopic salts are simply a broad category of salts which have the property of being able to absorb moisture directly from the atmosphere. The prior art does teach use of hygroscopic salt stabilizers for use in dust control, drilling, and construction, but the prior art fails to demonstrate how hygroscopic salts act as a stabilizing agent specifically pertaining to laser capture microdissection visualization fluid. In addition, the specification fails to provide any details of why this property specifically is used as a stabilization component, and why use of a hygroscopic salt would provide any benefit or novelty over any other stabilization component known in the art. Furthermore, there is no teaching in the specification as to why or how a hygroscopic salt would act to stabilize the visualization fluid.
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 1-4, 6-9, 11, 14, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simon et al. (US 2015/0147779 A1) as evidenced by Sigma Aldrich, Refractive Index Info, and Cornell University
Regarding claim 1: Simon et al. discloses a cleaning agent and mounting solution for microscopy which can be used to mount a specimen for observation for temporary or permanent mounting. (57) This reads on use of a visualization fluid. Simon further discloses that this mounting solution may comprise an ether (0023) and specifically lists use of methyl ether and 2,2,2-trichloroethylacetate (0070), which one skilled in the art would recognize has a low molecular weight of around 191.4 g/mol. Simon further discloses an embodiment of the invention using methanol (0078), which is a volatile organic liquid. Additionally, Simon discloses use of a monomeric unit to stabilize the mounting solution (0017) and use of a chemical preservative (0017). Lastly, Simon discloses use of a stain or dye in the composition. (0017)
Regarding claim 2: Simon discloses use of a low molecular weight ester (2,2,2-trichloroethylacetate, 0070) which a person skilled in the art would know to have a refractive index of 1.457, as evidenced by Sigma Aldrich.
Regarding claims 3 and 4: Simon discloses use of 2,2,2-trichloroethylacetate, which reads on both claim 3 as use of a short-chain acetate compound and claim 4 as use of an isomer of ethyl acetate.
Regarding claim 6: Simon discloses a preferred embodiment of the invention which comprises methanol (0077), which a person skilled in the art would know to have a refractive index of 1.3270 as evidenced by the database Refractive Index Info.
Regarding claims 7 and 8: Simon discloses use of methanol (0077) in a preferred embodiment of the invention, which reads both on claims 7 and 8 of a short-chain alcohol solvent comprising methanol.
Regarding claim 9: Simon discloses use of a salt solution or buffer and gives the option of use of citrate salt (0017). One skilled in the art would know that citrate salt is classified as a hygroscopic salt.
Regarding claim 11: Simon discloses use of a chemical preservative in order to preserve the integrity of the specimen after mounting and/or to extend its working lifetime. (0017)
Regarding claim 14: Simon discloses use of a stain or dye selected from a group comprising iodine (0017), which as evidenced by Cornell University, has a wavelength when optically excited of between 490-650 nm.
Regarding claim 44: Simon discloses that, a preferred embodiment of the invention, trichloroethanol (the low molecular weight ester, as discussed in claims 3 and 4 regarding the isomer 2,2,2-trichloroethylacetate) is used in a concentration of about 34.5%-97%, which overlaps the claimed range of about 10% to 40%. (0076)
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.
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.
Claim(s) 10, 12, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2015/0147779 A1) in view of Chafin et al. (WO 2016041890 A2), Sang et al. (KR 20200022989 A), and Kazuo et al. (JP 2012205571 A) as evidenced by Zhou et al. (Benzotriazole ultraviolet stabilizers in the environment: a review of analytical methods, occurrence, and human health impacts, 2023)
The teachings of Simon are discussed above. Simon fails to teach use of a hygroscopic salt, chaotropic agent, container to the required specifications as set forth in claims 15 and 16, the specified UV absorption compound, the ratio and use of ethyl acetate to ethanol, and use of either triazines, benzotriazoles, benzophenoes, or oxalanilides.
Regarding claim 10: Simon teaches use of a hydroscopic salt, but fails to teach use of specifically calcium chloride, calcium sulfate, magnesium sulfate, potassium sulfate, or sodium sulfate. Chafin teaches high-concentration aldehyde-based fixatives to fix tissue samples. (57) Specifically, Chafin teaches adding salts, including sodium sulfate and calcium chloride, to adjust the osmolarity of a fixing solution comprising an organic component (pg 16-17, D. Osmolarity and Inorganic Salts) to be used for the stabilization of biological tissue samples (pg 3, Summary of the Invention).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Chafin with the teachings of Simon. One skilled in the art would have had motivation and a reasonable expectation of success due to the teachings of Chafin, who state that the addition of sodium sulfate and/or calcium chloride allows for the osmolarity of a fixing solution to be adjusted and acts to stabilize biological tissues.
Regarding claim 12: Simon teaches use of a preservation component, but fails to specifically teach use of either a chaotropic agent or an RNase inhibitor. Sang teaches use of a nitrogen gas pressurized device for tissue transparency and antibody penetration enhancement. (0001) Specifically, Sang teaches use of urea (a known chaotropic agent) to be applied to a biological tissue sample, allowing for the benefit of adjusting concentration in order to adjust the refractive index of the mounting solution. (0050)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Sang with the teachings of Simon. One skilled in the art would have had motivation and a reasonable expectation of success due to the teachings of Sang, who state that the use of urea to adjust the concentration of the preservation component allows for the adjustment of the refractive index of the mounting solution.
Regarding claims 41-43: Simon fails to teach use of a compound configured to absorb near-UV and UV rays. Kazuo teaches the development of a laser microdissection method capable of observing abnormalities of a cell and intercellular organella and further preventing the hydrolysis of a nucleic acid. (Pg 1, Abstract) Kazuo specifically teaches use of an ultraviolet absorber, listing both benzophenones and benzotriazole as examples. (Pg 3, 3rd paragraph) Use of an ultraviolet absorber allows for the target site in a sample to be accurately and easily cut with an ultraviolet laser. (Pg 2, Description of Embodiments) As evidenced by Zhou et al, benzotriazole UV absorbers have a UV absorption wavelength length of 300-385 nm (pg 1, Introduction) further reading on claim 42 of the absorption range of 404 to about 414 nm and claim 42 of use of benzotriazoles and/or benzophenones.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kazuo with the teachings of Simon. A person skilled in the art would have had motivation and a reasonable expectation of success based on the teachings of Kazuo, who state that use of a UV absorption component allows for a sample to be accurately and easily cut with an ultraviolet laser.
Claim(s) 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2015/0147779 A1) in view of Stratis et al. (US 20140319141 A1) as evidenced by Bernard Laboratories, Inc
The teachings of Simon are discussed above. Simon fails to teach use of a container set to the specifications of claims 15 and 16.
Regarding claim 15: Simon fails to teach use of a container with a bulb or dropper region, tear or twist off seal, and dispensing spout made with inert material. Stratis teaches a system and method for mixing compounds which includes a transfer device that allows for diluent in a syringe to be introduced into a container having a first compound in a sterile manner. (57) Stratis further teaches that the bottle may be adapted with a dropper. (0011) Specifically, various dropper tips may be used with the invention (57) and has a twist-on cap which contains a special locking device. (0056) In an embodiment, the bottle further comprises a drain spout which allows for dispensation of the product (0080) Simon teaches that the invention is to be used with a plastic bottle such as an ophthalmic bottle (0023) which, as evidenced by Bernard Laboratories Inc., is chemically inert. Per Bernard Laboratories Inc., most plastic is chemically inert and will not react chemically with other substances (second paragraph).
Regarding claim 16: Stratis teaches that the device may comprise an additional filter within the dropper tip (0039).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Stratis with the teachings of Simon. One skilled in the art would have had motivation and a reasonable expectation of success due to the teachings of Stratis, who state that use of their transfer device with a plastic bottle and dropper allows for dispensation of the product and the introduction of a diluent into a container having a fist compound in a sterile manner. In addition, as evidenced by Bernard Laboratories Inc, use of an inert material such as the plastic bottle taught by Stratis allows for the container to not react chemically with substances contained within it.
Allowable Subject Matter
Claims 45-47 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 and once the 112a issue noted above is overcome.
Regarding claims 45-47: claims 45-47 require the use of ethyl acetate as a component of the visualization fluid. The prior art shows use of ethylene-vinyl acetate as a mounting agent used in laser-capture microdissection as seen in Brignole et al., but there is no evidence in the prior art of use specifically of ethyl acetate in the context of laser capture microdissection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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/HANNA MARIE THUESON/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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