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 Claims
Claims 1-14 are pending and the subject of this NON-FINAL Office Action. This is the first action on the merits.
Claim Interpretations
“Aqueous processing buffer” is broadly described as any buffer (para. 0027).
“High pressure” is never defined; at best 15-70 PSI examples are provided (para. 0026); thus, it encompasses any pressure above atmospheric (14.7 PSI).
“Solvent” is broadly described as any solvent (e.g. water, PBS, etc.; para. 0024).
Claims 7-9 described intended uses or results of the claims process; thus, they fail to provide any additional steps to the process. In other words, the claimed process yields the claimed results.
Duplicate Claim Warning
Claim 13 is a substantial duplicates of claim 11. The only difference between claims 11 and 13 are the preambles. The claims do not differ in the body of the claims. Thus, claims 11 and 13 do not substantially differ in scope because the preambles fail to further limit the body of the claims. See MPEP § 2111.02.
Applicant is advised that should claim 1 be found allowable, claims 11 and 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claim 10 is 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 pre-AIA the applicant regards as the invention.
“Accurately preserves and reveals” is a relative term with no referent. See MPEP § 2173.05(b). It is not clear how this is determined, or what accuracy is measured.
Claim Rejections - 35 USC § 102
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 –
(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 1-14 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by ANGROS (US20170328820).
As to claim 1-3 and 5-10, ANGROS teaches obtaining formalin-fixed, paraffin-embedded (FFPE) sections of the tissue sample dried on glass slides (Abstract; para. 0113, 0121); deparaffinizing the FFPE sections by incubating the glass slides in a succession of solvents (para. 0138, 0306, Examples- multiple reaction containers e.g. with deparaffinizing compositions of water and silicone solvents); exchanging the solvents in which the slides have been deparaffinized with an aqueous processing buffer pH of 8 (paras. 0138, 0210-11, Examples- recovery buffers); placing the slides in the processing buffer in a high pressure chamber (Examples); uniformly heating and pressurizing the slides in the chamber to at least 120° C in an atmosphere of at least 30 pounds per square inch (psi) for 10-60 min (Examples); cooling the slides to room temperature within 30 min (); exchanging the aqueous buffer with fresh solvent (Examples); and preparing the slides for in situ hybridization of RNA contained therein (e.g. para. 0216).
As to claim 4, ANGROS teaches wherein the processing buffer only partially fills the high pressure chamber during the heating and pressurizing (para. 0111).
As to claims 11 and 13, ANGROS teaches analyzing the prepared slides by in situ hybridization using multiplexed DNA probes complementary to RNA contained in the tissue (e.g. para. 0105- RNA or DNA probes in situ hybridization reagents, etc.).
As to claim 12, ANGROS teaches analyzing the prepared slides by immunohistochemistry using antibodies or other binding agents specific for tissue-specific antigens in the tissue (e.g. paras. 0004-05 & 0105- immunohistochemical reagents such as Ab).
As to claim 14, ANGROS teaches analyzing both protein using immunohistochemistry and nucleic acid/RNA using multiplex probes (id.)
Claims 1 and 3-14 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by CAPODIECI (US20060141502).
As to claim 1, 3 and 5-10, CAPODIECI teaches obtaining formalin-fixed, paraffin-embedded (FFPE) sections of the tissue sample dried on glass slides (paras. 0060ff); deparaffinizing the FFPE sections by incubating the glass slides in a succession of solvents (id.); exchanging the solvents in which the slides have been deparaffinized with an aqueous processing buffer pH of 8 (id.); placing the slides in the processing buffer in a high pressure chamber (id.); uniformly heating and pressurizing the slides in the chamber to at least 120° C in an atmosphere of 24 pounds per square inch (psi) for 10-60 min (id.); cooling the slides to room temperature within 30 min (id.); exchanging the aqueous buffer with fresh solvent (id.); and preparing the slides for in situ hybridization of RNA contained therein (id.).
As to claim 4, CAPODIECI teaches wherein the processing buffer only partially fills the high pressure chamber during the heating and pressurizing (id.).
As to claims 11 and 13, CAPODIECI teaches analyzing the prepared slides by in situ hybridization using multiplexed DNA probes complementary to RNA contained in the tissue (id.; para. 0010).
As to claim 12, CAPODIECI teaches analyzing the prepared slides by immunohistochemistry using antibodies or other binding agents specific for tissue-specific antigens in the tissue (id.).
As to claim 14, CAPODIECI teaches analyzing both protein using immunohistochemistry and nucleic acid/RNA using multiplex probes (id.)
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over CAPODIECI, in view of ANGROS.
The prior art as a whole demonstrates that it would have been obvious to a skilled artisan at the time of filing to apply familiar pressure options to the pressure chambers for RNA retrieval to achieve familiar RNA retrieval results with a reasonable expectation of success.
As explained above, CAPODIECI teaches FISH analysis of FFPE samples by preparing them using common deparaffinizing process followed by RNE retrieval using 24 PSI pressure and heat. Although CAPODIECI does not teach 30 PSI or more, yet this is a very familiar option in the art.
For example, as explained above, ANGROS teaches high-PSI (above 30 PSI) to retrieve nucleic acids.
In sum, the claims are directed to the application of familiar pressures to pressure-based RNA retrieval to achieve familiar results, rendering the claims obvious.
Prior Art
The following prior at also teaches deparaffinizing FFPE samples, followed by pressure-based RNA retrieval, followed by RNA and protein analysis such as FISH and IHC: US20180348103; US7326575; US20120009666; AU 2012247048; US8062897; US20090233803; US10295442; WO 2013155077; US20210030737; US20240043934.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681