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 .
Currently, claims 1-5 are pending and under examination.
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 –
(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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujita 2022 (Fujita et al; A report to explore the druggable gene mutations from cytological samples of High sensitivity detection test for multiple gene mutations; MINtS”, 62nd Annual Meeting of the Japanese Respiratory Society; Kyoto, Japan, April 22, 2022; cited in the IDS filed 6/6/2024).
With regard to claim 1, Fujita 2022 teaches (see page 3 “Flow of Test Preparation)
treating a biopsy sample from a lung cancer patient with negative pressure in an isotonic solution (saline), collecting the solution, and mixing it with a cytological specimen (lavage fluid after scraping brush, bronchial lavage fluid) to form a liquid mixture. Fujita 2022 teaches analysis of the samples for tumor cells.
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.
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 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Fujita 2022 in view of Oh (Oh et al; BioMed Research International, doi.org/10.1155/2013/546727; 2013, pages 1-10;).
Fujita 2022 teaches (see page 3 “Flow of Test Preparation”) treating a biopsy sample from a lung cancer patient with negative pressure in an isotonic solution (saline), collecting the solution, and mixing it with a cytological specimen (lavage fluid after scraping brush, bronchial lavage fluid) to form a liquid mixture. Fujita 2022 teaches analysis of the samples for tumor cells. With regard to claims 4 and 5, Fujita 2022 teaches analysis of nucleic acids in the tumor samples from the liquid using next generation sequencing. Fujita 2022 does not teach treating cells in the liquid mixture with a solution containing ammonium sulfate. However Oh teaches analysis of obtaining amplifiable DNA in a small number of cells, such as the cytological specimen liquid taught by Fujita 2022, by treating with ammonium sulfate (see whole document). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have included the use of ammonium sulfate as taught by Oh, in the method of Fujita 2022 because Oh teaches that it allowed for the best DNA quality and yield.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue (Inoue et al; PLOS One 12(4): e0176525; April 27, 2017, pages 1-14) in view of Fujita 2021 (Fujita et al; Cancer Medicine, vol 10, pages 8595-8603, 2021) and Goodacre (Goodacre et al; Ann Thorac Surg, vol 74, pages 276-277; 2002).
With regard to claim 1, Inoue teaches obtaining (see page 2, “Samples”) debris from fine needle aspirate biopsy (biopsy tissue taken from a lung cancer patient with negative pressure), as well as bronchial wash or bronchial brushing isolated during bronchoscopy (cytological specimen containing tumor cell). Inoue teaches that part of each sample was submitted for pathological examination to confirm the presence of cancer cells, while the rest was centrifuged and stored in RNAlater (claims 2 and 3) stabilizing solution. As evidenced by the teachings in the instant specification RNAlater solution necessarily contains ammonium sulfate (see para 0024). With regard to claims 4 and 5, Inoue teaches analysis of nucleic acids from the tumor cells using next generation sequencing (see page 3).
With regard to claim 1, Inoue does not teach that the needle aspirate specimen was obtained using negative pressure in an isotonic solution, however Goodacre teaches that using saline (isotonic solution) during fine needle aspiration reduced complications from bronchoscopy (see abstract, whole document). Goodacre teaches (figure 1) introducing a needle into a lesion, injecting saline, and then withdrawal of the needle (negative pressure) to obtain the sample. Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have included fine needle aspirate samples obtained as taught by Goodacre in the method of Inoue with a reasonable expectation of success because Goodacre teaches the protocol resulted in high diagnostic yield.
With regard to claim 1, Inoue in view of Goodacre does not teach samples were obtained from the same patient, however Fujita 2021 teaches analysis of different types of specimens for genetic analysis from the same lesion including cytological samples and tissue samples (page 8597, col 2 “Clinical samples”). Fujita 2021 teaches that these were considered a “sample set”. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have included samples taught by Inoue from the same lesion for the purpose of obtaining as much sample as possible for mutation analysis. Although Fujita 2021 does not teach that the components of the sets were combined into a single cell suspension, as set forth in the MPEP 2144.06 I, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).”. Further, given that Inoue teaches that the samples produced small amounts of DNA, the ordinary artisan would have been motivated to combine samples from the same lesion so as to increase the number of cells in the sample being processed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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