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 .
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 104211633 A (“CN ‘633”, machine translation provided), as further evidenced by Tai et al., PC3 Is a Cell Line Characteristic of Prostatic Small Cell Carcinoma, Prostate. 2011 Mar 22;71(15):1668–1679 (“Tai”).
CN ‘633 relates to 11 isoindole compounds, of which compound 6 is 3,5-dihydroxy-4-methoxybenzyl alcohol (“DHMBA”), isolated from Hericium erinaceus L547, and their antitumor effects. (Abstract). Per CN ‘633, the compounds are useful “for preventing and/or treating cancer or inhibiting the growth and/or proliferation of cancer cells”. CN ‘633 discloses that the cancer includes prostate cancer. It further discloses that the cancer cells are specifically human prostate cancer (PC) cells (e.g. PC3), which were purchased from ATCC for testing. Table 1 discloses the results of the compounds, to include DHMBA, in a cell proliferation inhibition assay (MTT method- which assesses cell death) on PC3 cells.
The above provides explicit disclosure for both inhibiting growth and inducing cell death.
CN ‘633 discloses that the PC3 cells are human prostate cancer cells, but not whether they are metastatic. This is further evidenced by Tai.
Tai discloses a study to compare the important and relevant features of two most commonly used PC cell lines, LNCaP and PC3, with prostatic adenocarcinoma and prostatic small cell neuroendocrine carcinoma (SCNC). Tai discloses that LNCaP and PC3 cells are derived from lymph node, and bone metastasis, respectively. “It has been well established through numerous studies that LNCaP cells express AR and PSA, are androgen-dependent with relatively indolent biologic behavior similar to the vast majority of the PCs encountered clinically [19,21]. PC3 cells, on the other hand, do not express AR and PSA and are androgen-independent [20–21]. They show highly aggressive behavior which is unlike most clinical cases of PCs. For many years, these two cell lines have been used by researchers to represent different spectrums of PC with LNCaP as the indolent form and PC3 as the aggressive form of PC. . . PC3 cells have features that are characteristic of prostatic SCNCs.” (Introduction).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over CN 104211633 A (“CN ‘633”, machine translation provided), further in view of Tai et al., PC3 Is a Cell Line Characteristic of Prostatic Small Cell Carcinoma, Prostate. 2011 Mar 22;71(15):1668–1679 (“Tai”).
CN ‘633 relates to 11 isoindole compounds, of which compound 6 is 3,5-dihydroxy-4-methoxybenzyl alcohol (“DHMBA”), isolated from Hericium erinaceus L547, and their antitumor effects. (Abstract). Per CN ‘633, the compounds are useful “for preventing and/or treating cancer or inhibiting the growth and/or proliferation of cancer cells”. CN ‘633 discloses that the cancer includes prostate cancer. It further discloses that the cancer cells are specifically human prostate cancer (PC) cells (e.g. PC3), which were purchased from ATCC for testing. Table 1 discloses the results of the compounds, to include DHMBA, in a cell proliferation inhibition assay (MTT method- which assesses cell death) on PC3 cells.
The above provides explicit disclosure for both inhibiting growth and inducing cell death.
CN ‘633 discloses that the PC3 cells are human prostate cancer cells, but not whether they are metastatic. This is further evidenced by Tai.
Tai discloses a study to compare the important and relevant features of two most commonly used PC cell lines, LNCaP and PC3, with prostatic adenocarcinoma and prostatic small cell neuroendocrine carcinoma (SCNC). Tai discloses that LNCaP and PC3 cells are derived from lymph node, and bone metastasis, respectively. “It has been well established through numerous studies that LNCaP cells express AR and PSA, are androgen-dependent with relatively indolent biologic behavior similar to the vast majority of the PCs encountered clinically [19,21]. PC3 cells, on the other hand, do not express AR and PSA and are androgen-independent [20–21]. They show highly aggressive behavior which is unlike most clinical cases of PCs. For many years, these two cell lines have been used by researchers to represent different spectrums of PC with LNCaP as the indolent form and PC3 as the aggressive form of PC. . . PC3 cells have features that are characteristic of prostatic SCNCs.” (Introduction).
CN ‘633 does not explicitly disclose inhibiting cell migration and invasive actions of DHMBA. It does disclose, however, that the prostate cancer studies were performed using PC3 cells. This is further remedied by the teachings of Tai.
Importantly for this rejection, Tai further provides disclosure on the migratory capability of these two cell lines. “In addition, xenograft tumors of LNCaP are slow growing and less invasive, while PC3 xenograft tumors proliferate rapidly and are more invasive. In in vitro assays, PC3 cells possess higher migratory capability than LNCaP cells. As a result, some researchers consider LNCaP and PC3 cells to represent less aggressive and more aggressive forms of prostatic adenocarcinoma, respectively. In some publications, the two cell lines have also been used to represent androgen-dependent and castration-resistant PCs, respectively. Therefore, certain molecular differences between the two cell lines have been considered to be responsible for the aggressiveness or the progression of prostatic adenocarcinoma.” (Discussion, p. 6).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date to combine the teachings of CN ‘633 and Tai in order to assess the inhibition of cell migration and invasion actions on human prostate cancer cells with DHMBA. The skilled artisan would have been motivated to do so because DHMBA is already shown by CN ‘633 to be effective in for preventing and/or treating cancer or inhibiting the growth and/or proliferation of cancer cells, and further, in the cell line PC3, which is derived from human metastatic cancer. Thus, the mere administration of DHMBA will inherently have an effect on this particular prostate cancer of inhibiting cell migration and invasive action of the PC3 cells. Moreover, motivation to do is further found in the disclosure of Tai, which provides that known characteristics of PC3 cells are that they are very aggressive form of prostatic adenocarcinoma, which is rapidly growing and invasive. Given that this is a known characteristic of this particular prostate cancer cell line, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to assess not on the inhibiting the growth and/or proliferation of cancer cells of DHMBA, but also its ability for this kind of a rapidly growing and invasive cancer also the ability of inhibition of cell migration and invasion actions of this compound on human prostate cancer cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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