Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
2. Examiner notes that the preliminary amendment filed 01/25/2024 has been entered into the record.
Priority
3. This application claims benefit of 63/479,019 filed 01/09/2023.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 03/25/2024 complies with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered on the merits. See attached copy of PTO-1449.
Status of the claims
5. The claims filed on 01/25/2024 have been entered. Claims 1-12 are pending and are currently examined.
Claim Objections
6. Claim 1 is objected to because of the following informalities: the recitation of “a subject” (line 1 of claim 1), which means any subject including those who do not require any treatment. Appropriate correction is required. Examiner suggests that Applicant consider including the phrase “in need thereof” immediately after the recitation “in a subject”.
Claim Rejections - 35 USC § 112
7. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
8. Claims 1-8 and 10-12 are 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.
(1) Applicant is intending to incorporate by reference Patent Nos. US 8,236,852 B2 and US8,710,272 B2 into the claims. For example, claim 1 is drawn to a method comprising administering a compound of formula I “wherein X, R3 and R4 are as defined in Patent Nos. US 8,236,852 B2 and US8,710,272 B2, incorporated herein by reference.” However, for the claims to be clear the compounds, including substituents, must be fully defined in the claims. 37 CFR 1.57 (c) states “an incorporation by reference must be set forth in the specification”.
Claims 2-7, 10-12 are included in this rejection as they depend from claim 1.
(2) Examiner notes that claim 8 recites “wherein R3, R4, R3', R4', L, Z and Y are as defined in Patent Nos. US 8,236,852 B2 and US 8,710,272 B2, incorporated herein by reference”. As described above for claim 1, the incorporation by reference in claim 8 similarly renders the claim unclear and indefinite.
(3) Examiner notes that for the sake of compact prosecution, the instant claim 1 will be examined as R3 and R4 read on alkoxy, hydroxy, and hydrogen and X reads on hydroxy, alkoxy, ethyl propionate, ethyl methyl carbonate, and carbonyl alkyl (see US Pat. No.: 8,236,852 column 2,lines 62-67).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-9 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
(1) Regarding claim 8, the compounds recited in the instant claim 8 (i.e., compounds according to formula IIa, IIb, VI) do not read on the ‘X’ substituent (i.e., hydroxy, alkoxy, ethyl propionate, ethyl methyl carbonate, and carbonyl alkyl) required by claim 1 as disclosed in US Pat. Nos.: 8,236,852 and 8,710,272. Further, claim 8 recites “wherein the compound of formula I is a compound of formula IIa, IIb, or VI… R3, R4, R3', R4', L, Z and Y are as defined in Patent Nos. US 8,236,852 B2 and US 8,710,272 B2” however, compound VI and the ‘Y’ substituent are not disclosed in US Pat. Nos.: 8,236,852.
(2) Regarding claim 9, ‘Compound A’ and ‘Compound B’ recited by the instant claim 9 do not read on the ‘X’ substituent (i.e., hydroxy, alkoxy, ethyl propionate, ethyl methyl carbonate, and carbonyl alkyl) required by claim 1 as disclosed in US Pat. Nos.: 8,236,852 and 8,710,272.
Thus, claims 8-9 do not properly depend from claim 1 and are not examined further in this action for patentability based on prior art.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
9. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1-7 and 10 are rejected under 35 U.S.C. 102 (a) (1)/(2) as being anticipated by Shih et al. (Published August 7 2012, US Pat. No.:8,236,852 as cited in the IDS filed on October 13, 2023).
Regarding Claims 1-7 and 10, Shih et al. teaches compounds that read on the compounds of Formula (I) of the instant claim1, namely those with at least one (substituted phenyl)-propenal moiety (see Col. 11, Lines 64-66; see formula (I) in Col, 12, lines 34-54) “possess activities, such as reducing the proliferation of cells that are believed to have or suspected of having a cancerous profile” (see Col. 12, Lines 1-3) and “were shown to reduce cancer cell growth or proliferation of cancer cells” (see Col. 12, Lines 34-61). Additionally, Shih et al. teaches compounds of Formula (I), specifically Monomer-1 and Monomer-5 (shown in Col. 3) were shown to be “capable of inhibiting cancer cell growth in vitro” using the CWR22Rv1 prostate cell line, as outlined in Example 2 and shown in Figure 5.
Thus, the teachings of Shih et al. above anticipate claims 1 and 8-10 as discussed above.
11. Regarding claims 2-7, the recitation of “… wherein the method is for…” in each of the claims does not indicate that the method is performing the limitation of the claim. Instead, the recitation indicates that the method is “for” the purpose or is intended to perform the limitation in each claim, and, therefore, do not recite any further structural limitation of the claims from which they depend they are also unpatentable in view of Shih et al.
However, for the sake of compact prosecution, Examiner notes that claims 2-7 are addressed by Shih et al. The teachings of Shih et al. discussed above in Section 10 read on claim 2 because the growth or proliferation of cancer cells was shown to be decreased. The teachings of Shih et al further read on claim 3 because decreasing cancer growth and proliferation will necessarily slow, inhibit, or stabilize the progression of cancer and claim 4 because by slowing cancer growth it will necessarily inhibit metastasis. Regarding claim 5, Shih et al. specifically teaches that the methods of the invention “prevent, treat, or ameliorate symptoms from cancer” (see Col. 19, lines 64 – Col. 20, lines 1-5). Regarding, claim 6, the method of treatment taught by Shih et al. will necessarily inhibit, block, or prevent the formation of aberrant cells associated with cancer. Regarding claim 7, because slowing cancer and inhibiting metastasis it will necessarily prevent recurrence of the cancer.
Thus, claims 2-7 are also be anticipated in view of Shih et al. as applied to claims 2-7.
Claim Rejections - 35 USC § 103
12. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
13. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shih et al. (Published August 7 2012, US Pat. No.:8,236,852 as cited in the IDS filed on October 13, 2023), as applied to claims 1-7 and 10 above, and in view of Schneider, M. A. et al. “Transmembrane serine protease 2 is a prognostic factor for lung adenocarcinoma.” International Journal of Oncology 60:39 (2022) (“Schneider et al.”) as cited in the IDS filed on October 13, 2023.
As discussed above (see §10-11), Shih et al. teaches the method of treating cancer (e.g., lung cancer) with the compounds of the instant claims 1, and the intended consequences of the method as required by instant claims 2-7.
Shih et al. differs from the instantly claimed invention in that is fails to teach the specific lung cancer (i.e., non-small cell lunger cancer, “NSCLC”) of instant claim 11 and the specific types of NSCLC (i.e., lung adenocarcinoma, “LUAD” and lung squamous cell carcinoma “LUSC”) of instant claim 12.
14. Schneider et al., describes that “TMPRSS2 is an oncogenic gene associated with several cancer entities” (see Abstract, line 4). Schneider et al., further teaches that TMPRSS2 expression is altered in NSCLC (e.g., LUAD and LUSC; see Results para. 1, Table 1, Fig. 1A). Schneider et al. further teaches that TMPRSS2 activates protease activated receptor (“PAR2”), which is “involved in epithelial-mesenchymal transition in lung ADC cells” and that “inhibition of TMPRSS2 by AAT (a TMPRSS2 inhibitor) may indirectly suppress the activation of PAR2 and subsequently prevent cancer progression” (see Discussion, para.5).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing the instant application, to combine the method of treating a lung cancer of Shih et al. with the teachings that TMPRSS2 is associated with LUAD and LUSC of Schneider et al.
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing of the instant application, to try and treat subtypes lung cancer, including specific manifestations of NSCLC (required by the instant claims 11-12) with a reasonable expectation of success as applied to the broader recitation of lung cancer in Shit et al. claim 17 (see MPEP 2143 §(I)(E)).
Thus, claims 11-12 would have been prima facie obvious over the teachings of Shih et al., the knowledge of one of ordinary skill in the art, and in further view of Schneider et al.
Conclusion
15. Claims 1-12 are rejected. No claims are allowed in this action.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN JEROME FOWLER whose telephone number is (571)272-0195. The examiner can normally be reached Monday - Friday 9-4PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALAN J FOWLER/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691