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
The amendment filed 12/18/2025 is acknowledged and has been entered.
Claims 74 and 76 have been amended. Claims 59-73 and 75 have been cancelled.
3. Claims 74 and 76-78 have been examined.
Grounds of Objection and Rejection Withdrawn
4. Unless specifically reiterated below, Applicant’s amendment and/or arguments have obviated or rendered moot the grounds of objection and rejection set forth in the previous Office action mailed 09/18/2025.
Grounds of Rejection Maintained
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
5. Claims 74 and 76-78 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) a human ALDH1A1 peptide (SEQ ID NO: 1) or ALDH1A3 peptide (SEQ ID NO: 2). This judicial exception is not integrated into a practical application because claimed peptide is a fragment of naturally occurring product known as ALDH1A1 or ALDH1A3 (see [0012-0013] and Table 1 of the published application). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims are drown to fragments of ALDH1A1 or ALDH1A3; although fragmenting ALDH1A1 or ALDH1A3 changes the fragments of ALDH1A1 or ALDH1A3 from its natural state, the resultant difference (e.g., “broken” bonds) is not significant enough to render the fragments of ALDH1A1 or ALDH1A3 markedly different, because the nucleic acid/amino acid sequence and structure of the ALDH1A1 or ALDH1A3 has not been altered.
The Applicant’s arguments:
Claim 74 has been amended to recite: i) only the combination of peptides 10-12 amino acid in light that comprise SEQ ID NO:1 and SEQ ID NO:6, and ii) that the physiologically tolerable buffer comprises PBS (phosphate- buffered saline).
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
As set forth above, although fragmenting ALDH1A1 or ALDH1A3 changes the fragments of ALDH1A1 or ALDH1A3 from its natural state, the resultant difference (e.g., “broken” bonds) is not significant enough to render the fragments of ALDH1A1 or ALDH1A3 markedly different, because the nucleic acid/amino acid sequence and structure of the ALDH1A1 or ALDH1A3 has not been altered.
Additionally, although claim 74 has been amended as “buffer comprises PBS”, however, adding PBS buffer does not change the structure and function of the peptides.
Claim Rejections - 35 USC § 103
6. 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 of this title, 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.
7. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
8. Claims 74 and 76-78 remain rejected under 35 U.S.C. 103 as being unpatentable over Visus et al. (Cancer Res., 2007, 67(21): 10538–10545, IDS) in view of Zhou et al. (US 20180078624, filed on 03/11/2016, IDS).
Claims 74 and 76-78 are herein drawn to a composition comprising: a) a human ALDH1A1 immunogenic peptide that is 10 to 12 amino acids in length and comprises SEQ ID NO:1, and b) a human ALDH1A3 immunogenic peptide that is 10 to 12 amino acids in length and comprises SEQ ID NO:6, and c) a physiologically tolerable buffer which comprises PBS (phosphate-buffered saline); and wherein the composition is free of: i) full-length ALDH1A1 and ALDH1A3 proteins, and ii) tumor cells and cell-lysates.
Visus et al. teach dendritic cells pulsed with ALDH1A188-96 (LLYKLADLI) peptide; see entire document, e.g. page 10539-right col.-second paragraph, page 10541-left col.-paragraph 5. ALDH1A188-96 (LLYKLADLI) peptide of Visus et al. is 9 amino acids in length. ALDH1A188-96 (LLYKLADLI) peptide of Visus et al. is 100% identical with the instant claimed SEQ ID NO: 1. Visus et al. teach ALDH1A3 (LLHQLADLV) which is the same as the instant claimed SEQ ID NO: 6; see page 10541-left col.-paragraph 5.
Visus et al. do not teach dendritic cells pulsed with two peptides.
However, this deficiency is remedied by Zhou et al.
Zhou et al. teach a method of preparing the population of dendritic cells pulsed with the plurality of tumor antigen peptides; see entire document, e.g. [0015], [0179], [0523], claim 16. Zhou et al. teach that the concentration of the tumor antigen peptides is about 0.1-200 μg/mL; see [0167].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to generate immature dendritic cells pulsed with ALDH1A188-96 (LLYKLADLI) peptide and ALDH1A3 (LLHQLADLV) peptide. One would have been motivated to do so because Visus et al. teach dendritic cells pulsed with ALDH1A188-96 (LLYKLADLI) peptide, Visus et al. teach ALDH1A3 (LLHQLADLV); Zhou et al. teach a method of preparing the population of dendritic cells pulsed with the plurality of tumor antigen peptides. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to generate immature dendritic cells pulsed with ALDH1A188-96 (LLYKLADLI) peptide and ALDH1A3 (LLHQLADLV) peptide, because a method of preparing the population of dendritic cells pulsed with the plurality of tumor antigen peptides as taught by Zhou et al.
The Applicant’s arguments:
The combination of these two peptides in PBS has unexpectedly superior (see the results of Example 2 and figures 4 - 6 of the present application).
Response to Arguments
Applicant’s arguments have been carefully considered but not found persuasive for the following reasons:
Example 2 shows that ALDH 1A1 plus 1A3 peptides-DC vaccines demonstrated additive protective effect on suppressing D5 tumor growth. Thus, combination of ALDH 1A1 plus 1A3 peptides-DC vaccines demonstrated additive protective effect on suppressing D5 tumor growth is obvious, because it is well-known in the art that synergism is an unexpected result and cannot be predicted, and additive effect can be predicted.
Conclusion
9. No claim is allowed.
10. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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