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 .
Priority
The instant application is a continuation application of US application 17934747 of US application 17929347, US application 17877515 of US application 17860600 of US application 17371755 of US application 17227885 of US application 16913788 of US application 16026707 of US Provisional application 62529758 filed 12/11/2015. The instant application will be examined with an effective filing date of 07/07/2017.
Status of the Claims/Application
Claims 1-20 are canceled. Claims 21-40 are new. Claims 21-40 are pending and are herein under examination on the merits.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/10/2023, 08/16/2023, 09/10/2024, 09/12/2024 and 03/09/2026 are acknowledged and are in compliance with the provisions of 37 CFR 1.97. They have been considered by the examiner.
Election/Restrictions
During a telephone conversation with Agent Yan, Duen-Hwa on 04/16/2026 and 04/17/2026 a provisional election was made without traverse to prosecute the invention of SEQ ID NO: 405, claim 1. Affirmation of this election must be made by applicant in replying to this Office action.
While applicant has elected SEQ ID NO: 405, the sequence is free of the art. However, upon further examination of the next sequences, the examiner is examining SEQ ID NO: 4 for which the rejections under 35 USC 103 are indicated below.
Claim Objections
Claims 21, 33 and 37 are objected to because of the following informalities: In claim 21 line 4, claim 33 ln 5 and claim 37 ln 5, the claims recites a range of “SEQ ID NO: … 348-477, 479-452, 454-476, 478-489…”. The range recitation is inconsistent as it goes from 348-477 to 479-452 (here reverse) to 454-476 repeating the SEQ ID NO: already recited in the range of 348-477. Appropriate correction is required.
For advancing the prosecution, the above objected recitation will be interpreted as to mean “SEQ ID NO: … 348-377, 379-452, 454-476, 478-489…”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 21-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO2009138236A1, and further in view of Gu et al. High expression of MAGE-A9 correlates with unfavorable survival in hepatocellular carcinoma. Sci Rep. 2014 Oct 15;4:6625 and US20090028888 A1, and as evidenced by NCBI BLAST Retrieved from <blast.ncbi.nlm.nih.gov/Blast.cgi#alnHdr_NP_001074259> on 04/23/2026, herein further referred to as Stevanovic, Gu, Bergeron and NCBI respectively.
Regarding claim 21, Stevanovic teaches of tumor associated peptides that serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses (Stevanovic Abstract) that can be in the form of a pharmaceutically acceptable salt (Stevanovic pg. 24 para. 5)
Gu teaches that melanoma-associated antigens MAGE-A9 the genes that expresses SEQ ID NO: 4 (SYEKVINYL) as evidenced by NCBI (see image below), plays an important role in the development of human cancer and that MAGE-A9 is significantly higher in cancerous cells than in non-cancerous cells and tissues (Gu Abstract). Gu further suggest that targeting MAGE-A9 can be recognized as a prognostic factor and may provide a promising therapeutic strategy for hepatocellular carcinoma (Gu pg. 6 col. 1 para. 3).
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Bergeron teaches a method for detecting MAGE-A9 in a biological sample and to diagnose, prevent and treatment of MAGE-A9 associated aberrant cell growth through targeting MAGE-A9 polypeptide and or polynucleotide (Bergeron Abstract). Bergeron further teaches SEQ ID NO: 142 as one of the motif-bearing peptide sequences which can be used in an HLA vaccine composition (Bergeron pg. 21 para. 0206-0207 and pg. 23 Tab. 6 (HLA-A24)).
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Therefore, it would have been obvious before the effective filing date for a skilled artisan to modify the teachings of Stevanovic in view of Gu and Bergeron with a reasonable high degree of predictable success to use SEQ ID NO: 142 of Bergeron which is the same as SEQ ID NO: 4 of the instant claim, in the formulation of Stevanovic to wherein the peptide will be in the form of a pharmaceutically acceptable salt that can be used in a vaccine against cancerous cells that overly express MAGE-9 as indicated by Gu. Therefore a skilled artisan would have been able to modify the teachings of Stevanovic in view of Gu and Bergeron to make peptide with SEQ ID NO: 142 of Bergeron in the form of a pharmaceutically acceptable salt as indicated by Stevanovic.
Regarding claim 22, an incorporating the analysis of claim 1 above, Stevanovic further teaches that the said peptides has the ability to bind to MHC class I molecule and has the capability of stimulating CD8 T cell (Stevanovic pg. 18 para 5 – pg. 20 para. 1 and pg. 75 claim 2).
Regarding claims 23-27, an incorporating the analysis of claim 1 above, Stevanovic further teaches that the composition can further comprises an adjuvant (Stevanovic pg. 24 para. 4) and a pharmaceutically acceptable salt, wherein the salt can be an acetic or a chloride salt (Stevanovic pg. 25 para. 2).
Regarding claim 28-30, an incorporating the analysis of claim 25 above, Stevanovic further teaches that the adjuvant can be IL-2 and IL-15 added to the composition so as to influence cell migration to lymphoid tissues and to accelerate maturation of cells into efficient antigen-presenting cells for T-lymphocytes (Stevanovic pg. 57 para.3 – pg. 58 para. 1).
Regarding claim 31, an incorporating the analysis of claim 1 above, Stevanovic further teaches that peptide maybe produced by Fmoc-polyamide mode of solid-phase peptide synthesis (Stevanovic pg. 47 para. 3).
Regarding claim 32, an incorporating the analysis of claim 1 above, Stevanovic further teaches that the composition may further comprise buffers and diluents (Stevanovic pg. 59 para. 5).
Regarding claim 33, Stevanovic further teaches that a population of T cells can be administered to a patient (Stevanovic pg. 55 para. 5) in a patient with cancer such as leukemia (Stevanovic pg. 9 para. 1).
Gu teaches that melanoma-associated antigens MAGE-A9 the genes that expresses SEQ ID NO: 4 (SYEKVINYL) as evidenced by NCBI (see image below), plays an important role in the development of human cancer and that MAGE-A9 is significantly higher in cancerous cells than in non-cancerous cells and tissues (Gu Abstract). Gu further suggest that targeting MAGE-A9 can be recognized as a prognostic factor and may provide a promising therapeutic strategy for hepatocellular carcinoma (Gu pg. 6 col. 1 para. 3).
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Bergeron teaches a method for detecting MAGE-A9 in a biological sample and to diagnose, prevent and treatment of MAGE-A9 associated aberrant cell growth through targeting MAGE-A9 polypeptide and or polynucleotide (Bergeron Abstract). Bergeron further teaches SEQ ID NO: 142 as one of the motif-bearing peptide sequences which can be used in an HLA vaccine composition (Bergeron pg. 21 para. 0206-0207 and pg. 23 Tab. 6 (HLA-A24)).
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Therefore, it would have been obvious before the effective filing date for a skilled artisan to modify the teachings of Stevanovic in view of Gu and Bergeron with a reasonable high degree of predictable success to administer T cells such as that of Stevanovic that selectively targets MAGE-A9 as indicated by Gu and Bergeron in patients having hepatocellular carcinoma where MAGE-A9 is significantly expressed. Therefore, a skilled artisan would have been able to modify the method of Stevanovic in view of Gu and Bergeron to administer a population of T cells that selectively recognizes SEQ ID NO: 140 of Bergeron (SEQ ID NO: 4 of instant claim) for the treatment of hepatocellular carcinoma.
Regarding claim 34, an incorporating the analysis of claim 33 above, Stevanovic further teaches that the said peptides has the ability to bind to MHC class I molecule and has the capability of stimulating CD8 T cell (Stevanovic pg. 18 para 5 – pg. 20 para. 1 and pg. 75 claim 2).
Regarding claims 35-36, an incorporating the analysis of claim 33 above, Stevanovic further teaches that the adjuvant can be IL-2 and IL-15 added to the composition so as to influence cell migration to lymphoid tissues and to accelerate maturation of cells into efficient antigen-presenting cells for T-lymphocytes (Stevanovic pg. 57 para.3 – pg. 58 para. 1).
Regarding claim 37, Stevanovic further teaches that a population of T cells can be administered to a patient for eliciting (Stevanovic Abstract and pg. 55 para. 5) in a patient with cancer such as leukemia (Stevanovic pg. 9 para. 1).
Gu teaches that melanoma-associated antigens MAGE-A9 the genes that expresses SEQ ID NO: 4 (SYEKVINYL) as evidenced by NCBI (see image below), plays an important role in the development of human cancer and that MAGE-A9 is significantly higher in cancerous cells than in non-cancerous cells and tissues (Gu Abstract). Gu further suggest that targeting MAGE-A9 can be recognized as a prognostic factor and may provide a promising therapeutic strategy for hepatocellular carcinoma (Gu pg. 6 col. 1 para. 3).
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Bergeron teaches a method for detecting MAGE-A9 in a biological sample and to diagnose, prevent and treatment of MAGE-A9 associated aberrant cell growth through targeting MAGE-A9 polypeptide and or polynucleotide (Bergeron Abstract). Bergeron further teaches SEQ ID NO: 142 as one of the motif-bearing peptide sequences which can be used in an HLA vaccine composition (Bergeron pg. 21 para. 0206-0207 and pg. 23 Tab. 6 (HLA-A24)).
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Therefore, it would have been obvious before the effective filing date for a skilled artisan to modify the teachings of Stevanovic in view of Gu and Bergeron with a reasonable high degree of predictable success to administer T cells such as that of Stevanovic that selectively targets MAGE-A9 as indicated by Gu and Bergeron in patients having hepatocellular carcinoma where MAGE-A9 is significantly expressed. Therefore, a skilled artisan would have been able to modify the method of Stevanovic in view of Gu and Bergeron to administer a population of T cells that selectively recognizes SEQ ID NO: 140 of Bergeron (SEQ ID NO: 4 of instant claim) for eliciting and immune response in a patient having hepatocellular carcinoma.
Regarding claim 38, an incorporating the analysis of claim 37 above, Stevanovic further teaches that the said peptides has the ability to bind to MHC class I molecule and has the capability of stimulating CD8 T cell (Stevanovic pg. 18 para 5 – pg. 20 para. 1 and pg. 75 claim 2).
Regarding claims 39-40, an incorporating the analysis of claim 37 above, Stevanovic further teaches that the adjuvant can be IL-2 and IL-15 added to the composition so as to influence cell migration to lymphoid tissues and to accelerate maturation of cells into efficient antigen-presenting cells for T-lymphocytes (Stevanovic pg. 57 para.3 – pg. 58 para. 1).
Conclusion
No Claims Allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL LED YOUTCHOM PENDIE whose telephone number is (571)272-6313. The examiner can normally be reached Mon - Fri: 8AM - 5PM CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanna Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL LED YOUTCHOM PENDIE/ Examiner, Art Unit 1647 /JOANNE HAMA/, Supervisory Patent Examiner, Art Unit 1647
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