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 .
Status of the Claims
Claims 1-16 are pending in the application.
Claims 2 and 9-16 are withdrawn.
Claims 1 and 3-8 are the subject of this office action.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825. This application contains a “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3)). A copy of the "Sequence Listing" in computer readable form (CRF) has been submitted; however, the content of the CRF does not comply with one or more of the requirements of 37 CFR 1.822 through 1.824, as indicated in the "Error Report" that indicates the "Sequence Listing" could not be accepted. Refer to attachment or document "Computer Readable Form (CRF) for Sequence Listing – Defective" dated 22 March 2025.
Required response – Applicant must provide:
A replacement "Sequence Listing" part of the disclosure, as described above in item 1); together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the replacement "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter and
An amendment to the specification to remove the “Sequence Listing previously submitted as a PDF file (37 CFR 1.821(c)(2)) or as physical sheets of paper (37 CFR 1.821(c)(3))
If the replacement "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, Applicant must also provide:
A CRF in accordance with 1.821(e)(1) or 1.821(e)(2) as required by 37 CFR 1.825(b)(6)(ii); and
Statement according to item 2) a) or b) above.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – The "Sequence Listing" has not been entered into the application because the amendment does not direct entry of either the "Sequence Listing" (as required by 37 CFR 1.825(a)(2) or 1.825(b)(2)) or contain the required Incorporation by Reference paragraph into the application.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1 and 3-8 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.
Claim 1 is rejected as indefinite because of the recitation “achieving detection of the tumor-specific T cells based on the detecting the specific molecules” wherein the phrase “based on” does not create a clear or defined relationship between the recited components, such that the metes and bounds of the limitation are unclear. Clarification is required.
Dependent claims 3-8 are rejected as indefinite because they depend from an indefinite claim and fail to remedy its deficiencies.
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.
(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.
Claims 1 and 3-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanlon et al (Enhanced stimulation of anti-ovarian cancer CD8(+) T cells by dendritic cells loaded with nanoparticle encapsulated tumor antigen. Am J Reprod Immunol. 2011 Jun;65(6):597-609. Epub 2011 Jan 18.; previously cited).
Regarding claim 1, Hanlon teaches a method comprising:
Incubating activators with peripheral immune cells, wherein the activators are selected from the group comprising tumor cells, tumor tissue whole cells, tumor cell lysate components, and tumor tissue whole cell lysate components; and detecting specific molecules of the tumor specific T cells, thus achieving detection of the tumor-specific T cells based on detecting the specific molecules; wherein the activators are selected from the group consisting of tumor cells, tumor tissue whole cells, tumor cell lysate components, and tumor tissue whole cell lysate components (Abstract: human DCs were generated from blood monocytes by conventional in vitro differentiation and loaded with either soluble tumor lysate or NP/lysate conjugates (NPL). These antigen loaded DCs were then used to stimulate autologous CD8+ T cells. Cytokine production and activation markers were evaluated in the CD8+ T cells; Pg. 3, Lysate Preparation: preparation of tumor cell lysate; Pg. 4, DC/T cell co-culture: autologous CD8+ T cells added to the wells containing DC at a 1:2 DC/T cell ratio and co-culture proceeded for 3 days; Pg. 5, Flow Cytometry of CD8+ T cells following DC stimulation: immediately following DC co-culture, T cell populations were analyzed for surface expression of known co-stimulatory molecules associated with stimulatory or inhibitory signaling. mAb recognizing surface molecules ICOS, CTLA-4 and PD-1 were co-stained with both CD8 and CD4 specific antibodies; Pg. 4, Luminex analysis of cytokine production);
Regarding claim 3, Hanlon further teaches the method wherein the lysate components are water-soluble and/or non-water-soluble lysate components and the tumor tissue whole cell lysate components are water-soluble and/or non-water-soluble lysate components (Pg. 3, Lysate preparation).
Regarding claim 4, Hanlon further teaches the method wherein the lysate components are in a free state or are loaded on nano/micron particles, and the tumor tissue whole cell lysate components are in a free state or are loaded on the nano/micron particles (Pg. 4, Nanoparticle preparation; Abstract: PLGA NP encapsulation of tumor-derived lysate protein).
Regarding claims 5-6, Hanlon further teaches the method wherein the lysate components are loaded inside and/or on the surfaces of nano/micron particles, and the tumor tissue whole cell lysate components are loaded inside and/or on the surfaces of the nano/micron particles, and wherein the nano/micron particles are made of organic materials, inorganic materials, or biological materials, and the nano/micron particles are nano particles or micron particles (Pg. 4, Nanoparticle preparation; Abstract: PLGA NP encapsulation of tumor-derived lysate protein antigens).
Regarding claim 7, Hanlon further teaches the method wherein the incubation step is carried out under conditions that cells can survive (Pg. 4, DC/T cell co-culture: DCs and T cells co-cultured for three days before harvesting).
Regarding claim 8, Hanlon further teaches the method wherein the specific molecules are proteins, peptides, nucleic acids, sugars, or lipids (Pg. 3, Lysate preparation: lysate obtained from epithelial ovarian cancer line TARA R182; Pg. 4, Luminex analysis of cytokine production; Pg. 5, Flow cytometry of CD8+ T cells following DC stimulation).
Response to Amendment
Applicant’s arguments filed 21 March 2026 have been fully considered.
Applicant’s arguments regarding the previous 112(b) rejections are persuasive in view of the amendments to the claims, and the previous 112(b) rejections are withdrawn. New grounds of 112(b) rejection which address the amended claims are presented above.
Regarding the 102 rejection, Applicant argues that Hanlon does not meet the instant claim because it does not teach the steps of detecting specific molecules and detecting tumor specific T cells. This argument is not persuasive. The instant independent claim requires “detecting specific molecules of the tumor-specific T cells, thus achieving detecting of the tumor-specific T cells based on the detecting the specific molecules”. As cited in the rejection, Hanlon teaches that flow cytometry is used to detect specific molecules of tumor specific T cells and thus to achieve detection of the tumor specific T cells themselves based on detection of the specific molecules. Thus, Hanlon is understood to read on this limitation of the instant claim.
Applicant further argues that the objective of Hanlon differs from that of the present invention, and that based on Hanlon, a person skilled in the art would have no motivation to contemplate detecting T cell content. This argument is not persuasive. The instant independent claim requires only “detecting specific molecules of the tumor-specific T cells, thus achieving detecting of the tumor-specific T cells based on the detecting the specific molecules” which Hanlon reads on through flow cytometry detection, as discussed above. The intended use of the claimed method does not distinguish it from the prior art, as long as the prior art teaches all actively recited steps and limitations of the claimed method. Additionally, Hanlon does teach a method comprising detection of tumor-specific T cells, which is what is explicitly stated in the preamble of the claim.
Applicant argues that Halon teaches lysate antigens as activators, while the present application shows that free whole cells can be used. This argument is not persuasive because the instant claims are not specifically limited to free whole cell activators, and the claims explicitly recite that the activators may be lysate components. Hanlon is not required to teach every possible embodiment of the instant claim in order to read on the instant claim.
Regarding claim 3 applicant argues that Hanlon does not teach “non-water-soluble lysate components”. This argument is not persuasive because the claim recites that lysate components “are water-soluble and/or non-water-soluble lysate components”, wherein non-water-soluble lysate components are therefore an alternative and are not required in addition to the teaching of water-soluble lysate components.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIS LUSI whose telephone number is (571)270-0694. The examiner can normally be reached M-Th 8am-6pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 9, 2026
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