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
Preliminary Amendment
1. Applicant's preliminary amendment filed November 21, 2022 is acknowledged and has been entered. Claims 3-7, 9, 10, and 12-17 have been amended. Claim 11 has been cancelled. Claim 18 has been added. Accordingly, claims 1-10 and 12-18 are pending and are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a). Based on the filing receipt, the effective filing date of this National Stage application, which is a 371 of PCT/NL2021/050367 filed 06/09/2021, is June 10, 2020 which is the filing date of Foreign Application EUROPEAN PATENT OFFICE (EPO) 20179302.3 filed 06/10/2020 from which the benefit of foreign priority is claimed.
Information Disclosure Statement
4. The listing of references in pages 36 and 37 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Trademark Usage
5. The use of the terms “BV450”, “QDOT525” and all others, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
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.
6. Claim 18 is 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 18 is vague and indefinite in reciting “A combination” because the term “combination” appears to define a configuration of factors rather than chemical components of a composition or molecular components a product. Perhaps, Applicant intends “An antibody cocktail combination” or “An antibody cocktail set.” See paragraphs [0008-0013] of Applicant’s disclosure.
Allowable Subject Matter
7. Claims 1-10 and 12-17 are allowable. Claims 1-10 and 12-18 are free of the prior art of record. Claim 18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
8. The prior art of record fails to teach or fairly suggest a kit for flow cytometric detection of specifically pediatric tumor cells which comprises a first reagent composition comprising fluorochrome-conjugated antibodies against cell surface markers: smCD3, CD4, CD8, CD19, CD45, CD56, CD99, CD271, GD2, and EpCAM in a first container; and a second reagent composition comprising cytoplasmic marker cyCD3, and nuclear marker nuMyogenin and/or nuclear marker nuMyoD1 in a second container; wherein
the antibodies against CD99/CD8 are conjugated to the same fluorochrome to represent a first marker pair,
the antibodies against EpCAM/CD4 are conjugated to the same fluorochrome to represent a second marker pair,
the antibody against CD271 is conjugated to the same fluorochrome as the antibody against either smCD3 or cyCD3 to represent a third marker pair: CD271/smCD3 or CD271/cyCD3;
wherein the antibodies are conjugated to eight or more fluorochromes; wherein between the first marker pair, the second marker pair, and the third marker pair, the fluorochromes are different and distinguishably distinct.
With the third marker pair CD271/cyCD3, antibodies against smCD3/CD19 are conjugated to the same fluorochrome to represent a fourth marker pair, wherein between different marker pairs, the fluorochromes are different and distinguishably distinct. The antibodies against nuMyogenin/nuMyoD1 are conjugated to the same fluorophore to form a fifth marker pair, wherein between different marker pairs, the fluorochromes are different and distinguishably distinct.
Claim Interpretation
9. Closest prior art:
Ferreira Facio et al. (Contribution of Multiparameter Flow Cytometry Immunophenotyping to the Diagnostic Screening and Classification of Pediatric Cancer. PLOS ONE 8: (3): e55534-e55535 (March 2013)- IDS) teaches kits for flow cytometric detection of cancer cells comprising fluorochrome-conjugated antibodies directed against CD45, CD56, GD2, CD99, CD8, EpCAM (CD326), CD4, smCD3, CD19, and CD271 in distinct combination sets for differential screening between tumoral versus reactive cells and hematological versus non-hematological cells. Ferreira Facio et al. also teach fluorochrome-conjugated antibodies directed against cyCD3, nuMyogenin, and nuMYOD1 in different combination sets (Abstract; pp 2-5). However, Ferreira Facio et al. neither teach nor suggest a kit configured in a manner as recited in Applicant’s claimed invention.
10. No claims are allowed.
Remarks
11. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Tembhare et al. (Utility of flow cytometric detection of circulating tumor cells (CTC) in the prediction of bm metastasis in children with neuroblastoma. Pedriatric Blood and Cancer 65, Supp. Supplement pp. S281. Abstract Number: PO-415 (November 2018))- Abstract teach that detecting CTCs in blood of children diagnosed with neuroblastoma provides a potentially prognostic impact using flow cytometric immunophenotyping of the CTCs having cell surface antigen markers: CD2, CD3, CD19, CD45, CD56, CD99, and CD271 (see entire Abstract)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GAILENE GABEL/Primary Examiner, Art Unit 1678
December 16, 2025