DETAILED ACTION
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 .
Application Status
Claims 1-5 were pending.
In response to the Non-Final Office Action, mailed 23 June 2025, Applicant filed an Amendment/Request for Reconsideration on 23 September 2025 whereby claims 1 and 4-5 were amended.
Therefore, claims 1-5 remain pending and currently under examination.
Priority
Examiner acknowledges receipt of the foreign priority application CN202110240151.4 submitted by Applicant on 23 September 2025.
This application is a national stage 371 application of PCT/CN2021/126508 filed 26 October 2021. This application claims foreign priority of CN202110240151.4 filed 04 March 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386 (c) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. However, the foreign priority document received on 23 September 2025 is not in English, and therefore, the examiner cannot ascertain whether said document discloses the invention for purposes of priority. Consequently, the effective filing date for applying prior art is 26 October 2021 (the date PCT/CN2021/126508 was filed).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, the filing date of the PCT/CN2021/126508 application, filed on 26 October 2021, will be used for the purpose of applying prior art.
Withdrawn Claim Rejections
Claims 1-5 were previously rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. Applicant’s submission of a receipt for the Notice of Acceptance of Cultural Deposit for Patent Procedures for cell strain ZYXY-T1, received 23 September 2025, is acknowledged. In addition, the Attorney of Record, Michael P. Wiersch, has stated on record over his signature in Applicant Arguments/Remarks Made (received 23 September 2025) the following:
that the cell strain has been deposited under the Budapest Treaty and that the cell strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent. See 37 CFR 1.808.
that the deposit will be maintained in a public depository for a period of 30 years after the date of deposit or 5 years after the last request for a sample. See 37 CFR 1.806.
Therefore, the rejection of claims 1-5 under 35 U.S.C. 112(a) has been withdrawn.
Claims 4-5 were previously rejected under 35 U.S.C. 112(b) as being indefinite for claiming a process without setting forth any steps involved in the process. In light of Applicant’s amendments to claims 4 and 5, the rejection of claims 4-5 under 35 U.S.C. 112(b) has been withdrawn.
Claims 4-5 were previously rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. In light of Applicant’s amendments to claims 4 and 5, the rejection of claims 4-5 under 35 U.S.C. 101 has been withdrawn.
Maintained Claim Rejections
Claim rejections under 35 U.S.C. 101:
With respect to claims 1-3, Applicant has amended claim 1 to now recite method steps to prepare the claimed cell strain as a means to overcome the previous rejection of record. However, this amendment was insufficient to overcome the previous 35 U.S.C. 101 rejection of claims 1-3 for the following reasons:
claim 1 is still claiming the cell strain, which is a composition of matter comprising a cell strain, not a method of preparing.
the claimed cell strain is still derived from naturally occurring human leukemia cells. The claim does not recite structural characteristics demonstrating that the claimed cell strain is markedly different from the naturally occurring tumor cells found in the patient.
Under Association for Molecular Pathology v. Myriad Genetics, Inc.,569 U.S. 576 (2013), the court held that naturally occurring products, even when isolated, are not patent-eligible unless they possess markedly different characteristics from their natural counterparts. Claims 1-3 do not recite genetic modifications, engineered alterations, or structural features not present in nature. Accordingly, the claimed cell strain is a product of nature and is not patent eligible. Claims 2 and 3, which further define the naturally occurring characteristics or recite progeny cells thereof, do not add any markedly different characteristics than what is found in nature and therefore, these claims are also directed to a product of nature.
Therefore, the previous rejection of claims 1-3 under 35 U.S.C. 101 is maintained:
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.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon judicial exception without significantly more. The claims are drawn to a human T-lymphoblastic leukemia/lymphoma cell strain ZYXY-T1. This judicial exception is not integrated into a practical application because the claims read on natural phenomena. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Cell strain ZYXY-T1 was prepared by:
Obtaining a 6 mL blood sample from a mail patient with ETP-ALL diagnosed by First Affiliated Hospital of Medical College of Zhejiang University [0026];
Isolating the leukemia mononuclear cells from the blood sample [0026];
Culturing the cells [0026] for 2 months [0027]; and
Allowing the cells for proliferate, grow in suspension, and become an immortalized cell strain [0027].
The cell strain did not undergo any modifications (e.g., genetic engineering) prior to its entry into the CCTCC depository under preservation number CCTCC No.: C202143. The claims encompass naturally occurring phenomena and nothing more because cell strain ZYXY-T1 is derived from a human patient’s blood without further substantial intervention to produce the cell culture claimed. Therefore, the claimed invention is not markedly different from naturally occurring products. Because there is no difference in the characteristics (structural, functional, or
otherwise) between the claimed and naturally occurring proteins, the claimed invention does not
have markedly different characteristics from what exists in nature. See, e.g., MPEP 2106, Ass’n
for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591-94, 106 USPQ2d 1972,
1979-81 (2013); Roche Molecular System, Inc. v. CEPHEID, 905 F.3d 1363, 1371, 128 USPQ2d
1221, 1227 (Fed. Cir. 2018).
Under the holding of Myriad, an isolated but otherwise unchanged nucleic acid was not patent eligible subject matter because it was not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring nucleic acid. The isolated cell strain of claim 1 is analogous to the isolated nucleic acid in Myriad. The claimed cell strain can be interpreted as being an isolated cell that is otherwise an unchanged. Thus, similar to the isolated nucleic acid, the isolated cell is not patent eligible subject matter because it is not different enough from cell that exists in nature to avoid improperly tying up the future use and study of the naturally occurring cell. As such, while being an isolated cell strain is structurally different from its natural counterpart because in nature the human T-lymphoblastic leukemia/lymphoma cell is found in a human subject, the isolated nature of the cell strain would not be considered a marked distinction from that natural counterpart, as the guidelines require.
Regarding claim 2, this claim further specifies the morphology of the cell has the expression profile of CD34 but not CD1α, CD8, and CD5 and has the functional property of being capable of growth in suspension. A review of the working examples in the specification indicate that these are properties characteristic of /inherent to the primary cell strain and are not properties gained by some type of transformation or exogenous addition/subtraction/alteration of the cell strain. As such, these additional elements do not further impart any additional elements that would markedly distinguish the claimed cell strain from its natural counterpart present in the human subject of origin.
Regarding claim 3, this claim is drawn to a progeny cell of the cell strain in claim 1. These are cells produced via cell proliferation and encompass cells that are structurally and functionally identical to the parent cell of base claim 1. As such, claim 3 does not recite any additional elements that markedly distinguish the claimed progeny cell from its natural counterpart. The isolated nature of the claimed cell strain does not impart a significant distinction to the claimed cell strain to distinguish it from its natural counterpart present in the human subject from which it was isolated.
Accordingly, the claims are directed to a judicial exception. Because the claims do not
include any additional features that could add significantly more to the exception, the claims do
not qualify as eligible subject matter under 35 U.S.C §101.
New Claim Rejections Necessitated by Amendment
Applicant has amended claims 1 and 4-5 which necessitated the subsequent claim rejections.
Claim rejections under 35 U.S.C. 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 1-5 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 directed to a human T-lymphoblastic leukemia/lymphoma cell strain, but further recites the cell strain is prepared by a construction method comprising a series of laboratory steps. It is unclear whether: 1) the claim is limited to a cell strain having the structural and biological characteristics of the deposited strain; 2) the claim is limited only to a cell strain prepared by the specifically recited preparation method; or 3) the preparation steps are merely exemplary and not limiting.
Accordingly, the metes and bounds of claim 1 are unclear and one of ordinary skill could not determine whether a cell strain having identical characteristics to the ZYXY-T1 cell strain, but prepared by a different method, would fall within the scope of the claim.
Claim 4 recites: “A method of the human T-lymphoblastic leukemia/lymphoma cell strain…” This phrase is grammatically unclear and fails to specify the operative steps constituting the method. Additionally, the limitation: “wherein the method comprising …” is grammatically unclear and fails to indicate whether the aforementioned intended purposes (a-g) may be limited to just one intended purpose or require multiple selections. Additionally, the limitation: “…introducing the progeny cells into an animal, as a subject” is grammatically unclear as to what constitutes a subject.
Claims 3 and 5 are also included in this rejection for their dependency upon rejected claims.
Conclusion
Claims 1-5 are rejected. No claim is allowed.
Communication
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 Julia A Rossi whose telephone number is (571) 272-0138. The examiner can normally be reached M-F 8:30-5:00.
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, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A ROSSI/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645
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