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 .
Claims 1-6 are under consideration.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a Circos diagram that comprises information about genomic variation that cannot be discern as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 1 recites, “wherein the cell stain”. “Stain” appears to be a misspelling and should recite, “strain”. Appropriate correction is required.
Claims 4 and 5 are objected to because of the following informalities: The recitation, “claims 1” is grammatically incorrect. Appropriate correction is required.
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.
Claims 4-6 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.
Claims 4-5 both recite, “according to any one of claims 1”. “According to any one of claims” would suggest that claims 4 and 5 are intended to refer back to multiple different claims in the alternative. However, “claims 1” suggest that the claim is only intended to refer back to claim 1. As such, the metes and bound of the claims are not apparent because it is not clear if claims 4 and 5 are intended to dependent upon multiple possible alternative claims or solely intended to refer back to claim 1. For purposes of identifying relevant art, the claims will be interpreted as being dependent upon claim 1 only.
Claims 5-6 provide for the use of “the human primary myelofibrosis cell strain”, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
For purposes of identifying relevant prior art, claims 5-6 will be interpreted as a product comprising the human primary myelofibrosis cell strain of claim 1” and the recited “use of” or and recited uses will be interpreted as intended uses for the claimed cell strain.
Claim Rejections - 35 USC § 112-Biological Deposit
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Independent claim 1, thus its dependent claims 2-6, recites “A human primary myelofibrosis cell strain, wherein the cell stain is named as human myelofibrosis cell ZYXY-M2, which is deposited in China Center for Type Culture Collection on January 20th, 2021, with a preservation number of CCTCC NO:C202145.”
As such, the invention of claims 1-6 employs specific biological matter. Since the cell strain is essential to the claimed invention, they must be obtained by a repeatable method set forth in the specification or otherwise readily available to the public. If the cell strain is not so obtainable or available, the requirements of 35 U.S.C.§ 112 may be satisfied by a deposit of the cell strain. The specification does not disclose a repeatable process to obtain the cell strain and it is not apparent if the cell strain is readily available to the public. It is noted that Applicant has deposited the cell strain as recited in claim 1 but there is no indication in the specification of public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over their signature and registration number, stating that the specific cell strain has been deposited under the Budapest Treaty and that the hybridoma will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over her or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained I a public depository for a period of 30 years or 5 years after the last request or the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R.§ 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P §2411.05, as well as to 37 C.F.R.§ 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information; however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information. Finally, Applicant is advised that the address for the ATCC has been changed, and that the new address should appear in the specification. The new address is:
American Type Culture Collection
10801 University Boulevard
Manassas, VA 20110-2209
Applicant is cautioned the deposit requirement remains even if the deposit number in the claims is changed to match that disclosed. The reasoning is the same. Claims 1-6 require a specific cell strain, which can only be obtained from applicant.
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.
(1) Claims 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recites A/The “use of the human primary myelofibrosis cell strain”.
Claims 5-6 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
(2) Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), a claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter).
As discussed above, claim 5 recites “Use of” and claim 6 recites, “The use according to claim 5”. “Use” claims are not considered to be one of the acceptable statutory categories of invention. As such, claim 5 and 6 do not meet the requirements for step 1 of the guidelines and therefore are patent ineligible subject matter.
Claim 1-4 recite, a or the “human primary myelofibrosis cell strain”. A cell strain is a product and thus claims 1-4 are drawn to a composition of matter comprising a cell strain. Thus claims 1-4 meet the requirements for step 1 of the analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), Claims 1-4 are directed to a cell strain, named ZYXY-M2, and its progeny. The specification teaches that the cell is obtained from a fresh white blood cell specimen isolated from a human male with primary myelofibrosis (see p. 6, [0029]). As such, the cell strain was found within a human PMF patient in nature. Thus the claimed cell strain is a product of nature which makes the claimed cell strain a judicial exception. As such, the first prong of the inquiry demonstrates that claims 1-4 do recite a judicial exception.
Regarding the second prong (2), claim 1-4 do not recite any additional applications of the recited cell strain and only provide structural/functional properties of the cell strain. Since the additional element solely provide structural/functional limitations, the claims do not recite any additional elements or a combination thereof that integrates the judicial exception identify in prong 1 as being integrated into a practical application. Further since the claims are not meaningfully limited to any particular practical application, the generic nature of the claim appears to monopolize the claimed cell population. Thus, claims 1-4 meet the requirement of step 2A as being directed to a judicial exception.
Third, if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception.
Regarding claim 1, the additional elements recited describe the cell strain as “a human primary myelofibrosis cell”. “Human” indicates that species origin of the cell. “Primary” indicates that the cell is a primary cell. Fiveable (printout from https://fiveable.me/key-terms/cell-biology/primary-cell-culture printed 11/14/2025, pages 1/3-3/3) provides a definition for a primary cell stating, “ Primary cell cultures are derived directly from tissues and maintain many original characteristics of those tissues, providing a more accurate representation of physiological conditions. In contrast, established cell lines are adapted for long-term growth and may acquire mutations or altered behaviors that diverge from the original tissue. This distinction is important when selecting which type of culture to use for specific experiments, particularly those investigating drug responses or cellular behavior.” See pages 1/3-2/3. As such, primary indicates that the human myelofibrosis cell is one that is taken directly from tissue of a human and is isolated but unaltered. “Strain” as recited indicates that the cells are particular to one specific human from which the cell was isolated. The remainder of the recited limitations are descriptive of the name of the cell designated by Applicant and the deposit information for the cell and do not further structurally or functionally limit the claimed cell strain. Thus, the additional elements recited by the claim add the structural element of the claimed cell strain being a human myelofibrosis cell that has been isolated from a human and placed in culture and is essentially unaltered other than being isolated from the human subject.
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 the claim 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 myelofibrosis 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. As such, claim 1 does not meet the requirements of step 2B of the 2019PEG because 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.
Regarding claim 2, this claim further specifies the morphology of the cell is one of a primitive red blood cell, has expression profiles of CD34-, CD11b-, and CD71+, and has the functional properties of being capable of growth in suspension or weak wall adherence. 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 element 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. As such, claim 2 does not meet the requirements of step 2B of the 2019PEG because 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.
Regarding claim 3, this claim further specifies genomic SNPs and InDel mutations closely associate with hematopoietic malignancies. The specification teaches that these SNP and Indel are present in endogenously in the cell strain and thus are not introduced by exogenous cell modification (see examples and Table 1). As such, these are markers inherent to the cell found in nature in the humans subject as well. Therefore, the limitations of claim 3 do not recite any additional elements that distinguish the claimed cell from its natural counterpart present in the human subject. As such, claim 3 does not meet the requirements of step 2B of the 2019PEG because 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.
Regarding claim 4, this claim specifies progeny cells. These are cell produced via cell proliferation and encompasses cells that are structurally and functionally identical to the parent cell of base claim 1. As such, claim 4 does not recite any additional elements that markedly distinguish the claimed progeny cell from its natural counterpart. As such, claim 4 does not meet the requirements of step 2B of the 2019PEG because 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.
In conclusion, claim 1-6 do not meet all the requirements of the 2019PEG and therefore are deemed patent ineligible.
Priority
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
As such, the effective filing date for the claims of the instant application is 3/10/2022.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al (Blood, (NOV 23 2021) Vol. 138, No. Suppl. 1, pp. 4594.).
Regarding claim 1, Zhou et al discloses PMF cells derived from human male patient 61 years old with PMF for 2 year. The PMF cell were designated ZYXY-M2 and is collected by China center for type culture cells. See abstract. As such, Zhou et al expressly disclose the cell of claim 1.
Regarding claim 2, Zhou et al. discloses that Giemsa-Wrights staining showed primitive erythrocytes and are CD71 positive. Zhou et al. is silent as to expression of CD41 and CD11b expression or lack thereof. However, the cell is described as being produced by the same method as recited in example 1, form the same patient, designated the same name and in the same collection as the PMF cell of application. As such, the cell of Zhou et al. inherently has the same CD expression profiles, absent evidence to the contrary.
Regarding claim 3, Zhou et al. discloses whole-genome-exon sequencing identified mutations of ASXL1, TP53, IKZF1, IDH1, FLT3, and TET1 (Figure B). Figure B is identical to Fig 4 in the instant application. As such, Zhou et al. expressly or inherently discloses the same mutations or lack thereof as claimed.
Regarding claim 4, the progeny cells as claimed identical to the cells of claim 1. As such, Zhou et al. discloses the progeny cells as discussed above.
Regarding claims 5-6, these claims are being interpreted as a product and has the identical PMF cell structure as claim 1. As such Zhou et al. discloses the cell as discussed above. The remaining limitations are being interpreted as multiple intended uses for the claimed cell and does not further structurally or functional impart additional limitation to the claimed cell. As such, Zhou et al discloses the limitations of claims 5-6. Further it is noted, Zhou et al discloses we established a cell line, ZYXY-M2, derived from a PMF patient and it would prove to be a valuable model for the study of PMF. ZYXY-M2 could help to explore the pathogenesis and development of PMF, novel drug screening, and may also help to set up xenograft PMF mouse models. See abstract. These discloses expressly disclose some of the recited intended uses claimed in claims 5 and 6.
In conclusion, the prior art of Zhou et al anticipates the claims because it expressly or inherently discloses all of the limitations of the claimed cell strain.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632