DETAILED ACTION
Claims 1-19 are currently pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 in the reply filed on 11/14/2025 is acknowledged. Applicant’s species elections to contacting red blood cell precursors with a composition comprising a zinc chelator, specifically TPEN (claims 1 and 3-5), and wherein the contacting inhibits survival of the red blood cell precursors (claim 1) is acknowledged.
Claims 6-7 are withdrawn since they are not directed to the elected zinc chelator species. Claim 8 is withdrawn since claim 8 is directed to the non-elected species of contacting inhibits terminal differentiation of the red blood cell precursors to mature red blood cells. Claims 9-19 are withdrawn as being directed to non-elected invention Groups II and III. Thus, claims 6-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025.
Priority
This application claims benefit as a CON of 16/292,922 (filed 3/5/2019; ABN) which claims benefit from provisional U.S. Application No. 62/638, 563 (filed 3/5/2018).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 4-5 are objected to because of the following informalities: typographical.
Claims 4 and 5 recite the zinc chelator TPEN: N,N,N',N'-Tetrakis(2-pyrimidyl)ethylenediamine. It is noted that Applicant’s specification at [0059] indicates that TPEN is the abbreviation for
N,N,N',N'-Tetrakis(2-pyridylmethyl)ethylenediamine, thus it appears that the term “pyrimidyl” should be replaced with “pyridylmethyl”.
Sigma evidences that TPEN, P4413 (specification [0059]) is: N,N,N',N'-Tetrakis(2-pyridylmethyl)ethylenediamine.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-5 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1, as currently drafted, recites contacting red blood cell precursors with a composition comprising “a zinc chelator” and the contacting inhibits survival of the red blood cell precursors. Dependent claims 2-5 either depend directly from claim 1, or incorporate the method of claim 1.
The claims encompass any amount of the recited zinc chelator.
Upon review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of inhibiting the survival of the red blood cell precursors by contacting the red blood cell precursors with any amount of the zinc chelator. Possession of an invention may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998).
In the instant case the only references in the specification to inhibiting the survival of the red blood cell precursors by contacting the red blood cell precursors with a zinc chelator are directed to contacting the cells with the zinc chelator TPEN (N,N,N',N'-Tetrakis(2-pyridylmethyl)ethylenediamine), specifically at a concentration of 10 µM (Specification at paragraphs [0059] and [0084]). A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of inhibiting the survival of the red blood cell precursors by contacting the red blood cell precursors with any amount of a zinc chelator.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
Claim Rejections - 35 USC § 102
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 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) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Misiti et al., (J. Clin. Invest, Vol 64, December 1979, pages 1573-1579; see PTO-892) (“Misiti”), as evidenced by BENCHCHEM (Comparing the effectiveness of EDTA and EGTA as chelating agents; 9 pages (2025), retrieved from the internet; see PTO-892) (“Benchchem”).
Misiti is directed to in vitro erythropoiesis of mouse erythroid progenitor cells (i.e., red blood cell precursors).
Regarding claims 1-3, Misiti teaches culturing the erythroid progenitor cells (i.e., cultured hematopoietic precursor cells), obtained from femoral marrow, in the presence of various concentrations of the chelating agent EGTA (ethylene glycol tetraacetic acid). Erythroid colony formation was inhibited by EGTA at concentrations of 3 mM, 5 mM and 10 mM (i.e., contacting inhibits survival of the red blood cell precursors) (see Table II and Results, right col, second paragraph, page 1574).
Benchchem evidences that EGTA is an effective metal ion chelator for various metal ions including zinc (i.e., a zinc chelator) and calcium (see Table 1 at page 2). Thus, although Misiti does not further comment on whether or not zinc chelation takes place, the fact that Misiti employs the same EGTA as the instant application ([0043]) means that any and all results of the method of Misiti, whether recognized at the time of publication or not, were inherently achieved by the reference method.
Thus, Misiti’s teaching anticipates claims 1-3.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Misiti, as applied to claims 1-3 above, and further in view of Cho et al (Nutrition Research and Practice (2007), 1, 29-35; see PTO-892) (“Cho”).
The teaching of Misiti is set forth above, and anticipates claims 1-3.
Regarding claims 4-5, it is noted that, although Misiti uses EGTA for limiting the metal ions in the erythroid progenitor cultures, Misiti does not further teach using TPEN (N,N,N',N'-Tetrakis(2-pyridylmethyl)ethylenediamine) as the metal ion chelator to limit the availability of zinc.
However, Cho is directed to trace mineral studies involving metal ion chelators (Abstract) and teaches that metal ion chelators such as TPEN and EGTA are both known for their use to limit the available metal ions contained in cellular culture medium (Introduction, left and right col, page 29).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing the invention to substitute TPEN for EGTA since both are known metal ion chelators used to limit the available metal ions, such as zinc, in cellular culture medium. Therefore, one of ordinary skill in the art would recognize this as simply substituting one type of zinc chelator for another useful for the same purpose ((KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007) pg 14 and 12). Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395.
Conclusion
No claim is allowed. No claim is free of prior art.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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, CHRISTOPHER BABIC can be reached at 571-272-8507. 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.
E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633