DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 9/11/25 has been entered in full. The specification is amended. Claim 10 is amended.
Applicants' election without traverse of Group IX, drawn to a method of using a nucleic acid inhibitor of Zkscan3 to inhibit the production or maturation to red blood cells was previously acknowledged. Claim 10 is now limited to the subject matter of Group IX, and thus is no longer a linking claim.
Claims 1-9 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim 10 is under consideration.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (4/22/25).
The objection to the specification at pages 2-3 is withdrawn in part in view of the amendments to the specification. Specifically, all grounds are withdrawn except those maintained below.
The objection to claim 10 at page 3 is withdrawn in view of the amendments to the claim that make it an independent claim.
The rejection of claim 10 at pages 1-3 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims that change the claim from a use without any active, positive steps delimiting how this use is actually practiced to a method setting forth such steps. With respect to the “using” step recited in line 4 of the claim as amended, MPEP 21703.05(q).II states, “In the case of Ex parte Porter, 25 USPQ2d 1144 (Bd. Pat. App. & Inter. 1992), the Board held that a claim which clearly recited the step of "utilizing" was not indefinite under 35 U.S.C. 112, second paragraph”.
The rejection of claim 10 at pages 4-8 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims.
Maintained Objections and/or Rejections
Specification
The disclosure is objected to because of the following informalities:
In the previous Office Action, the title was objected to for the following reasons:
“The title of the invention is not descriptive because (a) in part it is directed to a product (inhibitor, inhibitor composition or drug), but the elected invention is directed to a method; and (b) in part it is directly generically to a “use”, but the elected invention is directed to a method of using an inhibitor of Zkscan3 to inhibit red blood cell production and/or maturation”
In response, Applicants have amended the title to recite a “Use of Drug In Inhibiting the Production and Maturation of Red Blood Cells”. The objection to the title is maintained because the new title is still directed generally to any inhibitor drug used for inhibiting the production and maturation of red blood cells, whereas the claimed invention is limited to use of Zkscan3 inhibitor.
A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Use of an Inhibitor of Zkscan3 in Inhibiting the Production and Maturation of Red Blood Cells”.
Note on Prior Art Rejection(s)
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 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.
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 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyd et al, U.S. 2007/0298445, published 12/27/07 (cited previously). The earliest date to which the instant application claims priority is 8/13/20. This rejection was set forth previously at page 9 of the 4/22/25 Office action.
Clam 10 previously recited a “Use of the drug of claim 9 in inhibiting the production and maturation of red blood cells”, and was interpreted as encompassing a method of using the drug of claim 9 in inhibiting production and/or maturation of blood cells.
As amended, claim 10 encompasses a method of inhibiting the production and maturation of RBCs, comprising two steps: providing the drug, and using the drug in inhibiting the production and maturation of RBCs, and furthermore wherein the drug comprises an inhibitor that inhibits the expression of the Zkscan3 gene to reduce the level of an expression product, and wherein the inhibitor is RNA, and wherein a dosage form is selected from a group including a powder.
As set forth previously, Boyd teaches use of an siRNA that targets ZNF306 (see Abstract and ¶ 77), which is another name for Zkscan3 (as evidenced by the title of Yang et al, 2008. Cancer Res. 68(11): 4321-4330; cited on the 1/28/22 IDS). Boyd teaches that the siRNA inhibits translation of the target gene (¶ 77), and thus inhibits its expression and reduces the level of the expression product. Boyd further teaches that the therapeutic compositions of the invention can be formulated as a powder (¶ 117-119). Boyd further teaches that pharmaceutical preparations of the invention can be administered for treatment of disease, including cancer (e.g., ¶ 15, 110). Because the compound administered by Boyd is a compound encompassed by the inhibitor used in the method of instant claims, it would inherently produce the same result when administered; i.e., inhibiting the production and maturation of red blood cells, See MPEP 2112.I:
“"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)”
Furthermore, there is no requirement that Boyd recognized that such an effect happens. See MPEP 2112.II: “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)”
As such, Boyd teaches a method of providing a drug (siRNA inhibiting ZNF306/Zkscan3), and administering the drug, which would inherently result in inhibiting the product and maturation of red blood cells, and wherein the drug comprises an inhibitor that inhibits the expression the Zkscan3 gene to reduce the level of an expression product of the Zkscan3 gene (i.e., the siRNA inhibits the expression of ZNF306/Zkscan3) and wherein the inhibitor is selected from the group consisting of RNA, and wherein a dosage form of drug is a powder. As such, the teachings of Boyd anticipate claim 10 as amended.
At page 7 of the 9/11/25 reply, Applicants argue that Boyd fails to teach the element of amended claim 10, and request withdrawal of the rejection.
This argument has been fully considered but is not found persuasive because Boyd teaches the element of claim 10 as amended for the reasons set forth above, and therefore the rejection of claim 10 as anticipated by Boyd is maintained.
New objections and/or rejections necessitated by Applicants’ amendment
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, line 4, “red blood cell” should be “red blood cells” as in lines 2 and 8.
Appropriate correction is required.
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.
Claim 10 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 pre-AIA the applicant regards as the invention.
In claim 10, lines 12-13, the claim recites that a “dosage form of the drug is selected from…”; however, no step of the claim refers to a dose or dosage, or administration. Thus, it is unclear how “a dosage form” limits the steps of the method claim.
Conclusion
No claims are allowed.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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