DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s Response to Election/Restriction Filed and Arguments/Remarks, filed 04 November 2025, have been entered. Claims 1 and 5-23 are currently pending in the application. Claims 1, 5, 7, 8, 9, 11, 12, 13, 14, 16, 18, 19, 20, and 21 are independent claims.
Applicant’s election without traverse of the invention of Group I, drawn to a use of markers for isolation or enrichment of HSCs or a cell population containing HSCs, isolated or enriched HSCs or a cell population containing HSCs, a second isolated or enriched HSCs or a cell population containing HSCs, and a composition or kit for identifying, detecting, isolating, or enriching HSCs, is acknowledged.
Additionally, Applicant indicated a desire to pursue the combination of markers selected from:
CD48(-) and CD34 (+),
CD48(-) and c-kit(+), and
CD48(-), CD34(+), and c-kit(+).
Note, however, that no election of species was required by the Examiner in the Requirement for Restriction/Election mailed 04 September 2025, and as such no species election is in effect in the instant application.
Claims 8-14, 17, and 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 5-7, 15-16, and 18 are currently pending in the application and under examination to which the following grounds of rejection are applicable. An action on the merits follows.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2021/025050, filed 01 July 2021, which claims priority to JAPAN PCT/JP2020/025915, filed 01 July 2020, and JAPAN 2021-089502, filed 27 May 2021. Filing of a certified untranslated English copy of the JAPAN PCT/JP2020/025915, filed 01 July 2020, and JAPAN 2021-089502, filed 27 May 2021 are acknowledged.
Thus, the earliest possible priority for the instant application is 01 July 2020.
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.
Information Disclosure Statement
The information disclosure statements filed 03 March 2023, 16 August 2024, 16 August 2024, and 09 January 2025 have been considered by the Examiner.
Specification
The use of the term “BD FACSAriaIII” in [0116], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Note that the specification has not been inspected sufficiently to ensure identification of all uses of trade names and/or marks used in commerce. It is Applicant’s responsibility to ensure complete compliance.
The listing of references in 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.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities: claim 5 and 6 each recites, “one or more selected from”, which appears to be a typographical wherein the noun being modified by “one or more” is missing, such as “one or more markers selected from”. 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.
Claims 1, 5-7, 15-16, and 18 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 7 is included in this rejection due to its encompassing of independent claim 5.
Independent claim 1 has multiple issues of indefiniteness.
Independent claim 1 is directed to a “use of”. This claim is indefinite because it is unclear whether Applicant intends to claim a composition or a method. If Applicant intends to claim a method, the claim does not set forth any steps involved in a method/process, and so it is unclear what method/process Applicant is intending to encompass. Additionally, because this claim does not set forth any steps involved in the process, it results in an improper definition of a process, i.e., results in a claim which are not a proper process claim. Alternatively, if Applicant intends to claim a composition, the claim does not properly set forth components of a composition of matter. As such, the metes and bounds of the claim cannot be determined.
For the sake of compact prosecution, the Examiner has interpreted claim 1 to a method of isolating or enriching hematopoietic stem cells or a cell population containing hematopoietic stem cells.
Independent claim 1 additionally recites a list of markers linked by “and”, followed by “or one or more selected from a combination of CD48 and CD34, a combination of CD48 and c-Kit, and a combination of CD48, CD34, and c-Kit, or a combination thereof”, which his indefinite because it is unclear whether Applicant intends to claim the use of ALL listed markers or one of the three combinations listed, or whether Applicant intends to claim the use of any one of the listed markers, any one of the three recited combinations, or a combination of the individual markers and/or combinations of markers.
Further, recitation of “one or more selected from” is indefinite because it is unclear whether the groups being selected from is an open or a closed group.
As such, the metes and bounds of the claim cannot be determined.
The examiner recommends amending claim 1 or recite a proper Markush group where the markers should be selected from “the group consisting of A, B, and C”
Independent claim 5 has multiple issues of indefiniteness.
Independent claim 5 recites, “a cell population containing hematopoietic stem cells” both in lines 2 and 4, which is indefinite because it is unclear whether the recitation in line 4 is meant to be the same population as that recited in line 2.
Claim 5 also recites, “an expression pattern of one or more selected from”, which is indefinite because it is unclear how the expression (or lack of expression) of a single marker can constitute an “expression pattern”.
Claim 5 further recites, a list of markers linked by “and”, followed by “or one or more selected from a combination of CD48 and CD34, a combination of CD48 and c-Kit, and a combination of CD48, CD34, and c-Kit, or a combination thereof”, which his indefinite because it is unclear whether Applicant intends to claim the use of ALL listed markers or one of the three combinations listed, or whether Applicant intends to claim the use of any one of the listed markers, any one of the three recited combinations, or a combination of the individual markers and/or combinations of markers.
Further, recitation of “one or more selected from” is indefinite because it is unclear whether the groups being selected from is an open or a closed group.
As such, the metes and bounds of the claim cannot be determined.
Claim 6 recites “one or more selected from”, which is indefinite because it is unclear whether the groups being selected from is an open or a closed group. As such, the metes and bounds of the claim cannot be determined. Thus, claim 6 is in improper Markush form; a Markush group should be in the form “an expression pattern selected from the group consisting of A, B, and C”. Currently, it is not clear which species are included in the Markush group and which are not.
Claim 15 recites, “the cell population containing hematopoietic stem cells” in line 2. There is unclear antecedent basis for this limitation in the claim. Claim 15 is dependent on claim 5, which has two recitations of “a cell population containing hematopoietic stem cells” in lines 2 and 4. As such, the metes and bounds of the claim cannot be determined.
Claim 16 recites, “the cell population containing hematopoietic stem cells” in line 3. There is unclear antecedent basis for this limitation in the claim. Claim 16 recites “a cell population containing hematopoietic stem cells” in lines 1-2. Additionally, claim 16 is dependent on claim 5, which has two recitations of “a cell population containing hematopoietic stem cells” in lines 2 and 4. As such, the metes and bounds of the claim cannot be determined.
Claim 18 recites, “a marker according to claim 1”, which is indefinite because claim 1 is directed to use of markers and not to markers themselves. As such, the metes and bounds of the claim cannot be determined.
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.
NOTE: Pursuant to MPEP 2173.05(q): In view of the split of authority, the most appropriate course of action would be to reject a “use” claim under alternative grounds based on 35 U.S.C. 101 and 112.
Independent claim 1 is 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 claim fails to properly define a process.
Pursuant to MPEP 2173.05(q), other decisions suggest that a more appropriate basis for this type of rejection is 35 U.S.C. 101. In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid." Furthermore, pursuant to MPEP 2106.03, [a] process defines "actions", i.e., an invention that is claimed as an act or step, or a series of acts or steps. As explained by the Supreme Court, a "process" is "a mode of treatment of certain materials to produce a given result. It is an act, or a series of acts, performed upon the subject-matter to be transformed and reduced to a different state or thing." Gottschalk v. Benson, 409 U.S. 63, 70, 175 USPQ 673, 676 (1972) (italics added) (quoting Cochrane v. Deener, 94 U.S. 780, 788, 24 L. Ed. 139, 141 (1876)). Accord Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 ("The Supreme Court and this court have consistently interpreted the statutory term ‘process’ to require action"); NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of acts.") (quoting Minton v. Natl. Ass’n. of Securities Dealers, 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in 35 U.S.C. 100(b), the term "process" is synonymous with "method."
In the instant case, note that recitation “for isolation or enrichment of hematopoietic stem cells” is an intended use statement and does not provide an active method step to the claim. Therefore, given that claim 1 fails to recite any steps involved in the process of using the markers, it would then follow that the claimed uses without any active, positive steps delimiting how this use is actually practiced renders the claimed inventions patent ineligible subject matter by failing to constitute one of the four statutory categories.
Claim Interpretation
Claim 6 recites “an expression pattern” in line 3, which has been interpreted to indicate an optional limitation in that it does not specifically further limit the expression pattern recited in claim 5 and thereby presents an option for an expression pattern.
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, 5-7, 15-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tornack et al. [2017, European Journal of Immunology, 47, 1477-1487].
Regarding claim 1, Tornack discloses the use of markers for isolation or enrichment of hematopoietic stem cells, including CD11c, CD41, CD31, CD48, CD34, and/or c-Kit [abstract, pg. 1478, column 2 ¶ 3, pg. 1479 column 1 ¶ 2, pg. 1484 column 2 ¶ 2, Figure 1, 2, 3, 4].
Regarding claim 5, Tornack discloses a method for isolating or enriching HSCs comprising a) preparing a cell population containing HSCs; and b) isolating or enriching cells depending on an expression pattern of one or more markers selected from at least CD11c, CD41, CD31, CD48, CD34, and/or c-Kit [abstract, column 3 ¶ 3, column 4 ¶ 2, column 15 ¶ 2, 5, column 16 ¶ 2, Figure 1, 2, 3, 4].
Regarding claim 6, Tornack teaches wherein an expression pattern used as an index to select a cell population for isolation or enrichment includes an expression pattern combination of CD48- and c-kit+ [abstract, column 3 ¶ 3, column 4 ¶ 2, column 15 ¶ 2, Figure 1].
Regarding claim 7, Tornack teaches a sort isolated population of HSCs produced by the method of using one or more markers selected from at least CD11c, CD41, CD31, CD48, CD34, and/or c-Kit to isolate HSCs [abstract, column 3 ¶ 3, column 4 ¶ 2, column 15 ¶ 2, Figure 1, 2, 3, 4].
Regarding claim 15, Tornack teaches wherein the cell population containing HSCs is obtained from a living body (e.g., 8-10 weeks old male mice) [column 15 ¶ 5-column 16 ¶ 2].
Regarding claim 16, Tornack teaches an isolated HSC population produced by the method of using one or more markers selected from at least CD11c, CD41, CD31, CD48, CD34, and/or c-Kit to isolate HSCs, wherein the cell population containing HSCs is obtained from a living body (e.g., 8-10 weeks old male mice) [column 15 ¶ 5-column 16 ¶ 2].
Regarding claim 18, the preamble of this claim recites a “kit.” The specification, however, does not define this term, and so it is being interpreted to encompass any collection of reagents that includes all of the elements of the claims. Any further interpretation of the word is considered an intended use and does not impart any further structural limitation of on the claimed subject matter. As such, the “kit” as claimed in claim 18 is interpreted to encompass any composition comprising a reagent for quantifying or detecting an expression level of any on or more markers recited in claim 1.
Tornack discloses reagents for quantifying or detecting an expression level of at least markers CD11c, CD41, CD31, CD48, CD34, and/or c-Kit, including antibodies used to detect the markers on the cells [column 15 ¶ 2].
Accordingly, by teaching all the limitations of claims 1, 5-7, 15-16, and 18 as written, Tornack anticipates the instant invention as claimed.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634