Detailed Action
► Claim(s) 1-24 as presented in the paper(s) filed 01 MAY 13 is/are pending.
► The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Sequence Rules
► This application complies with the sequence rules and the sequence(s) have been entered by the Scientific and Technical Information Center.
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 therefore, subject to the conditions and requirements of this title".
Claim Rejections under 35 USC § 101
► Claim(s) 1-4 is/are reject 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. “The application of (i.e. the use of) “ is not a patentable category of invention under 35 USC 101.
35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► 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 Rejection(s) under 35 U.S.C. 112(b)/ 112 (pre-AIA ), second paragraph
► Claim(s) 1-7 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language.
Claims 1-4 and 7 are awkwardly worded and as such it is not clear as to the invention being claimed. Please clarify.
In particular, Claim 7 recites the phrase “which using”.. It is not clear what is intended. Please clarify. In addition, as there is no description or definition of the term eIF4A3 -IN-2, therefore it is not clear as to the metes and bounds of the claimed invention. Furthermore the phase “and for preparing a drug for treating breast cancer bone metastasis” on lines 2-3 is non-sequitur.
35 U.S.C. 102
► The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that may 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
35 U.S.C. 103
► 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.
► 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 Rejection(s) under 35 U.S.C. 102/103
► Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(2) or (a)(1) as being anticipated by or in the alternative under 35 U.S.C. 103 as obvious over Sigma [Northern Breeze Blotting Kits (MAY 2000) – hereinafter “Sigma”] or Fang et al [US 2014/0212884 – hereinafter “Fang”] or Housknecht et al [US 2003/0113815 – hereinafter “Housknecht”].
Claim 5 is drawn, in part , to a kit for detecting the expression level of molecular marker circlKBKB wherein the kit comprises a reagent capable of detecting an expression level of circlKBKB which kit comprises a reagent for practicing Northern blotting or RT-PCR or Q-PCR.
Sigma teach, see the entire document, a reagent kit (i.e. Northern Breeze blotting kit) which comprises a reagent(s) for performing expression analysis (i.e. Northern blotting). That said, Sigma does not teach or suggest determining the expression level of circlKBKB. However, this is an intended use limitation and as such does not further limit the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey , 152 USPQ 235 (CCPA 1967); In re Otto , 136 USPQ 458, 459 (CCPA 1963). The patentability of a composition (e.g. a reagent kit) depends on its structure and not its intended use.
Fang teach a kit comprising a reagent (s) for performing RT-PCR, see for example, para 68
Housknecht teach a kit comprising a reagent (s) for performing Q-PCR, see for example para 119.
► Claim(s) 7 is/are rejected under 35 U.S.C. 102(a)(2) or (a)(1) as being anticipated by Hortobagyi et al. [JAMA Oncology 3(7) : 906-912(2017) – hereinafter “Hortobagyi”] or Ratrout et al. [Pharmaceutical Chemistry Journal 48(12) : 837 (2015) – hereinafter “Ratrout”] or Kawamoto et al.[ ACS Chemical Biology 12:1760-1768 (2017) -hereinafter “Kawamoto”].
Hortobagyi teach a reagent/medicine (i.e. zoledronic acid) for treating breast cancer bone metastasis, see the entire document. Zoledronic acid is a bisphosphonate which is a medicine typically used to treat disease(s) of the bone disorders (e.g. Paget’s disease and osteoporosis and/or breast cancer bone metastasis).
Ratrout teach a reagent (e.g. acetone, see the section entitled “Materials” on p .837) for preparing Zoledronic acid , a medicine used in the treatment of breast cancer bone metastasis. Note Hortobagyi cited above. It is noted that neither Hortobagyi nor Ratrout teach the use of the circlKBKB generation inhibitor : “eIF4A3-IN-2” as is recited by Claim 7. However, in light of the ambiguity of Claim 7 this rejection is deemed proper.
Kawamoto teach a known inhibitor of eIF4A3 (i.e.eIF4A3-IN-2) which meets the limitation, “a reagent or medicine”. Note that the limitation(s) which reads “for treating breast cancer metastasis” and “inhibiting the generation of circlKBKB” were considered but are deemed to carry little weight as they are intended use limitations. Note the the invention is drawn to “A reagent and medicine for… ” Thus the invention dirscted to a product/composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. In re Casey , 152 USPQ 235 (CCPA 1967); In re Otto , 136 USPQ 458, 459 (CCPA 1963). eIF4A3 (ie, Eukaryotic Initiation Factor 4A3) was known as were reagent/medicine which inhibit the function of this initiation factor, see Kawamoto, abstract and Fig. 1. It is noted that Kawamoto does not teach that their eIF4A3-IN-2 inhibits the generation of circlKBKB, however, 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. Something which is old does not become patentable upon the discovery of a new property. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claim Objection(s)
► Claim(s) 6 is/are objected to because it is dependent upon a rejected independent base claim, however, Claim 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112 set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 6 is considered free of the prior art of record because a primer pair comprising SEQ ID NOs.:1-2 and/or a probe comprising SEQ ID NO.3 are novel and unobvious over the prior art of record.
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov
EXAMINER SEARCH NOTES
30 DEC 2025 - ECW
Databases searched: All available via PE2E SEARCH
CAplus, Medline and BIOSIS via STNext; and Google Scholar (note the search terms used below)
Reviewed the parent(s), if any, and any search(es) performed therein : see the BIB data sheet
Reviewed, the search(es), if any, performed by prior examiners including any international examiners.
Planned Search
STIC searched SEQ ID NO.s. 1-3
Search terms:
All Inventor(s) e.g. Chen.in. with Suwen.in.
circlKBKB or circKBKB
circ$RNA same KBKB
circ_0084100
breast cancer
bone SAME metastasis
eIF4A3 OR Eukaryotic Initiation Factor 4A3
eIF4A3-IN-2
expression
biomarker$ or marker$
inhibit$
Northern blot$
RT-PCR
QPCR
qPCR
► See the Examiner’s PE2E SEARCH notes/strategy in IFW