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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-3, 7 and 8) in the reply filed on 12/02/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/02/2025.
Drawings
The drawings are objected to because Figures 4-9 contain color drawings and there has been no granted petition to include color drawings in this application. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
More specifically, 37 C.F.R. 1.84(a)(2) states:
On rare occasions, color drawings may be necessary as the only practical medium by which to disclose the subject matter sought to be patented in a utility patent application…The Office will accept color drawings in utility patent applications only after granting a petition filed under this paragraph explaining why the color drawings are necessary. Any such petition must include the following:
(i) The fee set forth in § 1.17(h);
(ii) One (1) set of color drawings if submitted via the Office electronic filing system, or three (3) sets of color drawings if not submitted via the Office electronic filing system; and
(iii) An amendment to the specification to insert (unless the specification contains or has been previously amended to contain) the following language as the first paragraph of the brief description of the drawings:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
(Emphases added.) MPEP 608.02, part VIII, states:
Color drawings and color photographs are not accepted in utility applications filed under 35 U.S.C. 111 unless a petition filed under 37 CFR 1.84(a)(2) or (b)(2) is granted. Color drawings and color photographs are not permitted in international applications (see PCT Rule 11.13).
Unless a petition is filed and granted, color drawings or color photographs will not be accepted in a utility patent application filed under 35 U.S.C. 111. The examiner must object to the color drawings or color photographs as being improper and require applicant either to cancel the drawings or to provide substitute black and white drawings.
Priority
The disclosure of the prior-filed application, Application No. 16/445,322 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for claims 1-3, 7 and 8 of this application. The priority date of the current claims is 06/19/2019.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of Korea on 01/22/2019 (KR10-2019-0007842). It is noted, however, that applicant has not filed a certified copy of the KR10-2019-0007842 application as required by 37 CFR 1.55.
Claim Interpretation
The claims are drawn to compositions and kits, and are thus drawn to products. The claims recite an intended use for the composition and the kit (“for diagnosis or prognosis prediction of thyroid cancer” in claims 1 and 7). According to MPEP 2111.02(II), “[t]he claim preamble must be read in the context of the entire claim” and that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
In the instant case, the body of the claims set forth all the limitations of the claimed invention, whereas the preamble merely sets forth the intended use of the claimed products. Any agents capable of measuring adrenomedullin 2 (ADM2) gene or protein expression and kits comprising said agents, regardless of the intended use, would anticipate the claims.
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
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.
Claims 1-3, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chauhan et al. (Biol. Reprod (2009); 81: 777-783). The claims are drawn to a composition comprising an agent for measuring an expression level of mRNA or protein of ADM2 (adrenomedullin 2) and a kit therefor (claims 1 and 7); wherein the agent for measuring the mRNA level includes a primer, a probe, or an antisense oligonucleotide that specifically binds to the gene (claim 2); wherein the agent for measuring the protein level includes an antibody or an aptamer specific for the protein (claim 3), and wherein the kit is an RT-PCR kit, a DNA chip kit or a protein chip kit (claim 8).
Chuahan et al. teach methods of measuring ADM2 mRNA comprising RT-PCR analysis employing primers for ADM2 (see p. 778, left column and Figure 1). In addition, Chauhan et al. disclose a an ADM2 antibody for measuring protein (see p. 778, right column, 1st full paragraph and Figure 2; p. 779, Figure 3; p. 780, Figure 4). Since Chuahan et al. teach the agents for measuring an expression level of mRNA of ADM2 (adrenomedullin 2) gene and its protein, including primers and antibodies, this is reasonably construed as comprising a kit, which is generally defined as a collection of agents for conducting an assay. Even though the prior art of Chuahan et al. does not disclose measuring ADM2 in order to diagnose/prognose thyroid cancer, the primers and antibodies disclosed therein are capable of carrying out this intended use, as well as any other intended use for measuring ADM2. See In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963): “[f]rom the standpoint of patent law, a compound and all its properties are inseparable.” Thus, Chuahan et al. meet the limitations of claims 1-3, 7 and 8.
Claims 1, 2, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sproul et al. (WO2014100737). See the preceding rejection for a description of the instant claims. Sproul et al. disclose “a probe set comprising a plurality of target sequences”, including those that hybridize to ADM2 in order to analyze expression (see paragraphs [0009]-[0010]). The target sequences (i.e., biomarkers) can be measured by any known methods, including RT-PCR kits and microarrays (see paragraphs [0137]-[0148]. Since Sproul et al. teach the agents for measuring an expression level of mRNA of ADM2 (adrenomedullin 2), including a probe set, this is reasonably construed as comprising a kit, which is generally defined as a collection of agents for conducting an assay. Even though Sproul et al. do not disclose measuring ADM2 in order to diagnose/prognose thyroid cancer, the primers disclosed therein are capable of carrying out this intended use, as well as any other intended use for measuring ADM2. See In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963): “[f]rom the standpoint of patent law, a compound and all its properties are inseparable.” Thus, Thus, Sproul et al. teach the limitations of claims 1, 2, 7 and 8.
Claims 1, 3 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hollander et al. (Journal of Surgical Research 197 (2015) 219-224). See the preceding rejection for a description of the claims. Hollander teach measuring adrenomedullin 2 (ADM2) protein levels with an antibody (see p. 220, right column under “2.2 Immunohistochemistry” and p. 222, Figure 1 and Table 2). Since Hollander et al. teach the agent for measuring an expression level of mRNA of ADM2 (adrenomedullin 2) protein, namely, an antibody, this is reasonably construed as comprising a kit, which is generally defined as a collection of agents for conducting an assay. Even though the prior art of Hollander et al. does not disclose measuring ADM2 in order to diagnose/prognose thyroid cancer, the antibody disclosed therein is capable of carrying out this intended use, as well as any other intended use for measuring ADM2. See In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963): “[f]rom the standpoint of patent law, a compound and all its properties are inseparable.” Thus, Hollander et al. meet the limitations of claims 1, 3 and 7
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Panda et al. (WO2017077499) disclose kits and methods for measuring gene aberration of various genes, including ADM2 (see claims 1-5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675