DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election of Group I and the species of NUP58 in the reply filed on 09 June 2026 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)).
Claim Status
3. Claims 70-72 and 74-88 are pending.
Claims 71, 72 and 74-80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 70 and 81-88 read on the elected invention and have been examined herein.
Examiner’s Comment
4. Although claims 76 and 80 are withdrawn from consideration, in the interest of compact prosecution, it is noted that these claims are missing a period at the end of the claims.
Objection to Drawings / Objection to the Specification
5. The drawings are objected to under 37 CFR 1.83(a). The specification describes the figures in terms of colors. For example, Figure 3 is described at para [0035] in terms of the colors red and blue. Also, para [0045] of the specification states:
“Some figures and text contain color representations or entities. Color illustrations are available from the Applicant upon request or from an appropriate Patent Office. A fee may be imposed if obtained from a Patent Office.”
However, the figures have been filed in black and white. Thus, the description of the figures in the specification is not consistent with the drawings and the specification is thereby also objected to.
If the drawings are intended to be in black and white, the specification should be amended to delete the reference to the recited colors. Alternatively, corrected drawing sheets in compliance with 37 CFR 1.121(d) are required. Note that color drawings are only accepted on rare occasions when they are the only practical medium by which to disclose the subject matter to be patented. See MPEP 608.02(VIII).
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
If color photographs or color drawings are submitted, it is noted that color photographs and color drawings are not accepted unless a petition filed under 37 CFR 1.84(a)(2) is granted.
A petition for color drawings 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 EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, 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).
Appropriate correction is required.
Specification
6. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code – see, for example, para [0226]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code, such as “www.”. See MPEP § 608.01.
Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 70 and 81-88 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,637,715. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims and the claims of ‘715 are both inclusive of a composition comprising one or more joint inflammation cDNA biomarker synthesis and amplification reaction mixtures, the one or more joint inflammation cDNA biomarker synthesis and amplification reaction mixtures comprising a first reaction mixture comprising: a) DNA polymerase, b) reverse transcriptase, c) synovial fluid leukocyte whole cell RNA from a synovial joint of a subject, wherein the subject has joint pain in, or has at least one clinical sign of inflammation in, or proximal to, the synovial joint, or has joint pain in and at least one clinical sign of inflammation in, or proximal to, the synovial joint, d) oligonucleotide reverse transcription primers that serve to synthesize a joint inflammation cDNA biomarker from the synovial fluid leukocyte whole cell RNA in the presence of the reverse transcriptase, NUP58 cDNA synthesized in the first reaction mixture from the synovial fluid leukocyte whole cell RNA by at least one of the oligonucleotide reverse transcription primers and the reverse transcriptase, f) oligonucleotide amplification primers that hybridize to opposite complementary strands of the NUP58 cDNA and that serve to amplify NUP58 cDNA in the presence of the DNA polymerase, and g) amplified NUP58 cDNA resulting from amplifying NUP58 cDNA r in the first reaction mixture, wherein an amount of an amplified NUP58 cDNA in the first reaction mixture is indicative of an amount of a NUP58 RNA in the synovial fluid leukocyte whole cell RNA from a synovial joint of a subject. See claims 2-10 of ‘715 which recite that the composition comprises NUP58 cDNA, amplified NUP58 cDNA and NUP58 primers. Note that the present claims recite the open claim language of comprising and thereby may include additional cDNA and primers, including the POLR2G cDNA, amplified POLR2G cDNA and POLR2G amplification primers. Regarding present claims 81-88, dependent claims 11-18 of ‘715 recite the same limitations as present claims 81-88.
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Brandon et al (U.S. 20150218640A1; cited in the IDS) teaches that NUP58 (referred to as NUPL1 therein) is a biomarker of inflammatory response syndrome (IRS; e.g., para [1001], [0124], [0127] and [0142]).. Brandon teaches compositions comprising reverse transcribed mRNAs from leukocytes (e.g., para [0162]) and the use of whole cell RNA for performing nucleic acid detection assay (e.g., para [0138]). Brandon (para [1002]) states:
"The methods, compositions, apparatus and kits of the present invention take
advantage of the IRS biomarkers broadly described above and elsewhere herein to
provide an indicator for use in diagnosing the presence, absence or degree of the at
least one condition selected from a healthy condition (e.g., a normal condition or one in
which inSIRS and inSIRS are absent), inSIRS, ipSIRS or a stage of ipSIRS (e.g., a
stage of ipSIRS with a particular severity such as mild sepsis, severe sepsis and septic
shock), or in providing a prognosis of the at least one condition, which may involve: (a)
determining a plurality of IRS biomarker values, each IRS biomarker value being
indicative of a value measured or derived for at least one (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) IRS biomarker of a biological subject; (b) determining the indicator using a
combination of the plurality of IRS biomarker values (also referred to herein as a
"biomarker signature"), the indicator being at least partially indicative of the presence,
absence, degree or prognosis of the at least one condition, wherein: (i) at least two
(e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) IRS biomarkers have a mutual correlation in
respect of the at least one condition that lies within a mutual correlation range, the
mutual correlation range being between +0.9; and (ii) the indicator has a performance
value greater than or equal to a performance threshold representing the ability of the
indicator to diagnose the presence, absence or degree of the at least one condition, or
to provide a prognosis for the at least one condition, the performance threshold being
indicative of an explained variance of at least 0.3.”
Brandon also teaches that the methods disclosed therein encompass using samples that may be a synovial fluid sample (para [1013]). Brandon does not identify particular RNA biomarkers that are present in synovial fluid, and particularly does not teach that NUP58/NUPL1 RNA is present in synovial fluid leukocytes from a synovial joint of a subject, wherein the subject has joint pain in the synovial joint, or has at least one clinical sign of inflammation in, or proximal to, the synovial joint, or has joint pain in the synovial joint and at least one clinical sign of inflammation in, or proximal to, the synovial joint and does not teach or suggest the presently claimed compositions..
Gow et al (U.S. 20090010908A1) teaches assaying blood samples from subjects having chronic fatigue syndrome, which is characterized by joint pain, to detect the level of lNUPL1 (i.e., NUP58) mRNA that has been reverse transcribed by RT-PCR to generate cDNA (e.g., para [0097], [0100], [0102] and Table 6). Gow does not teach or suggest that NUP58 / NUPL1 mRNA is expressed in synovial fluid leukocyte cells from a synovial joint of a subject having joint pain in the synovial joint, or having at least one clinical sign of inflammation in, or proximal to, the synovial joint, or having joint pain in the synovial joint and does not teach or suggest the presently claimed compositions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLA J MYERS whose telephone number is (571)272-0747. The examiner can normally be reached M-Th 6:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLA J MYERS/Primary Examiner, Art Unit 1682
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