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 .
Response to Amendment
The preliminary amendment filed 06/11/2024 is acknowledged. Claims 1-70 are canceled and claims 71-91 are new. No restriction is being imposed in this case. Claims 71-91 are pending and under examination.
Sequence Rules
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. The instant application is not in compliance with the sequence rules, particularly 37 CFR 1.821(d), which requires that reference be made to a particular sequence identifier (SEQ ID NO: X) in the specification and claims at each disclosure of a sequence encompassed by the definitions set forth in 37 CFR 1.821(a)(1) and (a)(2). Specifically, claims 72, 73, 90 and 91 contain amino acid sequences without any corresponding sequence identifiers.
Appropriate correction is required.
Effective Filing Date
Applicant’s claim for the domestic benefit of prior-filed applications under 35 U.S.C. 119(e), 120 and 121 is acknowledged. No foreign priority claims are made. Based on the information given by Applicant and an inspection of the prior applications and patents, the examiner has concluded that the subject matter defined in claims 71, 74, 78, 80 and 82-89 is supported by the disclosures in application serial no. 15/186,322 (now US Patent 10,392,665); application serial no. 16/380,938 (now US Patent 10,961,584); application serial no. 17/189,048 (now US Patent 11,987,846) and at least the provisional application serial no. 62/182,349 (filed on 06/19/2015). In addition to the prior patents, the subject matter in claims 73, 81, 90 and 91 is disclosed in provisional application serial number 62/387,420 (filed on 12/24/2015). The subject matter of claims 72, 75-77 and 79, although supported in the prior patents, is not supported in the provisional applications because none of them disclose the recited amnio acid sequences, progestogens or gravidity and fetal gender; thus, these claims have a filing date of 06/17/2016. In summary, the effective filing date of claims 71, 74, 78, 80 and 82-89 is 06/19/2015, the effective filing date of claims 73, 81, 90 and 91 is 12/24/2015 and the effective filing date of claims 72, 75-77 and 79 is 06/17/2016.
Drawings
This acknowledges the petition filed under 37 CFR 1.84(a)(2) to allow color drawings (Figures 1-8, 10-19, 21-30, 34, 37-40, 42, 44-67, 106, and 108-111) was granted on 07/31/2024.
Claim Interpretation
The term “IBP4/SHBG” is interpreted as a ratio of IBP4 to SHBG.
The term “reversal value” is interpreted as defined in the instant specification at paragraph [00159]: “[t]he term ‘reversal value’ refers to the ratio of the relative peak area of an up-regulated analyte over the relative peak area of a down-regulated analyte and serves to both normalize variability and amplify diagnostic signal.
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 72 and 73 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 72 depends upon now canceled claim 1, therefore, the metes and bounds of claim 72 cannot be known. The claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant (see MPEP 2171). Claim 73, which depends upon claim 72, is hereby included in this rejection for depending upon an indefinite claim without resolving the indefiniteness.
Double Patenting
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.
US Patent 11,987,846
Claims 71-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,987,846 in view of Booth et al. (Growth Hormone & IGF Research 2000, 10, 224–229) and Hickok et al. (WO2014/144129). Although the instant case is a division of 17/189,048/US Patent 11,987,846, the prohibition against nonstatutory double patenting rejections under 35USC 121 does not apply because the restriction requirement issued in the ‘048 case was a species election requirement and Applicant elected the species of IBP4 and SHBG, to which the instant claims are also drawn. In other words, the instant claims are not consonant in scope with the original claims subject to restriction in the parent (see MPEP 804.02(B)).
Both claim sets are drawn to methods for providing prophylactic treatment of preterm birth in a pregnant human patient. The steps enumerated in the claims of the reference patent recite (i) measuring isolated biomarkers comprising IBP4 and SHBG in a biological sample (e.g., whole blood, plasma, serum, amniotic fluid, vaginal secretions, saliva, and urine), wherein measuring comprises subjecting the biological sample to a proteomics work-flow comprised of mass spectrometry (MS); (ii) calculating a risk score using a reversal value for IBP4/SHBG; and (iii) administering to said patient with a risk score above a reference a treatment regimen comprising a progesterone treatment, cervical cerclage, serial cervical length measurements, or an antenatal corticosteroid, wherein said progesterone treatment comprises administration of progestogen, 17-α hydroxyprogesterone caproate (by injection), or vaginal progesterone (in gel form), wherein said treatment regimen further comprises administration of cervical pessaries and wherein said sample is obtained between 19 and 21 weeks of gestational age.
The claims of the reference patent also recite the treatment comprises enhanced monitoring and clinical management regimen compared to a pregnant human patient not at risk for preterm birth comprising one or more of (a) more frequent prenatal care visits, (b) enhanced education regarding signs and symptoms of early preterm labor, or (c) alteration of treatment for diabetes and/or high blood pressure and an initial step of detecting a measurable feature for one or more risk indicia, wherein said risk indicia is selected from the group consisting of Body Mass Index (BMI), wherein said BMI is greater than 22 and less or equal to 37 kg/m2, gravidity and fetal gender. The claims of the reference patent recite that the proteomic work-flow comprises quantification of a stable isotope labeled (SIS) surrogate peptide of said biomarkers and said MS is selected from the group consisting of the same options as set forth in instant claims 87 and 88.
The differences between the claim sets are as follows. First, the claims of the reference patent require the measuring and calculating steps, while the instant claims recite that the patient has been identified for treatment by the measuring and calculating steps. Nevertheless, the more affirmatively recited method steps in the claims of the reference patent anticipate the instantly claimed methods. Second, the claims of the reference patent do not recite the biomarker amino acids sequences as recited in instant claims 72, 73, 90 and 91. Nevertheless, the claims of the reference patent disclose measuring biomarkers comprising IBP4 and SHBG and subjecting them to MS (see claim 1). Using the specification of the reference patent as a lexicon disclose biomarkers listed in Table 26 (column 19, lines 56-60), including QCHPALDGQR and IALGGLLFPASNLR. Furthermore, an SHBG peptide comprising IALGGLLFPASNLR was purified via mass spectrometry (see Table 54, paragraph [00238] at p. 154 of Hickok and colleagues). In addition, an IGFBP-4 peptide comprising QCHPALDGQR, was purified via mass spectrometry (see P4 of Booth et al., p. 225, right column, Figure 1). When read in the light of the prior art, the claims reciting the sequences of the peptide biomarkers are not patentably distinguishable over the claims of the reference patent.
Thus, the instant claims are not patentably distinguishable over those of the reference patent.
Application No. 18/560,831
Claims 71-91 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 23, 37, 39, 41, 43, 49-51, 54-57, 62, 65, 67, 68, 70, 72, 78, 111, 114-117, 125, 133-136, 138, 140, 143, 144, 146-148 and 151 of copending Application No. 18/560,831 in view of Booth et al. (Growth Hormone & IGF Research 2000, 10, 224–229) and Hickok et al. (WO2014/144129). The claims of the reference application recite methods of determining probability for preterm birth in a pregnant female comprising steps of measuring via the same methods recited in instant claims 86-88 in a biological sample (e.g., whole blood, plasma, serum, saliva, urine, amniotic fluid or cervical vaginal fluid) at least one reversal group comprising at least three pairs of biomarkers selected from the group consisting of IBP4/SHBG, IBP4/TETN, EGLN/SHBG, EGLN/TETN, PRL/SHBG, and PRL/TETN and determining a reversal value for each measured reversal group of biomarkers, wherein said reversal value exhibits a change between pregnant females at risk for pre-term birth and term controls and wherein the third reversal pair and the second reversal pair are not the same.
The claims of the reference application also recite determining body mass index (BMI), as well as one or more risk indicia to combine with the measurement of said reversal group or reversal value of biomarkers into a test score that, when compared to a reference score, exhibits a change in score between pregnant females at risk for pre-term birth and term controls expressed as a risk score. The claims of the reference application recite a composition or panel comprising a reversal group of recited biomarkers as well as methods of treatment, including cervical cerclage, administration of 17-α hydroxyprogesterone caproate, vaginal progesterone gel, antenatal corticosteroids, cervical pessaries, or elevated care.
The differences between the claim sets are as follows. The claims of the reference application do not recite the biomarker amino acids sequences as recited in instant claims 72, 73, 90 and 91. Nevertheless, the claims of the reference patent recite measuring biomarkers comprising IBP4 and SHBG and subjecting them to MS. Using the specification of the reference application as a lexicon, the biomarkers are defined in Tables 2 and 3 as including QCHPALDGQR and IALGGLLFPASNLR. Furthermore, an SHBG peptide comprising IALGGLLFPASNLR was purified via mass spectrometry (see Table 54, paragraph [00238] at p. 154 of Hickok and colleagues). In addition, an IGFBP-4 peptide comprising QCHPALDGQR, was purified via mass spectrometry (see P4 of Booth et al., p. 225, right column, Figure 1). When read in the light of the prior art, the claims reciting the sequences of the peptide biomarkers are not patentably distinguishable over the claims of the reference application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. While Pawlowski et al. (WO 2012/170711, published 13 December 2012—on IDS filed 12/30/2021) teach the detection of IGFBP-4 and SHBG (among others) in maternal serum to predict disease, including adverse pregnancy outcomes such as preterm birth (see p. 13, paragraph [0060]; Table at p. 15, the row entitled “Pregnancy related physiological states, conditions, or affiliated diseases: genetic risk, adverse pregnancy outcomes”; p. 64, paragraph [00279]; p. 67, paragraph [00292]; Table at p. 86, p. 87, p. 88, p. 89, (under “Disease Markers”) using proteomic techniques (see p. 14, paragraph [0064]; p. 108, paragraph [00378]; p. 109, paragraph [00381]), they do not teach the calculation of a risk score based upon a reversal value as is required in the instant claims.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 5712720911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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