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
Newly amended claims appear to be directed to species combinations that are independent or distinct from the invention originally claimed for the following reasons: the claims have been amended to recite “an amount of biomarkers of a biomarker panel in said sample, the biomarker panel comprising (i) FAM20A and OLAH; and (ii) ITGA7; or MMP9; or ADM; or TDRD9; or CD177…”. The claims originally required the combination of FAM20A and OLAH be assayed, however the amendment to “an amount of biomarkers of a biomarker panel” appears to allow for a single biomarker from (i) or (ii), or a combination of the recited biomarkers that does not require both FAM20A and OLAH.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, combinations of biomarkers that do not include both FAM20A and OLAH are withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The election of species between the combination of FAM20 and OLAH with any of the additional biomarkers in the claims is withdrawn. Claims 60, 62, and 63 are rejoined and examined herein, as necessitated by amendment.
Any rejection not reiterated, is withdrawn in view of the amendments to the claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 49-51 and 55-67 are pending in the instant application. The following rejections are either reiterated or are newly added as necessitated by the amendment dated 12/30/2025. This action is FINAL.
Duplicate Claims Warning
Applicant is advised that should claim 64 be found allowable, claim 66 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
112(b)
Claims 49-51 and 55-67 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
A) The claims have been amended to recite “an amount of biomarkers of a biomarker panel in said sample, the biomarker panel comprising (i) FAM20A and OLAH; and (ii) ITGA7; or MMP9; or ADM; or TDRD9; or CD177…”. The claims originally required the combination of FAM20A and OLAH be assayed, however the amendment to “an amount of biomarkers of a biomarker panel” is confusing because it is not clear which biomarkers from (i) and (ii) are required. It is not clear if the claim can be drawn to a single biomarker from (i) or (ii), or if it requires both FAM20A and OLAH, and one of the biomarkers in (ii). Accordingly, the metes and bounds of the claims are unclear.
B) The claims alternately refer to “biomarkers”, a “biomarker panel”, a “sepsis biomarker panel”, and a “SIRS biomarker panel”. This creates confusion because the repeated recitation of “wherein no more than 21 biomarkers are assayed” in different steps of the independent and dependent claims is unclear. It is not clear if the upper limit of 21 assayed biomarkers refers to a) all of the biomarkers assayed in the entire method-including the different biomarker panels, b) if it refers to the number of biomarkers assayed in a particular step (that is, not the method as a whole), or c) if it refers to the biomarkers in each panel. If embodiment b) or c) is what is intended, it is noted that dependent claims 60, 62, or 63 do not further limit the independent claims 49 and 61 in this situation. If embodiment a) is intended, due to the recitation of the different biomarker panels, the phrase “no more than 21 biomarkers” in the dependent claims lacks sufficient antecedent basis. All of the claims are included in the rejection due to the inclusion of the vague and confusing recitation in all of the claims. This confusion in turn renders the metes and bounds of the scope of claims 49, 61, and 66-67 unclear in terms of the upper limit of assayed biomarkers encompassed by the claims. It is suggested that the claims be amended to refer to a “total biomarker panel” of “no more than 21 assayed biomarkers in the method”, for example, and to amend the dependent claims to refer to a SIRS or sepsis subpanel of the total biomarker panel.
C) Claim 62 is indefinite in the administering step. Step d requires “identifying a concentration difference”, while step e recites “administering a therapy”. However the additional “wherein” recitation in step e renders the claim indefinite because it is not clear if therapy is only administered if there is an elevated concentration difference or if the therapy is administered regardless of what the concentration difference is. While the claim recites “detecting a concentration difference” between a patient sample and control and further recite “elevated”, the claims do not make clear if the patient sample is elevated relative to the control or vice versa. As such the metes and bounds of the claims are unclear.
112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
.
Claims 60, 62, and 63 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims are dependent on independent claims 49 and 61, respectively. Claims 49 and 61 appear to be limited to no more than 21 biomarkers assayed, however the dependent claims appear to allow for assaying more than 21 biomarkers in total due to the repeated phrase “wherein no more than 21 biomarkers are assayed” in different steps of the dependent claims. See 112(b) rejection above for an explanation of the possible embodiments encompassed by the amended claim recitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
Claims 49-51, 54-60, and 65-67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emonts as evidenced by number Genbank Accession number BC036222.1 and Genbank Accession number BC050372.
It is noted that the claim 49 has been amended to recite “no more than 21 biomarkers are assayed”. However, given that this recitation is also repeated at different steps in dependent claims pertaining to different biomarker panels, it appears that the claimed methods allow for more than 21 total biomarkers assayed. Since neither the specification nor the claims clearly define the maximum number of assayed biomarkers in the entire method, or define what is essential (claim 67), the claims have been given their broadest reasonable interpretation to encompass the teachings of Emonts.
With regard to claim 49, Emonts teaches obtaining blood samples (claims 50 and 51) from patients with meningococcal sepsis (systemic inflammatory condition) and performing gene expression analysis on the nucleic acids (claim 54) in the sample using the Affymetrix HG U133 2.0 microarray platform (see Methods). Since the Affymetrix HG U133 2.0 arrays contain oligonucleotide probes (claim 55) for detecting expression of FAM20A, OLAH, and ADM, Emonts inherently teaches assaying for the amount of the biomarkers. It is noted that the claim is considered open and therefore, allows for the analysis of additional biomarkers. Although the claims also recite “selected from the group consisting of”, this is considered open as the specification does not teach what the basic and novel characteristics of the invention are in terms of biomarkers for analysis.
With regard to claims 56 and 58, Genbank accession number BC036222.1 teaches the sequence of FAM20A, which comprises SEQ ID NO: 94. Therefore, probes to FAM20A necessarily having at least 80% sequence identity to SEQ ID NO: 94.
With regard to claims 57 and 59, Genbank accession number BC050372.1 teaches the sequence of OLAH, which comprises SEQ ID NO: 146. Therefore, probes to OLAH necessarily have at least 80% sequence identity to SEQ ID NO: 146.
Therefore, the teachings of Emonts anticipates the claimed invention This rejection can be overcome by clearly reciting the upper limit of the number of biomarkers assayed in the entire method, not just particular steps. For example, the claims could be amended to refer to a “total biomarker panel” of “no more than 21 assayed biomarkers in the method”, and to amend the dependent claims to refer to a SIRS and a sepsis subpanel of the total biomarker panel.
Applicants arguments regarding the rejection over Emonts have been thoroughly and carefully considered but were not found persuasive to overcome the rejection for the reasons set forth herein.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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