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 .
Status of the Application
The Amendment and Response filed July 31, 2026 is acknowledged.
Claims 1-4 and 6-31 were pending. Claims 1-4, 6-8, 11-20 and new claims 32-35 are being examined on the merits. Claims 9-10 and 21-31 are canceled.
Response to Arguments
Applicant’s arguments filed July 31, 2026 have been fully considered.
All of the previously made rejections are WITHDRAWN in view of Applicant’s arguments
and amendments to the claims.
Claim Interpretation
Claim 1 recites, in part, “detecting … full-length androgen receptor (AR-FL)”. The instant specification teaches that the cDNA sequence for the full-length androgen receptor is 3568 nucleotides in length (SEQ ID NO. 2, pp. 9-11). The instant specification also teaches that AR-FL can be detected using the primers of SEQ ID NOs. 7 and 8, which span the exon junction between exons 7 and 8 (Fig. 1A, p. 21: Table 2). Thus, performing PCR with SEQ ID NOs. 7 and 8 creates an amplicon which is much shorter than the 3568 full-length sequence.
For purposes of examination, in the claims, the limitation “full-length androgen receptor
(AR-FL)” is being interpreted in a nominal manner, as opposed to a descriptive manner. That is, the limitation is not being construed as being limited to describing all 3568 nucleotides (i.e., the full-length) of the androgen receptor. Rather, the limitation is being construed as a name for any subpart of or all of the particular 8 exon splice variant of the androgen receptor depicted in Fig. 1A. Thus, the “detecting … full-length androgen receptor (AR-FL)” limitation can be satisfied by detecting only a portion of the AR-FL.
Claim Rejections - 35 USC § 112
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 3, 7 and 32 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.
Claims 3, 7 and 32 each contain the trademark/trade name “FAM”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the source of a fluorophore and, accordingly, the identification/description is indefinite.
To overcome this rejection, the claims can be amended to either remove “FAM” or to replace it with its corresponding chemical name: “6-carboxyfluorescein”.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 2-3 and 6-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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.
Claim 2 recites the limitation “one or more droplet digital PCR reactions, each …
performed in a separate droplet comprising … SEQ ID NO: 7 … SEQ ID NO: 8 … and … SEQ ID NO: 9”. Claim 2 depends from claim 1, which requires “at least two of said different primer-/probe-sets are used concurrently in separate droplets”. Thus, claim 1 requires at least two reactions, while claim 2 only requires at least one reaction. Consequently, claim 2 does not incorporate all of the limitations of claim 1 and is in improper dependent form. Claims 3 and 6-7 are rejected with analogous reasoning.
To overcome this rejection, claims 2 and 6 could be amended to recite, e.g., “[t]he
method of claim 1, wherein at least one of the at least two said different primer-/probe-sets comprises … SEQ ID NO: [X] … SEQ ID NO: [Y] … and … SEQ ID NO: [Z] …”, or something similar, so that is clear that each of claims 2 and 6 require the “at least two” different primer-/probe-sets of claim 1 and further one of those two is limited to the enumerated SEQ ID NOs.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Prior Art and Allowable Subject Matter
Claims 1-4, 6-8, 11-20 and 32-35 are free of the art for the reasons already of record in the Non-Final Office Action mailed April 6, 2026 (p. 3, Response to arguments section).
Claims 2-3, 6-7 and 32 are rejected under 35 USC §§ 112(b) and/or (d), but are free of the art.
Claims 1, 4, 8, 11-20 and 33-35 are allowed.
Conclusion
Claims 1-4, 6-8, 11-20 and 32-35 are being examined. Claims 1, 4, 8, 11-20 and 33-35 are allowed. Claims 2-3, 6-7 and 32 are rejected.
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 CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
