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 January 14, 2026, and the Request for Continued Examination filed January 28, 2026, are each acknowledged.
Claims 1-31 were pending. Claims 1, 4 and 8-20 are being examined on the merits. Previously withdrawn claims 2-3 and 6-7 are rejoined, and are also being examined on the merits. Claim 5 is canceled. Claims 21-31 remain withdrawn.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 14, 2026 has been entered.
Election/Restrictions
Claim 1 is allowable. The election of species requirement between the species of groups (a), (b) and (c) of the Group I invention, as set forth in the Office action mailed on July 8, 2022, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The election of species requirement as to the Group I invention is hereby withdrawn, and claims 2-3 and 6-7 are rejoined.
However, regarding the restriction requirement, as set forth in the Office action mailed on July 8, 2022, claims 21-31, directed to Groups II and III remain withdrawn from consideration because they do not require all the limitations of an allowable claim.
Response to Arguments
Applicant’s arguments filed January 22, 2026 have been fully considered.
All of the previously made rejections are WITHDRAWN in view of Applicant’s arguments
and amendments to the claims.
Response to arguments regarding prior art rejections
The Examiner agrees that the prior art does not teach or suggest the instant amendment to claim 1 reciting “the capturing comprising depleting the sample of CD45+ cells and selecting TfR-positive/EpCAM-negative/CD45-negative cells”. The Examiner also agrees with Applicant’s characterizations of the teachings of the cited references as they relate to the instant claim 1 amendment, and agrees with Applicant’s conclusions as to why the amended subject matter is not taught or suggested by the prior art (Remarks, pp. 8-9).
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(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, 6-7 and 9 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 limitations “a primer comprising at least 15 nucleotides of a SEQ ID
NO: 7 sequence and a primer comprising at least 15 nucleotides of a SEQ ID NO: 8 sequence”. Claim 1, from which claim 2 depends, requires “a primer according to the sequence as set forth in SEQ ID NO: 7 and a primer according to the sequence as set forth in SEQ ID NO: 8”. Thus, claim 1 recites one molecule corresponding to SEQ ID NO: 7 and one molecule corresponding to SEQ ID NO: 8, while claim 2 recites a genus of molecules corresponding to SEQ ID NO: 7 or any other molecule that shares at least 15 nucleotides of SEQ ID NO: 7, and a genus of molecules corresponding to SEQ ID NO: 8 or any other molecule that shares at least 15 nucleotides of SEQ ID NO: 8. Since claim 2 comprises an entire genus of primers corresponding to each SEQ ID NO, claim 2 does not further limit claim 1 and is in improper dependent form. Claim 3 is rejected with corresponding reasoning as to SEQ ID NO: 9, and claims 6-7 are rejected with corresponding reasoning as to SEQ ID NOs: 15-16 and 17, respectively.
Claim 9 recites the limitation “wherein capturing … comprises isolating cells that express transferrin receptor”. Since claim 9 depends from claim 1, and since claim 1 has been amended to require isolating cells that express transferrin receptor, claim 9 does not further limit claim 1, and is in improper dependent form.
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.
Allowable Subject Matter and Withdrawn Claims
Claims 1, 4, 8, 10-20 are allowed.
Claims 2-3, 6-7 and 9 are rejected under 35 USC § 112(b), indefiniteness, but are free of the art.
Withdrawn claims 21-31 are not eligible for rejoinder. The Examiner suggests canceling the withdrawn claims.
Conclusion
Claims 1-4 and 6-20 are being examined. Claims 1, 4, 8 and 10-20 are allowed. Claims 2-3, 6-7 and 9 are rejected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
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