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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 February 2026 has been entered.
Response to Amendments/Arguments
Applicant’s amendments have rendered the rejection under 35 USCC §112(b) moot, and the rejection is withdrawn.
Applicant’s arguments, filed 11 February 2026, with respect to the rejection(s) of the pending claims, as amended, over Gaitas and Khandare have been fully considered and are partially persuasive.
Applicant argues at page 9 that the references fail to teach an apparatus that treats the blood with a method that results in the blood leaving the device has a “hemolysis index in the range of 10-5 to 10-2 %.” However, Applicant’s arguments are narrower than the claimed apparatus. Applicant sets forth an apparatus with a channel and glass beads. Applicant argues that a channel with glass beads yields a specific hemolysis index, but does not set forth, in the claims, how this index is achieved. The limitation amounts to a recitation of the results of a procedure, but a procedure has not been claimed. The recitation of the desired hemolysis index does not further limit the structure of the claimed apparatus, and does not patentably distinguish over the cited prior art.
Applicant argues at page 10 that the present inventors discovered that the particle size of the adsorbent bead affected the performance of the bead, which is a new and unexpected result of changing the particle size. However, the Specification does not provide sufficient evidence that alteration of the bead size unexpectedly affected performance of the bead.
Applicant argues that Gaitas discloses a wide range of channel dimensions, flow rates, and channel connections. A wide range of dimensions and flow rates does not teach away, nor disqualify the use of Gaitas to render the claimed invention as obvious.
Applicant argues that Khandare does not teach a device for removing CTC from a patient, teaching only capture of CTC under static conditions. The conditions of the capture do not structurally limit the apparatus as claimed by Applicant.
Applicant argues that the newly claimed dimensions in claims 26-33 provide unexpected results. However, the Specification contains insufficient disclosure of such unexpected results.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0334312 to Gaitas et al in view of US 2021/0106742 to Khandare.
In the specification and figures, Gaitas discloses the apparatus and method substantially as claimed by Applicant. With regard to claim 1, Gaitas discloses a hemocompatible device 102/103 (blood is flowed back to the patient, demonstrating hemocompatibility) that may capture and remove a circulating tumor cell (CTC) from blood of a patient 101, wherein the device comprises a channel/reservoir 103 with adsorbent glass beads 104 with at least one ligand that binds to the circulating tumor cell, and returns blood to the patient (see FIGS 1-4, ¶0011, 0014, 0056).
Gaitas discloses that the beads are smaller than those claimed by Applicant (1um to 1mm). However, Khandare discloses an apparatus for removing CTC from a patient comprising a system with glass beads coated with ligands that capture CTC, wherein the glass beads may be 2mm (see ¶0010, 0030, 0082, Table 1). It has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(B).
Applicant’s recitation of the hemolysis index does not structurally limit the claimed apparatus and does not patentably distinguish over the cited prior art.
With regard to claims 2-3, 5, Gaitas discloses that the entrapment chamber 103 may comprise spirals and pillars (columns, see ¶0012).
With regard to claim 14, Gaitas discloses that more than one type of ligand may be provided on the glass beads (see ¶0014).
With regard to claim 15, 24, and 25, Gaitas fails to suggest the use of the claimed materials in the device. However Khandare discloses a hemocompatible treatment device with adsorbents that may be functionalized and reacted with ligands (see ¶0088). The functionalizing agent may comprise APTES, GPTMS, GPTES, MPTMS, or MPTES, and the ligand may be anti EpCAM or transferrin (see ¶0025, 0027). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the adsorbents as disclosed by Khandare in the treatment device suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
With regard to claim 17, the type of cancer targeted does not add patentable limitations to the structure of the claimed apparatus, and does not distinguish over the prior art. Nonetheless, Khandare discloses that the apparatus may be used to treat colon cancer (see ¶0311-0312), demonstrating that such usage is known in the art.
With regard to claims 29-33, Applicant is setting forth various dimensions of the claimed apparatus. However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(B).
With regard to claims 34 and 35, Gaitas discloses the method as claimed by Applicant wherein blood from a cancer patient is passed through the apparatus suggested by Gaita and Khandare, counting captured cells (thereby providing an estimate of cells remaining within the treated blood, and returning the treated blood to the patient (see ¶0015, 0068). With regard to the method preserving the morphology and viability of the red blood cells, Applicant is setting forth a result of a claimed procedure—if the blood is treated in the prior art by the same steps as claimed by Applicant, it follows naturally that the claimed result is achieved by the prior art.
With regard to claim 36, Gaita discloses that the blood may be processed in a time chosen to maximize capture efficiency, which may be ~30-60 minutes (see ¶0067).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 10 March 2026