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
Applicant’s election without traverse of Group II (claims 39-50) in the reply filed on 03 September 2025 is acknowledged.
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 39 and 46-49 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 39 recites the limitation "the enclosed body" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claims 46 and 49 contain the trademark/trade name IRDye® 800CW. 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 a specific NIR fluorophore and, accordingly, the identification/description is indefinite. Claims 47-48 are rejected for depending on claim 46.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 39-41, 43, 44, and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madar et al (US 2004/0092825).
Regarding claim 39, Madar discloses:
A tracer lesion detection system (Fig. 2), comprising: a tracer (¶0077); and a detection device (300; Fig. 3A), including: a plurality of tracer sensors (330; ¶0140 – an array of sensors), configured to detect measurement values both at a surface and underneath the surface of a gastrointestinal tract (¶0051); a battery (360; ¶0155 – power supply), configured to power the plurality of tracer sensors (330); a memory (340; ¶0151), configured to receive measurement values detected by the plurality of tracer sensors (¶0151-0153); and a transmitter (350; ¶0154), configured to transmit measurement values detected by the plurality of tracer sensors (330) to an external device (250) after the enclosed body has passed entirely through the gastrointestinal tract (¶0154), wherein the detection device (300) further includes a steering feature (384) that ensures the detection is oriented in an intended direction while passing through the gastrointestinal tract (¶0160), wherein the plurality of tracer sensors (330) is further configured to trigger release of a drug within the gastrointestinal tract (¶0157), and wherein the plurality of tracer sensors (330) further estimate distances between the enclosed body and walls of the gastrointestinal tract for normalizing signals (¶0121).
Regarding claim 40, Madar discloses:
The tracer lesion detection system of claim 39, wherein the plurality of tracer sensors (330) is configured to detect a plurality of tracer spikes of the tracer (¶0152 – measures and processes intensity of signal).
Regarding claim 41, Madar discloses:
The tracer lesion detection system of claim 40, wherein the measurement values detected by the plurality of tracer sensors comprise a series of data points including the plurality of spikes (¶0152).
Regarding claim 43, Madar discloses:
The tracer lesion detection system of claim 39, further comprising a hyperspectral camera (¶0140 – miniature color video cameras), configured to selectively capture images or video of the gastrointestinal tract when triggered by a tracer signal (¶0140).
Regarding claim 44, Madar discloses:
The tracer lesion detection system of claim 39, wherein the plurality of tracer sensors trigger release of the drug within the gastrointestinal tract via at least one of light, hyperthermia, ultrasound, or pH change (¶0111 – positioning is determined by fluorescence signal, which is a type of light).
Regarding claim 50, Madar discloses:
The tracer lesion detection system of claim 39, wherein the tracer is administered to a patient orally or by intravenous (IV) injection (¶0077).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Madar in view of Meron et al (US 2010/0137686).
Regarding claim 42, Madar discloses the tracer lesion detection system of claim 39 but is silent regarding “the steering feature is at least one of a long flexible tail and an expandable polymer.” However, Meron teaches a capsule with a detector (Fig. 1A), thus being in the same field of endeavor, with a steering feature in the form of a hydrogel filling that can swell (¶0066-0067), forming an expandable polymer. This polymer allows an outer coating (200; Fig. 9A) to burst and expose control appendages (210). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Madar to incorporate the steering feature and its expandable polymer of Meron as such a modification is the result of a simple substitution of one known element (the steering feature of Meron) for another known element (the magnetic or rotor steering feature of Madar) to obtain predictable results (controlling the movement of an ingested detector capsule).
Claims 45 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Madar in view of Heuveling et al (NPL, “Nanocolloidal albumin-IRDye 800CW”, attached).
Regarding claim 45, Madar discloses the tracer lesion detection system of claim 39 but is silent regarding “the tracer includes at least one of near-infrared fluorescence (NIRF) labeled liposomal nanoparticles or NIRF nanovesicles.” However, Heuveling teaches a tracer for medical use, thus being in the same field of endeavor, in the form of a fluorescent dye IRDye 800CW coupled to human serum albumin particles, forming nanocolloidal albumin-IRDye 800CW (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have used near-infrared fluorescence (NIRF) labeled liposomal nanoparticles or NIRF nanovesicles as taught by Heuveling as such a modification would be the result of a simple substitution of one known element (the tracer of Heuveling) for another known element (the fluorescent label of Madar) to obtain predictable results (tracing and tracking cancerous cells).
Regarding claim 49, Madar in view of Heuveling discloses the tracer lesion detection system of claim 39, but is silent regarding “the tracer is NIRF labeled polymeric nanoparticles, wherein the NIRF labeled polymeric nanoparticles are selected from: IRDye® 800CW labeled hyaluronic acid nanoparticles, and IRDye® 800CW labeled Albumin nanoparticles.” However, Heuveling teaches a tracer for medical use in the form of a fluorescent dye IRDye 800CW coupled to human serum albumin particles, forming nanocolloidal albumin-IRDye 800CW (Abstract). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have used near-infrared fluorescence (NIRF) labeled liposomal nanoparticles as taught by Heuveling as such a modification would be the result of a simple substitution of one known element (the tracer of Heuveling) for another known element (the fluorescent label of Madar) to obtain predictable results (tracing and tracking cancerous cells).
Claims 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Madar in view of Du et al (“Nuclear and Fluorescent Labeled PD-1-Liposome-DOX-64Cu/IRDye800CW”, attached).
Regarding claim 45, Madar discloses the tracer lesion detection system of claim 39 but is silent regarding “the tracer includes at least one of near-infrared fluorescence (NIRF) labeled liposomal nanoparticles or NIRF nanovesicles.” However, Du teaches a tracer for medical use, thus being in the same field of endeavor, in the form of a mixture of DSPC, cholesterol, DSPE-IRDye800CW, DSPE-DOTA, and DSPE− PEG-PD-1 with doxorubicin mixed in (page 3979, column 2). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have used near-infrared fluorescence (NIRF) labeled liposomal nanoparticles as taught by Du as such a modification would be the result of a simple substitution of one known element (the tracer of Du) for another known element (the fluorescent label of Madar) to obtain predictable results (tracing and tracking cancerous cells).
Regarding claim 46, Madar in view of Du discloses:
The tracer lesion detection system of claim 45, wherein the NIRF-labeled liposomal nanoparticles (taught by Du in rejection of claim 45) comprises a mixture of lipids selected from the group consisting of 1,2-Dipalmitoyl-sn-glycero-3-phosphocholine (DPPC; 16:0 PC), 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC 18:0), (w-methoxy-polyethylene glycol 2000)-N-carboxy-1,2-distearoyl-sn-glycero-3-phosphoethanolamine (PEG.sup.2000-DSPE) (page 3979, column 1) and combinations thereof, and a NIRF labelling agent selected from the group consisting of IRDye® 800CW-DSA, near-infrared (NIR) nanoparticles, and combinations thereof, wherein the IRDye® 800CW-DSA is a conjugate of IRDye® 800CW with a lipid of N,N-Distearylamidomethylamine (DSA) (page 3979, column 1).
Regarding claim 47, Madar in view of Du discloses:
The tracer lesion detection system of claim 46, wherein the NIRF-labeled liposomal nanoparticles further comprises a drug and/or an active pharmaceutical ingredient (API) (page 3979, column 2 – DOX is doxorubicin).
Regarding claim 48, Madar in view of Du discloses:
The tracer lesion detection system of claim 47, wherein the drug or active pharmaceutical ingredient (API) is chemotherapeutic such as doxorubicin (page 3979, column 2 – DOX is doxorubicin).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783