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 .
Terminal Disclaimer
The terminal disclaimer filed on 29 April 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of:
Yoo; James J. et al. US 10537689 B2
Yoo; James J. et al. US 11759579 B2
has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 30 April 2026 have been fully considered but they are not persuasive.
Regarding the argument that “the Examiner is picking and choosing elements from unrelated embodiments presented in separate sections of the reference to allegedly arrive at the invention as claimed, in a manner that is not suggested by the teachings of Warren”, Warren discloses multiple features as embodiments that are mutually inclusive (“the invention is not limited to the specific embodiments disclosed hereinabove, and that many modifications and other embodiments are intended to be included within the scope of the invention” [0603]).
Regarding the argument that “to be anticipatory under section 102, a single reference must disclose all of the claimed elements ‘arranged as in the claim,’” Examiner notes that Warren discloses “The invention includes embodiments of a tool for in vitro or in vivo use in biological, tissue-engineering, and medical processes” wherein “all embodiments disclosed herein for application in vivo may suitably be adapted for in vitro use and for tabletop settings. Similarly, embodiments disclosed herein for in vitro application may also be used or adapted for use in vivo. The described embodiments are not to be viewed as limited to either in vivo or in vitro usage” ([0060]). Thus, Warren’s invention as a whole encompasses all of the disclosed embodiments. Specifically, Warren’s invention includes “a material dispenser 100”, “a material destroyer 200”, “an imaging device 500, a detector 600, and a location control device 800” and also “material remover 300”, “temperature controller 400”, “apparatus stabilizer 900”, and “therapeutic emitter 700” ([0060-0062]). These features all exist in a single invention where the elements 100-900 work together to control the invention and is arranged to function as claimed.
Regarding the argument that “There is no teaching in Warren, at paragraph [0369] or elsewhere in the reference, of an optical detector configured to perform detection of data to create a map of an area of interest of a patient, nor a dispenser operatively associated with the optical detector and configured to deliver cells and/or compositions to the area of interest of the patient based upon the data and/or the map, as claimed”, Warren discloses an optical detector configured to perform detection of data to create a map of an area of interest of a patient, and a dispenser operatively associated with the optical detector and configured to deliver cells and/or compositions to the area of interest of the patient based upon the data and/or the map, as discussed in the previous office action. “A desired tissue or bone construct” is an area of interest of a patient. Furthermore, Warren specifically discloses that “The CAD file enables the dispenser to follow the conformal surface precisely without direct surface contact. This precise control allows tight cross-section control as well as the ability to follow and write on rough, uneven surfaces, and up and over features without damaging or distorting them” ([0369]).
Regarding the argument that “Warren provides contact force-based methods for positioning a dispenser in the apparatus of Warren during deposition” and not “during detection as claimed”, it is noted that the features of Warren may be conducted in real time ([0016], [0064], [0099], [0106], [0373]) and that it is well known within the art that the optical detection methods account for movements of the patient. Furthermore, the phrase “during detection” is a statement of intended use or field of use and does not impart any limiting structure to the invention. Since Warren’s device is capable of performing the function of accounting for the movements of the patient in real time, Warren’s device is capable of performing the claimed function during detection. MPEP 2114 (II).
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 62 and 65-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warren et al. (US 20040253365 A1).
Regarding Claim 62, Warren discloses a delivery system ("apparatus and methods for depositing materials on a substrate" Abstract) comprising:
an optical detector ("detector 600 permits visualization through various spectroscopies including laser-induced fluorescence (LIF), time-resolved LIF, infrared (IR), Raman scattering, ultrasound, optical coherence tomography (OCT); and/or terahertz imaging interrogation to distinguish healthy and diseased tissues" [0060]) comprising a three-dimensional scanner ("OCT is an interferometric imaging technique that can provide detailed three-dimensional views of the subsurface microstructures of biological tissue" [0125]), wherein the optical detector is configured to perform detection of data to create a map of an area of interest of a patient ("provide detailed three-dimensional views of the subsurface microstructures of biological tissue" [0125]);
a depth detector ("Tactile sensors" [0287]) operatively associated with the optical detector ([0285-0291]; FIG.1) and configured to account for movement of the patient during the detection ("feedback signal may be used by a z-controller processor 3750 to control the z positioning of the dispenser 3700 via a z-controller step motor 3760" [0303]; "devices and methods for providing accurate positioning of the tip end of the tool with respect to the substrate, even a moving substrate, during the deposition process or other processes … Thus, small movements of the patient can be easily accommodated" [0373]);
a dispenser ("material dispenser 100" [0263]) operatively associated with the optical detector (see FIG. 5) and configured to deliver cells and/or compositions ("to deposit, the scaffold material, cells, growth factors, enzymes, saline wash, and a vacuum for extraction, as desired" [0263]) to the area of interest based upon the data and/or the map ("endoscopic tip end of the tool may "find" the desired area or position of interest" [0264]; "CT, OCT, MRI, or laser prescanning data could be used to generate a computer-aided design (CAD) model of the desired tissue or bone construct" [0369]);
a three-dimensional plotter ("planar location controller may be synchronized with the linear location controller so that the control device can selectively position the material dispenser 100 in xyz space" [0227-0228]) operatively connected with the three-dimensional scanner (FIGs. 4-7); and
a controller ("location control device 800" [0227]; FIG. 36) operatively connected with the dispenser ([0094]; "material dispenser further comprises at least one location control device 800" [0227-0228]).
Regarding Claim 65, Warren discloses the dispenser comprises a plurality of nozzles ("multiple discrete feed channels 120" [0276]).
Regarding Claim 66, Warren discloses one or more cartridges loaded with the cells and/or compositions ("material reservoir" [0278]), wherein the nozzles are in fluid communication with the one or more cartridges ("Each feed channel 120 within the dispenser may have its own reservoir that is remotely actuated to dispense a material through the feed channel. The integration of feed channels close to the dispensing nozzles" [0261-0264]; FIGs. 5-7).
Regarding Claim 67, Warren discloses the nozzles are configured for pressure-based delivery of the cells and/or compositions ("pump 148 that applies a positive pressure to material in the at least one feed channel 120" [0256]).
Regarding Claim 68, Warren discloses the cells and/or compositions comprise cells selected from the group consisting of cartilage cells, bone cells, muscle cells, vascular cells, skin cells, and combinations thereof ("cartilage, skin, and bone tissue replacements" [0066] & [0418]).
Regarding Claim 69, Warren discloses the area of interest is a closed wound ("treatment for wounds" [0139-0140]).
Regarding Claim 70, Warren discloses the area of interest comprises an injury or disease of the patient ("treatment of Alzheimer's disease, spinal cord injuries, or Parkinson's disease" [0065]).
Regarding Claim 71, Warren discloses a computing system ("computer to control the tool" [0095]) comprising:
a processor ("control circuitry may include, e.g., a microprocessor" [0311]); and
a memory ("memory cache" [0229]) coupled to the processor and comprising computer readable program code ("computer algorithms" [0122]; "routines" [0238]; "computation-based codes" [0344]; "program data" [0413]; "preprogrammed" [0422]; "programming" [0456]) that when executed by the processor causes the processor to perform operations comprising:
interpreting the data from the optical detector to form the map of the area of interest ("transform the image information obtained in the previous step into computer-aided design and manufacturing (CAD/CAM) program data. This transformation of images into machine language allows the images to be constructed by the HAT computer automation" [0413]);
transforming the map into a negative mold of the area of interest, wherein the mold comprises a plurality of Z-axis layers ("images are processed by computer algorithms and the resulting images appear as slices taken through the tissue … summed as a whole to replicate a 3D picture of the tissue or organ" [0120-0123]); and
overlaying each of the Z-axis layers with a series of lines ("planar location controller adapted to selectively position the tip orifice within both x and y dimensions (i.e., a plane)" [0227]), wherein the lines provide a path for the dispenser to deliver the cells and/or compositions to the area of interest ("planar location controller may be synchronized with the linear location controller so that the control device can selectively position the material dispenser 100 in xyz space" [0227-0230]).
Regarding Claim 72, Warren discloses a surgical device that is configured to provide the optical detector and/or the dispenser with access to the area of interest ("tool can be inserted into the subject's body through a surgical incision and positioned such that the tissue engineering material can be deposited at the target area within the subject's body" [0385]).
Regarding Claim 73, Warren discloses the surgical device is an endoscopic device ("endoscopic device" [0378]).
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.
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.
Claims 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Warren.
Regarding Claim 63, Warren fails to specify the depth detector comprises an infrared detector and/or a laser scanner. However, Warren teaches "piezoelectric sensors or optical means” may be used for feedback [0360]; and that "optical feedback sensor" may use IR ([0363]; "IR region of the spectrum can then be used" [0364]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Warren to incorporate the claimed limitations to suitably allow “positional control of the tool with respect to the target area” ([0060]) without damaging the surrounding tissue ([0061]).
Regarding Claim 63, Warren discloses the three-dimensional scanner is a hand-held laser scanner ("system includes the necessary power supplies, delivery mechanisms, laser, and computer to control the tool. An umbilical cord is connected to the system that can be handheld by a surgeon" [0095]).
Conclusion
THIS ACTION IS MADE FINAL. 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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights