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 Claims
As directed by the amendment filed on 3 August 2023: claim(s) 1-61 have been cancelled, claim(s) 62-72 have been added. Thus, claims 62-73 are presently pending.
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]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 62-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, and 13-14 of U.S. Patent No. 10537689 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent anticipates the instant claims at least as follows:
Instant claims
Patent 10537689
62
1
63
2
64
3, 4
65
5
66
6
67
7
68
9
69, 70
14
71
13
Claims 62-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11759579 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because all the limitations of instant claim 62 are to be found in claim 1 of the Patent. The difference lies in the fact that the instant claims include more elements and are thus much more specific. Thus, the Patent claim 1 is in effect a "species" of the "generic" invention of the claim 62 of instant Application. It has been held that the generic invention is "anticipated" by the "species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 62 of the Application is anticipated by claim 1 of the Patent, it is not patentably distinct from the claim 1 of the Patent. The remaining claims are rejected at least due to their dependency upon a rejected claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
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