DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 11 and 12 contain the trademark/trade name RGD535, RGD525, FullCure 720, TangoPlus, TangoBlackPlus, TangoBlack and TangoGrey. 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 the stiff and compliant materials and, accordingly, the identification/description is indefinite.
Claims 10-13, 16 and 17 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. Claims 10-12, 16 and 17 recite “stiff or rigid,” “stiffer” or “compliant.” It is unclear what qualifies as stiff, rigid or compliant. These terms have not been defined in the specification, and as they are relative terms, are indefinite. Claims 13 and 16 recite “gel-like” or “very soft tissue.” These terms are similarly indefinite because they have not been defined such that two people of ordinary skill may have different ideas of what qualifies as gel-like or very soft tissue. For purposes of examination, the claims will be interpreted such that many materials will satisfy the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-7, 13 and 18 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 2006/0105011 Sun et al.
Regarding claim 1, Sun teaches a physical reconstruction of a body part (paragraph 0002) comprising
a digital material (paragraph 0035) formed with a combination of at least two modeling materials (hydrogels) having different mechanical properties (viscosity, paragraph 0037),
deposited by multi-material additive manufacturing (paragraph 0037),
wherein said combination of modeling materials is configured to mimic a desired mechanical and/or physical property of the body part on a per voxel basis (paragraph 0037),
wherein the voxels are defined based on image data of the body part (paragraph 0035).
Regarding claim 2, Sun teaches that said at least two modeling materials are deposited based on bitmap images (paragraph 0035) defining the body part (paragraph 0037), wherein each pixel in the bitmap image is represented by a plurality of drops deposited by multi- material additive manufacturing, the plurality of drops defining the digital material (paragraph 0047, microdroplet).
Regarding claim 3, Sun teaches that the digital material is defined by a ratio between the at least two modeling materials (paragraph 0048).
Regarding claim 4, Sun teaches that a pattern of deposition of the at least two modeling materials defining a digital material is pseudo random (paragraph 0049, spraying).
Regarding claim 5, Sun teaches that a pattern of deposition of the at least two molding materials defining a digital material is a structured pattern (paragraph 0049, droplet deposition building a scaffold).
Regarding claim 6, Sun teaches that the digital material is defined over a plurality of layers (paragraphs 0059 and 0060, z-axis building).
Regarding claim 7, Sun teaches that the different mechanical properties of said modeling materials are stiffness and flexibility (viscosity, paragraph 0037).
Regarding claim 13, Sun teaches that one of the at least two modeling materials is a gel, wherein the gel is capable of mimicking very soft tissue (paragraph 0014).
Regarding claim 18, Sun teaches that the image data is received from one or more imaging devices selected from a group including a CT scanner and MRI (paragraph 0039).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19 and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0105011 Sun et al.
Regarding claims 19 and 20, Sun teaches the voxels (paragraph 0037).
Please note, claims 19 and 20 include product by process language (raster to raster translation). The discussion above tends to show the claimed product is the same as what is taught by the prior art. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” (In re Thorpe, 227 USPQ 964,966). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to Applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983), MPEP 2113. In this case, the process of *** appears to form the same product as that of the instant invention. Applicant may provide evidence proving an unobvious difference between the products.
Claims 8-12, 14, 16 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0105011 Sun et al as applied to claim 1 above, and further in view of WO 2011/135496 Dikovsky et al.
Regarding claims 8-10, Dikovsky does not explicitly teach that RGD535 is stiff and the Tango materials are compliant, or the elastic moduli of the materials. However, as Sun in view of Dikovsky satisfies all of the previous limitations, the combination’s materials are indistinguishable from the claimed materials (as-filed spec page 16, lines 6-18). Therefore, it is reasonable to expect that the combination would also have an elastic modulus of 0.01 MPa to 3 Gpa. “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established” (MPEP 2112.01 Section I).
Additionally, when the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention, the examiner has basis for shifting the burden of proof to Applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP §2112, Section V. In this case, Sigmund appears to form the same product with the same structure as that of the instant invention. Applicant may provide evidence proving a difference between the products.
Regarding claims 11-12, Sun teaches the physical reconstruction, but does not teach the specific materials or elastic modulus. Dikovsky teaches additive manufacturing of freeform objects, including the use of RGD535, TangoPlus, TangoBlack and TangoBlackPlus (paragraph 0034, lines 10-19). It would have been obvious to one of ordinary skill in the art before the time of invention to include the materials of Dikovsky in the product of Sun because these materials have improved toughness (page 41), impact resistance, and load properties (page 43).
Regarding claim 14, Sun teaches the physical reconstruction, but does not teach the liquid material. Dikovsky teaches additive manufacturing of freeform objects, including wherein one digital material is gel-like (“soft” page 34, lines 10-19 and page 43, lines 14-15, where the soft gel-like material taught reads on “liquid”), and the liquid material is capable of remaining in a liquid state during the entire additive manufacturing process. It would have been obvious to one of ordinary skill in the art before the time of invention to include the liquid material of Dikovsky in the product of Sun because this allows for a greater variety of potential applications.
Regarding claim 16, Sun teaches the physical reconstruction, but does not teach the encapsulation arrangement. Dikovsky teaches additive manufacturing of freeform objects, including wherein one digital material is gel-like (“soft” page 34, lines 10-19 and page 43, lines 14-15), and surrounded by (figure 2A) a stiffer material (page 34, lines 10-19). It would have been obvious to one of ordinary skill in the art before the time of invention to include the encapsulation structure of Dikovsky in the product of Sun because this allows for a greater variety of potential applications.
Regarding claim 17, Dikovsky teaches that the stiffer material is configured to encapsulate the liquid (figure 2A, where the soft gel-like material taught reads on “liquid”).
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2006/0105011 Sun et al in view of WO 2011/135496 Dikovsky et al as applied to claim 14 above, and further in view of JP 3583142 (hereinafter JP’142).
Regarding claim 15, Sun in view of Dikovsky teaches the physical reconstruction with a liquid material. Neither Sun nor Dikovsky teaches PEG400. JP’142 teaches a tissue regeneration matrix where PEG 400 is used (page 9, 5th paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to include the PEG400 of JP’142 in the product of Sun in view of Dikovsky because this material is biocompatible and has a low melting point (page 9, 5th paragraph).
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Megha M Gaitonde whose telephone number is (571)270-3598. The examiner can normally be reached Monday-Friday 8:30 am to 5 pm.
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, Frank Vineis can be reached at 571-270-1547. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHA M GAITONDE/Primary Examiner, Art Unit 1781
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