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 .
DETAILED ACTION
This Office action is in response to the application filed on 01/16/2025. Currently claims 1-19 are pending in the application.
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.
Claim 4-5 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 pre-AIA the applicant regards as the invention.
Regarding claims 4-5, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
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 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. 103 that form the basis for the rejections under this section made 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 non-obviousness.
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 1-11, and 13-18 are rejected under 35 U.S.C.103 as being obvious over O'Sullivan et al (US Patent Application Publication Number 2020/0354542 A1), hereafter, referred to as “O'Sullivan”. It is noted that O'Sullivan qualifies as prior art under 35 U.S.C. 102(a)(2), as it is an application for patent published under 122(b), names another inventor, and was effectively filed before the effective filing date of the claimed invention. Regarding the latter, it is the national phase filing of PCT/EP2018/073748 that was filed on 9/4/2018 (and claims to a GB filing dated 9/4/2017) and designating the U.S. and, therefore, was effectively filed prior to the earliest effective filing date of 12/31/2018 of the present invention.
Regarding claims 1-2, O'Sullivan teaches a three-dimensional object formed from a formulation usable in additive manufacturing (See the title and abstract). A preferred formulation of O'Sullivan includes one or more curable materials which are photopolymerizable materials that polymerize and/or undergo cross-linking upon exposure to radiation as well as 1 to 15 wt.% of a radiopaque material (para [0066-0070]). It is indicated that the polymeric precursors are "adapted for photopolymerization to form a solidified article" (para [0068]). Such precursors that are adapted for photopolymerization are, by definition, photopolymerizable. And since the definition of photopolymerization is: polymerization under the influence of radiant energy (as light) per https://www.merriam-webster.com/medical/ photopolymerization, the materials in this portion of O'Sullivan would meet the limitations of the curable materials as recited in claim 1. Regarding the radiopaque material, the range of 1 to 15 wt.% overlaps the recited range rendering it obvious. Furthermore, O'Sullivan discloses the use of such a formulation in making calibration standard for a medical radiography apparatus and that in making such calibration standards (para. [0075]), and also discloses using amounts of radiopaque materials that are 5 and 10 wt.% and the examples used to make the device shown in Figure 9A (para. [0154-0165]). Therefore, it would have been obvious to modify the preferred formulation disclosed in (para. [0066-0070]) to include 5 and/or 10 wt.% radiopaque material so that the formulation can be used to make a calibration standard as suggested by O'Sullivan.
Lastly, O'Sullivan discloses that the formulations, when hardened, will have at least 400 up to 1200 or more HU (Hounsfield Units) (para. [0042]). O'Sullivan does not disclose that the HU is a CT number at 70 kV and admits that the HU can vary from image-to image and/or apparatus-to-apparatus. But O'Sullivan suggests that the differences between these will only vary by 5-10 HU (See para. [0029], especially the last two sentences of the paragraph). Thus, one of ordinary skill in the art would have expected that the hardened formulations of O'Sullivan having an HU of 400-1200 HU would meet the claim 1 requirement of the HU of at least 100 using a CT scan at 70kV.
Regarding claim 3, O'Sullivan teaches a three-dimensional object, wherein the formulation further comprises a photoinitiator (para. [0058]).
Regarding claim 4, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, when hardened, will have at least 400 up to 1200 or more HU (Hounsfield Units) (para. [0042]). O'Sullivan does not disclose that the HU is a CT number at 70 kV and admits that the HU can vary from image-to image and/or apparatus-to-apparatus. But O'Sullivan suggests that the differences between these will only vary by 5-10 HU (See para. [0029], especially the last two sentences of the paragraph). Thus, one of ordinary skill in the art would have expected that the hardened formulations of O'Sullivan having an HU of 400-1200 HU would meet the claim 2 requirement of the HU of at least 500 using a CT scan at 70kV.
Regarding claim 5, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein an amount of the radiopaque material ranges from 5 to 25 %, by weight of the total weight of the formulation; by teaching that a range of 1 to 15 wt.% overlaps the recited range rendering it obvious (para. [0067]). Furthermore, O'Sullivan discloses the use of such a formulation in making calibration standard for a medical radiography apparatus and that in making such calibration standards, thereby discloses using amounts of radiopaque materials that are in the claimed range (para. [0075, 0154-0165]).
Regarding claim 6, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque material comprises a radiopaque element or a radiopaque compound comprising a radiopaque element; by teaching that the radiopaque particles comprise a metal and/or a metal compound, for example a pure or unalloyed metal, an alloy thereof, an inorganic compound such as a ceramic comprising the metal, an organometallic comprising the metal and/or mixtures thereof. The radiopaque particles may comprise a plurality of such metals (para. [0031]).
Regarding claim 7, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque element is selected from iodine, tungsten, tantalum, gadolinium, Yttrium, gold, bismuth and barium (para. [0031-0033]).
Regarding claim 8, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque material is barium sulfate (para. [0035]).
Regarding claim 9, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque material is in a form of nanoparticles or a nano-powder, optionally dispersed or dissolved in a liquid carrier (para. [0041]).
Regarding claim 10, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque material is formed from 0.1 to 25 wt.% radiopaque particles (claim 1), and 40 to 80 wt.% monomeric, oligomeric and/or polymeric composition (claim 4). It would have been obvious to any ordinary artisan that the final property of the object would be a function of the amount of ingredients in the formulation, and therefore the density would be a function of the ingredient amount used in the formulation. Additionally, the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of the variable might be characterized as routine experimentation. Therefore, maintaining the liquid material having a density of at least 2 grams/cm3 would be a matter of optimization that would be performed under routine experimentation. Please see In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
Regarding claim 11, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque material is a curable material which is a photopolymerizable material that polymerizes and/or undergoes cross-linking upon exposure to radiation and which contains one or more photocurable groups (para. [0045-0054]) and one or more radiopaque elements or one or more groups containing a radiopaque element (para. [0029-0036]).
Regarding claim 13, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the radiopaque material comprises an opaque solid material dispersed in a photocurable material (para. [0041]).
Regarding claim 14, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the solid opaque material is a metal oxide (para. [0035-0036]).
Regarding claim 15, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, wherein the curable materials are UV-curable materials which polymerize and/or undergo cross-linking upon exposure to UV irradiation (para. [0045-0046]).
Regarding claim 16, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object, further comprises a surfactant and/or dispersant; by teaching to use monomeric precursors, which may control, at least in part, curing speed, crosslink density, surface properties, and/or viscosity of the flowable liquid formulation. Examples of monomeric precursors include styrenes, N-vinylpyrrolidone and acrylates (also known as acrylic monomers, commonly used as dispersant).
Regarding claims 17-18, O'Sullivan teaches a three-dimensional object, wherein the hardened material is obtained by dispensing at least one said formulation to sequentially form a plurality of layers in a configured pattern corresponding to a shape of the object, and exposing at least a portion of the dispensed layers to said curing condition; by teaching processes used to create three-dimensional articles in which layers of material are formed under computer control to create the articles. Stereolithography (SLA) and DLP (Digital Light Processing) are examples of 3D printing processes in which flowable liquid formulations are formed into solidified articles. Photopolymerization is typically used in SLA and/or DLP to form a solid from the liquid formulations (para. [0026]). O'Sullivan teaches to use the flowable liquid formulation for the 3D printing of a three-dimensional object. O'Sullivan further teaches that the additive manufacturing is performed in one or more of a 3D inkjet printing arrays, by teaching that the 3D printing process may comprise of inkjet SLA and/or DLP printers typically deposit successive layers ultra-thin layers (between 16 and 30 μm) of the photopolymer liquid formulations (para. [0026]).
Claim 12 is rejected under 35 U.S.C.103 as being obvious over O'Sullivan et al (US Patent Application Publication Number 2020/0354542 A1), in view of Artola et al. (Artola et al: "Elimination of barium sulphate from acrylic bone cements. Use of two iodine-containing monomers", Biomaterials, Elsevier, Amsterdam, NL, vol. 24, no. 22, 1 October 2003, pages 4071-4080), hereafter, referred to as “Artola”.
Regarding claim 12, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object is usable in additive manufacturing process of forming a three-dimensional object. But O'Sullivan fails to explicitly teach that the formulation, wherein the radiopaque element is selected from bromine and iodine. However, Artola relates to curable compositions for bone cement applications based on acrylate monomers and radiopaque components like iodine-methacrylate-monomers and MMA. Artola teaches a curable radiopaque material comprising one or more curable groups and one or more radiopaque elements by teaching to use two different cements, one containing 5 vol% 2-[2', 3', 5'-triiodobenzoyl] ethyl methacrylate (TIBMA) and the other containing 3,5-diiodine salicylic methacrylate (DISMA). In both cases, the mechanical properties of these new cements were better than those of the barium sulphate-containing cement. The radiopacity obtained was comparable to that of the aforementioned cement and all the samples showed good biocompatibility (abstract). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of filing the claimed invention, to incorporate the teaching of Artola, and use a radiopaque material containing bromine and iodine, because that would provide enhanced mechanical properties (conclusion section) in addition to providing shielding effect.
Claim 19 is rejected under 35 U.S.C.103 as being obvious over O'Sullivan et al (US Patent Application Publication Number 2020/0354542 A1), in view of Pappas et al. (US Patent Application Publication Number 2016/0256711 A1), hereafter, referred to as “Pappas”.
Regarding claim 19, O'Sullivan teaches a three-dimensional object, wherein the formulation used to form the object is usable in additive manufacturing process of forming a three-dimensional object. O'Sullivan teaches forming a solidified article having a desired radiopacity and/or regions of differing or graded radiopacity. For instance, it is an aim of embodiments of the invention to provide an article formed by 3D printing comprising a region of a desired radiopacity (para. [0006]). But O'Sullivan fails to explicitly teach that the formulation is used, wherein the three-dimensional object is a radiological phantom. However, Pappas teaches that the verification of patient treatment dosages typically is accomplished with dose measurement phantoms. The phantom simulates the body tissue and utilizes dosimeters to measure the radiation dosage before the treatment process on the patient is commenced. Conventional phantoms, however, are not patient specific. Pappas further teaches that a three-dimensional model of the portion of the patient may be created based on the at least one set of first medical images. At least one dosimeter may be inserted into at least a portion of the model. The dosimeter is configured to measure exposure to radiation. The model may be irradiated in accordance with a radiotherapy treatment plan created by a treatment planning system. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of filing the claimed invention, to incorporate the teaching of Pappas, and use the composition of O'Sullivan to form a phantom, because that would allow to form a phantom specific to a patient, which would be useful in the treatment process before a specific treatment is commenced. Since both the references deal with shielding and effect of exposure of radiation, one would have reasonable expectation of success from the combination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD M AMEEN whose telephone number is (469) 295 9214. The examiner can normally be reached on M-F from 9.00 am to 6.00 pm (Eastern Time).
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/MOHAMMAD M AMEEN/Primary Examiner, Art Unit 1742
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