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 24-32) and species of methacrylate, urethane acrylate, Pd (palladium)-103, anticancer agent, solution, ultraviolet radiation, and benzoyl peroxide in the reply filed on June 16, 2026 is acknowledged.
Specification
The abstract of the disclosure is objected to because it is too short in length (31 words). Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally be limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Appropriate correction is required.
Claim Rejections - 35 USC § 112 New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 29 recites “activating the radioisotope precursor occurs after contacting the multi-layer composition with the target tissue area.” The temporal limitation of “after contacting the multi-layer composition with the target tissue area” lacks written description support in the application as originally filed. The original specification only discloses “activating the one or more radioisotope precursors after the curable composition has been cured” (¶ 57 of the specification filed June 15, 2023). Introducing the specific time point of “after contacting the multi-layer composition with the target tissue area” constitutes impermissible new matter that exceeds the scope of the original disclosure, raising a doubt as to the inventor’s possession of the claimed invention at the time of filing.
Claim 32 recites “receiving, by the additive manufacturing device, the 3D model of the target tissue area from an external data source.” The limitation of “from an external data source” lacks written description support in the application as originally filed. The original specification only discloses “preparing the model may include downloading the model from a model repository or any other suitable source” (¶ 108 of the specification filed June 15, 2023). Introducing the new term “external data source” constitutes impermissible new matter that exceeds the scope of the original disclosure, raising a doubt as to the inventor’s possession of the claimed invention at the time of filing.
If Applicant is in disagreement with the Examiner regarding support for the claims, Applicant is respectfully requested to point to paragraph number wherein support may be found for the instant invention.
Appropriate correction/amendment is required.
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 24-27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kenney et al. (US 2017 0283655; cited on PTO-892) in view of Pashazadeh et al. (Transactions on Additive Manufacturing Meets Medicine, 2019; cited on PTO-892) and Nair (US 2013 0030070; cited on IDS filed April 5, 2024).
Regarding claim 24, Kenney discloses a method of forming a three-dimensional (3D) article comprising I ) printing (depositing) a first photocurable silicone composition with a 3D printer (additive manufacturing device) to form a layer (first layer); II ) irradiating (exposing) the layer with an energy source to form an at least partially (substantially) cured layer; and III ) printing (depositing) a second photocurable silicone composition (second layer) (claim 1). Kenney discloses that the composition can comprise radiation-sensitive group that forms a reactive species such as free radicals upon exposure to irradiation (¶ 86), and that the composition can comprise a photoinitiator such as free radical photoinitioator which catalyze curing via irradiation (¶ 88). Regarding claim 27, Kenney discloses that when the layers are applied wet-on-wet, and/or when the layers are only partially cured, irradiating may affect cure of more than just the subsequently printed layer and the cure may extend beyond or across the print line (¶ 39). It can be expected that the generated free radical of the first layer can initiate a curing process in the second layer and force them to lock together between the layers.
Kenney does not disclose the use for a target tissue area and the use of the composition comprising a monomer such as methacrylate, an oligomer such as urethane acrylate, and a radioisotope (instant claims 24-26). Kenney does not disclose the target area configuration defines a non-uniform spatial distribution of the radioisotope (instant claim 30).
Pashazadeh discloses a brachytherapy method using 3D printing technology employing beta-emitting isotopes (abstract). Pashazadeh discloses that the beta-emitting patches can allow for directed, effective, and controlled dose delivery to the skin tumors, thus mitigating exposure to sensitive strictures (abstract). Pashazadeh discloses that the digital model for printing the patches can be based on the specific tumor information such as shape, size, and depth of the tumor, obtained pre-treatment using imaging modalities (page 1, column 1, ¶ 3). Regarding claim 30, Pashazadeh discloses that desired radiation dose profile can be created by adjusting the digital model of the scaffold so the radiation dose of the patch will match the surface anatomy of the skin tumor (page 1, column 2, ¶ 4). Pashazadeh discloses that 3D printing can allow the fabrication of radioactive patches with an intensity modulated dose pattern (non-uniform spatial distribution), achieved by printing specific parts of the patch with more than one line (page 1, column 2, ¶ 5).
Nair discloses a method for preparing a crosslinked organic porous particle comprising polymerizable monomer and oligomer, a free radical initiator, and a radioisotope ( ¶ 91; ¶ 97; ¶ 146). Nair discloses that the free radical initiator can be activated by heat or light, and that the amount of the initiator and activation condition are adjustable (¶ 97). Regarding claims 25 and 26, Nair discloses monomers and oligomers can be (meth)acrylate and urethane acrylate (¶91; ¶ 93). Nair discloses that the composition can have various uses such as pharmaceuticals (¶ 36).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kenney by replacing the composition with the composition of Nair comprising (meth)acrylate, urethane acrylate, a free radical initiator, and a radioisotope, and by creating a non-uniform, radiation dose pattern to prepare a more effective composition for customized tissue-specific radiotherapy. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Pashazadeh teaches that a 3D printing technique can be applied to prepare radioactive patches with a desired dose pattern for brachytherapy of a target tissue, and Nair discloses that a composition comprising (meth)acrylate, urethane acrylate, a free radical initiator, and a radioisotope can be used for pharmaceuticals. Further, a person of ordinary skill in the art would have been motivated to utilize such a photocurable resin mixture in order to prepare a more accurate, flexible, and durable composition using an additive manufacturing device (3D printing). A person of ordinary skill in the art would have been motivated to make a customized, target tissue-specific composition with a non-uniform spatial distribution of the radioisotope in the composition in order to ensure the ability to selectively concentrate radioactive decay into the target tissue while sparing healthy cells. Accordingly, applying the teachings of Pashazadeh and Nair to the method of Kenney constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
Claims 28, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kenney, Pashazadeh, and Nair as applied to claims 24-27 and 30 above, and further in view of Russell et al. (US 4,702,228, 1987; cited on IDS filed April 5, 2024).
Kenney, Pashazadeh, and Nair are discussed above.
None of Kenney, Pashazadeh, and Nair discloses that the step of activating a radioisotope precursor using energetic particles to produce the radioisotope in the composition after contacting the multi-layer composition with the target tissue area (instant claims 28 and 29). None of Kenney, Pashazadeh, and Nair discloses that the curable composition is bioabsorbable or biocompatible (instant claim 31).
Russell discloses a seed for implantation into tumors within a human body for emitting X-rays to destroy or reduce tumors (abstract). Russell discloses the seeds can contain Pd-102 (radioisotope precursor) which is activated by exposure to a neutron flux so as to contain Pd-103 (radioisotope) (abstract). Russell discloses that the Pd-102 can be activated by exposure to neutron flux preferably after its encasement in a shell (column 3, lines 23-25). Russell discloses that the shell can be stable and biocompatible within the body (column 3, lines 17-18).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kenney, Pashazadeh, and Nair by adding a step of activating a radioisotope precursor such as Pd-102 to produce the radioisotope such as Pd-103 after contacting the multi-layer composition with the target area, and by utilizing a biocompatible material in order to prepare a safer composition. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Russell teaches that the Pd-102 can be activated later by exposure to a neutron flux preferably after its encasement in a shell for brachytherapy using Pd-103, and that the material encapsulating the Pd-102 can be biocompatible. Further, a person of ordinary skill in the art would have been motivated to utilize a radioisotope precursor and activate it after it reaches its target in order to achieve a longer storage time, reduce toxic drifting, and spare healthy cells. A person of ordinary skill in the art would have been motivated to utilize biocompatible composition in order to safely apply it to living tissues without toxic reactions or immune rejection. Accordingly, applying the teachings of Russell to the method of Kenney, Pashazadeh, and Nair constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Kenney, Pashazadeh, and Nair as applied to claims 24-27 and 30 above, and further in view of Angelini et al. (US 2018 0021140; cited on PTO-892).
Kenney, Pashazadeh, and Nair are discussed above. Pashazadeh discloses that the digital model can be obtained using imaging modalities (page 1, column 1, ¶ 3).
None of Kenney, Pashazadeh, and Nair discloses the step of receiving the 3D model of the target tissue area from an external data source.
Angelini disclose a method for creating a 3D tissue construct of desired shape using 3D printing system (abstract, ¶ 6). Angelini disclose that preparing the model can include downloading the model form a model repository or any other suitable source, using scanners, receiving user input, or using commercially available software (¶¶ 132-135).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kenney, Pashazadeh, and Nair by adding a step of receiving the 3D model of the target tissue area from an external data source. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Angelini teaches that a model for 3D printing can be received from various sources. Further, a person of ordinary skill in the art would have been motivated to utilize various data sources such as an external data source for a 3D model in order to prepare more suitable composition for the target area. It would have been customary for an artisan of ordinary skill to select the data source for the 3D model in order to best achieve the desired, customized composition. Accordingly, applying the teachings of Angelini to the method of Kenney, Pashazadeh, and Nair constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claim obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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