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 .
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 8 is 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.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Similarly, the limitation of claim 8 is not directed to the system itself, rather, it is directed to the use of the system of claim 1. The claim is indefinite since it creates confusion as to when direct infringement occurs.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 10-11 of co-pending Application No. 18/292,958 in view of Roberson US 20220139263
Claim 1: Claim 1 of the ‘958 application provides a teaching of a surgical training model, comprising: a plurality of adjacent cassettes joined together.
However, the ‘958 patent application is silent on the teaching
The model being a spine, wherein the model simulate, wherein the cassettes comprising spacer cassettes each being removable and replaceable with one or more anatomy cassette(s) that simulates an anatomy and or pathology in the spine, wherein adjacent cassettes comprise: joined cassettes with a join, or unattached cassettes when not joined, the join between attached cassettes being substantially fixed so that, other than allowing for unattached cassettes, the attached cassettes do not move relative to one another about said join.
However, the Roberson reference provides a teaching of wherein the model being a spine, wherein the cassettes comprising spacer cassettes each being removable and replaceable with one or more anatomy cassette(s) that simulates an anatomy and or pathology in the spine (see paragraph 81 showing the joining of two vertebrae model and paragraph 120 describing how the model can be utilized to model different spinal condition and deformities) and wherein adjacent cassettes comprise: joined cassettes with a join (see paragraph 80 being joined by screw and paragraph 119 connection using tension wire), or unattached cassettes when not joined, the join between attached cassettes being substantially fixed so that, other than allowing for unattached cassettes, the attached cassettes do not move relative to one another about said join (see paragraph 120 showing the model can withstand certain amount of forces when being applied against it).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Roberson reference with the feature wherein the model is a spine, wherein the model simulate, wherein the cassettes comprising spacer cassettes each being removable and replaceable with one or more anatomy cassette(s) that simulates an anatomy and or pathology in the spine, wherein adjacent cassettes comprise: joined cassettes with a join, or unattached cassettes when not joined, the join between attached cassettes being substantially fixed so that, other than allowing for unattached cassettes, the attached cassettes do not move relative to one another about said join, as taught by the Roberson reference provides a teaching of providing a realistic training environment.
Claim 2: Claim 2 of the ‘958 application provides a teaching of wherein at least each anatomy cassetes is 3D printed.
Claim 3: While claim 1-2 of the ‘958 application is silent wherein at least anatomy cassettes is manufactured by a combination of manufacturing processes. However, the examiner interprets the difference between claim 3 of this application and claim 1-2 of the ‘958 application lies on the method of manufacturing. 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, 777 F.2d 695, 698, 227 USPQ 964, 966. Accordingly, claim 1-2 of the ‘958 application still reads on the limitation of claim 3 in this application.
Claim 4: The ‘958 application is silent on the teaching of wherein each spacer cassette is removably associable to an adjacent spacer cassette or adjacent anatomy cassette to provide a simulated human spine with a substantially full range of natural movement.
However, the Roberson wherein each spacer cassette is removably associable to an adjacent spacer cassette or adjacent anatomy cassette to provide a simulated human spine with a substantially full range of natural movement (see paragraph 79-80 showing movement and axial movement when force is applied).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the 958 application with the feature of wherein each spacer cassette is removably associable to an adjacent spacer cassette or adjacent anatomy cassette to provide a simulated human spine with a substantially full range of natural movement, as taught by the Roberson reference provides a teaching of providing a realistic training environment.
Claim 5-6: Claim 10-11 of the ‘958 application provides a teaching of each anatomy cassette is provided with one or more of a pathology, disease, deformity, dislocation, fracture or injury of any kind comprising a lodged foreign body, or any alignment that can cause pain and wherein the model is a tailored anatomical model based on patient dimensions and each anatomy cassette simulates a specific anatomy, pathology, disease, deformity, dislocation, fracture or injury of any kind comprising a lodged foreign body, or any alignment that can cause pain, that could be subject to surgical intervention.
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 10-11 of copending Application No. 18/292,958 in view of Roberson US 20220139263 and further in view of Gallagher US 20180090033 A1
Claim 8: The ‘958 patent application and the Roberson reference provides a teaching of a method of providing training of a surgical procedure, the system comprising providing a surgical training model according to claim 1 (see the rejection of claim 1 above).
The ‘958 patent application is silent on the teaching of operating or allowing others to perform an operation on the anatomy cassette(s) in the model, the operation being robotic, endoscopic or open surgery; providing feedback on the operation to assist in surgical training.
However, the Gallagher reference provides a teaching of operating or allowing others to perform an operation on the anatomy cassette(s) in the model the operation being endoscopic (see paragraph 37 and 39 showing the a trainee performing endoscopic surgery being monitored by an expert); and providing feedback on the operation to assist in surgical training (see paragraph 46 scoresheet evaluation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Roberson reference with the feature of operating or allowing others to perform an operation on the anatomy cassette(s) in the model, the operation being robotic, endoscopic or open surgery; providing feedback on the operation to assist in surgical training, as taught by the Gallagher reference, in order to provide an objective feedback to the trainee to improve their surgical skill.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2, 10-11 of copending Application No. 18/292,958 in view of Roberson US 20220139263 and further in view of Pellegrin 20080138781
Claim 7: The limitation of claim 1 shares similar limitations to the limitations of claim 1. Accordingly, please refer the rejection of claim 1 above.
The ‘958 patent application is silent on the teaching of a base simulating at least the abdomen of a body and wherein the base comprising an elongate cavity therein for receiving cassettes.
The Pellegrin reference provides a teaching of a base simulating at least the abdomen of a body (see FIG. 2 item 20) and wherein the base comprising an elongate cavity therein for receiving cassettes (see FIG. 2 item 30 showing the spinal section being inserted into the abdomen section).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pellegrin with the feature of a base simulating at least the abdomen of a body and wherein the base comprising an elongate cavity therein for receiving cassettes, as taught by the Pellegrin reference, in order to provide a realistic training environment (see paragraph 8).
This is a provisional nonstatutory double patenting rejection.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Roberson US 20220139263
Claim 1: The Roberson reference provides a teaching of a surgical training model (see paragraph 2 training models and method for spinal surgery), comprising:
a plurality of adjacent cassettes1 joined together to simulate a spine (see FIG. 2A as different part that makes up two spinal cord) , the cassettes comprising spacer cassettes each being removable and replaceable with one or more anatomy cassette(s) that simulates an anatomy and or pathology in the spine (see paragraph 81 showing the joining of two vertebrae model and paragraph 120 describing how the model can be utilized to model different spinal condition and deformities), wherein adjacent cassettes comprise: joined cassettes with a join, or unattached cassettes when not joined (see paragraph 80 being joined by screw and paragraph 119 connection using tension wire), the join between attached cassettes being substantially fixed so that, other than allowing for unattached cassettes, the attached cassettes do not move relative to one another about said join (see paragraph 120 showing the model can withstand certain amount of forces when being applied against it).
Claim 2: The Roberson reference provide a teaching of wherein at least each anatomy cassette is 3D printed (see paragraph 123).
Claim 3: The Roberson reference is silent on the teaching of wherein the at least each anatomy cassette is manufactured by a combination of manufacturing processes. “[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, 777 F.2d 695, 698, 227 USPQ 964, 966. In this particular case, it is unclear that the limitation of claim 3 creates a different product or a product with a structural difference between the Roberson and the limitation of claim 3. As such, the examiner takes the position that the Roberson reference still reads on the limitation of claim 3 since the Applicant has not provided any evidence that creating the anatomy cassettes by a combination of manufacturing processes a different product or a product with a structural difference from the Roberson reference.
Claim 4: The Roberson wherein each spacer cassette is removably associable to an adjacent spacer cassette or adjacent anatomy cassette to provide a simulated human spine with a substantially full range of natural movement (see paragraph 79-80 showing movement and axial movement when force is applied).
Claim 5: The Roberson reference provides a teaching of wherein each anatomy cassette is provided with one or more of a pathology, deformity (see paragraph 109 showing a type 1 deformity in which the spine contains a single structural main thoracic curve with possible nonstructural proximal and thorocolumbar/lumbar curves).
Claim 6: The Roberson reference provides a teaching wherein the model is a tailored anatomical model based on patient dimensions (see paragraph 124 the use of CT scans and CAD models to produce patient specific model). The Roberson reference provides a teaching of each anatomy cassette simulates a specific anatomy, pathology, deformity (see paragraph 109 showing a type 1 deformity in which the spine contains a single structural main thoracic curve with possible nonstructural proximal and thorocolumbar/lumbar curves)
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 (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 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson US 20220139263 and in view of Pellegrin 20080138781
Claim 7: The Roberson reference provide a teaching of a surgical training model (see paragraph 2 training models and method for spinal surgery), comprising:
a plurality of adjacent cassettes arranged together in the cavity to simulate a spine, the cassettes comprising spacer cassettes each being removable and replaceable with one or more anatomy cassette(s) that simulate an anatomy and or pathology in the spine (see paragraph 81 showing the joining of two vertebrae model and paragraph 120 describing how the model can be utilized to model different spinal condition and deformities), wherein adjacent cassettes comprise: joined cassettes with a join, or unattached cassettes when not joined (joined (see paragraph 80 being joined by screw and paragraph 119 connection using tension wire), the join between attached cassettes being substantially fixed by location in the cavity so that, other than allowing for unattached cassettes, the attached cassettes do not move relative to one another when joined (see paragraph 120 showing the model can withstand certain amount of forces when being applied against it).
The Roberson reference is silent on the teaching of a base simulating at least the abdomen of a body and wherein the base comprising an elongate cavity therein for receiving cassettes.
The Pellegrin reference provides a teaching of a base simulating at least the abdomen of a body (see FIG. 2 item 20) and wherein the base comprising an elongate cavity therein for receiving cassettes (see FIG. 2 item 30 showing the spinal section being inserted into the abdomen section).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Pellegrin with the feature of a base simulating at least the abdomen of a body and wherein the base comprising an elongate cavity therein for receiving cassettes, as taught by the Pellegrin reference, in order to provide a realistic training environment (see paragraph 8).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Roberson US 20220139263 and in view of Gallagher US 20180090033 A1
Claim 8: The Roberson reference provides a teaching of a method of providing training of a surgical procedure, the system comprising providing a surgical training model according to claim 1 (see the rejection of claim 1).
The Roberson reference is silent on the teaching of operating or allowing others to perform an operation on the anatomy cassette(s) in the model, the operation being robotic, endoscopic or open surgery; providing feedback on the operation to assist in surgical training.
However, the Gallagher reference provides a teaching of operating or allowing others to perform an operation on the anatomy cassette(s) in the model the operation being endoscopic (see paragraph 37 and 39 showing the a trainee performing endoscopic surgery being monitored by an expert); and providing feedback on the operation to assist in surgical training (see paragraph 46 scoresheet evaluation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Roberson reference with the feature of operating or allowing others to perform an operation on the anatomy cassette(s) in the model, the operation being robotic, endoscopic or open surgery; providing feedback on the operation to assist in surgical training, as taught by the Gallagher reference, in order to provide an objective feedback to the trainee to improve their surgical skill.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J UTAMA whose telephone number is (571)272-1676. The examiner can normally be reached 9:00 - 17:30 Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT J UTAMA/ Primary Examiner, Art Unit 3715
1 A cassette is interpreted as interchangeable parts of the surgical training model in line with applicant’s specification page 4 line 1-5