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 Objections
Claims 2-19 are objected to because of the following informalities:
Regarding claim 2, “System for immobilization” in line 1 should be recited as “A system for immobilization”.
Regarding claims 3-10, “System” in line 1 should be recited as “The system”.
Regarding claim 11, “Method for immobilization” in line 1 should be recited as “A method for immobilization”.
Regarding claims 12-15, “Method” in line 1 should be recited as “The method”.
Regarding claim 16, “Kit for immobilization” in line 1 should be recited as “A kit for immobilization”.
Regarding claims 17-19, “Kit” in line 1 should be recited as “The kit”.
Appropriate correction is required.
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(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Mooij (US 9,808,648 B2) in view of Wortmann et al. (referred to as “Wortmann”) (US 11,278,368 B2).
Regarding claim 16, De Moojj discloses a kit for immobilization of a patient body part for radiotherapy applications (see Abstract and Figs. 1-3 and 10-17), comprising:
a device (1), comprising at least one flanged support member (3) and at least one support member fixation means (4) for mounting the at least one flanged support member (3) to a fixation surface (7) at a distance from said fixation surface (7) (see Figs. 1-3; device 1 comprises a flanged support member 3 and a plurality of upstanding circumferential support legs 4 for mounting the flanged support member 3 to a fixation surface 7 at a distance from the fixation surface 7);
a first frame (12), comprising a first sheet (11), wherein the first frame (12) forms a circumferential rim for the first sheet (11) (see Figs. 1-5; circumferential rim 12 is a first frame that forms a circumferential rim for and comprises a first thermoplastic sheet 11);
optionally a second frame (12’), comprising a second sheet (11’), wherein the second frame (12’) forms a circumferential rim for the second sheet (see Figs. 1-5; circumferential rim 12’ is a second frame that forms a circumferential rim for and comprises a second thermoplastic sheet 11’), wherein the second frame (12’) is superimposable on the first frame (12) (see Figs. 1-5; the circumferential frame 12’ is superimposable on the circumferential frame 12).
De Mooij is silent on wherein the at least one flanged support member comprises at one side a curved extension towards the fixation surface.
However, Wortmann teaches an analogous kit for immobilization of a patient body part for radiotherapy applications (see Figs. 1-4 and Abstract), and an analogous at least one flanged support member (1) (see Figs. 1-4), wherein the at least one flanged support member (1) comprises at one side a curved extension towards the fixation surface (2) (see Figs. 1-4; the support rail structure 1 is an analogous flanged support member and comprises a curved extension towards the patient rest 2 at one side, which is labeled in Annotated Fig. 1 of Wortmann below), providing to follow the natural curve of a human neck.
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 at least one flanged support member (3) in the device of De Mooij to include at one side a curved extension towards the fixation surface as taught by Wortmann to have provided an improved kit for immobilization that follows the natural curve of a human neck.
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Annotated Fig. 1 of Wortmann.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Mooij in view of Wortmann further in view of Nichols (US 5,337,760).
Regarding claim 19, De Mooij in view of Wortmann discloses the invention as discussed in claim 16.
De Mooij in view of Wortmann is silent on wherein the second sheet comprises a cutout, resulting in a first strap and a second strap, wherein the first strap and the second strap are extending from a first side of the second frame to a second side of the second frame, opposite to the first side.
However, Nichols teaches an analogous frame (12) (head frame assembly, see Figs. 1-2), and wherein a sheet comprises a cutout, resulting in a first strap (56) and a second strap (60) (see Figs. 1-2; straps 56, 60 make up a sheet as they are a broad, thin, usually rectangular piece of material, thus resulting in a first strap 56 and a second strap 60, and the straps 56, 60 when placed on the frame assembly 12, form a cutout for a patient’s eyes, nose, and lips as seen in Fig. 2), wherein the first strap (56) and the second strap (60) are extending from a first side of the frame (12) to a second side of the frame (12), opposite to the first side (see Figs. 1-2; when the straps 56, 60 are placed on the frame assembly 12, the straps 56, 60 each extend from a first side to a second side of the frame assembly 12, opposite to the first side), providing a cutout allowing for better breathing for a patient, and better visibility of the patient for medical professionals.
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 second sheet (12’ of De Moojj) in the device of De Moojj in view of Wortmann to comprise a cutout, resulting in a first strap and a second strap, wherein the first strap and the second strap are extending from a first side of the second frame to a second side of the second frame, opposite to the first side as taught by Nichols to have provided an improved kit for immobilization that has a cutout allowing for better breathing for a patient, and better visibility of the patient for medical professionals.
Allowable Subject Matter
Claims 17-18 are allowed.
Claims 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art drawn to De Mooij in view of Wortmann fails to show or make obvious the claimed combinations of elements, particularly the limitations set forth in claims 17-18, which recite features not taught or suggested by the prior art drawn to De Mooij in view of Wortmann.
De Mooij in view of Wortmann fails to disclose or fairly suggest wherein the first frame or the first frame and the second frame are flat and comprise at least at one side a deformable part, wherein the deformable part is deformable in a direction transverse to the fixation surface. Although the sheets are deformable, the frames are not and there is no obvious reason to make them so, as both fix the frames to a planar section of the flanged support member.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 2-15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 2-15 of prior U.S. Patent No. 12,280,272 B2. This is a statutory double patenting rejection.
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 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 of U.S. Patent No. 12,280,272 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 16 of patent ‘272 recites the limitations of a kit for immobilization of a patient body part for radiotherapy applications, comprising: a device, comprising at least one flanged support member and at least one support member fixation means for mounting the at least one flanged support member to a fixation surface at a distance from said fixation surface; a first frame, comprising a first sheet, wherein the first frame forms a circumferential rim for the first sheet; optionally a second frame, comprising a second sheet, wherein the second frame forms a circumferential rim for the second sheet, wherein the second frame is superimposable on the first frame; characterized in that the at least one flanged support member comprises at one side a curved extension towards the fixation surface.
With respect to claim 17 of the instant application, all of the limitations are found in claim 15 of patent ‘272.
With respect to claim 18 of the instant application, all of the limitations are found in claim 17 of patent ‘272.
With respect to claim 19 of the instant application, all of the limitations are found in claim 18 of patent ‘272.
Conclusion
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/ROBIN HAN/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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