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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: feedback mechanism in claim 29, and articulation drive in claims 21 and 30.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being 3 interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 30-31, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rieker et al (US Patent 20080033415A1).
Rieker recites a mechanical esophageal displacement system. Specifically in regards to claim 30, Rieker discloses an outer tube (elongate body 105) s defining a plurality of vacuum holes (apertures 168) spaced circumferentially around the outer tube (body 105) and an internal vacuum passage (grooves 164 on guide body 160) in fluid communication with the plurality of vacuum holes (apertures 164) (Fig. 1B, 2B, 2F, 3B, 3D; Page 3 Para. [0048], Page 4 Para. [0050], Page 6 Para [0065] and [0068], and Page 7 Para. [0073]). Rieker also discloses a tube tip (tip 110) located at the distal end of the outer tube (body 105) (Fig. 2F).
Rieker an esophageal positioning device (handle 125 with knob 140, ratchet mechanism and tendons 108,109)sized to be received within the outer tube (105), the esophageal positioning device (handle 125 with knob 140, ratchet mechanism and tendons 108,109) including: a first segment (proximal portion of tendons 108,109 connected to handle 125) defining a central axis; a second segment (portion of tendons 108,109 through section 115,117) defining a second segment proximal end pivotally connected to the first segment (proximal portion of tendons 108,109 connected to handle 125) and a second segment distal end; and an articulation drive (ratchet mechanism by means of knob 140) that pivots the second segment (tendons 108,109 in section 115) relative to the first segment (proximal portion of tendons 108,109 connected to handle 125) upon articulation between first and second positions (Fig. 1B, 2B, 2F-2G, 3B, 3D; Page 6 Para. [0068], Page 7 Para. [0073], Page 3 Para. [0048], Page 5 Para. [0063]). Wherein the second segment distal end is disposed along the central axis in the first position and the second segment distal end is displaced from the central axis in the second position, and wherein the second segment distal end remains a same distance from the second segment proximal end in the first and second positions (Fig. 2F and 2G).
In regards to claim 31, Rieker recites wherein the second segment (tendons 108,109 through section 115) is sized to displace the esophageal wall (10) by about 4 centimeters upon articulation (Page 5 Para. [0061]).
In regards to claims 37, Rieker recites wherein at least one of the plurality of vacuum holes (apertures 168) is positioned adjacent the second segment (tendons 108,109 through section 115) (Fig. 2F and 3B, 3D; and Page 6 Para. [0065]-[0066] and [0068]).
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.
Claims 32 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rieker in view of Kasic, II (US Patent 20170105715A1).
Rieker discloses an esophageal positioning device and an introducer as recited above. In regards to claim 32, Rieker recites wherein the tube tip (tip 110) comprises a soft, circular contour, wherein the tip (110) is bonded to the distal end of the outer tube (body 105) (Fig. Page 4 Para. [0049] and Page 3 Para. [0048]; and Fig. 3D). However, Rieker is silent as to the tip being comprised of hard polymer.
Kasic discloses a mechanical esophageal system (Systems, Devices, Components and Methods for Displacing and Repositioning the Esophagus Away from the Heart during Atrial Ablation Surgical Procedures). In regards to claims 32, Kasic recites wherein the tube tip (end 90) comprises a hard polymer tip (90) having a soft, circular contour, wherein the tip (90) is bonded to the distal end of the outer tube (catheter 50) (Fig. 2A-2B; and Page 7 Para. [0067]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the apparatus of Rieker by having the tip be made of polymer as recited in Kasic in order to have a suitable flexible elastic material appropriate for use inside a patient's body (Page 5 Para. [0053]).
Rieker discloses an esophageal positioning device and an introducer as recited above. In regards to claim 36, Rieker recites wherein the outer tube (105) further includes a plurality of radiopaque markers positioned adjacent the first and second segments, and wherein the plurality of radiopaque markers span distally to the tube tip (Rieker recites that the radiopaque markers on curved section or the curved section can be made of radio opaque material) (Page 1-2 Para. [0008] and Page 9 Para. [0088]). However, Rieker is silent as to the first segment being connected to the second segment by a joint. Kasic discloses a mechanical esophageal system (Systems, Devices, Components and Methods for Displacing and Repositioning the Esophagus Away from the Heart during Atrial Ablation Surgical Procedures). In regards to claims 36, Kasic recites wherein the second segment (114) is pivotally connected to the first segment (112) via a joint (joint 130a), wherein the introducer further comprises a plurality of radiopaque markers located proximal to a location where the pivot pin (joint 130a) would reside within the introducer, wherein the plurality of radiopaque markers span distally from the location to the tube tip (90) (Fig. 2a-2b and 6-7; and Page 5 Para. [0051]-[0054], Page 6 para. [0056]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the apparatus of Rieker by having the segments articulate by means of a joint as shown in Kasic in order to have segments that are configured to rotate within substantially a same plane such that torque can be efficiently transmitted from a proximal end to a distal end (Page 5 Para. [0051]).
Claims 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rieker in view of Weller et al (US Patent 20070233161A1).
Rieker discloses an esophageal positioning device and an introducer as recited above. In regards to claims 33-34, Rieker recites the use of a vacuum associated with the assembly 100 therefore, it also recites line hook up that is in fluid communication with the one or more internal vacuum passages (grooves 164) (Page 7 Para. [0073] and Page 6 Para. [0068]; and Page 1-2 and Para. [0008]). However, Rieker is silent as to a vacuum port.
Weller in regards to claims 33 recites wherein the tube (member 12) further includes a vacuum port (port 44) comprising a vacuum port body (body of port 44) and a vacuum port cap (cap is housing between the seal housing 42 and proximal end of member 12), wherein the vacuum port body (body of port 44) comprises a vacuum, wherein the vacuum port body (body of port 44) is bonded to both the outer tube (member 12) and the vacuum port cap (cap is housing between the seal housing 42 and proximal end of member 12) to create an air tight seal (Fig. 1B; and Page 6 Para. [0095]). Weller also recites in regards to claim 34, wherein the vacuum port body (body of port 44) further includes a vacuum port valve and a lever, wherein the lever controls the vacuum system (Fig. 1B). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the apparatus of Rieker by having vacuum port as shown in Weller in order to delivery of fluids or gases into the hollow body organ (Page 6 Para. [0095]).
Claims 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rieker in view of Weller as applied to claims 33 above, and in further view of Belson (US Patent 20070135803A1) and Kasic.
Rieker in view of Weller discloses an esophageal positioning device and an introducer as recited above. In regards to claim 35, Rieker in view of Weller recite a vacuum port cap (Weller: cap is housing between housing 42 and member 12) that is bonded to a vacuum port body (see Weller Fig. 1A), and a handle (Rieker 125) of the esophageal positioning device (Rieker: handle 125 with tendons 108,109) is coupled to the proximal end of the outer tube (Rieker body 105) (Rieker: Fig. 2F). However, they are silent as to the cap being selectively couple or composed of a hard polymer
Belson in regards to claim 35, recites wherein the cap (top of umbilicus 90) selectively couples two pieces together (Fig. 59A-59B; and Page 31 Para. [0383]-[0384]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the apparatus of Rieker in view of Weller by having selective coupling as shown in Bellson in order to ensure that both pieces are aligned (Page 31 Para. [0383]). However, the references are still silent as to the cap being composed of a hard polymer
Kasic discloses a mechanical esophageal system (Systems, Devices, Components and Methods for Displacing and Repositioning the Esophagus Away from the Heart during Atrial Ablation Surgical Procedures). In regards to claim 35, Kasic recites wherein the cap comprises a hard polymer (Fig. 2A-2B; and Page 7 Para. [0067]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the apparatus of Rieker in view of Weller and Belson by having the cap be made of polymer as recited in Kasic in order to have a suitable flexible elastic material appropriate for use inside a patient's body (Page 5 Para. [0053]).
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12364802 referred herein as Pat. ‘802. Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Pat. ‘802. Pat. ‘802 recites a mechanical esophageal displacement system comprising: a handle [claim 1 col. 16 lines 18-19]; a first segment coupled to the handle [claim 1 col. 16 lines 20]; a second segment pivotably connected to the first segment, the second segment defining a constant length and shape claim 1 col. 16 lines 21-27]; an articulation drive that pivots the second segment about the first segment [claim 1 col. 16 lines 28-29]; and an introducer including a soft outer tube, the soft outer tube defining a plurality of radial vacuum holes [claim 1 col. 16 lines 30-34].
Claims 22-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-9 of Pat. ‘802 for reciting substantially similar limitations.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of Pat. ‘802. Pat. ‘802 recites a mechanical esophageal displacement system comprising: an outer tube defining a plurality of vacuum holes spaced circumferentially around the outer tube and an internal vacuum passage in fluid communication with the plurality of vacuum holes [claim 10 Col. 17 lines 4-10]; a tube tip located at a distal end of the outer tube [claim 10 Col. 17 lines 11]; and an esophageal positioning device sized to be received within the outer tube[claim 10 Col. 17 lines 12-13], the esophageal positioning device including: a first segment defining a central axis; a second segment defining a second segment proximal end pivotally connected to the first segment and a second segment distal end; and an articulation drive that pivots the second segment relative to the first segment upon actuation between a first position and a second position, wherein the second segment distal end is disposed along the central axis in the first position and the second segment distal end is displaced from the central axis in the second position, and wherein the second segment distal end remains a same distance from the second segment proximal end in the first position and the second position [claim 10 Col. 17 lines 14-30].
Claims 31-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-20 of Pat. ‘802 for reciting substantially similar limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
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