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 is in response to the non-provisional application filed 06/18/2025.
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 1-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,633,575 (Blacker et al.)
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-22 of the application generally recite an apparatus with a base, a base drive member, and a mechanism coupled to the base to maintain a position of the elongated medical device removably positioned within the lumen relative to the hemostasis valve while the base and the mechanism are moved along the first path and the catheter is held to the base, which is not patentably distinct from what is recited in claims 1-28 of the patent.
It is clear that all the elements of claims 1-22 are to be found in claims 1-28 of the patent. The difference between claims 1-22 of the application and claims 1-28 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 1-28 of the patent is in effect a “species” of the “generic” invention of claims 1-22 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-8, 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0276391 (Yu) in view of U.S. Patent Publication Number 2002/0010425 (Guo et al.)
Regarding claims 1, 19, 20, 22 Yu discloses as shown in Figures 1, 3 an apparatus comprising: a base (carriage 104, see paragraph [0015]) comprising a device (housing attached to proximal end of sheath 130, shown in annotated Figure 3 provided below) to releasably hold a catheter (sheath 130, see paragraph [0022]) to the base, a portion of the catheter received within a hemostasis valve, the catheter defining a lumen configured to receive an elongated medical device; a base drive member (wheels 316, see paragraph [0023]) capable of moving the base relative to along a first path while the catheter is held to the base such that the catheter moves relative to; see paragraph [0025]; and a mechanism (leader carriage 106, active drive mechanism 314, see paragraphs [0018], [0023]) coupled to the base to maintain a position of the elongated medical device removably positioned within the lumen relative to the while the base and the mechanism are moved along the first path and the catheter is held to the base, wherein the catheter is an over the wire device and the lumen extends from a proximal end to a distal end of the catheter, wherein a portion of the elongated medical device is maintained in a substantially fixed location relative to the hemostasis valve as the base moves along the first path, and wherein a distance between the portion of the elongated medical device and the base changes as the base moves along the first path, and in synchronization with a moving velocity of the base, thereby maintaining a position of a distal portion of the elongated medical device against a force caused by the motion of the catheter. See paragraph [0025].
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Yu fails to disclose a hemostasis valve to receive a portion of a catheter defining a lumen.
Guo, from the same field of endeavor teaches a similar apparatus with a catheter as shown in Figures 2, 10, where the apparatus includes a hemostasis valve (hemostasis valve 10) configured to receive a catheter; see paragraph [0052] for the purpose of providing a seal around the catheter to prevent the introduction of air into the body and the leakage of fluid out of the body. See paragraph [0007].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Yu to include the hemostasis cannula assembly 70 into the apparatus disclosed by Yu such that the base drive member was capable of moving the base relative to the hemostasis valve along a first path while the catheter is held to the base such that the catheter moves relative to the hemostasis valve; and the mechanism is capable of maintaining a position of an elongated medical device removably positioned within the lumen relative to the hemostasis valve while the base is moved along the first path and the catheter is held to the base, in order to seal around sheath 130 and to prevent the introduction of air into the body and the leakage of fluid out of the body.
Regarding claims 2, 4 Yu discloses wherein the first path is a direction that is substantially parallel to both a longitudinal axis of the elongated medical device and a longitudinal axis of the catheter, wherein at least a portion of the first path is linear. See paragraph [0022].
Regarding claim 3, Yu discloses a distal portion of the elongated medical device is capable of being maintained in a substantially fixed location relative to an anatomical feature within a patient as the base moves along the first path, and wherein a distance between the distal portion of the elongated medical device and the base is capable of being changed as the base moves along the first path. See paragraph [0025].
Regarding claim 5, Yu discloses wherein at least a portion of the first path is non- linear (Yu discloses lifting the carriages which would make the path non-linear and also rotating carriage 104 which would also cause a non-linear path). See paragraph [0022].
Regarding claim 6, Yu discloses wherein the base is capable of moving along the elongated medical device as the base moves along the first path. See paragraph [0025].
Regarding claim 7, Yu discloses wherein the mechanism includes a discrete movement drive mechanism (at least one of rollers 318, see paragraph [0023]) that is capable of moving the elongated medical device relative to the base in a series of discrete distances. See paragraph [0023].
Regarding claim 8, Yu discloses wherein the base drive member moves the base with one or more degrees of freedom (forward and back or left or right as shown in Figure 3). See paragraph [0022].
Regarding claim 21, Yu discloses as shown in Figures 1, 3 an apparatus comprising: a base (carriage 104, see paragraph [0015]) comprising a device (housing attached to proximal end of sheath 130, shown in annotated Figure 3 provided below) to releasably hold a catheter (sheath 130, see paragraph [0022]) to the base, a portion of the catheter received, the catheter defining a lumen configured to receive an elongated medical device; a base drive member (wheels 316, see paragraph [0023]) to move the base relative to along a first path while the catheter is held to the base such that the catheter moves relative; and a mechanism (leader carriage 106, active drive mechanism 314, see paragraphs [0018], [0023]) coupled to the base to maintain a position of the elongated medical device removably positioned within the lumen relative while the base and the mechanism are moved along the first path and the catheter is held to the base, wherein the catheter is positioned within directly without being in a lumen of another catheter device in the hemostasis valve (any part of sheath is capable of not being positioned in a lumen of another catheter device).
Yu fails to disclose a hemostasis valve to receive a portion of a catheter defining a lumen.
Guo, from the same field of endeavor teaches a similar apparatus with a catheter as shown in Figures 2, 10, where the apparatus includes a hemostasis valve (hemostasis valve 10) configured to receive a catheter; see paragraph [0052] for the purpose of providing a seal around the catheter to prevent the introduction of air into the body and the leakage of fluid out of the body. See paragraph [0007].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Yu to include the hemostasis cannula assembly 70 into the apparatus disclosed by Yu such that the base drive member was capable of moving the base relative to the hemostasis valve along a first path while the catheter is held to the base such that the catheter moves relative to the hemostasis valve; and the mechanism is capable of maintaining a position of an elongated medical device removably positioned within the lumen relative to the hemostasis valve while the base is moved along the first path and the catheter is held to the base, in order to seal around sheath 130 and to prevent the introduction of air into the body and the leakage of fluid out of the body.
Claim(s) 1, 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2010/0069833 (Wenderow et al.) in view of U.S. Publication Number 2010/0204646 (Plicchi) and Publication Number 2002/0010425 (Guo et al.)
Regarding claim 1, Wenderow discloses as shown in Figures 2, 2A, 6 an apparatus comprising: a base (base plate 318, see paragraph [0083]) comprising a device (cover 44, see paragraph [0063] or coupling mechanism 162, see paragraph [0074]) capable of releasably holding (by presenting an obstacle to removal of working catheter 54, the cover 44 necessarily holds it in) a catheter to the base. Wenderow also teaches the cover 44 is the cause the driving mechanism engaging or holding the catheter in paragraph [0051], or Wenderow discloses working catheter 54 goes through y-connector of guide catheter 144 which is removably held by coupling mechanism 162; see paragraphs [0069], [0073]; [0074]; thus it would necessarily follow that coupling mechanism 162 releasably holds working catheter 54 via y-connector of guide catheter 144) the catheter to the base, the catheter defining a lumen configured to receive an elongated medical device; a base drive member (base 302, see paragraph [0083]) to move the base relative to along a first path while the catheter is held to the base such that the catheter moves relative to; and a mechanism (first axial drive mechanism 48, first rotational drive mechanism 56, latch 210 see paragraphs [0050], [0053], [0060]) coupled to the base to maintain a position of the elongated medical device removably positioned within the lumen relative to the hemostasis valve while the base and the mechanism are moved along the first path and the catheter is held to the base.
Regrading claims 9-11, Wenderow discloses wherein the base drive member is moved by a robotic arm (arm 18, see paragraph [0041]) having one or more degrees of freedom, wherein the robotic arm moves the base relative to an access site on a patient, wherein the robotic arm moves the base relative to a position on a patient bed.
Claim 12, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0276391 (Yu) in view of U.S. Patent Publication Number 2002/0010425 (Guo et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2006/0041245 (Ferry et al.)
Regarding claim 12, Yu fails to disclose wherein the catheter is a rapid exchange device having a monorail portion having a lumen therein for a fixed length, the elongated medical device being movably received in the lumen of the monorail portion.
Ferry, from the same field of endeavor teaches a similar apparatus as shown in Figure 17 where the catheter includes a rapid exchange device having a monorail portion having a lumen therein for a fixed length, the elongated medical device being movably received in the lumen of the monorail portion. See claim 45.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Yu by substituting the catheter disclosed by Yu for the rapid exchange device having a monorail portion disclosed by Ferry because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0276391 (Yu) in view of U.S. Patent Publication Number 2002/0010425 (Guo et al.) as applied to claims 1 and 14 above, and further in view of U.S. Patent Publication Number 2007/0060879 (Weitzner et al)
Regarding claims 13, 14 Yu fails to disclose a distal clamp removably clamping a portion of the elongate medical device once a distal end of a monorail potion of the catheter is between the distal clamp and the base.
Weitzner, from the same field of endeavor teaches a similar apparatus as shown in Figures 17A-17B which includes a distal clamp (1310) removably clamping a portion of the elongate medical device once a distal end of a monorail potion of the catheter is between the distal clamp and the base, for the purpose of removably coupling the guidewire to the apparatus. See paragraph [0114].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Yu by substituting the structure which couples the guidewire to leader carriage 106 for the clamp disclosed by Weitzner because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claim 15, Yu in view of Gu and Weitzner discloses wherein the elongated medical device is capable of moving relative to the mechanism when the distal clamp clamps the elongated medical device thereto, if a small enough amount of clamping force is used. See paragraph [0108] of Weitzner.
Regarding claim 16, Yu in view of Gu and Weitzner disclose wherein the elongated medical device is capable of being removed from the mono rail by an elongated medical device removal drive (the other one of rollers 318, see paragraph [0023] of Yu) that moves the elongated medical device through the monorail in a second direction such that the proximal end of the elongated medical device is pulled through the monorail toward the hemostasis valve.
Claim(s) 17, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2014/0276391 (Yu) in view of U.S. Patent Publication Number 2002/0010425 (Guo et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2007/0060879 (Weitzner et al)
Regarding claim 17 Yu fails to disclose the mechanism includes a first clamp and a second clamp.
Weitzner, from the same field of endeavor teaches a similar apparatus as shown in Figures 17A-17B which includes a first clamp (1310) removably clamping a portion of the elongate medical device once a distal end of a monorail potion of the catheter is between the distal clamp and the base, for the purpose of removably coupling the guidewire to the apparatus. See paragraph [0114].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Yu by substituting the structure which couples the guidewire to leader carriage 106 for the clamp disclosed by Weitzner because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
It would have been further obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the apparatus disclosed by Yu by including a second clamp because it would only require the duplication of parts without changing how the device operates. see In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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