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 .
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 1-11 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-11 of prior U.S. Patent No. 12,171,660. This is a statutory double patenting rejection.
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 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe et al. (Pub. No.: US 2013/0338763).
Rowe et al. (hereinafter, Rowe) discloses a transcatheter device (e.g., abstract) comprising:
a main shaft 26;
a proximal portion (e.g., fig. 5, portion near anchor 24) comprising a proximal segment of the main shaft and an intravascular anchor 24;
a distal tail 32 comprising a distal portion of the main shaft (e.g., fig. 5), wherein the distal tail has a length in the range of 10-40 cm long (not inherently disclosed) (e.g., fig. 5, fig. 49)
a spacer body 34 mounted on the main shaft and located between the proximal segment of the main shaft and the distal tail (e.g., fig. 5).
As provided in italicized text above, Rowe does not specify the distal tail has a length of 10-14cm in length. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the distal tail of Row with a 10-40 cm length as an obvious dimension to suit the various sizes of the human body. Selection of this dimensional range would have occurred using known methods and would have yielded predictable results.
For claim 13, Rowe discloses the transcatheter device of claim 12, wherein the spacer body has a non-linear shape (e.g., fig. 5).
For claim 14, Rowe discloses the transcatheter device of claim 12, wherein the distal tail comprises a bend (e.g., fig. 50A-C).
For claim 15, Rowe discloses the transcatheter device of claim 12, wherein the distal tail comprises a proximal segment and a distal segment, wherein the distal segment has a thinner diameter than the proximal segment (e.g., fig. 50A, proximal segment is the collar above the spacer body).
For claim 16, Rowe does not specify the transcatheter device of claim 12, wherein the spacer body has a length in the range of range of 4-13 cm. Instead, Rowe is silent as to the length of the spacer body. However, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have selected a spacer body length of 4-13cm as an obvious expedient in order to appropriately coapt with the native leaflets. Selection of this dimensional range would have occurred using known methods and would have yielded predictable results.
For claim 17, Rowe discloses the transcatheter device of claim 12, wherein the intravascular anchor is a spiral coil (e.g., fig. 37).
For claim 18, Rowe discloses the transcatheter device of claim 17, wherein the intravascular anchor has at least two spirals (e.g., fig. 38).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rowe et al. (Pub. No.: US 2013/0338763) in view of Kim (EP 3 662 867 A2) (As cited in Applicant’s IDS).
Rowe discloses a coaptation assembly comprising: a transcatheter device of claim 12 (see explanation of Rowe with respect to claim 12, supra), however, Rowe does not specify the main shaft 26 comprises a lumen; a guidewire traveling through the lumen of the main shaft; a moveable delivery sheath 20 that covers the spacer body and intravascular anchor (e.g., fig. 1A); a deployment catheter 32 for intravascular deployment of the transcatheter device. Rowe does not specify the main shaft 26 comprises a lumen, with a guidewire. Kim teaches a coaptation assembly where the main shaft 20 includes a lumen for guidewire 50 (fig. 3). It would have been obvious to one of ordinary skill in the art to have provided the main shaft 26 of Rowe with a lumen and included a guidewire 50 as taught by Kim for the purpose of providing a guiding and navigating line to aid in the proper location and positioning of the implant in the body. This modification would have occurred using known methods and would have yielded predictable results.
For claim 20, Kim teaches the transcatheter device assembly of claim 19, further comprising an entry opening on the main shaft at a location between the intravascular anchor and the spacer body and an exit opening on the main shaft at a tip of the distal tail; wherein the lumen of the main shaft extends from the entry opening to the exit opening; wherein the guidewire travels through the lumen from the entry opening to the exit opening (e.g., fig. 3).
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774