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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 11, 2025 has been entered.
This Office action is responsive to an amendment filed November 11, 2025. Claims 1-7, 9, 11-29 & 31-34 are pending. No claim has been amended. Claims 8, 10 & 30 have been canceled.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4-5, 17, 31 & 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al. (US 2017/0079519) (“Sung” hereinafter) in view of Belef et al. (US 6,475,226) (“Belef” hereinafter) further in view of Bauer (US 4,907,598).
In regards to claim 1, Sung discloses a balloon-anchored, biopsy (i.e., tissue removal) device 1010 for acquiring a biopsy sample of a target organ in a subject (see at least par 0006), the biopsy (i.e., tissue removal) device 1010 comprising:
a first elongated tube enclosing a first lumen 1016 with a first proximal end and a distal tip, wherein a section of the first elongated tube near the distal tip comprises a balloon 1030 that when inserted into a blood vessel (see par 0036) of a target organ of a subject and inflated, anchors the section in the blood vessel (see par 0036) near a biopsy site in the target organ (see at least par 0011);
PNG
media_image1.png
179
488
media_image1.png
Greyscale
a second elongated tube enclosing a second lumen 1016a with a second proximal end and a second distal end, which is positioned at the biopsy site of the target organ when the first elongated tube is anchored in the blood vessel (see par 0036) by the inflated balloon 1030, wherein a predefined length of the first and the second elongated tubes are longitudinally attached to one another such that the distal exit 1017a is positioned at a proximal end of the section of the first elongated tube;
a flexible biopsy needle (see at least par 0014) for insertion into the second lumen 1016a of the second elongated tube for navigation to the biopsy site, wherein the flexible biopsy needle is configured to exit the distal exit 1017a of the second lumen 1016a for penetration into tissue of the target organ at the biopsy site at a predefined angle between a longitudinal axis of the section of the first elongated tube and a longitudinal axis of the flexible biopsy needle, and to acquire a biopsy sample of the target organ at the biopsy site (see at least abstract, figs. 18A-B and par 00012, 0122-0125).
Sung discloses a balloon-anchored biopsy (i.e., tissue removal) device 1010, as described above, that fails to explicitly teach a device comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation; wherein the predefined angle is not modified by the balloon and the needle is configured such that while the balloon is inflated, the needle is not in physical contact, directly or indirectly with the balloon.
However, Belef teaches that it is known to provide a device comprising a second elongated tube 42 comprising a beveled distal exit 62 of the second lumen (see at least fig. 3B), the distal tip and the beveled distal exit 62 disposed in a substantially similar orientation; wherein the predefined angle is not modified by the balloon 38 and the tissue penetrating member 46 is configured such that while the balloon 38 is inflated,
PNG
media_image2.png
149
525
media_image2.png
Greyscale
the needle is not in physical contact, directly or indirectly with the balloon (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8).
Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Sung comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation, as taught by Belef; wherein the predefined angle is not modified by the balloon, as taught by Belef, and the needle thereof is configured such that while the balloon is inflated, the tissue penetrating member, such as the needle of Sung, is not in physical contact, directly or indirectly with the balloon as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Sung) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sung as modified by Belef discloses a biopsy needle, as described above, that fails to explicitly teach a biopsy needle comprising a flexible biopsy needle attached to a distal end of a wire; wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section.
However, Bauer teaches that it is known to provide a biopsy needle comprising a
PNG
media_image3.png
674
546
media_image3.png
Greyscale
flexible biopsy needle 1 attached to a distal end of a wire (4, 5); wherein the flexible biopsy needle 1 comprises a cutting cannula 6 and a stylet 7, the stylet 7 having distal section and a specimen notch proximate to the distal section (see at least abstract, col. 1, lines 27-30 and col. 2, lines 11-19).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Sung as modified by Belef comprising a flexible biopsy needle attached to a distal end of a wire; wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Sung) for another (i.e., the biopsy needle as taught by Bauer) to obtain predictable results such as providing a flexible biopsy needle capable of cooperating with a flexible catheter for histologically drawing tissues (see at least col. 1, lines 24-30 of Bauer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Sung as modified by Belef discloses the biopsy (i.e., tissue removal) device 1010 according to claim 1, wherein the flexible biopsy needle is a Tru-cut biopsy needle. However, Bauer teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the flexible biopsy needle is a Tru-cut biopsy needle 1 (see at least abstract, col. 1, lines 27-30 and col. 2, lines 11-19). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Sung as modified by Belef wherein the flexible biopsy needle is a Tru-cut biopsy needle by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Sung) for another (i.e., the biopsy needle as taught by Bauer) to obtain predictable results such as providing a flexible biopsy needle capable of cooperating with a flexible catheter for histologically drawing tissues (see at least col. 1, lines 24-30 of Bauer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 4, the combination of Sung, Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, wherein the target organ capable of being a liver.
In regards to claim 5, the combination of Sung, Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 4, wherein the blood vessel is capable of being a hepatic vein of the liver.
In regards to claim 17, Sung as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a device wherein the flexible biopsy needle comprises wherein the stylet is hollow and a stylet wire is inserted into an overlapping joint. However, Bauer teaches that it is known to provide a device wherein the flexible biopsy needle comprises the stylet 7 is hollow and a stylet wire 4 inserted into an overlapping joint (see at least figs. 1-2). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy device of Sung as modified by Belef wherein the stylet is hollow and a stylet wire is inserted into an overlapping joint as taught by Bauer in order to join two dissimilar parts of the needle in a manner that would not detach as is known in the art.
In regards to claim 31, Sung as modified by Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a device wherein said balloon comprises angled edges. However, Belef teaches that it is known to provide a device wherein said balloon 38 comprises angled edges (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8). Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Sung as modified by Bauer wherein said balloon comprises angled edges as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the balloon as taught by Sung) for another (i.e., the balloon as taught by Belef) to obtain predictable results such as anchoring the distal end of the catheter in the blood vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 33, Sung discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the predefined angle is formed when the flexible biopsy needle is advanced through the beveled distal exit of the second lumen thus forming an oblique configuration. However, Belef teaches that it is known to provide a device wherein the predefined angle is formed when the flexible tissue penetrating member 46 is advanced through the beveled distal exit of the second lumen thus forming an oblique configuration (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Bauer wherein the predefined angle is formed when the flexible penetrating member, such as the flexible needle of Sung, is advanced through the beveled distal exit of the second lumen thus forming an oblique configuration as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Sung) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 34, Sung as modified by Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the second distal end tilts relative to the longitudinal axis of the section of the first elongated tube. However, Belef teaches that it is known to provide a device wherein the second distal end (i.e., defined by exit port 62) tilts relative to the longitudinal axis of the section of the first elongated tube 42 (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Bauer wherein the second distal end tilts relative to the longitudinal axis of the section of the first elongated tube as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Sung) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Aigner (US 4,540,402).
Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy device wherein the first elongated tube and the second elongated tube respectively comprise a balloon catheter and a guide catheter.
However, Aigner teaches that it is known to provide a device wherein the first elongated tube 1 and the second elongated tube 3 respectively comprise a
PNG
media_image4.png
126
420
media_image4.png
Greyscale
balloon catheter 1 and a guide catheter 3 (see at least abstract, fig. 4, and col. 1, lines 42-50 & 66-68, col. 2, lines 1-2 and col. 3, lines 1-42).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was made to provide biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the first elongated tube and the second elongated tube respectively comprise a balloon catheter and a guide catheter as taught by Aigner since such a modification would amount to a simple substitution of one known element (i.e., the multilumen catheter of Sung) for another (i.e., the double catheter of Aigner) to obtain predictable results such as access a body site--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Wang (US 4,702,260).
In regards to claim 6, Sung as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device 1010 according to claim 1, that fails to explicitly teach a device further comprising a locking means coupled to the second proximal end for fixing the position of the flexible biopsy needle at the distal end of the wire for insertion into the second lumen of the second elongated tube. However, Wang teaches that it is known to provide a device 10 further comprising a locking mechanism 18 coupled to the second proximal end for fixing the position of the flexible biopsy needle 16 at the distal end of the wire 29 in the lumen (see at least figs. 3 & 13-19 and par 0092). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer further comprising a locking means coupled to the second proximal end for fixing the position of the flexible biopsy needle at the distal end of the wire for insertion into the second lumen of the second elongated tube as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Sung) to a known device (i.e., as taught by Wang) ready for improvement to achieve a predictable result such as permitting the needle to be releasably fixed into position--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 7, Sung as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device 1010 according to claim 6, that fails to explicitly teach a device wherein the locking means is selected from the group consisting of a Tuohy Borst adapter, a luer lock, and a compressible clamp. However, Wang teaches that it is known to provide a device 100 wherein components of the locking mechanism is a luer lock 18 (see at least figs. 3 & 13-19 and par 0092). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the locking means is a luer lock as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Sung) to a known device (i.e., as taught by Wang) ready for improvement to achieve a predictable result such as permitting the needle to be releasably fixed into position--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Tsonton et al. (US 2005/0277829) (“Tsonton” hereinafter).
Sung as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device 1010 according to claim 8, that fails to explicitly teach a device wherein the flexible needle comprises a flattened band and an alignment notch for maintaining an alignment of the cutting cannula and the stylet.
However, Tsonton teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle comprises a flattened band (2016, 2024), and an alignment notch (2014, 2022) for maintaining an alignment of the cutting cannula 2000 and the stylet (2010, 2020) (see at least figs. 69-70 and par 0185).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the flexible needle thereof comprises a flattened band and an alignment notch for maintaining an alignment of the cutting cannula and the stylet as taught by Tsonton since such a modification would amount to applying a known technique (i.e., as taught by Tsonton) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as visualizing the needle position under an imaging modality--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Voorhees (US 2004/01222418).
Sung as modified by Belef and Bauer discloses the device 100 according to claim 1, that fails to explicitly teach a device further comprising an outer tube with the predefined length into which the first elongated tube and the second elongated tube are inserted so as to longitudinally attach the first elongated tube and the second elongated tube to one another.
However, Voorhees teaches that it is known to provide a device further comprising an outer tube 150 with the predefined length into which the first elongated tube 106 and the second elongated tube 108 are inserted so as to longitudinally attach the first elongated tube 106 and the second elongated tube 108 to one another (see at least abstract and figs. 1-6 and par 0020 & 0026-0027).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Sung as modified by Belef and Bauer further comprising an outer tube with the predefined length into which the first elongated tube and the second elongated tube are inserted so as to longitudinally attach the first elongated tube and the second elongated tube to one another as taught by Voorhees in order to selectively lock the first and second elongated tubes together.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Flaherty et al. (US 6,726,677) (“Flaherty” hereinafter).
Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the diameter of the inflated balloon is larger than the diameter of the blood vessel.
However, Flaherty teaches that it is known to provide a device wherein the diameter of the inflated balloon 50 is larger than the diameter of the blood vessel (i.e., for dilation, compression or tamponade of tissue, stretching taut) (see at least fig. 1 and col. 8, lines 1-40).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Sung as modified by Belef and Bauer wherein the diameter of the inflated balloon is larger than the diameter of the blood vessel as taught by Flaherty in order to selectively dilate the blood vessel to block blood flow through the first blood vessel, stabilize the catheter within the vessel, and/or dilate the vessel.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of De Cicco et al. (US 2016/0015422) (“De Cicco” hereinafter).
In regards to claim 13, Sung as modified by Belef and Bauer discloses the device 100 according to claim 1, that fails to explicitly teach wherein the diameter of the inflated balloon is no larger than 20% of the diameter of the blood vessel.
However, De Cicco discloses a device wherein the diameter of the inflated balloon (1751, 1753) is no larger than 20% of the diameter of the blood vessel (see at least abstract, figs. 17-20 and par 0083-0090).
Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the diameter of the inflated balloon is no larger than 20% of the diameter of the blood vessel as taught by De Cicco since such a modification would amount to applying a known technique (i.e., as taught by De Cicco) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as providing biopsy (i.e., tissue removal) device for use in connection with a transjugular intrahepatic portosystemic shunt (TIPS) procedure--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Swain et al. (US 2004/0186514) (“Swain” hereinafter).
Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach biopsy needle further comprising a connecting tube for insertion into the second lumen for guiding the flexible needle at the distal end of the wire to the biopsy site.
However, Swain teaches that it is known to provide a device comprising a connecting tube 7 for insertion into the second lumen 4 for guiding the flexible needle 5 to the biopsy site (see at least figs. 1, 1a-b & 2 and par 0030-0035).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer further comprising a connecting tube for insertion into the second lumen for guiding the flexible needle to the biopsy site as taught by Swain at the distal end of the wire as taught by Sung since such a modification would amount to applying a known technique (i.e., as taught by Swain) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as selectively deliver or protect the operative components--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Melsheimer (US 2012/0220894).
Sung as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a device wherein the flexible biopsy needle comprises a stylet joined to a stylet wire in an end-to-end joint.
However, Melsheimer teaches that it is known to provide a device wherein the flexible biopsy needle comprises a stylet 66A-C joined to a stylet wire 60A-C in an end-to-end joint (see at least figs. 14a-c and par 0043-0044).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the flexible biopsy needle comprises a stylet joined to a stylet wire in an end-to-end joint as taught by Melsheimer in order to join two dissimilar parts of the needle in a manner that would not detach.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Stanley et al. (US 2013/0046201) (“Stanley” hereinafter).
In regards to claim 18, Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy device wherein the flexible needle comprises an inner stylet and outer stylet with a cutting edge arranged in a concentric configuration. However, Stanley teaches that it is known to provide a biopsy device wherein the needle comprises an inner stylet 22 and outer stylet 124 with a cutting edge arranged in a concentric configuration (see at least figs. 8A-B and par 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Sung as modified by Belef and Bauer wherein the flexible needle thereof comprises an inner stylet and outer stylet with a cutting edge arranged in a concentric configuration as taught by Stanley since such a modification would amount to a simple substitution of one known element (i.e., as taught by Sung) for another (i.e., as taught by Stanley) to obtain predictable results such as obtaining a full-circular core of tissue with improved results over existing devices and provide samples that are easier to study (see at least par 0002 & 0004 of Stanley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 19, Sung as modified by Belef and Bauer discloses the device according to claim 18, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the flexible needle is configured to acquire the biopsy sample by rotating the outer stylet with the cutting edge relative to the inner stylet when the flexible needle is within the tissue of the target organ. However, Stanley teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle is configured to acquire the biopsy sample by rotating the outer stylet 124 with the cutting edge relative to the inner stylet 22 when the needle is within the tissue of the target organ (see at least figs. 8A-B and par 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Sung as modified by Belef and Bauer wherein the flexible needle thereof is configured to acquire the biopsy sample by rotating the outer stylet with the cutting edge relative to the inner stylet, as taught by Stanley, when the flexible needle thereof is within the tissue of the target organ since such a modification would amount to a simple substitution of one known element (i.e., as taught by Sung) for another (i.e., as taught by Stanley) to obtain predictable results such as obtaining a full-circular core of tissue with improved results over existing devices and provide samples that are easier to study (see at least par 0002 & 0004 of Stanley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 20, Sung as modified by Belef and Bauer discloses the device according to claim 19, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the flexible needle is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet remains in a rotated position substantially opposite to the inner stylet. However, Stanley teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet 124 remains in a rotated position substantially opposite to the inner stylet 22 (see at least figs. 8A-B and par 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Sung as modified by Belef and Bauer wherein the flexible needle thereof is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet remains in a rotated position substantially opposite to the inner stylet as taught by Stanley since such a modification would amount to a simple substitution of one known element (i.e., as taught by Sung) for another (i.e., as taught by Stanley) to obtain predictable results such as obtaining a full-circular core of tissue with improved results over existing devices and provide samples that are easier to study (see at least par 0002 & 0004 of Stanley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Heilman et al. (US 2016/0136398) (“Heilman” hereinafter).
Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy device further comprising a rigid contoured section coupled to the distal end of the second elongated tube for increasing the predefined angle when the balloon is inflated.
However, Heilman teaches that it is known to provide a biopsy (i.e., tissue removal) device further comprising a rigid contoured section 370 (shown in fig. 20A) (see par 0186 & 0191) coupled to the distal end 344 of the second elongated tube 304 for increasing the predefined angle when the balloon 380b is inflated (see at least figs. 21A-D and par 0191-0192).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer further comprising a rigid contoured section coupled to the distal end of the second elongated tube for increasing the predefined angle when the balloon is inflated as taught by Heilman in order to selectively deflect the biopsy needle towards the tissue.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Bosch et al. (WO 2010/063676) (“Bosch” hereinafter).
Sung as modified by Belef and Bauer discloses the device according to claim 1, wherein the second elongated tube is coupled to a pressure transducer for measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer in a signal processing unit.
However, Bosch teaches that it is known to provide a device wherein the first elongated tube is coupled to a pressure transducer for measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer in a signal processing unit (see at least abstract, figs. 1-2; pg. 3, lines 3-25 & pg. 4, lines 11-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the device of Sung as modified by Belef and Bauer wherein the second elongated tube thereof is coupled to a pressure transducer thereof for measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer in a signal processing unit as taught by Bosch since such a modification would amount to applying a known technique (i.e., as taught by Bosch) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as measuring for an indication of portal vein hypertension, which is developed during cirrhosis when there is an increase of the resistance to blood flow through the liver and an increase of the inflow in the portal vein, and is the main cause of mortality and of liver transplant in affected patients (see at least pg. 1, lines 16-35 & pg. 2, lines 1-29 of Bosch)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 24 & 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung et al. (US 2017/0079519) (“Sung” hereinafter) in view of in view of Chan et al. (US 7,273,469) (“Chan” hereinafter), Belef et al. (US 6,475,226) (“Belef” hereinafter), Bauer (US 4,907,598), Mark et al. (US 2006/0184153) (“Mark” hereinafter) further in view of Bauer (US 4,907,598).
In regards to claim 24, Sung discloses a method for acquiring a biopsy sample of a target organ of a subject using a balloon-anchored biopsy (i.e., tissue removal) device 1010, the method including:
inserting a biopsy (i.e., tissue removal) device 1010 into a subject, the biopsy (i.e., tissue removal) device 1010 comprising:
a first elongated tube enclosing a first lumen 1016 with a first proximal end and.a distal tip, wherein a section of the first elongated tube near the distal tip comprises a balloon 1030 that when inserted into a blood vessel (see par 0036) of a target organ of a subject and inflated, anchors the section in the blood vessel (see par 0036) near a biopsy site in the target organ (see at least par 0011);
PNG
media_image1.png
179
488
media_image1.png
Greyscale
a second elongated tube enclosing a second lumen 1016a with a second proximal end and a second distal end, which is positioned at the biopsy site of the target organ when the first elongated tube is anchored in the blood vessel (see par 0036) by the inflated balloon 1030, wherein a predefined length of the first and the second elongated tubes are longitudinally attached to one another such that the distal exit 1017a is positioned at a proximal end of the section of the first elongated tube;
a flexible biopsy needle (see at least par 0014) for insertion into the second lumen 1016a of the second elongated tube for navigation to the biopsy site, wherein the flexible biopsy needle is configured to exit the distal exit 1017a of the second lumen 1016a for penetration into tissue of the target organ at the biopsy site at a predefined angle between a longitudinal axis of the section of the first elongated tube and a longitudinal axis of the flexible biopsy needle, and to acquire a biopsy sample of the target organ at the biopsy site (see at least abstract, figs. 18A-B and par 00012, 0122-0125);
navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel (see par 0036) of the target organ near the site;
inflating the balloon 1030 in the blood vessel (see par 0036);
pushing the flexible biopsy needle into the tissue of the target organ at the biopsy site at the predefined angle;
acquiring a biopsy sample of the target organ at the biopsy site using the flexible biopsy needle; and
withdrawing the needle from the second lumen 1016a so as to retrieve the acquired biopsy sample (see at least abstract, figs. 18A-B and par 00012, 0122-0125).
Sung discloses a method, as described above, that fails to explicitly teach a method comprising percutaneously inserting a biopsy (i.e., tissue removal) device 1010 into a vein of a limb of a subject, and navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site.
However, Chan teaches that it is known to a method comprising percutaneously inserting a device into a vein of a limb of a subject, the device comprising:
a first elongated tube 22 enclosing a first lumen with a first proximal end and, a distal tip, wherein a section of the first elongated tube 22 near the distal tip comprises a balloon 20 that when inserted into a blood vessel of a target organ of a subject and inflated, anchors the section in the blood vessel near a site in the target organ; a second elongated tube 42 enclosing a second lumen with a second proximal end and a second distal end comprising a beveled distal exit 135 of the second lumen 42, which is positioned at the site of the target organ when the first elongated tube 22 is anchored in the blood vessel by the inflated balloon 20, wherein a predefined length of the first and the second elongated tubes (22, 42) are longitudinally attached to one another (see at least figs. 3-4) such that the beveled distal exit 135 is positioned at a proximal end of the section of the first elongated tube 22; wherein the first elongated tube 22 is more flexible than the second elongated tube (i.e., by virtue of their relative cross-sections or thickness); navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site; inflating the balloon 20 in the blood vessel; pushing the flexible needle 47 into the tissue of the target organ at the site at the predefined angle; and withdrawing the needle 47 from the second lumen (see at least figs. 4).
Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sung comprising percutaneously inserting a biopsy (i.e., tissue removal) device 1010 into a vein of a limb of a subject, and navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site as taught by Chan since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Sung) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sung as modified by Chan discloses a method, as described above, that fails to explicitly teach a method comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation; wherein the predefined angle is not modified by the balloon and the needle is configured such that while the balloon is inflated, the needle is not in physical contact, directly or indirectly with the balloon.
However, Belef teaches that it is known to provide a method comprising a second elongated tube 42 comprising a beveled distal exit 62
PNG
media_image2.png
149
525
media_image2.png
Greyscale
of the second lumen (see at least fig. 3B), the distal tip and the beveled distal exit 62 disposed in a substantially similar orientation (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8).
Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Sung as modified by Chan comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation as taught by Belef; wherein the predefined angle is not modified by the balloon, as taught by Belef, and the needle thereof is configured such that while the balloon is inflated, the tissue penetrating member, such as the needle of Sung, is not in physical contact, directly or indirectly with the balloon as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Sung) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sung as modified by Chan and Belef discloses a method, as described above, that fails to explicitly teach a method with the device comprising a flexible biopsy needle attached to a distal end of a wire, the method comprising withdrawing the wire from the second lumen so as to retrieve the acquired biopsy sample.
However, Mark teaches that it is known to provide a biopsy needle comprising a flexible biopsy needle 110 attached to a distal end of a wire 76 (see at least abstract, figs. 4-21 and par 0044, 0048-0049, 0053-0055, 0058-0059 & 0061-0064).
Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sung as modified by Chan and Belef with a flexible biopsy needle attached to a distal end of a wire as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Sung) for another (i.e., the biopsy needle as taught by Mark) to obtain predictable results such as providing a transjugular biopsy (i.e., tissue removal) device that is flexible to overcome the resultant binding force imparted by the introducer on the needle coring assembly and is capable of repeated uses without a measurable degradation in performance (see at least par 0014 of Mark)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Sung as modified by Chan and Belef discloses the method, as described above, that fails to explicitly teach a method wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section.
However, Bauer teaches that it is known to provide a method comprising a
PNG
media_image3.png
674
546
media_image3.png
Greyscale
flexible biopsy needle 1 attached to a distal end of a wire (4, 5); wherein the flexible biopsy needle 1 comprises a cutting cannula 6 and a stylet 7, the stylet 7 having distal section and a specimen notch proximate to the distal section (see at least abstract, col. 1, lines 27-30 and col. 2, lines 11-19).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sung as modified by Chan and Belef comprising a flexible biopsy needle attached to a distal end of a wire; wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Sung) for another (i.e., the biopsy needle as taught by Bauer) to obtain predictable results such as providing a flexible biopsy needle capable of cooperating with a flexible catheter for histologically drawing tissues (see at least col. 1, lines 24-30 of Bauer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 27, Sung as modified by Chan, Belef and Bauer discloses the method according to claim 24, that fails to explicitly teach a method wherein percutaneously inserting the biopsy (i.e., tissue removal) device into the vein of the limb of the subject comprises inserting the biopsy (i.e., tissue removal) device through a lumen of a sheath in the vein. However, Mark teaches that it is known to provide a method wherein percutaneously inserting the biopsy (i.e., tissue removal) device 52 into the vein of the limb of the subject comprises inserting the biopsy (i.e., tissue removal) device 52 through a lumen 36 of a sheath 34 in the vein (see at least abstract, figs. 4-21 and par 0044, 0048-0049, 0053-0055, 0058-0059 & 0061-0064). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Sung as modified by Chan, Belef and Bauer wherein percutaneously inserting the biopsy device into the vein of the limb of the subject comprises inserting the biopsy device through a lumen of a sheath in the vein as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Sung) for another (i.e., the biopsy needle as taught by Mark) to obtain predictable results such as providing a transjugular biopsy (i.e., tissue removal) device that is flexible to overcome the resultant binding force imparted by the introducer on the needle coring assembly and is capable of repeated uses without a measurable degradation in performance (see at least par 0014 of Mark)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 28, Sung as modified by Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly teach a method wherein the balloon comprises a distal balloon and a proximal balloon, and wherein inflating the balloon comprises inflating the distal balloon and the proximal balloon separately or together in the blood vessel. However, Chan teaches that it is known to provide a method wherein the balloon comprises a distal balloon 420B and a proximal balloon 420A, and wherein inflating the balloon comprises inflating the distal balloon 420B and the proximal balloon 420A separately or together in the blood vessel (see at least abstract, figs. 29 & 31 and col. 23, lines 55-67 and col. 24, lines 1-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sung as modified by Belef, Bauer and Mark wherein the balloon comprises a distal balloon and a proximal balloon, and wherein inflating the balloon comprises inflating the distal balloon and the proximal balloon separately or together in the blood vessel as taught by Chan since such a modification would amount to applying a known technique (i.e., as taught by Chan) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as providing greater coverage for the biopsy procedure by performing multiple tissue penetrations at multiple sites while reducing the number of balloon movement for making multiple tissue penetrations along the vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Chan (‘469), Belef (‘226), Bauer (‘598), Mark (‘153) further in view of Miller (US 2012/0123327).
In regards to claim 25, Sung as modified by Chan, Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly a method wherein the limb comprises an arm of the subject and the vein comprises a cephalic vein of the arm. However, Miller teaches that it is known to provide a method wherein the limb comprises an arm of the subject and the vein comprises a cephalic vein of the arm (see at least par 0084). Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sung as modified by Chan, Belef, Bauer and Mark wherein the limb comprises an arm of the subject and the vein comprises a cephalic vein of the arm as taught by Miller since Miller teaches that it is known to access the right heart chambers for biopsy procedures through venous access in the cephalic veins.
In regards to claim 26, Sung as modified by Chan, Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly teach a method wherein the limb comprises a leg of the subject and the vein comprises a femoral vein of the leg. However, Miller teaches that it is known to provide a method wherein the limb comprises a leg of the subject and the vein comprises a femoral vein of the leg (see at least par 0084). Therefore, since Sung discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Sung as modified by Chan, Belef, Bauer and Mark wherein the limb comprises a leg of the subject and the vein comprises a femoral vein of the leg as taught by Miller since Miller teaches that it is known to access the right heart chambers for biopsy procedures through venous access in the femoral veins.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Chan (‘469), Belef (‘226), Bauer (‘598), Mark (‘153) further in view of Bosch et al. (WO 2010/063676) (“Bosch” hereinafter).
Sung as modified by Chan, Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly teach a method wherein the second elongated tube is coupled to a pressure transducer, and further comprising measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer.
However, Bosch teaches that it is known to provide a method further comprising measuring a hepatic venous pressure gradient (HVPG) (see at least abstract, figs. 1-2; pg. 3, lines 3-25 & pg. 4, lines 11-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Sung as modified by Chan, Belef, Bauer and Mark wherein the second elongated tube thereof is coupled to a pressure transducer, and further comprising measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer as taught by as taught by Bosch since such a modification would amount to applying a known technique (i.e., as taught by Bosch) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as measuring for an indication of portal vein hypertension, which is developed during cirrhosis when there is an increase of the resistance to blood flow through the liver and an increase of the inflow in the portal vein, and is the main cause of mortality and of liver transplant in affected patients (see at least pg. 1, lines 16-35 & pg. 2, lines 1-29 of Bosch)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 14, 22 & 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sung (‘519) in view of Belef (‘226), Bauer (‘598) further in view of Chan et al. (US 7,273,469) (“Chan” hereinafter).
In regards to claim 14, Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the predefined angle is in the range of 15-45 degrees. However, Chan teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the predefined angle is in the range of 15-45 degrees (i.e., about 15 º to less than about 90º) (see at least figs. 1 & 16-17 and col. 6, lines 10-15, col. 12, lines 25-31, col. 15, lines 36-45). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the predefined angle is in the range of 15-45 degrees as taught by Chan since such a modification would amount to a simple substitution of one known element (i.e., the balloon of Sung) for another (i.e., the balloon of Chan) to obtain predictable results such as stabilizing the catheter and/or deflecting needle to a selected non-zero angle so as to thereby control the angle at which the needle contacts the body lumen wall during a diagnostic or therapeutic procedure--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 22, Sung as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the balloon comprises a distal balloon and a proximal balloon, which are inflatable separately or together in the blood vessel. However, Chan teaches that it is known to provide a device wherein the balloon comprises a distal balloon 420B and a proximal balloon 420A, which are inflatable separately or together in the blood vessel (see at least abstract, figs. 29 & 31 and col. 23, lines 55-67 and col. 24, lines 1-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein the balloon comprises a distal balloon and a proximal balloon, which are inflatable separately or together in the blood vessel as taught by Chan since such a modification would amount to applying a known technique (i.e., as taught by Chan) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as providing greater coverage for the biopsy procedure by performing multiple tissue penetrations at multiple sites while reducing the number of balloon movement for making multiple tissue penetrations along the vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 32, Sung as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 22, that fails to explicitly teach a biopsy needle wherein said distal balloon and proximal balloon, each comprises angled edges. However, Chan teaches that it is known to provide a device wherein said distal balloon 420B and proximal balloon 420A, each comprises angled edges (see at least abstract, figs. 29 & 31 and col. 23, lines 55-67 and col. 24, lines 1-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Sung as modified by Belef and Bauer wherein said distal balloon and proximal balloon, each comprises angled edges as taught by Chang since such a modification would amount to applying a known technique (i.e., as taught by Chan) to a known device (i.e., as taught by Sung) ready for improvement to achieve a predictable result such as providing greater coverage for the biopsy procedure by performing multiple tissue penetrations at multiple sites while reducing the number of balloon movement for making multiple tissue penetrations along the vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 1-2, 4-5, 17, 31 & 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon et al. (US 5,464,395) (“Faxon” hereinafter) in view of Belef et al. (US 6,475,226) (“Belef” hereinafter) further in view of Bauer (US 4,907,598).
In regards to claim 1, Faxon discloses a balloon-anchored, biopsy (i.e., tissue removal) device 205 for acquiring a biopsy sample of a target organ in a subject (see at least par 0006), the biopsy (i.e., tissue removal) device comprising:
a first elongated tube enclosing a first lumen 115 with a first proximal end and a distal tip, wherein a section of the first elongated tube near the distal tip comprises a balloon 210 that when inserted into a blood vessel of a target organ of a subject and inflated, anchors the section in the blood vessel near a biopsy site in the target organ (see at least abstract and figs. 17-19);
PNG
media_image5.png
615
615
media_image5.png
Greyscale
a second elongated tube enclosing a second lumen 55 with a second proximal end and a second distal end, which is positioned at the biopsy site of the target organ when the first elongated tube is anchored in the blood vessel by the inflated balloon 210, wherein a predefined length of the first and the second elongated tubes are longitudinally attached to one another such that the distal exit 65 is positioned at a proximal end of the section of the first elongated tube (see at least figs. 17-19);
a flexible biopsy needle 20 for insertion into the second lumen 55 of the second elongated tube for navigation to the biopsy site, wherein the flexible biopsy needle is configured to exit the distal exit 65 of the second lumen 55 for penetration into tissue of the target organ at the biopsy site at a predefined angle between a longitudinal axis of the section of the first elongated tube and a longitudinal axis of the flexible biopsy needle 20, and to acquire a biopsy sample of the target organ at the biopsy site (see at least abstract, figs. 17-19 and col. 5, lines 45-65, col. 6, lines 38-50, col. 9, lines 33-40 & col. 10, lines 21-48).
Faxon discloses a balloon-anchored biopsy (i.e., tissue removal) device, as described above, that fails to explicitly teach a device comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation; wherein the predefined angle is not modified by the balloon and the needle is configured such that while the balloon is inflated, the needle is not in physical contact, directly or indirectly with the balloon.
However, Belef teaches that it is known to provide a device comprising a second elongated tube 42 comprising a beveled distal exit 62 of the second lumen (see at least fig. 3B), the distal tip and the beveled distal
exit 62 disposed in a substantially similar orientation; wherein the predefined angle is not modified by the balloon 38 and the tissue penetrating member 46 is configured such that while the balloon is inflated, the needle is not in physical
PNG
media_image2.png
149
525
media_image2.png
Greyscale
contact, directly or indirectly with the balloon (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8).
Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Faxon comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation, as taught by Belef; wherein the predefined angle is not modified by the balloon, as taught by Belef, and the needle thereof is configured such that while the balloon is inflated, the tissue penetrating member, such as the needle of Faxon, is not in physical contact, directly or indirectly with the balloon as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Faxon) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Faxon as modified by Belef discloses a biopsy needle, as described above, that fails to explicitly teach a biopsy needle comprising a flexible biopsy needle attached to a distal end of a wire; wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section.
However, Bauer teaches that it is known to provide a biopsy needle comprising a
PNG
media_image3.png
674
546
media_image3.png
Greyscale
flexible biopsy needle 1 attached to a distal end of a wire (4, 5); wherein the flexible biopsy needle 1 comprises a cutting cannula 6 and a stylet 7, the stylet 7 having distal section and a specimen notch proximate to the distal section (see at least abstract, col. 1, lines 27-30 and col. 2, lines 11-19).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Faxon as modified by Belef with a flexible biopsy needle attached to a distal end of a wire; wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Faxon) for another (i.e., the biopsy needle as taught by Bauer) to obtain predictable results such as providing a flexible biopsy needle capable of cooperating with a flexible catheter for histologically drawing tissues (see at least col. 1, lines 24-30 of Bauer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Faxon as modified by Belef discloses the biopsy device according to claim 1, wherein the flexible biopsy needle is a Tru-cut biopsy needle. However, Bauer teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the flexible biopsy needle is a Tru-cut biopsy needle 1 (see at least abstract, col. 1, lines 27-30 and col. 2, lines 11-19). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Faxon as modified by Belef wherein the flexible biopsy needle is a Tru-cut biopsy needle by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Faxon) for another (i.e., the biopsy needle as taught by Bauer) to obtain predictable results such as providing a flexible biopsy needle capable of cooperating with a flexible catheter for histologically drawing tissues (see at least col. 1, lines 24-30 of Bauer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 4, the combination of Faxon, Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, wherein the target organ capable of being a liver.
In regards to claim 5, the combination of Faxon, Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 4, wherein the blood vessel is capable of being a hepatic vein of the liver.
In regards to claim 17, Faxon as modified by Belef discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a device wherein the flexible biopsy needle comprises a hollow stylet and a stylet wire inserted into an overlapping joint. However, Bauer teaches that it is known to provide a device wherein the flexible biopsy needle comprises a hollow stylet 7 and a stylet wire (4, 5) inserted into an overlapping joint (see at least figs. 1-2). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy device of Faxon as modified by Belef wherein the flexible biopsy needle comprises a hollow stylet and a stylet wire inserted into an overlapping joint as taught by Bauer in order to join two dissimilar parts of the needle in a manner that would not detach as is known in the art.
In regards to claim 31, Faxon discloses the biopsy (i.e., tissue removal) device according to claim 1, wherein said balloon 210 comprises angled edges (see at least figs. 17-18).
In regards to claim 33, Faxon as modified by Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the predefined angle is formed when the flexible biopsy needle is advanced through the beveled distal exit of the second lumen thus forming an oblique configuration. However, Belef teaches that it is known to provide a device wherein the predefined angle is formed when the flexible tissue penetrating member 46 is advanced through the beveled distal exit of the second lumen thus forming an oblique configuration (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy device of Faxon as modified by Bauer wherein the predefined angle is formed when the flexible penetrating member, such as the flexible needle of Faxon, is advanced through the beveled distal exit of the second lumen thus forming an oblique configuration as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Faxon) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 34, Faxon as modified by Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the second distal end tilts relative to the longitudinal axis of the section of the first elongated tube. However, Belef teaches that it is known to provide a device wherein the second distal end (i.e., defined by exit port 62) tilts relative to the longitudinal axis of the section of the first elongated tube 42 (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Bauer wherein the second distal end tilts relative to the longitudinal axis of the section of the first elongated tube as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Faxon) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Aigner (US 4,540,402).
Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the first elongated tube and the second elongated tube respectively comprise a balloon catheter and a guide catheter.
However, Aigner teaches that it is known to provide a device wherein the first elongated tube 1 and the second elongated tube 3 respectively comprise a
PNG
media_image4.png
126
420
media_image4.png
Greyscale
balloon catheter 1 and a guide catheter 3 (see at least abstract, fig. 4, and col. 1, lines 42-50 & 66-68, col. 2, lines 1-2 and col. 3, lines 1-42).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant's invention was made to provide biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the first elongated tube and the second elongated tube respectively comprise a balloon catheter and a guide catheter as taught by Aigner since such a modification would amount to a simple substitution of one known element (i.e., the multilumen catheter of Faxon) for another (i.e., the double catheter of Aigner) to obtain predictable results such as access a body site--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Wang (US 4,702,260).
In regards to claim 6, Faxon as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a device further comprising a locking means coupled to the second proximal end for fixing the position of the flexible biopsy needle at the distal end of the wire for insertion into the second lumen of the second elongated tube. However, Wang teaches that it is known to provide a device 10 further comprising a locking mechanism 18 coupled to the second proximal end for fixing the position of the flexible biopsy needle 16 at the distal end of the wire 29 in the lumen (see at least figs. 3 & 13-19 and par 0092). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer further comprising a locking means coupled to the second proximal end for fixing the position of the flexible biopsy needle at the distal end of the wire for insertion into the second lumen of the second elongated tube as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Faxon) to a known device (i.e., as taught by Wang) ready for improvement to achieve a predictable result such as permitting the needle to be releasably fixed into position--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 7, Faxon as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 6, that fails to explicitly teach a device wherein the locking means is selected from the group consisting of a Tuohy Borst adapter, a luer lock, and a compressible clamp. However, Wang teaches that it is known to provide a device 100 wherein components of the locking mechanism is a luer lock 18 (see at least figs. 3 & 13-19 and par 0092). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the locking means is a luer lock as taught by Wang since such a modification would amount to applying a known technique (i.e., as taught by Faxon) to a known device (i.e., as taught by Wang) ready for improvement to achieve a predictable result such as permitting the needle to be releasably fixed into position--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Tsonton et al. (US 2005/0277829) (“Tsonton” hereinafter).
Faxon as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 8, that fails to explicitly teach a device wherein the flexible needle comprises a flattened band and an alignment notch for maintaining an alignment of the cutting cannula and the stylet.
However, Tsonton teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle comprises a flattened band (2016, 2024), and an alignment notch (2014, 2022) for maintaining an alignment of the cutting cannula 2000 and the stylet (2010, 2020) (see at least figs. 69-70 and par 0185).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the flexible needle thereof comprises a flattened band and an alignment notch for maintaining an alignment of the cutting cannula and the stylet as taught by Tsonton since such a modification would amount to applying a known technique (i.e., as taught by Tsonton) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as visualizing the needle position under an imaging modality--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Voorhees (US 2004/01222418).
Faxon as modified by Belef and Bauer discloses the device 100 according to claim 1, that fails to explicitly teach a device further comprising an outer tube with the predefined length into which the first elongated tube and the second elongated tube are inserted so as to longitudinally attach the first elongated tube and the second elongated tube to one another.
However, Voorhees teaches that it is known to provide a device further comprising an outer tube 150 with the predefined length into which the first elongated tube 106 and the second elongated tube 108 are inserted so as to longitudinally attach the first elongated tube 106 and the second elongated tube 108 to one another (see at least abstract and figs. 1-6 and par 0020 & 0026-0027).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Faxon as modified by Belef and Bauer further comprising an outer tube with the predefined length into which the first elongated tube and the second elongated tube are inserted so as to longitudinally attach the first elongated tube and the second elongated tube to one another as taught by Voorhees in order to selectively lock the first and second elongated tubes together.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Flaherty et al. (US 6,726,677) (“Flaherty” hereinafter).
Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the diameter of the inflated balloon is larger than the diameter of the blood vessel.
However, Flaherty teaches that it is known to provide a device wherein the diameter of the inflated balloon 50 is larger than the diameter of the blood vessel (i.e., for dilation, compression or tamponade of tissue, stretching taut) (see at least fig. 1 and col. 8, lines 1-40).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Faxon as modified by Belef and Bauer wherein the diameter of the inflated balloon is larger than the diameter of the blood vessel as taught by Flaherty in order to selectively dilate the blood vessel to block blood flow through the first blood vessel, stabilize the catheter within the vessel, and/or dilate the vessel.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of De Cicco et al. (US 2016/0015422) (“De Cicco” hereinafter).
In regards to claim 13, Faxon as modified by Belef and Bauer discloses the device 100 according to claim 1, that fails to explicitly teach wherein the diameter of the inflated balloon is no larger than 20% of the diameter of the blood vessel.
However, De Cicco discloses a device wherein the diameter of the inflated balloon (1751, 1753) is no larger than 20% of the diameter of the blood vessel (see at least abstract, figs. 17-20 and par 0083-0090).
Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the diameter of the inflated balloon is no larger than 20% of the diameter of the blood vessel as taught by De Cicco since such a modification would amount to applying a known technique (i.e., as taught by De Cicco) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as providing biopsy (i.e., tissue removal) device for use in connection with a transjugular intrahepatic portosystemic shunt (TIPS) procedure--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Swain et al. (US 2004/0186514) (“Swain” hereinafter).
Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach biopsy needle further comprising a connecting tube for insertion into the second lumen for guiding the flexible needle at the distal end of the wire to the biopsy site.
However, Swain teaches that it is known to provide a device comprising a connecting tube 7 for insertion into the second lumen 4 for guiding the flexible needle 5 to the biopsy site (see at least figs. 1, 1a-b & 2 and par 0030-0035).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer further comprising a connecting tube for insertion into the second lumen for guiding the flexible needle to the biopsy site as taught by Swain at the distal end of the wire as taught by Faxon since such a modification would amount to applying a known technique (i.e., as taught by Swain) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as selectively deliver or protect the operative components--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Melsheimer (US 2012/0220894).
Faxon as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 1, that fails to explicitly teach a device wherein the flexible biopsy needle comprises a stylet joined to a stylet wire in an end-to-end joint.
However, Melsheimer teaches that it is known to provide a device wherein the flexible biopsy needle comprises a stylet 66A-C joined to a stylet wire 60A-C in an end-to-end joint (see at least figs. 14a-c and par 0043-0044).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the flexible biopsy needle comprises a stylet joined to a stylet wire in an end-to-end joint as taught by Melsheimer in order to join two dissimilar parts of the needle in a manner that would not detach.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Stanley et al. (US 2013/0046201) (“Stanley” hereinafter).
In regards to claim 18, Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the flexible needle comprises an inner stylet and outer stylet with a cutting edge arranged in a concentric configuration. However, Stanley teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle comprises an inner stylet 22 and outer stylet 124 with a cutting edge arranged in a concentric configuration (see at least figs. 8A-B and par 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Faxon as modified by Belef and Bauer wherein the flexible needle thereof comprises an inner stylet and outer stylet with a cutting edge arranged in a concentric configuration as taught by Stanley since such a modification would amount to a simple substitution of one known element (i.e., as taught by Faxon) for another (i.e., as taught by Stanley) to obtain predictable results such as obtaining a full-circular core of tissue with improved results over existing devices and provide samples that are easier to study (see at least par 0002 & 0004 of Stanley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 19, Faxon as modified by Belef and Bauer discloses the device according to claim 18, that fails to explicitly teach a biopsy device wherein the flexible needle is configured to acquire the biopsy sample by rotating the outer stylet with the cutting edge relative to the inner stylet when the flexible needle is within the tissue of the target organ. However, Stanley teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle is configured to acquire the biopsy sample by rotating the outer stylet 124 with the cutting edge relative to the inner stylet 22 when the needle is within the tissue of the target organ (see at least figs. 8A-B and par 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Faxon as modified by Belef and Bauer wherein the flexible needle thereof is configured to acquire the biopsy sample by rotating the outer stylet with the cutting edge relative to the inner stylet, as taught by Stanley, when the flexible needle thereof is within the tissue of the target organ since such a modification would amount to a simple substitution of one known element (i.e., as taught by Faxon) for another (i.e., as taught by Stanley) to obtain predictable results such as obtaining a full-circular core of tissue with improved results over existing devices and provide samples that are easier to study (see at least par 0002 & 0004 of Stanley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 20, Faxon as modified by Belef and Bauer discloses the device according to claim 19, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the flexible needle is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet remains in a rotated position substantially opposite to the inner stylet. However, Stanley teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the needle is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet 124 remains in a rotated position substantially opposite to the inner stylet 22 (see at least figs. 8A-B and par 0052-0053). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the device of Faxon as modified by Belef and Bauer wherein the flexible needle thereof is configured to encapsulate the acquired biopsy sample in a specimen notch when the outer stylet remains in a rotated position substantially opposite to the inner stylet as taught by Stanley since such a modification would amount to a simple substitution of one known element (i.e., as taught by Faxon) for another (i.e., as taught by Stanley) to obtain predictable results such as obtaining a full-circular core of tissue with improved results over existing devices and provide samples that are easier to study (see at least par 0002 & 0004 of Stanley)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Heilman et al. (US 2016/0136398) (“Heilman” hereinafter).
Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device further comprising a rigid contoured section coupled to the distal end of the second elongated tube for increasing the predefined angle when the balloon is inflated.
However, Heilman teaches that it is known to provide a biopsy (i.e., tissue removal) device further comprising a rigid contoured section 370 (shown in fig. 20A) (see par 0186 & 0191) coupled to the distal end 344 of the second elongated tube 304 for increasing the predefined angle when the balloon 380b is inflated (see at least figs. 21A-D and par 0191-0192).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer further comprising a rigid contoured section coupled to the distal end of the second elongated tube for increasing the predefined angle when the balloon is inflated as taught by Heilman in order to selectively deflect the biopsy needle towards the tissue.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Bosch et al. (WO 2010/063676) (“Bosch” hereinafter).
Faxon as modified by Belef and Bauer discloses the device according to claim 1, wherein the second elongated tube is coupled to a pressure transducer for measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer in a signal processing unit.
However, Bosch teaches that it is known to provide a device wherein the first elongated tube is coupled to a pressure transducer for measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer in a signal processing unit (see at least abstract, figs. 1-2; pg. 3, lines 3-25 & pg. 4, lines 11-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the device of Faxon as modified by Belef and Bauer wherein the second elongated tube thereof is coupled to a pressure transducer thereof for measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer in a signal processing unit as taught by Bosch since such a modification would amount to applying a known technique (i.e., as taught by Bosch) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as measuring for an indication of portal vein hypertension, which is developed during cirrhosis when there is an increase of the resistance to blood flow through the liver and an increase of the inflow in the portal vein, and is the main cause of mortality and of liver transplant in affected patients (see at least pg. 1, lines 16-35 & pg. 2, lines 1-29 of Bosch)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 24 & 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon et al. (US 5,464,395) (“Faxon” hereinafter) in view of in view of Chan et al. (US 7,273,469) (“Chan” hereinafter), Belef et al. (US 6,475,226) (“Belef” hereinafter), Bauer (US 4,907,598) further in view of Mark et al. (US 2006/0184153) (“Mark” hereinafter).
In regards to claim 24, Faxon discloses a method for acquiring a biopsy (i.e., tissue) sample of a target organ of a subject using a balloon-anchored biopsy (i.e., tissue removal) device 205, the method including:
inserting a biopsy (i.e., tissue removal) device into a subject, the biopsy (i.e., tissue removal) device comprising:
a first elongated tube enclosing a first lumen 115 with a first proximal end and a distal tip, wherein a section of the first elongated tube near the distal tip comprises a balloon 210 that when inserted into a blood vessel of a target organ of a subject and inflated, anchors the section in the blood vessel near a biopsy site in the target organ (see at least abstract and figs. 17-19);
PNG
media_image5.png
615
615
media_image5.png
Greyscale
a second elongated tube enclosing a second lumen 55 with a second proximal end and a second distal end, which is positioned at the biopsy site of the target organ when the first elongated tube is anchored in the blood vessel (see par 0036) by the inflated balloon 210, wherein a predefined length of the first and the second elongated tubes are longitudinally attached to one another such that the distal exit 65 is positioned at a proximal end of the section of the first elongated tube;
a flexible biopsy needle 20 for insertion into the second lumen 55 of the second elongated tube for navigation to the biopsy site, wherein the flexible biopsy needle is configured to exit the distal exit 65 of the second lumen 55 for penetration into tissue of the target organ at the biopsy site at a predefined angle between a longitudinal axis of the section of the first elongated tube and a longitudinal axis of the flexible biopsy needle, and to acquire a biopsy sample of the target organ at the biopsy site (see at least abstract, figs. 17-19 and col. 5, lines 45-65, col. 6, lines 38-50, col. 9, lines 33-40 & col. 10, lines 21-48);
navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site (see at least col. 6, lines 63-67 & col. 7, lines 1 & 11-21);
inflating the balloon 210 in the blood vessel (see col. 7, lines 29-31);
pushing the flexible biopsy needle into the tissue of the target organ at the biopsy site at the predefined angle (see col. 7, lines 50-62);
acquiring a biopsy (i.e., tissue) sample of the target organ at the biopsy site using the flexible biopsy needle 20 (see (see at least col. 9, lines 33-40); and
withdrawing the needle 20 from the second lumen 55 so as to retrieve the acquired biopsy sample (see at least abstract, figs. 17-19 and col. 5, lines 45-65, col. 6, lines 38-50, col. 9, lines 33-40 & col. 10, lines 21-48).
Faxon discloses a method, as described above, that fails to explicitly teach a method comprising percutaneously inserting a biopsy (i.e., tissue removal) device into a vein of a limb of a subject, and navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site.
However, Chan teaches that it is known to a method comprising percutaneously inserting a device into a vein of a limb of a subject, the device comprising:
a first elongated tube 22 enclosing a first lumen with a first proximal end and, a distal tip, wherein a section of the first elongated tube 22 near the distal tip comprises a balloon 20 that when inserted into a blood vessel of a target organ of a subject and inflated, anchors the section in the blood vessel near a site in the target organ; a second elongated tube 42 enclosing a second lumen with a second proximal end and a second distal end comprising a beveled distal exit 135 of the second lumen 42, which is positioned at the site of the target organ when the first elongated tube 22 is anchored in the blood vessel by the inflated balloon 20, wherein a predefined length of the first and the second elongated tubes (22, 42) are longitudinally attached to one another (see at least figs. 3-4) such that the beveled distal exit 135 is positioned at a proximal end of the section of the first elongated tube 22; wherein the first elongated tube 22 is more flexible than the second elongated tube (i.e., by virtue of their relative cross-sections or thickness); navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site; inflating the balloon 20 in the blood vessel; pushing the flexible needle 47 into the tissue of the target organ at the site at the predefined angle; and withdrawing the needle 47 from the second lumen (see at least figs. 4).
Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Faxon comprising percutaneously inserting a biopsy (i.e., tissue removal) device into a vein of a limb of a subject, and navigating the distal tip from the vein through a vascular system of the subject and into the blood vessel of the target organ near the site as taught by Chan since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Faxon) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Faxon as modified by Chan discloses a method, as described above, that fails to explicitly teach a method comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation; wherein the predefined angle is not modified by the balloon and the needle is configured such that while the balloon is inflated, the needle is not in physical contact, directly or indirectly with the balloon.
However, Belef teaches that it is known to provide a method comprising a second elongated tube 42 comprising a beveled distal exit 62
PNG
media_image2.png
149
525
media_image2.png
Greyscale
of the second lumen (see at least fig. 3B), the distal tip and the beveled distal exit 62 disposed in a substantially similar orientation (see at least abstract, figs. 3A-E and col. 8, lines 34-67, col. 9, lines 1-67 and col. 10, lines 1-8).
Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Faxon as modified by Chan comprising a second elongated tube comprising a beveled distal exit of the second lumen, the distal tip and the beveled distal exit disposed in a substantially similar orientation as taught by Belef; wherein the predefined angle is not modified by the balloon, as taught by Belef, and the needle thereof is configured such that while the balloon is inflated, the tissue penetrating member, such as the needle of Faxon, is not in physical contact, directly or indirectly with the balloon as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Faxon) for another (i.e., the catheter exit port as taught by Belef) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Faxon as modified by Chan and Belef discloses a method, as described above, that fails to explicitly teach a method with the device comprising a flexible biopsy needle attached to a distal end of a wire, the method comprising withdrawing the wire from the second lumen so as to retrieve the acquired biopsy sample.
However, Mark teaches that it is known to provide a biopsy needle comprising a flexible biopsy needle 110 attached to a distal end of a wire 76 (see at least abstract, figs. 4-21 and par 0044, 0048-0049, 0053-0055, 0058-0059 & 0061-0064).
Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Faxon as modified by Chan and Belef with a flexible biopsy needle attached to a distal end of a wire as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Faxon) for another (i.e., the biopsy needle as taught by Mark) to obtain predictable results such as providing a transjugular biopsy (i.e., tissue removal) device that is flexible to overcome the resultant binding force imparted by the introducer on the needle coring assembly and is capable of repeated uses without a measurable degradation in performance (see at least par 0014 of Mark)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Faxon as modified by Chan and Belef discloses the method, as described above, that fails to explicitly teach a method wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section.
However, Bauer teaches that it is known to provide a method comprising a
PNG
media_image3.png
674
546
media_image3.png
Greyscale
flexible biopsy needle 1 attached to a distal end of a wire (4, 5); wherein the flexible biopsy needle 1 comprises a cutting cannula 6 and a stylet 7, the stylet 7 having distal section and a specimen notch proximate to the distal section (see at least abstract, col. 1, lines 27-30 and col. 2, lines 11-19).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Faxon as modified by Chan and Belef with a flexible biopsy needle attached to a distal end of a wire; wherein the flexible biopsy needle comprises a cutting cannula and a stylet, the stylet having distal section and a specimen notch proximate to the distal section as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Faxon) for another (i.e., the biopsy needle as taught by Bauer) to obtain predictable results such as providing a flexible biopsy needle capable of cooperating with a flexible catheter for histologically drawing tissues (see at least col. 1, lines 24-30 of Bauer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 27, Faxon as modified by Chan and Belef discloses the method according to claim 24, that fails to explicitly teach a method wherein percutaneously inserting the biopsy device into the vein of the limb of the subject comprises inserting the biopsy device through a lumen of a sheath in the vein. However, Mark teaches that it is known to provide a method wherein percutaneously inserting the biopsy (i.e., tissue removal) device 52 into the vein of the limb of the subject comprises inserting the biopsy (i.e., tissue removal) device 52 through a lumen 36 of a sheath 34 in the vein (see at least abstract, figs. 4-21 and par 0044, 0048-0049, 0053-0055, 0058-0059 & 0061-0064). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Faxon as modified by Chan and Belef wherein percutaneously inserting the biopsy (i.e., tissue removal) device into the vein of the limb of the subject comprises inserting the biopsy (i.e., tissue removal) device through a lumen of a sheath in the vein as taught by Bauer since such a modification would amount to a simple substitution of one known element (i.e., the biopsy needle as taught by Faxon) for another (i.e., the biopsy needle as taught by Mark) to obtain predictable results such as providing a transjugular biopsy (i.e., tissue removal) device that is flexible to overcome the resultant binding force imparted by the introducer on the needle coring assembly and is capable of repeated uses without a measurable degradation in performance (see at least par 0014 of Mark)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 28, Faxon as modified by Belef and Mark discloses the method according to claim 24, that fails to explicitly teach a method wherein the balloon comprises a distal balloon and a proximal balloon, and wherein inflating the balloon comprises inflating the distal balloon and the proximal balloon separately or together in the blood vessel. However, Chan teaches that it is known to provide a method wherein the balloon comprises a distal balloon 420B and a proximal balloon 420A, and wherein inflating the balloon comprises inflating the distal balloon 420B and the proximal balloon 420A separately or together in the blood vessel (see at least abstract, figs. 29 & 31 and col. 23, lines 55-67 and col. 24, lines 1-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Faxon as modified by Belef and Mark wherein the balloon comprises a distal balloon and a proximal balloon, and wherein inflating the balloon comprises inflating the distal balloon and the proximal balloon separately or together in the blood vessel as taught by Chan since such a modification would amount to applying a known technique (i.e., as taught by Chan) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as providing greater coverage for the biopsy procedure by performing multiple tissue penetrations at multiple sites while reducing the number of balloon movement for making multiple tissue penetrations along the vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Chan (‘469), Belef (‘226), Bauer (‘598), Mark (‘153) further in view of Miller (US 2012/0123327).
In regards to claim 25, Faxon as modified by Chan, Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly a method wherein the limb comprises an arm of the subject and the vein comprises a cephalic vein of the arm. However, Miller teaches that it is known to provide a method wherein the limb comprises an arm of the subject and the vein comprises a cephalic vein of the arm (see at least par 0084). Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Faxon as modified by Chan, Belef, Bauer and Mark wherein the limb comprises an arm of the subject and the vein comprises a cephalic vein of the arm as taught by Miller since Miller teaches that it is known to access the right heart chambers for biopsy procedures through venous access in the cephalic veins.
In regards to claim 26, Faxon as modified by Chan, Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly teach a method wherein the limb comprises a leg of the subject and the vein comprises a femoral vein of the leg. However, Miller teaches that it is known to provide a method wherein the limb comprises a leg of the subject and the vein comprises a femoral vein of the leg (see at least par 0084). Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Faxon as modified by Chan, Belef, Bauer and Mark wherein the limb comprises a leg of the subject and the vein comprises a femoral vein of the leg as taught by Miller since Miller teaches that it is known to access the right heart chambers for biopsy procedures through venous access in the femoral veins.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Chan (‘469), Belef (‘226), Bauer (‘598), Mark (‘153) further in view of Bosch et al. (WO 2010/063676) (“Bosch” hereinafter).
Faxon as modified by Chan, Belef, Bauer and Mark discloses the method according to claim 24, that fails to explicitly teach a method wherein the second elongated tube is coupled to a pressure transducer, and further comprising measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer.
However, Bosch teaches that it is known to provide a method further comprising measuring a hepatic venous pressure gradient (HVPG) (see at least abstract, figs. 1-2; pg. 3, lines 3-25 & pg. 4, lines 11-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was made to provide the method of Faxon as modified by Chan, Belef, Bauer and Mark wherein the second elongated tube thereof is coupled to a pressure transducer, and further comprising measuring a hepatic venous pressure gradient (HVPG) by processing a signal from the pressure transducer as taught by as taught by Bosch since such a modification would amount to applying a known technique (i.e., as taught by Bosch) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as measuring for an indication of portal vein hypertension, which is developed during cirrhosis when there is an increase of the resistance to blood flow through the liver and an increase of the inflow in the portal vein, and is the main cause of mortality and of liver transplant in affected patients (see at least pg. 1, lines 16-35 & pg. 2, lines 1-29 of Bosch)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598), Heilman (‘398) further in view of Chan et al. (US 7,273,469) (“Chan” hereinafter).
Faxon as modified by Belef, Bauer and Heilman discloses the biopsy (i.e., tissue removal) device according to claim 21, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the distal beveled exit is positioned over the inflatable balloon.
However, Chan teaches that it is known to provide a device wherein the distal beveled exit 135 is positioned over the inflatable balloon 20 (see at least abstract, figs. 1-4, 16-17 & 24-27 and col. 5, lines 60-67, col. 6, lines 10-15, col. 7, lines 1-43 and col. 12, lines 25-31 and col. 15, lines 36-45).
Therefore, since Faxon discloses a biopsy (i.e., tissue removal) device that can be utilized in other body systems wherein a region of interest containing desired tissue, blood, or other body fluid or substance is within a certain proximity to a luminal structure, respectively, including but not limited to the cardiovascular system and constituent blood vessels (see at least par 0036), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy needle of Faxon as modified by Belef, Bauer and Heilman wherein the distal beveled exit is positioned over the inflatable balloon as taught by Belef since such a modification would amount to a simple substitution of one known element (i.e., the catheter exit port as taught by Faxon) for another (i.e., the catheter as taught by Chan) to obtain predictable results such as utilizing said catheter in other body systems wherein a region of interest such as the cardiovascular system and constituent blood vessels to selectively direct the biopsy needle into the tissue at a predetermined angle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 14, 22 & 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faxon (‘395) in view of Belef (‘226), Bauer (‘598) further in view of Chan et al. (US 7,273,469) (“Chan” hereinafter).
In regards to claim 14, Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the predefined angle is in the range of 15-45 degrees. However, Chan teaches that it is known to provide a biopsy (i.e., tissue removal) device wherein the predefined angle is in the range of 15-45 degrees (i.e., about 15 º to less than about 90º) (see at least figs. 1 & 16-17 and col. 6, lines 10-15, col. 12, lines 25-31, col. 15, lines 36-45). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the predefined angle is in the range of 15-45 degrees as taught by Chan since such a modification would amount to a simple substitution of one known element (i.e., the balloon of Faxon) for another (i.e., the balloon of Chan) to obtain predictable results such as stabilizing the catheter and/or deflecting needle to a selected non-zero angle so as to thereby control the angle at which the needle contacts the body lumen wall during a diagnostic or therapeutic procedure--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 22, Faxon as modified by Belef and Bauer discloses the device according to claim 1, that fails to explicitly teach a biopsy (i.e., tissue removal) device wherein the balloon comprises a distal balloon and a proximal balloon, which are inflatable separately or together in the blood vessel. However, Chan teaches that it is known to provide a device wherein the balloon comprises a distal balloon 420B and a proximal balloon 420A, which are inflatable separately or together in the blood vessel (see at least abstract, figs. 29 & 31 and col. 23, lines 55-67 and col. 24, lines 1-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein the balloon comprises a distal balloon and a proximal balloon, which are inflatable separately or together in the blood vessel as taught by Chan since such a modification would amount to applying a known technique (i.e., as taught by Chan) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as providing greater coverage for the biopsy procedure by performing multiple tissue penetrations at multiple sites while reducing the number of balloon movement for making multiple tissue penetrations along the vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 32, Faxon as modified by Belef and Bauer discloses the biopsy (i.e., tissue removal) device according to claim 22, that fails to explicitly teach a biopsy needle wherein said distal balloon and proximal balloon, each comprises angled edges. However, Chan teaches that it is known to provide a device wherein said distal balloon 420B and proximal balloon 420A, each comprises angled edges (see at least abstract, figs. 29 & 31 and col. 23, lines 55-67 and col. 24, lines 1-51). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the biopsy (i.e., tissue removal) device of Faxon as modified by Belef and Bauer wherein said distal balloon and proximal balloon, each comprises angled edges as taught by Chang since such a modification would amount to applying a known technique (i.e., as taught by Chan) to a known device (i.e., as taught by Faxon) ready for improvement to achieve a predictable result such as providing greater coverage for the biopsy procedure by performing multiple tissue penetrations at multiple sites while reducing the number of balloon movement for making multiple tissue penetrations along the vessel--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant's arguments filed November 11, 2025 have been fully considered but they are not persuasive. Applicant contends that Belef fails to teach or suggest a beveled distal exit, much less a beveled distal exit that is substantially parallel to a distal tip of the first elongated tube. The Office respectfully traverses. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., beveled distal exit that is substantially parallel to a distal tip of the first elongated tube or a variable exit angle) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In fact, Applicant contends that Belef fails to teach a beveled exit at all. The Office respectfully traverses. For example, as shown at least in fig. 3A thereof, Belef clearly discloses an exit hole 62 on an angled surface. As such, the Office submits that the exit hole 62 is therefore necessarily beveled since the edges of the exit hole 62 necessarily sit on a slant surface, which makes the exit hole 62 beveled as depicted below.
PNG
media_image6.png
398
778
media_image6.png
Greyscale
Moreover, as shown at least in fig. 3A of Belef, the beveled distal exit 62 and the distal opening (from which guidewire 40 exits) are forward-facing, and are therefore “disposed in a substantially similar orientation” as required in the claim(s). The Office notes that the term “substantially similar” is a relative term of degree that includes any, at least partially forward-facing, orientation. In fact, as evidenced by claim 14 of the instant application, an angle of 45 degrees from the longitudinal axis of the elongated tube is considered to be in “substantially similar” orientation.
With respect to the Applicant’s argument that the claim requires “a variable exit angle,” the Office respectfully disagrees. The limitations in claim 14, which address an angle that may be in the range of 15-45 degrees clearly requires a single fixed angle that may be in the range of 15-45 degrees. In fact, claim 1 clearly refers to that fixed angle as “a predefined angle between a longitudinal axis of the section of the first elongated tube and a longitudinal axis of the flexible biopsy needle.” Therefore, the Applicant’s argument is not followed.
In view of the foregoing, the rejections over at least Belef are maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached on 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RENE T TOWA/ Primary Examiner, Art Unit 3791