DETAILED ACTION
The following is a Final Office Action on the merits.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
Acknowledgment is made to the amendment received 6/23/2026.
Applicant’s amendments to the drawings are sufficient to overcome the drawings objection set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC 112 rejection set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the double patenting rejection set forth in the previous office action.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “comprising spline proximal ends connected to a respective one of the plurality of electrical wires, wherein at least one electrode is electrically connected to a respective one of the splines in turn connected to a respective one of the electrical wires” to -comprising spline proximal ends connected to the plurality of electrical wires, wherein at least one electrode is electrically connected to a respective one of the plurality of splines which is in turn connected to a respective one of the plurality of electrical wires- in ll. 3-8 in limitation f). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “the deployed splines” to -the deployed plurality of splines- in the last line of limitation g). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “comprising spline proximal ends that are connected to a respective one of the plurality of electrical wires, wherein at least one electrode is electrically connected to a respective one of the splines in turn connected to a respective one of the electrical wires” to -comprising spline proximal ends that are connected to the plurality of electrical wires, wherein at least one electrode is electrically connected to a respective one of the plurality of splines which is in turn connected to a respective one of the plurality of electrical wires- in ll. 3-9 in limitation vi). Appropriate correction is required.
Claim 18 is objected to because of the following informalities: amend “wherein a plurality of electrodes are electrically connected to each of the four pre-shaped memory wires in turn connected to a respective one of the electrical wires” to -wherein a plurality of electrodes are electrically connected to each of the four pre-shaped memory wires which are in turn connected to a respective one of the plurality of electrical wires” in ll. 4-8 of limitation g) . Appropriate correction is required.
Claim 20 is objected to because of the following informalities: amend “the orientation markers” to -the at last two orientation markers- in ll. 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9-10, 13, 15-17 & 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the distal electrode array" in ll. 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the distal electrode array" in ll. 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the distal electrode array" in ll. 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the distal electrode array" in ll. 6 of limitation b). There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the at least one electrode of the distal electrode array" in ll. 2-3 (there is no previous recitation of “at least one electrode of the distal electrode array”). There is insufficient antecedent basis for this limitation in the claim.
Claims 15-17 depend from claim 13 and are thus also rejected.
Claim 21 recites the limitation "the distal electrode array" in ll. 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
Claim 18 recites “wherein a plurality of electrodes are electrically connected to each of the four pre-shaped memory wires in turn connected to a respective one of the electrical wires”. This limitation is interpreted as each pre-shaped memory wire being electrically connected to a plurality of electrodes and one electrical wire.
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, 3-5, 9 & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster, Jr. (5,782,239, previously cited) in view of Tegg et al. (2010/0168647, previously cited).
Concerning claim 1, as illustrated in at least Figs. 8-12, Webster, Jr. discloses a catheter assembly (electrophysiological mapping system; Col. 4, ll. 47-57), comprising:
a) an elongated catheter comprising an inner surface defining an axial lumen extending from a catheter proximal open end to an opposed distal end of the catheter (inner catheter 42 has an inner surface defining a central axial lumen extending between open proximal and distal ends; Col. 8-9, ll. 61-11);
c) a guide shaft comprising a guide shaft proximal portion extending to a spaced-apart guide shaft distal portion (puller wire 40 and TEFLON sheath have spaced apart proximal and distal portions; Col. 9-10, ll. 12-7)
d) a distal cap connected to a distal end of the guide shaft (arms 52 couple to distal fitting 44; Col. 8-9, ll. 61-11), , and wherein the distal portion of the guide shaft extends proximally from the distal cap to the proximal portion of the guide shaft which is axially movable (puller wire 40 and TEFLON sheath have a distal portion that extends proximally from the distal fitting 44 to the proximal portion which is axially movable; Col. 10, ll. 49-14);
e) a plurality of electrical wires extending through the axial lumen of the catheter from the proximal open end to the distal open end of the catheter (lead wires 72 extend between the proximal end and distal end of inner catheter 42 through its central axial lumen; Col. 9-10, ll. 49-7); and
f) a plurality of pre-shaped memory splines extending proximally from the end cap and comprising spline proximal ends connected to a respective one of the plurality of electrical wires, wherein at least one electrode is electrically connected to a respective one of the splines in turn connected to a respective one of the electrical wires, and wherein the plurality of splines reside in the catheter lumen between the tube outer surface and the inner surface of the catheter (electrode basket 46 comprises four arms 52, each having multiple electrodes, that connect to lead wires 72 and made of a superelastic/shape memory material, arms 52 extending from distal fitting 44, arms 52 residing within the inner surface of the catheter; Col. 8-9, ll. 61-11, Col. 9-10, ll. 49-7), and
g) wherein the plurality of splines in the deployed position (basket 46 moves between an outward expansion position and a collapsed position within catheter 42; Col. 8-9, ll. 61-11).
Webster, Jr. et al. fail to disclose the catheter distal end to be an open distal end, a flexible tube extending through the axial lumen of the catheter and comprising a tube proximal open end spaced from a tube distal open end, wherein the flexible tube has a tubular sidewall defining a tube lumen of a first, inner diameter, and a tube outer surface; wherein the distal open end of the flexible tube is spaced proximally with respect to the distal cap; and a guide shaft comprising a guide shaft proximal portion extending to a spaced-apart guide shaft distal portion, the guide shaft having a second, outer diameter that is less than the first, inner diameter of the flexible tube lumen, wherein the guide shaft extends proximally from the distal cap and is received in and is axially movably received in the tube lumen of the flexible tube, and wherein with the proximal portion of the guide shaft received in the tube lumen, an annulus is formed by the tube lumen of the first diameter surrounding the guide shaft of the second diameter, the annulus between the outer surface of the guide shaft surrounded by the inner lumen of the flexible tube is sufficient to permit flushing the area adjacent to the deployed splines. However, Tegg et al. disclose an analogous catheter assembly (10) comprising a catheter (30 comprising braided section 52 & cover 54) comprising a distal open end at interstitial spaces (51), a distal electrode array (25) comprising a plurality of splines (36) and at least one electrode (58) and a distal cap (42). Tegg et al. further disclose the catheter (30, 52 & 54) distal end to be an open end (interstitial spaces of inner shaft 50 can be used for fluid tubing), a flexible tube (32) extending through the axial lumen of the catheter (30, 52 & 54) and comprising a tube proximal open end spaced from a tube distal open end (proximal and distal ends of tube 32 or tubing housed within deployment member 31 have openings 34a,b/34a’,b’), wherein the flexible tube (32) has a tubular sidewall defining a tube lumen of a first, inner diameter, and a tube outer surface; wherein the distal open end (34a/a’) of the flexible tube (32) is spaced proximally with respect to a distal cap (42); and a guide shaft (31) having a second, outer diameter that is less than the first, inner diameter of the flexible tube lumen, wherein the guide shaft (31) extends proximally from the distal cap (42) and is received in and is axially movable in the tube lumen of the flexible tube (32), and wherein with the guide shaft (31) received in the tube lumen, an annulus is formed by the tube lumen of the first diameter surrounding the guide shaft (31) of the second diameter, the annulus between the outer surface of the guide shaft (31) surrounded by the inner lumen of the flexible tube (32) is sufficient to permit flushing the area adjacent to the deployed splines (36). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. et al. to further comprise a catheter open distal end, a flexible tube extending through the axial lumen of the catheter and comprising a tube proximal open end spaced from a tube distal open end, wherein the flexible tube has a tubular sidewall defining a tube lumen of a first, inner diameter, and a tube outer surface; wherein the distal open end of the flexible tube is spaced proximally with respect to the distal cap; and a guide shaft comprising a guide shaft proximal portion extending to a spaced-apart guide shaft distal portion, the guide shaft having a second, outer diameter that is less than the first, inner diameter of the flexible tube lumen, wherein the guide shaft extends proximally from the distal cap and is received in and is axially movably received in the tube lumen of the flexible tube, and wherein with the proximal portion of the guide shaft received in the tube lumen, an annulus is formed by the tube lumen of the first diameter surrounding the guide shaft of the second diameter, the annulus between the outer surface of the guide shaft surrounded by the inner lumen of the flexible tube is sufficient to permit flushing the area adjacent to the deployed splines in order to provide the benefit of fluid delivery during the procedure to reduce the risk of blood clots or thrombus formation and a deployment member that expands and contracts the splines as taught by Tegg et al. ([0010], [0013], [0032], [0034], [0037], [0044]; Fig. 2a-3a)
Concerning claim 3, while Webster, Jr. et al. disclose a polygonal shaped fixture (26/68) at the distal end of the catheter (42), where the number of openings between the fixture (26/68) and an inner surface of the catheter (30, 27) and number of arms (36 is equal to the number of sides of the polygon fixture (68) (Col. 7, ll. 1-10 & 48-65, Col. 9-10, ll. 49-7), Webster, Jr. et al. fail to disclose the fixture to be a cross-shaped fixture and has four openings corresponding to four pre-shaped shape memory splines that extend through four openings formed by the cross-shaped fixture and the inner surface of the catheter. However, in an alternative embodiment of Fig. 1-7, Webster, Jr. teaches that the number of sides of a polygonal fixture is equal to the number of spines. Webster further teaches that a lesser number of arms is more practical in that it is smaller and easier to differentiate the electrodes. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Figs. 8-12 of Webster, Jr. in view of Tegg et al. such that the fixture is cross-shaped and has four openings corresponding to four pre-shaped shape memory splines that extend through four openings formed by the cross-shaped fixture and the inner surface of the catheter in order to provide the benefit of a lesser number of arms that is more practical in that it is smaller and easier to differentiate the electrodes as taught by Webster, Jr. (Col. 7, ll. 1-10 & 48-65, Col. 9-10, ll. 49-7) The Examiner notes that while Webster, Jr. notes a disadvantage of the lesser number of arms, Webster, Jr. fails to specifically teach away from a lesser number and mapping is still possible with four arms. Webster, Jr. et al. fail to disclose the electrical wires connected to the shape memory splines and extending through one of the openings of the fixture and the inner surface of the catheter. However, Tegg et al. further disclose a fixture (50) wherein electrical conductors (59) connected to splines (36) and extend through a respective one opening (51) formed by the shaped fixture (50) and the inner surface of the catheter (30, 52 & 54), each spline connecting to at last one electrical wire of the plurality of electrical wires. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. et al. in view of Tegg et al. such that four electrical wires connected to the four shape memory splines extend through each of the four openings of the fixture and the inner surface of the catheter in order to provide the benefit of forming electrode wires directly on the basket wires as taught by Tegg et al. ([0044-0046]; Fig. 3a & 5a-b)
Concerning claim 4, Webster, Jr. et al. in view of Tegg et al. disclose the cross-shaped fixture (50) has a center opening (60) and the flexible tube (32) extends through the center opening (60) in the cross-shaped fixture (50) at the distal open end of the elongated catheter (30, 52 & 54) ([0049]; Fig. 4).
Concerning claim 5, Webster, Jr. et al. disclose a) a proximal hub (48) connected to the proximal catheter open end (40); and b) an electrical plug (24) electrically connected to the plurality of electrical wires (72) at the proximal hub (48) (Col. 5, ll. 38-51, Col. 9-10, ll. 49-7; Fig. 8).
Concerning claim 9, Webster, Jr. disclose four electrodes (11) are attached to each of the four splines (52) (Col. 5, ll. 38-50; Fig. 10).
Concerning claim 12, Webster, in view of Tegg et al. fail to disclose the tubular sidewall of the flexible tube is devoid of any perforations or openings. However, Tegg et al. disclose an alternative embodiment in Fig. 3B, where the fluid openings (34’) are located in a distal fixture of the distal cap (42) to enable closer delivery to the distal portion of the basket and can be implemented with or without openings in the sidewall of the flexible tube (32). Thus, at the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster in view of Tegg et al. such that the fluid openings are located only in the fixture of the proximal and/or distal ends of the basket and the tubular sidewall of the flexible tube is devoid of any perforations or openings in order to provide the benefit of enabling fluid delivery closer to the proximal and/or distal ends of the basket in view of the teachings by Tegg et al. to provide fluid delivery closer to the end of the basket. ([0042-0043]; Fig. 3b)
Claim(s) 6 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239, previously cited) in view of Tegg et al. (2010/0168647, previously cited), as applied to claim 2, in further view of Okuyama (2014/0350553, previously cited).
Concerning claim 6, Webster, Jr. et al. fail to disclose a tubing extending from a proximal hub at the proximal catheter open end. Tegg et al. further disclose a tubing (syringe tubing) extending from a proximal hub at the proximal catheter open end (Fig. 1). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, et al. in view of Tegg et al. to further comprise a tubing extending from a proximal hub at the proximal catheter open end in order to provide the benefit of connecting to a fluid source as taught by Tegg et al. ([0042]; Fig. 1) Webster, Jr. et al. in view of Tegg et al. fail to disclose the tubing connecting to a multiway stopcock. However, Okuyama discloses a catheter assembly (100) comprising an elongated catheter (2) and a distal electrode array (10), the catheter assembly further comprising aa flexible tube (21) disposed in the axial lumen of the catheter (2) and a tubing (inherent) extending from the proximal hub at the proximal catheter open end to a multiway stop cock (T-shaped stockcock). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, JR. in view of Tegg et al. to further comprise a tubing extending from the proximal hub at the proximal catheter open end to a multiway stop cock in order to provide the benefit of successfully controlling with a simple configuration insertion and emission of fluid into/from the lumen as taught by Okuyama. ([0051-0052]; Fig. 1 & 5)
Claim(s) 7, 13 & 15-16 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239, previously cited) in view of Tegg et al. (2010/0168647, previously cited), as applied to claim 1, in further view of Barajas et al. (6,167,291, previously cited).
Concerning claim 7, while Webster, Jr. discloses an ablation and recording device (4) (Col. 5, ll. 26-37), Webster, Jr. fails to specifically disclose a switching module that is configured to selectively connect a recorder module and an ablation energy generator to the electrical plug, wherein the recorder module is configured to receive electrical mapping signals from the distal electrode array, and the ablation energy generator is configured to provide electrical ablation energy to the distal electrode array. However, Barajas et al. disclose a catheter assembly comprising a catheter electrode array (12) and a switching module (24/28) that is configured to selectively connect a recorder module (32) and an ablation energy generator (30) to an electrical plug (14), wherein the recorder module (32) is configured to receive electrical mapping signals from the distal electrode array (12), and the ablation energy generator (30) is configured to provide electrical ablation energy to the distal electrode array (12). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. in view of Tegg et al. to further comprise disclose a switching module that is configured to selectively connect a recorder module and an ablation energy generator to the electrical plug, wherein the recorder module is configured to receive electrical mapping signals from the distal electrode array, and the ablation energy generator is configured to provide electrical ablation energy to the distal electrode array in order to provide the benefit of connecting each electrode to the desired componentry as taught by Barajas et al. (Col. 2-3, ll. 58-12; Fig. 1)
Claim 13 is rejected upon the same rationale as applied to claims 1 & 7.
Claim 15 is rejected upon the same rationale as applied to claim 3.
Claim 16 is rejected upon the same rationale as applied to claim 4.
Claim(s) 8 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239, previously cited) in view of Tegg et al. (2010/0168647, previously cited), as applied to claim 5, in further view of ZHU et al. (CN111388085, cited in IDS).
Concerning claim 8, Webster, Jr. in view of Tegg et al. fail to disclose at least one of the pre-shaped shape-memory wires is covered with a thermoplastic polyurethane (TPU). However, Zhu et al. disclose a basket assembly comprising an insulating material coating an electrode tube body that is polyurethane TPU. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. in view of Tegg et al. such that the covering material is TPU in order to provide the benefit of a material that meets biological performance as taught by Zhu ([0015]) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claim(s) 10 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239, previously cited) in view of Tegg et al. (2010/0168647, previously cited), as applied to claim 1, in further view of Olson et al. (2019/0021620, previously cited) and ZHU et al. (CN111388085, cited in IDS).
Concerning claim 10, Webster, Jr. in view of Tegg et al. fail to disclose at least one of the electrodes connected to the four pre-shaped shape-memory wires has a thermoplastic polyurethane (TPU) cover with a cutout window to expose a surface of the electrode. However, Olson et al. disclose a catheter assembly (18) comprising a distal electrode array (30) configured to have a basket shape and including electrodes (42). Olson et al. further disclose each electrode (42) can have a polyurethane cover (56) with a cutout window (58) to expose the electrodes surface to come in contact with the ablated surface (60). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. in view of Tegg et al. such that each electrode can have a thermoplastic polyurethane (TPU) cover with a cutout window to expose the electrodes surface to come in contact with the ablated surface in order to provide the benefit of the conductive material of the electrode not being in contact with the blood pool, thus preventing the electrode from reception of at least a portion of a far field signal as taught by Olson et al. ([0009], [0062-0064]; Fig. 2-9). Webster, Jr. in view of Tegg et al. and Olson et al. fail to disclose the cover to be TPU. However, Zhu et al. disclose a basket assembly comprising an insulating material coating an electrode tube body that is polyurethane TPU. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. in view of Tegg et al. and Olson et al. such that the covering material is TPU in order to provide the benefit of a material that meets biological performance as taught by Zhu ([0015]) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claim 18 is rejected upon the same rationale as presented for claims 1, 3-4 & 10.
Claim(s) 11 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239) in view of Tegg et al. (2010/0168647), as applied to claim 1, in further view of Margolis (2013/0289369).
Concerning claim 11, Webster, Jr. in view of Tegg et al. fail to disclose at least two orientation markers are disposed on a respective one of the plurality of splines, and wherein the orientation markers are not electrically connected to the four electrical wires. However, Margolis disclose a catheter comprising a distal electrode basket formed of shape-memory wires (400) and at least two orientation markers (600a) are disposed on a respective one (400a) of the pre-shaped shape-memory wires (400) and not electrically connected to electrical wires (560) connected to the electrodes (410). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Webster, Jr. in view of Tegg et al. to further comprise at least two orientation markers are disposed on a respective one of the four pre-shaped shape-memory wires, and wherein the orientation markers are not electrically connected to the four electrical wires in order to provide the benefit being visible to imaging guidance taught by Margolis ([0071], [0095], [0109]; Fig. 13).
Claim(s) 17 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239) in view of Tegg et al. (2010/0168647) and Barajas et al. (6,167,291), as applied to claim 13, in further view of Olson et al. (2019/0021620) and ZHU et al. (CN111388085, cited in IDS).
Claim 17 is rejected upon the same rationale as applied to claim 10.
Claim(s) 20 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239) in view of Tegg et al. (2010/0168647), Olson et al. (2019/0021620) and ZHU et al. (CN111388085, cited in IDS), as applied to claim 18, in further view of Margolis (2013/0289369).
Claim 20 is rejected upon the same rationale as provided for claim 11.
Claim(s) 21 is/are rejected under 35 USC 103 as being unpatentable over Webster, Jr. (5,782,239) in view of Tegg et al. (2010/0168647), Olson et al. (2019/0021620), ZHU et al. (CN111388085, cited in IDS) and Margolis (2013/0289369), as applied to claim 18, in further view of Barajas et al. (6,167,291).
Claim 21 is rejected upon the same rationale as provided for claim 7.
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not persuasive.
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., spines of Webster and Tegg “expand outwardly and contract inwardly in a fundamentally different manner than the splines comprising the catheter assembly”) 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). The Examiner notes the “fundamentally different manner” (“[p]roviding a plurality of splines that are movable out of and into catheter as the splines are deployed between expanded and collapsed configurations” (Pg. 19 of arguments) is not recited. The splines of both Webster & Tegg are collapsed via proximal movement of their respective guide shafts, but then are also capable of being received in outer catheter (66) of Webster or outer tubing (30) of Tegg ([0032])
The Examiner notes to Applicant: the claims fail to recite the distal open end of the flexible tube to be a distal most end that is located proximally from the distal cap, where the open end is configured such that flushing fluid is directed distally from the open end.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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