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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7,11-13,29-32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner notes that the argument that the prior art fails to teach the new limitation of the openings being 1mm-15mm from the distal end of the catheter is moot, as a new reference is applied to teach this limitation.
Regarding Ravenscroft, the examiner notes that as the openings are offset from one another, but are on different sides of a longitudinal axis, they are interpreted to be at least partially diametrically opposed. The rejection below has been updated.
Regarding Schon, the argument is found to be non-persuasive. While the examiner agrees that Schon is directed to different catheters, Schon states that both catheters are single lumen where one catheter is an intake comprising intake openings (16), and one catheter (18) comprises return openings (column 8 lines 65-67, column 9 lines 1-6). Further distance “b” is the distance between the distal ends of the two catheters, as stated by the applicant on page 9 of the remarks. The examiner notes therefore the distance between an intake and return open of Schon is at least 2cm (as the distance between the distal ends is 2cm), where said separation distance between the two openings in the lumen suitably allows the device to function in intaking and returning blood. Therefore, applying a distance of at least 2cm between an inlet and outlet opening on their respective lumens is suitable in catheters, and thus the combination of prior arts is upheld.
Election/Restrictions
Newly submitted claims 42-46 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-7,11-13,29-32, drawn to a catheter device.
Group II, claim(s) 42-46, drawn to a catheter device comprising a tip.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a catheter body with a plurality of side openings, where said side openings are at least partially diametrically opposed, and a first as second side opening correspond to a first and second lumen, respectively, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ravenscroft, as previously applied. Ravenscroft teaches a catheter (figure 2a) with an elongate body (210), with two side openings (222 and 224), at least partially diametrically opposed (Seen to be opposite each other), where each opening corresponds to a different lumen (221 and 223, see para. 0066). The examiner notes that claims 42-46 require specific tip structure where said tip is configured to be attached to the device, and thus would have been provided with a restriction upon first action.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 42-46 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-7,11-12, 18,30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellisario et al. US 9155862, hereafter Bellisario, provided in the IDS, and further in view of Ravenscroft et al. US 2015/0126972 and Schon et al. US 5718692, hereafter Ravenscroft and Schon and further in view of Speiser US 2017/0128695, hereafter Speiser.
Regarding claim 1, Bellisario discloses
A catheter (abstract) comprising: an elongated body defining a longitudinal axis (figure 14a-c wherein the longitudinal axis is interpreted as the length, also see “A” in figure 2), and at least a first biconcave side opening and a second biconcave side opening (figure 14c column 8 lines 38-51 (1126)), wherein the elongated body comprises a first lumen in fluid communication with the first biconcave side opening (figure 2 (22)) and a second lumen in fluid communication with the second biconcave side opening (figure 2 (23)) (See also column 5 lines 43-59). The examiner notes that although figure 2 does not expressly show the biconcave openings of figure 14c, the lumens are aligned with openings on the catheter as evidenced by figures 3-14, wherein the figures show various shapes for which the openings would be. Should applicant disagree with this argument, the examiner notes that as Bellisario discloses a dual lumen catheter where catheters may include various embodiments of openings connected to the catheter lumens, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the biconcave openings seen in figure 14c with the dual lumen catheter seen in figure 2.
Bellisario however, fails to disclose wherein a distal end of the first biconcave side opening is longitudinally offset from a distal end of the second biconcave side opening.
Ravenscroft teaches a catheter device and is thus considered analogous to the claimed invention. Ravenscroft teaches that the catheter device has two separate interior chambers for applications such as hemodialysis where one chamber draws blood and the other directs filtered blood back into the body (para. 0067). Ravenscroft depicts, in figure 2A that the chambers have two chamber openings (222 and 224) that are positioned a similar distance from the distal (interpreted as aligned, as seen in the figure) (para. 0068). Ravenscroft further teaches that although this orientation is taught, the openings may also be at different distances from the distal end (as seen in figure 3 with openings 322 and 324). The examiner notes that as seen in figure 3, the chamber openings can be seen to be both axially and circumferentially displaced from one another. Ravenscroft teaches that the configuration (not aligned openings) is more efficient in reducing the amount of filtered and nonfiltered blood being mixed. Therefore, as Ravenscroft teaches that hemodialysis catheters having two chambers may have openings to the respective chambers either aligned or displaced from one another, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the openings of Bellisario to be completely longitudinally offset from one (as seen in Ravenscroft figure 3). Doing so would involve the use of known technique (offsetting chamber openings) to improve similar devices (blood circulating catheters) in the same way (reducing mixing of filtered and unfiltered blood), and thus a prima facie case of obviousness exists.
The examiner notes that while the combination of Bellisario and Ravenscroft teach that the openings may be completely offset from one another (see figure 3 of Ravenscroft), there is no specific disclosure of the distance being at least 1mm apart.
Schon teaches a catheter device and is thus considered analogous to the claimed invention. Schon teaches that the device is used for hemodialysis (column 8 line 55), where column 9, lines 15-43, teaches that as a means to keep treated and untreated blood separate, traditional spacing of return and intake openings in multiple lumen catheters is about 2cm, whereas the device of Schon is at about 4cm, as a means to prevent recirculation. Therefore, as Schon teaches that it is known in the art to have intake and return openings for multi-lumen hemodialysis catheter separated by a distance of at least 2cm, it would have been obvious to one having ordinary skill in the art prior the effective filing date of the claimed invention to modify the distance between the separated openings of Bellisario and Ravenscroft by at least 2cm. Doing so would involve applying a known technique to a known device ready for improvement to yield predictable results, said results being the prevention of recirculation.
Regarding the amendments filed 03/16/2026, the examiner notes that the prior arts fail to teach that the side openings are at least partially diametrically opposed. The examiner notes that while Ravenscroft, as previously detailed under the same rejection has the openings on opposite sides of the catheter and corresponding to different lumens, it is interpreted that they are at least partially diametrically opposed.
The amendments filed 03/16/26 further require wherein a distal end of the first side opening and a distal end of the second side opening are 1 mm to 15mm from a distal end of the catheter. The prior arts fail to teach a specific distance.
Speiser teaches a catheter device and is thus considered analogous to the claimed invention. Speiser teaches that the catheter device comprises openings (4” and 5” in figure 9a) where said openings are suitably 1-3mm (from the center) to distal end of the elongated body (para. 0072). Speiser further states that various distances may be suitable ranging from 750µm to 10mm. Therefore, as Speiser teaches that openings in catheters are suitably located in a range of 750µm to 10mm from the distal end of the catheter, and function, as intended at said distance, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the openings of the prior art to be placed at a distance between 750µm and 10mm from the distal end of the catheter device. The examiner notes that as said range overlaps with the claimed range, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 1, wherein the first and second side openings has a proximal end, a distal end, a first side extending from the proximal end to the distal end, and a second side opposing the first side and extending from the proximal end to the distal end, wherein when the elongated body is straight, the first and second sides, of each respective side, curve towards each other between the proximal and distal ends (Bellisario Fig. 14A-C, distal end (1128) proximal end (1127)). As seen in figure 14A, the opening extends between the proximal and distal end where the two sides (top and bottom of the opening) are opposed and the first and second side curve toward each other.
Regarding claim 3, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 2. The examiner notes that although this embodiment of Bellisario does not disclose wherein the proximal and distal ends are not aligned along an axis parallel to the longitudinal axis of the elongated body, Bellisario discloses other shapes of the opening in which this feature is disclosed. As detailed under the rejection of claim 1, Bellisario discloses that the shape of the opening may change depending on desired characteristics, where one such shape is seen in figure 9A, where opposing ends of the opening are not aligned at a parallel axis. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shape of the opening to be nonaligned at the opposing ends as seen in figure 9A of Bellisario. See also MPEP section 2144.04 Section IV B, where change of shape has been used as obviousness rationale in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 4, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 2, wherein the first and second side openings defines a side opening axis intersecting the proximal and distal ends of each of respective side openings, wherein the first and second sides each defines a curve that curves inwards towards each respective side opening axis. The examiner notes that a side opening axis would be formed through the figure-eight shape seen in figure 14A of Bellisario.
Regarding claim 5, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 4, wherein the curve is closest to the side opening axis at a midpoint of the respective first side or second side. The examiner notes that as the opening seen in figure 14A of Bellisario is continuously curved at both sides of the opening, the curve would be closest to the side opening at a midpoint of the first and second sides. Should the applicant not agree with this interpretation, the examiner notes that as detailed under the rejection of claim 1, per MPEP section 2144.04 Section IV B, where change of shape has been used as obviousness rationale In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 6, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 1, wherein the first and second side opening defines a side opening axis extending between proximal and distal ends of each respective side opening, and a transverse axis transverse to the side opening axis, and wherein each respective side opening is symmetric about the transverse axis. The examiner notes that a transverse axis can be seen in figure 14B of Bellisario labelled B’.
Regarding claim 7, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 1, wherein the first and second side opening defines rounded proximal and distal ends. The examiner notes that as seen in figure 14A of Bellisario, the proximal and distal ends of the opening are both rounded.
Regarding claim 11, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 1, wherein a proximal end of the first side opening is not aligned with a proximal end of the second side opening along a longitudinal axis of the elongated body. The examiner notes that under the rejection of claim 1, Bellisario was found obvious to modify via the teachings of Ravenscroft to provide openings that are both circumferentially and axially separated from one another. As such the first and second side opening have no alignment and thus read to the claim.
Regarding claim 12, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 1, further comprising a tapered catheter tip at a distal end of the elongated body, wherein the tapered catheter tip defines a tip lumen in fluid communication with the first body lumen (Bellisario Figure 2, catheter tip (40) with lumens (42)). The examiner notes that per figures 1-3, the catheter tip can be seen in fluid communication with the lumens of the body as well as the tip being tapered. Bellisario Column 5 lines 4-5 detail that the tip is tapered.
Claim(s) 29,31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellisario et al. US 9155862, hereafter Bellisario, provided in the IDS in view of Ravenscroft and Schon and Speiser, as previously applied.
Regarding claim 29, Bellisario discloses
A catheter (abstract) comprising: an elongated body defining a plurality of body lumen (abstract, figure 2, lumen (22 and second lumen 23), see also figure 8a-c where the catheter comprises a body (520) a lumen (not shown) per column 6, lines 64-66), wherein the elongated body comprises a sidewall (outer body of catheter) defining a plurality side opening in fluid communication with the body lumen (Fig. 14A-C (1126), column 8 lines 38-51), the side opening having a proximal end, a distal end Fig. 14A-C, distal end (1128) proximal end (1127)), a first side extending from the proximal end to the distal end, and a second side opposing the first side and extending from the proximal end to the distal end (the examiner notes that the first and second side are interpreted as the top and bottom of the opening, which run between the proximal and distal ends), wherein each of the first side and the second side defines a continuous curve that curves towards the other of the first side or the second side in a direction towards a midpoint of the respective first or second side (Fig. 14a-c).
The examiner notes that although figure 2 does not expressly show the biconcave openings of figure 14c, the lumens are aligned with openings on the catheter as evidenced by figures 3-14, wherein the figures show various shapes for which the openings would be. Should applicant disagree with this argument, the examiner notes that as Bellisario discloses a dual lumen catheter where catheters may include various embodiments of openings connected to the catheter lumens, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the biconcave openings seen in figure 14c with the dual lumen catheter seen in figure 2.
The examiner notes that should applicant disagree with the interpretation of “continuous curve, figures 8-14 show various shapes for the opening which are selected based on desired characteristics (see columns 7 and 8). Per MPEP section 2144.04 Section IV B, change of shape has been used as obviousness rationale if a person of ordinary skill in the art would have found the change obvious absent persuasive evidence that the particular configuration of the claimed shape was significant In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Therefore, as Bellisario discloses various shaped embodiments which all function to allow fluid flow into various portions of the catheter, where said shapes are seen as obvious embodiments of one another due to their use on the same catheter structure (figures 8-14 of Bellisario), it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shape of the opening to be a continuous curve as seen in figure 10A of Bellisario, as Bellisario discloses that the shape of the opening may change depending on desired characteristics.
Bellisario however, fails to disclose wherein a distal end of the first biconcave side opening is longitudinally offset from a distal end of the second side opening.
Ravenscroft teaches a catheter device and is thus considered analogous to the claimed invention. Ravenscroft teaches that the catheter device has two separate interior chambers for applications such as hemodialysis where one chamber draws blood and the other directs filtered blood back into the body (para. 0067). Ravenscroft depicts, in figure 2A that the chambers have two chamber openings (222 and 224) that are positioned a similar distance from the distal (interpreted as aligned, as seen in the figure) (para. 0068). Ravenscroft further teaches that although this orientation is taught, the openings may also be at different distances from the distal end (as seen in figure 3 with openings 322 and 324). The examiner notes that as seen in figure 3, the chamber openings can be seen to be both axially and circumferentially displaced from one another. Ravenscroft teaches that the configuration (not aligned openings) is more efficient in reducing the amount of filtered and nonfiltered blood being mixed. Therefore, as Ravenscroft teaches that hemodialysis catheters having two chambers may have openings to the respective chambers either aligned or displaced from one another, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the openings of Bellisario to be completely longitudinally offset from one (as seen in Ravenscroft figure 3). Doing so would involve the use of known technique (offsetting chamber openings) to improve similar devices (blood circulating catheters) in the same way (reducing mixing of filtered and unfiltered blood), and thus a prima facie case of obviousness exists.
The examiner notes that while the combination of Bellisario and Ravenscroft teach that the openings may be completely offset from one another (see figure 3 of Ravenscroft), there is no specific disclosure of the distance being at least 1mm apart.
Schon teaches a catheter device and is thus considered analogous to the claimed invention. Schon teaches that the device is used for hemodialysis (column 8 line 55), where column 9, lines 15-43, teaches that as a means to keep treated and untreated blood separate, traditional spacing of return and intake openings in multiple lumen catheters is about 2cm, whereas the device of Schon is at about 4cm, as a means to prevent recirculation. Therefore, as Schon teaches that it is known in the art to have intake and return openings for multi-lumen hemodialysis catheter separated by a distance of at least 2cm, it would have been obvious to one having ordinary skill in the art prior the effective filing date of the claimed invention to modify the distance between the separated openings of Bellisario and Ravenscroft by at least 2cm. Doing so would involve applying a known technique to a known device ready for improvement to yield predictable results, said results being the prevention of recirculation.
Regarding the amendments filed 03/16/2026, the examiner notes that the prior arts fail to teach that the side openings are at least partially diametrically opposed. The examiner notes that while Ravenscroft, as previously detailed under the same rejection has the openings on opposite sides of the catheter and corresponding to different lumens, it is interpreted that they are at least partially diametrically opposed.
The amendments filed 03/16/26 further require wherein a distal end of the first side opening and a distal end of the second side opening are 1 mm to 15mm from a distal end of the catheter. The prior arts fail to teach a specific distance.
Speiser teaches a catheter device and is thus considered analogous to the claimed invention. Speiser teaches that the catheter device comprises openings (4” and 5” in figure 9a) where said openings are suitably 1-3mm (from the center) to distal end of the elongated body (para. 0072). Speiser further states that various distances may be suitable ranging from 750µm to 10mm. Therefore, as Speiser teaches that openings in catheters are suitably located in a range of 750µm to 10mm from the distal end of the catheter, and function, as intended at said distance, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the openings of the prior art to be placed at a distance between 750µm and 10mm from the distal end of the catheter device. The examiner notes that as said range overlaps with the claimed range, it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 31, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 29, wherein a proximal end of the first side opening is not aligned with a proximal end of the second side opening along a longitudinal axis of the elongated body. The examiner notes that under the rejection of claim 17, Bellisario was found obvious to modify via the teachings of Ravenscroft to provide openings that are both circumferentially and axially separated from one another. As such the first and second side opening have no alignment and thus read to the claim.
Regarding claim 32, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 29, wherein the proximal end of the side opening is circumferentially offset from the distal end of the side opening. The examiner notes that under the rejection of claim 17, Bellisario was found obvious to modify via the teachings of Ravenscroft to provide openings that are both circumferentially and axially separated from one another. As such the first and second side opening have no alignment and thus read to the claim.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellisario in view of Ravenscroft, Schon, and Speiser and further in view of Braga US 2008/0082080, hereafter Braga.
Regarding claim 13, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 12. However, Bellisario fails to specifically disclose wherein the tapered catheter tip does not define a lumen in fluid communication with the second body lumen. Bellisario does teach the use of insertable connecting members (48), however said members are not taught to preclude fluid flow into the catheter tip.
Braga teaches a catheter and is thus considered analogous to the claimed invention. Braga teaches that the catheter comprises first and second lumens (Fig. 10, lumens 30,32), where said lumens are located on a catheter wall and associated with two openings (42,44). Said catheter further connects to tapered tip (58), where the catheter comprises extension (60 and 62) for placement within the connection between the tip and the inner lumens (para. 0036). Said extensions are adapted to establish an interference relationship with the lumens, thus preventing flow, as extension (60) is devoid of a lumen per paragraph 0036. Said extensions are taught to assist in directing fluid. Therefore, based on the configuration of the extensions, Braga teaches a dual lumen catheter, where each lumen is associated with a separate opening, and wherein the tapered catheter tip is not in fluid communication with the second lumen, as extension 60 precludes fluid flow into the tip. Therefore, to aid in directing fluid flow in dual lumen catheters, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide insertable connectors of Bellisario with capability to block fluid flow through at least one of the lumens into the tip, as taught in Braga.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bellisario in view of Ravenscroft, Schon, and Speiser and further in view of Moehle, previously applied.
Regarding claim 30, Bellisario, Ravenscroft, Schon, and Speiser teach
The catheter of claim 29, wherein the first and second sides curve towards each other between the proximal and distal ends of the side opening to define a biconcave shape. The examiner notes that as detailed under the rejection of claim 29, the shape of the openings seen in figure 14c are interpreted as biconcave.
The examiner notes, that as detailed under the response to arguments, should applicant argue that the shape of Bellisario’s openings are not biconcave, the examiner makes note of Moehle
Moehle discloses a catheter and is thus considered analogous to the claimed invention. Moehle teaches that said catheter comprises opposed side openings (figure 4). Per paragraph 0053, said openings are said to be figure-eight shaped or an analemma, both of which are interpreted to be a “biconcave” shape as claimed, where said shape allows for prevention of undesired suctioning (para. 0054), assists in imparting a distal direction to fluids being ejected (para. 0055), and minimizes the radical redirection of fluid (para. 0055). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a figure-eight shape for the openings of Bellisario as Bellisario discloses various suitable shapes (figure 3-14), and doing so would achieve the aforementioned benefits of preventing undesired suctioning, and minimizing radical fluid redirection.
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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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