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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 C.F.R. § 1.114 (“RCE”), including the fee set forth in 37 C.F.R. § 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. § 1.114, and the fee set forth in 37 C.F.R. § 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R. § 1.114. Applicant's submission filed on 26 February 2026 (“Reply”) has been entered.
Response to Amendment
This Action is responsive to the RCE and Reply. As directed in the Reply:
Claims 11 and 13 have been amended;
Claims 1-10 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 11-17 are presently pending in this application.
The Reply does not comply with 37 C.F.R. § 1.121 because it does not include a complete listing of all of the pending claims - Claim 17 was not presented in the claims portion of the Reply.
As a courtesy to Applicant, the Reply has been treated on the merits without requiring a supplemental reply to remedy the foregoing deficiency; this treatment does not, however, relieve Applicant of this or any other requirement of Title 37, C.F.R., for any future papers filed in this application.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not persuasive.
Claim objections
Applicant’s revision of Claim 13 is appreciated and removes some, but not all, of the bases for the objection to that claim; Claims 11 and 13 remain objected to for the same and additional reasons. The Examiner suggests the following revisions to Claim 11.
In Claim 11:
“an extraction thread threaded through [[in]] said catheter distal end receivers, wherein the extraction thread is configured to [[be located along]] extend from at least one catheter distal end receiver of said catheter distal end receivers [[, wherein the extraction thread is configured to extend]] and beyond a patient's urethra, wherein said extraction thread is connected to a snap cap at an end of the extraction thread, the snap cap and a portion of the extraction thread located external relative to a patient's body when the coil is positioned within a patient’s bladder, wherein the snap cap comprises a magnetic structure to facilitate location of the extraction thread end;”
In Claim 13:
“an extraction thread received in said catheter distal end receivers, wherein said extraction thread is connected to a snap cap at an end of the extraction thread, the snap cap and a portion of the extraction thread located external relative to a patient's body when the coil is positioned within a patient’s bladder, wherein the snap cap comprises a disc-shaped magnetic structure to facilitate location of the extraction thread end . . . .”
Finality of the prior Action
Applicant argues (Reply, pp 6-7) that the finality of the prior Action was improper, because Applicant amended the claims when filing the RCE. First, the argument is moot, because Applicant filed an RCE after the last Action, and thus did not preserve any right it had to petition for review of the finality of the Action.
Second, the analysis involved when determining if an Action can be made final is far more complex than that presented by Applicant in its remarks. Applicant’s attention is directed to M.P.E.P. § 706.07(b). Because an underlying issue in that analysis is whether Applicant’s amendment to a claim ‘necessitated a new ground of rejection,’ M.P.E.P. § 1207.03’s detailed discussions of whether a ground of rejection is new governs and articulates the Office’s positions on the issue. In the instant case, just because Applicant added a limitation to a claim does not, by itself, immunize the application from a first-action-final Action after the filing of an RCE with that amendment; instead, the fundamental question is: did the amendment require application of a fundamentally different rejection, or is it instead the same rejection based on the same record evidence and logic. Here, the answer was No, and thus the finality of the prior Action was proper. As a further example, the instant Action has not been made final, because the underlying evidence and/or logic of the rejection has changed sufficiently that Applicant has not yet been afforded an opportunity to respond to the substance of the rejections, which invokes the safeguards concerning agency action in the Administrative Procedure Act (5 U.S.C. §§ 551-559).
Rejection under 35 U.S.C. § 103
A keystone of Applicant’s arguments (Reply, pp. 7-11) is that, in Applicant’s view, “[t]he Cited References Fail to Teach, Suggest, or Motivate a Halo Portion Curled Around in the Halo Form” (capitalization in original). The meaning of “halo,” and thus also “halo form,” is discussed at length below, and Applicant’s characterization of the term, “. . . a halo as referring to a ring, circle, or annular region surrounding something,” (id. at 8) is mostly consistent with the meaning discussed below, with the important difference being that, in the context of this application, “halo” means a broken, but otherwise complete, circle - this application has no support (35 U.S.C. § 112(a)) for an unbroken halo portion of a catheter shaft.
Applicant then asserts that Chen does not disclose a halo portion; the Action does not allege that it does, but that Galloway supplies that structure.
Applicant then addresses (Reply, beginning at pg. 9, last paragraph) Galloway, alleging that it has a spiral configuration with only approximately 120 degrees of curvature, referencing its Figs. 3A and 3B. Assuming, arguendo, this to be true, the claim does not exclude Galloway’s shape - the claim’s transition phrase is “comprising,” the claim’s proximal end of the catheter ‘comprises’ a coil and “includes” a halo portion, and a swan neck “containing a right angle element.” The meaning of the term “swan neck” has been prosecuted at length in this application and its parent, and does not carry with it a specific structure. Thus, Applicant reads into these terms and phrases limitations which are not in the claims, and are only vaguely described in the original disclosure.
Applicant then argues (Reply, pg. 10, second full paragraph) that Galloway teaches away from a halo portion curled into a halo form, because, in Applicant’s view, the fact that it includes a trans-sphincter portion means it shouldn’t have a halo formed coil at its proximal end. But the one does not follow from the other: how the catheter is anchored in the bladder is distinct from whether or not the catheter bridges the sphincter - these are functionally independent features to a person of ordinary skill in the art. Furthermore, Chen supplies the feature of stenting the prostatic urethra while not bridging the voluntary sphincter - not Galloway.
Applicant next argues (Reply, pg. 10, last paragraph) that Galloway does not illustrate it sheath 30 “as being completely surrounded by catheter 10.” While, in a top plan view, this may be correct, it is irrelevant to the obviousness of combining Chen with Galloway in the manner stated in the prior Action and below.
Applicant lastly argues (Reply, pg. 11) that Yachia does not make up for Chen and Galloway with respect to the claimed combinations, referencing features of Yachia’s device upon which the rejection does not rely (its coil); accordingly, Applicant is, again, arguing against a rejection that was not made (Yachia is relied upon for its teachings concerning an antimigration feature, not its coil).
Claim Objections
Claims 11 and 13 are objected to because of the following informalities.
In Claim 11:
at lines 8-12, “said proximal end of said catheter body comprising a coil and includes a halo portion curled around in the halo form, a swan neck element containing a right angle element; when said catheter is in a coiled orientation and said stylet withdrawn from said fluid passage” is grammatically incorrect and the semicolon should be a comma;
at lines 15-17, the clauses “an extraction thread threaded through in [sic] said catheter distal end receivers, wherein the extraction thread is configured to be located along one catheter distal end receiver of said catheter distal end receivers” invite confusion, because: “threaded through in” is redundant; and, the first line positively states that the thread is in all of the receivers, while the second clause states the thread is only configured to be located along one of them, which appears to contradict the first clause; and
In Claim 13, the foregoing paragraph from Claim 11, lines 15-17, repeated in Claim 13, is objectionable for the same reasons.
Appropriate correction is required.
Claim Interpretation
The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
Claim 13 recites, inter alia:
said catheter body being formed from a molding process wherein said catheter body is formed in a mold, heated, and cooled, such that said catheter body is configured to automatically transform from a first, straightened orientation into a second, coiled orientation when placed . . . .
This clause is a product-by-process feature of the claim, and has been treated as described in M.P.E.P. § 2113, i.e., the clause has been treated as being limited to only the structure implied by the steps recited in the clause: “configured to automatically transform from a first, straightened orientation into a second, coiled orientation.”
Applicant has added the positive limitation to the claims that the catheter body includes a “halo portion curled in the [sic: “a”] halo form” (see rejection below for lack of clarity). “Halo” and “halo form” are not technical terms in the mechanical arts, but there is a device in the orthopedic arts called a “halo brace, see below. The original application does not engage in lexicography to impose its own definition. The following definitions from general purpose dictionaries are therefore useful in assessing its meaning.
www.merriam-webster.com/dictionary/halo
a circle of light appearing to surround the sun or moon and resulting from refraction or reflection of light by ice particles in the atmosphere
halo brace: an orthopedic device used to immobilize the head and neck (as to treat fracture of neck vertebrae) that consists of a metal band placed around the head and fastened to the skull usually with metal pins and that is attached by extensions to an inflexible vest
dictionary.cambridge.org/us/dictionary/english/halo
a ring of light around the head of a holy person in a religious drawing or painting
a ring of light around the head of a holy person in a religious drawing or painting
www.collinsdictionary.com/us/dictionary/english/halo
A halo is a circle of light that is shown in pictures around the head of a holy figure such as a saint or angel.
a ring of light that seems to encircle the sun, moon, or other luminous body: it results from the refraction of light through ice crystals in our atmosphere
a symbolic disk or ring of light shown around or above the head of a saint, etc., as in pictures; nimbus
The “halo brace” usage does not appear to have much meaning, relevant here, different from the other definitions, inasmuch as it references a circular band of metal. See, e.g., U.S. Patent Nos. 4,541,421 and 3,957,040, examples of early orthopedic halo braces.
The application as filed referred to portion 6 of the catheter as being, or including, a halo portion; see para. [0058], [0062], for example. The application does not, however, indicate where the halo portion of the catheter begins or ends along the catheter’s length. [0058] states, “. . . having a halo portion 6 connected to a stem portion 8 via a swan neck bend 7 such that the halo portion is along a plane perpendicular to the direction of the stem portion” (emphasis added); this ‘perpendicularity’ is not a claimed feature, but the clause illuminates what Applicant meant when it used the term “halo.”
From the foregoing definitions, a person of ordinary skill in the art would understand “halo” to mean an unbroken circle; importantly, however, the disclosed halo portion of the catheter is not an unbroken circle, but is instead a circular coil with a terminal end that overlaps vertically with a more proximal portion of the circular coil, thus making it a broken circle resembling, in a way, a split ring commonly used for holding keys - albeit with only a short amount of overlapping catheter. This is the broadest reasonable interpretation, read in light of the specification, of the term “halo” as used in this application.
Claim Rejections - 35 USC § 112
Claims 11-17 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.
In Claim 11, line 9, and Claim 13, line 15, “the halo form” lacks a positive antecedent basis; it has been treated as “a halo form.”
In Claim 11, line 8, the claim states that the catheter comprises “a coil and includes a halo portion;” however, based on the underlying specification and drawings, the coil includes the halo portion. Thus, the word “and” in the foregoing phrase renders the scope of the claim indefinite, because it is inconsistent with the underlying disclosure; it has been treated as “which.”
In Claim 13, lines 14-15, the clause “comprising a single coil terminating and includes a halo portion” is grammatically flawed, at least because it mixes tenses; it has been treated as, “comprising a single coil terminating at [[and includes]] a halo portion.”
Claim Rejections - 35 USC § 103
Claims 11-17 (as best understood, see treatments above) are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Publ. No. 2018/0043135, by Chen et al. (“Chen”) in view of U.S. Patent No. 4,738,667, granted to Galloway (“Galloway”), and U.S. Patent App. Pub. No. 2018/0161542, by Yachia et al. (“Yachia”), optionally further in view of U.S. Patent App. Pub. No. 2019/0091442, by Erbey, II, et al. (previously of record; “Erbey”),
Concerning Claim 11, Chen describes a catheter system substantially as claimed by Applicant, as follows.
Claim 11: A catheter system for a halo-style catheter configured for transforming a catheter from a first, straight orientation to a second, coiled orientation, the catheter system comprising:
a catheter (Fig. 1B: 102) having a catheter body (122) including a proximal end (120), a distal end (at 144) and an internal fluid passage closed at said proximal end (at 120; [0073] “closed cone”) and open at said distal end (144);
a pusher including a stylet received in said catheter passage, wherein the pusher is configured to push said catheter into the straight orientation (not illustrated, but described at [0037] and throughout);
said catheter configured for placement in a patient's bladder, wherein the distal end of said catheter is configured to engage with a patient's sphincter (Fig. 2B, the distal end is located at the sphincter 110);
said catheter distal end including multiple receivers (Fig. 8A, holes 804);
an extraction thread (Fig. 8A, 126) threaded through in [sic] said catheter distal end receivers (as Chen expressly teaches securing the suture to the catheter, a person of ordinary skill in the art would immediately understand the dotted lines in its Fig. 8A to indicate that the suture passes through the wall of the catheter through the holes 804), wherein the extraction thread is configured to be secured along at least one catheter distal end receiver of said catheter distal end receivers (see treatment above; as Chen’s thread 122 exits one of its holes, the thread is configured to be secured as the claim has been treated), wherein the extraction thread is configured to extend beyond a patient's urethra (see treatment above; Fig. 1A), wherein said extraction thread is connected to a snap cap (128, 1412, 1512) at an end of the extraction thread, the snap cap and the extraction thread are configured to be located external to a patient’s body (Figs. 1A, 7, 14, 15), wherein the snap cap comprises a structure to facilitate location of the extraction thread (id.; [0057]); and
said extraction thread configured to pull said catheter from the patient's bladder and past the patient's sphincter (id., [0085]).
Chen does not, however, describe that the proximal end of the catheter body comprises a coil and includes a halo portion curled around in a halo form, a swan neck element containing a right angle element, when the catheter in its coiled orientation and the stylet withdrawn from said fluid passage, but does disclose that the proximal portion 124 of its catheter, which retains the catheter in the bladder ostium, is changed from a straight configuration (e.g., Fig. 3A) to a wider, retaining position (Fig. 3B) by removal of the stylet or outer sleeve ([0012], among others). Thus, a first difference between Chen and the subject matter of Claim 11 is the shape of the proximal retaining [AltContent: ]feature of the catheter, that is, “a coil and includes a halo portion curled around in a halo form, a swan neck element containing a right angle element, when the catheter in its coiled orientation.”
Galloway relates to urinary catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Galloway teaches that the proximal retaining feature of a urinary catheter can be formed as a coil (10) and includes a partial halo portion curled around in a partial halo form (Figs. 2-3B, showing it to have a planar portion which encircles its linear portion), a swan neck element (see the annotated figure above, SNE, encircled) containing a right angle element (shown with the two lines intersecting at a right angle), when the catheter in its coiled orientation, when the insertion device (a sleeve) is removed, so that the device can have a relatively small outer diameter, which is easy to use (col. 2, lines 5-18), and better hold the catheter in place (col. 1, lines 12-43, discussing the shortcomings of its prior art).
It 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, to construct Chen’s urinary catheter such that its proximal retaining feature includes a coil and includes a halo portion curled around in a halo form, a swan neck element containing a right angle element, when the catheter in its coiled orientation and the stylet withdrawn from said fluid passage, because Galloway teaches doing so in a closely related urinary catheter to better stabilize the catheter when used, and to simplify its deployment.
Galloway’s coil includes a partial, not complete, “halo,” which is viewed as a disclosure of a planar, circular portion of its catheter which has a radial angle (in polar and/or cylindrical coordinates) less than 360 degrees by an unidentified amount (although its figures illustrate that angle to be close to 360 degrees), while the claimed “halo” has a radial angle of at least 360 degrees.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the coil of Chen-Galloway’s catheter as a complete halo, i.e., having at least 360 radial angle, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, Chen-Galloway’s catheter would not operate differently with the claimed complete halo coil portion, because urine in the bladder would still flow into the catheter’s eyelets through the break in the circle of the halo at the end of the catheter, and over the coil itself, and the catheter would still be anchored in the same manner in the bladder os; thus, the Chen-Galloway catheter would function appropriately having the claimed complete halo portion. Further, Applicant assigns no criticality on the completeness of the halo, indicating simply that the catheter coil includes the halo portion without attributing any particular function or attribute to the completeness of the “halo” (Specification @ [0058], [0062]).
Optionally, Erbey relates to urine drainage catheters, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Erbey teaches that the anchoring portion of the catheter (130, 330, 410, 500, 1230, 1330, 2230, 3230, 4230, 5012, 5013) can be constructed to include at least a complete halo portion (see Fig. 1V, portion extending between terminal end 440 and the portion immediately proximal of it along the coil), which a person of ordinary skill in the art would understand would make the catheter less likely to dislodge when retracted, and thus would be more likely to stay in place.
It 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, to construct Chen/Galloway’s urinary catheter’s coil such that it includes a complete halo, because Erbey teaches doing so in a closely related urinary catheter to better assure that the coiled anchor does not dislodge.
Chen describes its “antimigration device” 128 as “a flexible tab” which is outside of the patient’s body (see [0057]), but does not expressly describe “wherein said extraction thread is connected to a snap cap located outside of the patient's body, wherein the snap cap comprises magnetic material.” A full review of the instant Specification reveals no additional features of the claimed “snap cap” other than those discussed in [0020], including the sentence, “[i]n patients with diminished manual dexterity, a magnet can be placed on the snap cap and on the end of the stylet device.” The applications’ drawings do not meaningfully add to this disclosure; the application includes no specific definition of these two words. The words “snap cap” thus are afforded their ordinary and customary meanings, as they would be understood by a person of ordinary skill in the art, that is, a structure which can act as a cap, and which can be snapped to something else. Chen’s antimigration device 128 appears disc-like in shape, and thus in the shape of a cap; and it stated to be flexible, thus capable of snapping into another (unclaimed) and appropriately sized structure.
Yachia relates to urinary catheters which stent the prostatic urethra and include an extracorporeal antimigration device and thread, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Yachia teaches that the antimigration device 28, 128, 228, 328, attached to thread 126, can be made magnetic (Abstract, [0048], passim), so that the antimigration device can be captured with a magnetic tool 412, which a person of ordinary skill in the art understands thus reduces the need for manual dexterity to secure the antimigration device, so that the thread can be used for catheter straightening and, optionally, removal.
It 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, to construct Chen/Galloway’s urinary catheter such that its snap cap antimigration device includes a magnetic material, because Yachia teaches doing so in a closely related urinary catheter to permit capture of the snap cap with a magnetic tool.
Claim 12: (The catheter system according to claim 11) wherein said extraction thread is placed adjacent said catheter body thereby leaving said catheter passage at least partially unobstructed (thread 126 causes the passage in Chen’s catheter to be as ‘unobstructed’ as does Applicant’s suture/thread).
Claim 17: (The catheter system according to claim 11,) wherein the pusher is configured to be removed after placement (Chen: [0012], “. . . when the stylet or outer sleeve is removed;” [0018], “[t]he method may then include removing the removable connecting segment and stylet or the outer sleeve from the urethra in response to observing the urine or other bodily fluid;” [0055], “the stylet or sleeve may be removed”), such that, upon removal, the catheter system allows passage of urine without an external tubular structure and an external collection device (Chen’s device does not depend on either an external tubular structure and an external collection device to allows passage of urine).
Concerning Claims 13-16, Chen describes a catheter system substantially as claimed by Applicant, as follows.
Claim 13: A catheter system (100) for a halo-style catheter capable of transforming the halo-style catheter from a first, straight orientation to a second, coiled orientation for use within a patient body, the catheter system comprising:
A catheter (Fig. 1B: 102) having a catheter body including a proximal end (122) and a distal end (at 144), said catheter body being formed from a molding process wherein said catheter body is formed in a mold, heated, and cooled (see treatment above - the end product of these steps is not distinguishable from Chen’s catheter),
said catheter body configured to be placed into position within said patient body using a pusher device comprising a stylet configured to retain said catheter body in said first, straight orientation while being placed (not illustrated, but described at [0037] and throughout);
said catheter body configured to transform into said second orientation when said stylet is removed ([0037]; compare Figs. 3A, 3B);
wherein said proximal end of the catheter body terminates into a tapered tip (at 120, Fig. 3A);
a straight stem (Fig. 2B, 122) culminating in said distal end of said catheter body, said straight stem configured to stent a prostatic urethra and to be placed above said sphincter such that said distal end of said catheter body is superior said sphincter (see treatment above), and does not contact nor pass through said sphincter when in said second orientation (id.);
said distal end of said catheter body comprising a suture-to-tube portion comprising a pair of receivers passing through at least a portion of said distal end of said catheter body (Fig. 8A, holes 804), said suture-to-tube portion configured to allow for positioning and removing the catheter body (the portion of 122 illustrated in Fig. 8A is fully capable of being positioned and removed);
an extraction thread (122) received in said catheter distal end receivers (Fig. 8A), wherein said extraction thread is connected to a snap cap at an end of the extraction thread (128, 1412, 1512; see discussion above concerning Claim 11) located external relative to a patient's body (see treatment above; Fig. 1A), wherein the snap cap comprises a structure to facilitate location of the extraction thread end (as illustrated in Fig. 1A, 7A, 14, and 15, the retention element appears to be round, because the illustrations are perspective views, thus making the element disc-shaped);
wherein the extraction thread comprises an extra-luminal suture (see treatment above) configured to be placed external to a lumen of said catheter body and external to a pusher configured to be inserted into said lumen (see Fig. 8A, showing the suture thread 122 being external to the catheter lumen and, thus, the pusher), wherein said extra-luminal suture is configured to be located along one of the receivers of said pair of receivers (Chen’s thread extends through one of the holes and therefore is configured as claimed), wherein said lumen is configured to transport fluid through said catheter body ([0054]);
wherein when said extra-luminal suture is placed within said pair of receivers, said extra-luminal suture is configured to prevent complete obstruction of said lumen (the suture 126 prevents obstruction of the catheter lumen to the same extent Applicant’s does), and is further configured for tethering of said catheter body, to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body (suture 126 is fully capable of performing these functions); and
whereas the catheter body functions as a prostatic urethral stent while inserted in said patient body with said distal end located above said sphincter without contacting said sphincter when in said second orientation (Fig. 2B).
Chen does not, however, describe its catheter system to include the following features:
that the catheter is a halo-style catheter, such that said catheter body is configured to automatically transform from a first, straightened orientation into a second, coiled orientation when placed into position within said patient body;
said proximal end of said catheter body comprising a single coil terminating in a halo portion (see treatment above) curled around in the halo form, a swan neck element containing a right-angle bend and wherein said swan neck element and said right-angle bend are configured to form a stabilizing elbow,
said stabilizing elbow configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back proximal to a patient’s sphincter,
the stabilizing elbow terminating into the straight stem,
said single coil being perpendicular to said straight portion,
a single first eyelet located along a horizontal plane of said single coil,
a single second eyelet located along said stabilizing elbow, or
the snap-cap comprises a magnetic structure.
Galloway (see annotated figure, above) relates to urinary catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Galloway teaches that the proximal retaining feature of a urinary catheter can be formed to have the foregoing features, so that the device can have a relatively small outer diameter, which is easy to use (col. 2, lines 5-18), and better hold the catheter in place (col. 1, lines 12-43, discussing the shortcomings of its prior art):
the catheter is a halo-style catheter (Fig. 2A), such that said catheter body is configured to automatically transform from a first, straightened orientation into a second, coiled orientation when placed into position within into position within said patient body (see Figs. 2A, 2B, and col. 2, lines 55-58);
the proximal end of the catheter body comprising a single coil (see figure) terminating in a partial halo portion (see treatment above) curled around in the halo form, a swan neck (upstanding portion SNE) element containing a right-angle bend (the two dotted lines show the right-angle bend portion of the encircled ‘swan neck element’) and wherein said swan neck element and said right-angle bend are configured to form a stabilizing elbow (together, the SNE and right angle bend form a stabilizing elbow as claimed by Applicant, because they stabilize the horizontal portion relative to the vertical portion, as shown in Fig. 4),
said stabilizing elbow configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back proximal to a patient’s sphincter (catheter 10 is flexible enough to be straightened and to curl up, Figs. 2A, 2B),
the stabilizing elbow terminating into the straight stem (Fig. 1, to which the lead line for ref. no. 10 points),
said single coil being perpendicular to a straight portion (Fig. 2A shows perpendicularity between the coil and the straight portion),
a single first eyelet located along a horizontal plane of said single coil (20, right side of Fig. 3B), and
a single second eyelet (the other hole 20) located along said stabilizing elbow (positioned at the bottom of the swan neck and thus along the elbow).
It 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, to construct Chen’s urinary catheter such that its proximal retaining feature is a coil with the foregoing features, because Galloway teaches doing so in a closely related urinary catheter to better stabilize the catheter when used, and to simplify its deployment.
See above concerning the partial halo portion of the coil, with respect to Claim 11, which applies equally to Claim 13. See above concerning Yachia and the use of a magnetic element at the end of a thread/suture.
It 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, to construct Chen-Galloway’s urinary catheter such that its proximal coil includes the foregoing features, and its snap cap antimigration device includes a magnetic material, because Chen-Galloway’s urinary catheter would function identically with the claimed full halo portion, Erbey teaches doing so in a closely related urinary drainage catheter, and because Yachia teaches doing so in a closely related urinary catheter to permit capture of the snap cap with a magnetic tool.
Claim 14: (The catheter system of claim 13,) further comprising:
said catheter body distal end including said pair of receivers (see treatment above; Chen shows at least four holes 804in Fig. 8A);
said extra-luminal suture (Chen, Fig. 8A, 126) received in said catheter body distal end receivers (as Chen expressly teaches securing the suture to the catheter, a person of ordinary skill in the art would immediately understand the dotted lines in its Fig. 8A to indicate that the suture passes through the wall of the catheter through the holes 804) wherein an extraction thread [see treatment above] is configured to extend beyond the patient's urethra (Chen, Fig. 1A); and
said extra-luminal suture configured to pull said catheter from the patient's bladder and past the patient's sphincter ([0085]).
Claim 15: (The catheter system according to claim 14) wherein said extra-luminal suture is placed adjacent said catheter body (Fig. 8A: Chen’s thread is not embedded in the catheter body and, thus, is adjacent to it) whereby said catheter passage is at least partially unobstructed (id.).
Claim 16: (The catheter system according to claim 15,) further comprises multiple receivers including said two receivers, wherein said multiple receivers comprise at least stacked receivers oriented above and along one side of said catheter body (Chen, Fig. 8A, shows four holes 804 arranged in the proximal-distal direction).
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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