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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Parent Application 2051143-2, filed in Sweden on 01 October 2020 has been received.
Claim Objections
The claims contain minor informalities.
In claims 5 and 10, the language “… the patient is in need [[or]] of urinating …” should be changed for clarity.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lark; Tomer et al. (US 20210000361 A1) in view of Bolmsjo; Magnus et al. (US 20060111691 A1) in view of Ajao; Mobolaji Oluwaseun et al. ("CystoSure™: A Unique Catheter-Based Instrument …” 2017) in view of Whalen, Mark J. et al. (US 20050107721 A1, WO 2002017990 A2).
Regarding claim 1, Lark discloses a diagnostic kit (¶ [0001], [0008], a system and method of measuring IAP; ¶ [0175] FIG. 2 describes a block diagram … UO/IAP medical measuring device (1000));
comprising an indwelling catheter comprising an introduction stent unit with a top and bottom portion (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110);
said introduction stent unit also comprising a bladder fluid opening (¶ [0176], The lumen of the catheter is in fluid communication with the volume of the bladder);
wherein said introduction stent unit has a length configured to be arranged with the top inside of the bladder of a patient and with the bottom portion arranged inside of the urethra before the external urinary sphincter muscle of the patient when seen from the bladder and outwards (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110, and secured in place in the usual way);
said indwelling catheter also comprising a balloon stopper unit in connection with and fillable via a balloon filling tube and out from a balloon fluid inlet opening arranged on the introduction stent unit (Fig. 2, catheter 101 includes a retention balloon and therefore includes a balloon filling tube); and
wherein the filling of the balloon stopper unit with a sterile fluid, is intended when the balloon stopper unit is arranged inside of the bladder of the patient to provide for a stopper function of the balloon stopper unit against the bladder neck of the patient (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110, and secured in place in the usual way).
Lark does not explicitly disclose both an introduction stent and a catheter filling unit, pull thread, set volume of saline solution contained in a syringe or a drainage and diagnosis container. Lark also does not explicitly infuse a volume of saline into the patient’s bladder or diagnose based on calculating a urinated volume in relation to a saline volume. Bolmsjo discloses a partial-length indwelling urinary catheter (¶ [0002], [0017], [0043] catheter 20 … shown in FIG. 1);
said catheter comprising two connectable and separable main units being an introduction stent unit with a top and bottom portion (¶ [0043], [0045], indwelling catheter 20; ¶ [0046], main body 58 of the catheter 20);
said introduction stent unit also comprising a bladder fluid opening, wherein said introduction stent unit has a length configured to be arranged with the top inside of the bladder of a patient and with the bottom portion arranged inside of the urethra before the external urinary sphincter muscle of the patient when seen from the bladder and outwards (¶ [0054], At least one and preferably a pair of urine inlet openings 64 are formed through the end piece 62. The openings 64 communicate between the exterior of the end piece 62 and the passageway 56 of the main body 58);
a catheter filling unit with an open bottom end and a top portion (¶ [0043], insertion tool 22);
said catheter filling unit being detachable form the indwelling catheter (¶ [0065] The separable connection 52 between the insertion tool 22 and the indwelling catheter 20 includes a sleeve 84, shown in FIG. 5);
said indwelling catheter also comprising a balloon stopper unit in connection with and thus possible to fill via a balloon filling tube out from a balloon fluid inlet opening arranged on the introduction stent unit (¶ [0044], A balloon 40 on the indwelling catheter 20 is inflated with fluid conducted through an inflation passageway 42 of an inflation tube 44);
a pull thread fixedly arranged on the introduction stent unit to enable pulling of the introduction stent unit when the catheter filling unit is detached from the indwelling catheter (¶ [0050], The control cord 57 may take the form of a relatively thin synthetic or natural line which does not stretch appreciably when pulled. The control cord 57 is connected at one end to a main body 58 of the indwelling catheter 20 (FIGS. 2 and 3), and the other end extends through the urinary canal 36 beyond the point where the canal 36 opens from the penis; ¶ [0051] The balloon 40 is sufficiently flexible to expand and compress around the tissue of the bladder neck 46 when the control cord 57 is pulled; ¶ [0062] The control cord 57 is secured to the main body 58 in a way which prevents the cord 57 from disconnecting from the main body 58 even when significant pulling force is applied to the control cord 57);
said diagnostic kit also comprising a set volume of saline solution, or a solution with a similar equivalent osmotic balance, contained in a syringe connectable to the open bottom end of the catheter filling unit (¶ [0086], To eliminate those clots … flush the interior passageway 56 with saline … The flushing fluid may be delivered to the catheters 20, 90 and 92 through the interior channel 88 of the insertion tool 22 while the insertion tool remains connected to the indwelling catheter, after insertion of the indwelling catheter. Flushing the indwelling catheter is described in greater detail in the previous U.S. patent application noted above of which this invention is a continuation in part).
Bolmsjo allows a user to discharge urine at will and avoids the need to use a less-desirable full-length catheter (¶ [0017]) and also reduces the risk of urinary infection from a traditional cystometry study (¶ [0092]). One would be motivated to modify Lark with Bolmsjo’s two separable main units and pull thread since Lark calls for using any type of catheter to deliver fluid to the patient’s bladder (¶ [0154] Unlike U.S. Pat. No. 5,385,563 … this invention does not require use of a special catheter, and any standard type of urinary catheters is suitable). Therefore, it would have been obvious to modify Lark with Bolmsjo’s two separable main units and pull thread in order to drain urine from a patient’s bladder or diagnose the patient with fewer side effects.
Lark and Bolmsjo are silent whether the introduction stent unit from the top to the bottom portion has a total length in the range of 30 - 70 mm. The introduction stent’s total length is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The stent total length determines how well the catheter and stent unit will fit inside the patient’s urethra. For example, Bolmsjo acknowledges a need to customize the catheter for different patients based on the length of their urethra (¶ [0076] The use of the extendable urine conducting conduits 94 and 96 also allows the main bodies 58 of the catheters 90 and 92 to be a set or fixed size for different physiological lengths of the prostatic urethra 28 within different males). Therefore, it would have been obvious to adjust the stent total length in order to accommodate a majority of patients. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Lark and Bolmsjo lack a drainage and diagnosis container. Ajao discloses a catheter-based access sheath which makes cystoscopy safe, simple, and standardized (p. 169, Abstract);
comprising an indwelling catheter an introduction stent unit with a top and bottom portion (p. 170, Fig. 1 CystoSure four-way catheter with distal flat pancake balloon and four proximal ports: red for balloon inflation, yellow for outflow, blue for inflow, and purple for scope insertion);
said indwelling catheter also comprising a balloon stopper unit (p. 170, The proximal end of the catheter has a traditional three-way configuration with a blue fluid inflow port, a yellow urine outflow port, and an orange balloon inflation port, but also adds a fourth central purple port with a self-sealing valve to allow for passage of a cystoscope (Fig. 1));
said diagnostic kit also comprising a set volume of saline solution contained in a syringe connectable to the open bottom end of the catheter filling unit (p. 172, Bladder fill can be performed using the traditional syringe technique attached to the yellow outflow port with the blue inflow port clamped or using an IV bag/tubing attached to the blue inflow port with the yellow outflow port clamped … Patient’s bladder sensations including first sensation, mild urge, moderate urge, strong urge, and maximum cystometric capacity are measured and recorded); and
a drainage and diagnosis container with volume markings (p. 172, With the bladder full, backfill is stopped at the maximum bladder capacity and the clinician is called to perform cystoscopy … Finally, the patient is asked to void again in a uroflow or measured container).
Ajao demonstrates how to measure a patient’s bladder volume during a cystometry or cystoscopy visit (p. 172, Patient’s bladder sensations including first sensation, mild urge, moderate urge, strong urge, and maximum cystometric capacity are measured and recorded). One would be motivated to modify Lark and Bolmsjo with Ajao’s saline syringe and drainage container to supply saline from a known container and to quantify the patient’s bladder volume since Bolmsjo calls for flushing the patient’s bladder (¶ [0086], [0087], [0089], [0090]); and Lark calls for infusing saline into the patient’s bladder (¶ [0165] In order to accurately measure intra-abdominal pressure … when the bladder holds a known volume of fluid … saline or another biocompatible liquid can be used). Therefore, it would have been obvious to modify Lark and Bolmsjo with Ajao’s saline syringe and drainage container in order to fill or rinse the patient’s bladder with a known fluid source.
Lark, Bolmsjo and Ajao do not explicitly disclose that the syringe comprises sterile fluid. Whalen discloses a diagnostic urethral assembly (¶ [0002], [0022], [0023], [0038], FIGS. 2 and 3, the diagnostic urethral assembly 10);
including an indwelling catheter (¶ [0038], an elongate support member 12 receivable within an elongate body 14);
also comprising a balloon stopper unit in connection with and fillable via a balloon filling tube (¶ [0045] Referring now to FIGS. 2 and 3, the assembly body 14 insertion sequence is as follows. The balloon 28 is initially in an unexpanded state … the balloon 28 is expanded by the introduction of fluid into the luer fitting 38 using a 5 or 10 cc syringe; ¶ [0064], Fluid from the balloon 28 is released by withdrawal via syringe (not show) at the balloon filling port 38 positioned at the distal extremity 18 of the body 14);
a balloon filling syringe connectable to the balloon filling tube connectable to a receptacle situated on the end of the balloon filling tube before a valve arrangement, wherein said balloon filling syringe comprises sterile fluid intended to fill the balloon stopper unit (¶ [0043], The balloon 28, which is shown in an expanded state, is generally expandable … by the introduction of sterile or other physiologically compatible fluid into an inflation port 38 (e.g., a female luer fitting) using a syringe or other known fluid delivery methodology).
Whalen selects a commonly available fluid for filling a catheter’s balloon, and which does not carry pathogens or jeopardize the patient. Saline syringes are a staple of medical equipment since they find wide applications in medicine. For example, saline syringes are used to dilute or flush injectable drugs, to maintain the patency of a vascular catheter or to irrigate wounds or sinuses. The saline in these syringes is sterilized by default, since un-sterilized fluid can carry pathogens and expose patients to infection. One would be motivated to modify Lark, Bolmsjo and Ajao with Whalen’s sterile saline syringe to protect the patient against pathogens and to use a widely available medical product. Therefore, it would have been obvious to modify Lark, Bolmsjo and Ajao with Whalen’s sterile saline syringe in order to use a widely available medical supply that protects the patient from pathogens.
Regarding claim 5, Lark discloses method for performing a diagnostic test before a potential prostate surgery/treatment (¶ [0001], [0008], a system and method of measuring IAP; ¶ [0175] FIG. 2 describes a block diagram … UO/IAP medical measuring device (1000));
said method comprising: arranging an indwelling catheter inside of the urethra and up into the bladder of a patient, said indwelling catheter comprising an introduction stent unit with a top and bottom portion (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110);
said introduction stent unit also comprising a bladder fluid opening (¶ [0176], The lumen of the catheter is in fluid communication with the volume of the bladder);
wherein said introduction stent unit has a length configured to be arranged with the top inside of the bladder of a patient and with the bottom portion arranged inside of the urethra before the external urinary sphincter muscle of the patient when seen from the bladder and outwards (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110, and secured in place in the usual way);
said indwelling catheter also comprising a balloon stopper unit in connection with and fillable via a balloon filling tube and out from a balloon fluid inlet opening arranged on the introduction stent unit (Fig. 2, catheter 101 includes a retention balloon and therefore includes a balloon filling tube);
wherein the filling of the balloon stopper unit is intended when the balloon stopper unit is arranged inside of the bladder of the patient to provide for a stopper function of the balloon stopper unit against the bladder neck of the patient (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110, and secured in place in the usual way); and
said method also comprising filling the balloon stopper unit with a fluid, to fixedly arrange the top of the introduction stent unit inside of the bladder of the patient (¶ [0176] A urine catheter 101 is inserted through the urethra into the bladder 110, and secured in place in the usual way).
Lark does not explicitly describe a catheter comprising two connectable and separable main units or sterile fluid and also lacks a catheter filling unit and pull thread. Bolmsjo discloses a partial-length indwelling urinary catheter (¶ [0002], [0017], [0043] catheter 20 … shown in FIG. 1);
said indwelling catheter comprising two connectable and separable main units being an introduction stent unit with a top and bottom portion (¶ [0043], [0045], indwelling catheter 20; ¶ [0046], main body 58 of the catheter 20);
a catheter filling unit with an open bottom end and a top portion (¶ [0043], insertion tool 22);
said catheter filling unit being detachable form the indwelling catheter (¶ [0065] The separable connection 52 between the insertion tool 22 and the indwelling catheter 20 includes a sleeve 84, shown in FIG. 5);
a pull thread fixedly arranged on the introduction stent unit to enable pulling of the introduction stent unit when the catheter filling unit is detached from the indwelling catheter (¶ [0050], The control cord 57 may take the form of a relatively thin synthetic or natural line … connected at one end to a main body 58 of the indwelling catheter 20 (FIGS. 2 and 3); ¶ [0051], [0062] The control cord 57 is secured to the main body 58 … even when significant pulling force is applied to the control cord 57);
said diagnostic kit also comprising a balloon filling syringe connectable to the balloon filling tube, connectable to a receptacle situated on the end of the balloon filling tube before a valve arrangement (¶ [0086], To eliminate those clots … flush the interior passageway 56 with saline … The flushing fluid may be delivered to the catheters 20, 90 and 92 through the interior channel 88 of the insertion tool 22 while the insertion tool remains connected to the indwelling catheter, after insertion of the indwelling catheter).
Bolmsjo allows a user to discharge urine and also reduces the risk of urinary infection (¶ [0017], [0092]). Regarding the rationale and motivation to modify Lark with Bolmsjo’s introduction stent, catheter filling unit, pull thread and saline solution, see the discussion of claim 1 above.
Lark and Bolmsjo are silent whether the introduction stent unit from the top to the bottom portion has a total length in the range of 30 - 70 mm. This feature is interpreted as a result-effective variable. Regarding the rationale and motivation to optimize Lark and Bolmsjo’s catheter length, see the discussion of claim 1 above.
Lark and Bolmsjo do not explicitly flow a volume of saline into the patient’s bladder or diagnose based on calculating a urinated volume in relation to a saline volume. Ajao discloses a catheter and method comprising flowing a volume of saline solution, or a solution with a similar equivalent osmotic balance, contained in a syringe into the bladder of the patient until the patient is in need or urinating; noting the volume filled into the bladder (p. 172, Bladder fill can be performed using the traditional syringe technique attached to the yellow outflow port with the blue inflow port clamped or using an IV bag/tubing attached to the blue inflow port with the yellow outflow port clamped);
instructing the patient to perform certain movements during a certain time frame; organizing for patient-driven urination from the patient into a drainage and diagnosis container with volume markings; noting the urinated volume from the patient (p. 172, Patient’s bladder sensations including first sensation, mild urge, moderate urge, strong urge, and maximum cystometric capacity are measured and recorded … After completion of cystoscopy, the cystoscope and catheter are removed in unison to visualize the urethra and cough stress test is performed in the lying and standing position to assess for stress incontinence … Finally, the patient is asked to void again in a uroflow or measured container);
finally performing a diagnosis based on the calculation of urinated volume in relation to the volume of saline solution, or corresponding solution, infused into the bladder of the patient (p. 172, Patient’s bladder sensations … and maximum cystometric capacity are measured and recorded).
Ajao demonstrates how to measure a patient’s bladder volume during a cystometry or cystoscopy visit. Regarding the rationale and motivation to modify Lark and Bolmsjo with Ajao’s saline syringe, drainage container and various measuring steps, see the discussion of claim 1 above.
Lark, Bolmsjo and Ajao do not explicitly disclose that the balloon filling syringe comprises sterile fluid. Whalen discloses a diagnostic urethral assembly or kit (¶ [0002], [0022], [0023], [0038], FIGS. 2 and 3, the diagnostic urethral assembly 10);
said diagnostic kit also comprising a balloon filling syringe, wherein said balloon filling syringe comprises sterile fluid intended to fill a balloon stopper unit (¶ [0043], The balloon 28, which is shown in an expanded state, is generally expandable … by the introduction of sterile or other physiologically compatible fluid into an inflation port 38 (e.g., a female luer fitting) using a syringe or other known fluid delivery methodology).
Whalen reduces the risk of transmitting pathogens to a patient and also uses a commonly available medical supply. Regarding the rationale and motivation to modify Lark, Bolmsjo and Ajao with Whalen’s sterile saline syringe, see the discussion of claim 1 above.
Regarding claim 2, Lark lacks a spiral balloon filling tube and does not explicitly disclose a filling syringe. Bolmsjo discloses a balloon filling tube having a portion with a spiral shape along the balloon filling tube at a position outside and a distance from the bottom portion of the introduction stent unit, to enable anchoring inside of the urethra and outside of the external urinary sphincter muscle of the patient when seen from the bladder and outwards (¶ [0047] The inflation tube 44 is formed with a permanently helically coiled section 54 shown in FIGS. 1-3 and 6-9; ¶ [0063], The helically coiled section 54 is loosely wound around the insertion tool 22).
Bolmsjo aligns a stent with an insertion tool and also anchors the stent after the insertion tool has been withdrawn (¶ [0067], During insertion in this manner, the coiled section 54, which is wrapped around the insertion tool 22, helps keep the forward or distal portion of the inflation tube 44 aligned with and progressing with the indwelling catheter 20; ¶ [0070], while the coiled section 54 prevents the indwelling catheter 20 from moving out of the prostatic urethra 28 and into the bladder 32). Regarding the rationale and motivation to modify Lark with Bolmsjo’s stent or indwelling urinary catheter, see the discussion of claim 1 above.
Regarding claim 3, Lark, Bolmsjo and Ajao lack sterile water in a syringe. Whalen discloses a sterile fluid that is sterile water (¶ [0070], The balloon 28, which is shown in an expanded state, is generally expandable about a proximal portion of the assembly body 14 for engagement with the bladder neck 220, as by the introduction of sterile or other physiologically compatible fluid into an inflation port 38 (e.g., a female luer fitting) using a syringe or other known fluid delivery methodology).
Regarding the rationale and motivation to modify Lark, Bolmsjo and Ajao with Whalen’s sterile fluid syringe, see the discussion of claim 1 above.
Regarding claims 6-10, Lark does not explicitly evaluate a patient for prostate surgery. Bolmsjo diagnoses a patient’s suitability for prostate surgery (¶ [0024] Another aspect of the invention is a method of diagnosing urinary tract retention in a male human caused by one of either a blockage in a prostatic urethra or by a weak bladder).
Bolmsjo does not explicitly evaluate a patient based on calculating a ratio of urinated volume to volume of saline solution.
Ajao discloses a method wherein a diagnosis considers a ratio of urinated volume to volume of saline solution infused into the bladder (p. 172, Patient’s bladder sensations including first sensation, mild urge, moderate urge, strong urge, and maximum cystometric capacity are measured and recorded);
wherein the diagnosis is directed to evaluating if a patient is a suitable candidate for prostate surgery or treatment based on the urinated volume during a set time range, preferably a time range being a time range of 30 seconds or less (p. 172, CystoSure™ allows comprehensive bladder evaluation to assess function and anatomy in under 10 min and most of the evaluation can be performed by an office staff rather than the physician … With CystoSure™, cystoscopy could be performed at the bedside in under 5 minutes if postoperative hematuria is noted and bladder injury is suspected);
wherein the diagnosis also include at least one of the following: evaluation with reference to if the patient is able to urinate on request; and evaluation with reference to if the patient is able to avoid leakage during movement (p. 172, Leakage around the catheter suggesting urge incontinence is also observed).
A skilled artisan would have been able to modify Lark and Bolmsjo with Ajao’s volume calculation by infusing saline through Bolmsjo’s catheter and then following Ajao’s remaining steps and calculations. Regarding the rationale and motivation to modify Lark and Bolmsjo with Ajao’s volume calculations, see the discussion of claims 1 and 5 above.
Response to Arguments
The objections to claims 1, 5, 6, 9 and 10 for minor informalities are and the rejections of claims 1, 3, 5-7, 9 and 10 under 35 USC § 112 are withdrawn in view of the amendments filed 25 August 2025.
Applicant’s arguments filed 25 August 2025 regarding the rejection of claims 1-3 and 5-10 as amended, under 35 USC § 103 over Lark, Bolmsjo and Ajao have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Lark, Bolmsjo, Ajao and Whalen (see above).
Applicant submits that in contrast to the present claims, Bolmsjo discloses a partial-length catheter selectively movable within the prostatic urethra to open a urine drainage passageway through and obstructed portion of the prostatic urethra or to open the external urinary sphincter muscle and thereby discharge urine from the bladder (remarks p. 10). Applicant asserts that Bolmsjo fails to cure the defects in Lark (remarks p. 10). Examiner responds that Bolmsjo’s catheter matches all the claimed features of Applicant’s catheter, namely a pair of main units being an introduction stent unit with a top and bottom portion (¶ [0043], [0045], indwelling catheter 20; ¶ [0046], main body 58 of the catheter 20); a detachable catheter filling unit (¶ [0065] The separable connection 52 … in FIG. 5); a balloon stopper (¶ [0044], balloon 40); and a pull thread (¶ [0050], [0051], [0062] control cord 57).
Applicant asserts that although it is shown in Bolmsjo to use a syringe for inflating the balloon it is not mentioned that this syringe should contain sterilized fluid (remarks p. 10). Applicant reasons that neither Lark alone or in combination with Bolmsjo disclose or suggest the Applicant's recited diagnostic kit, and therefore fails to disclose or suggest a diagnostic kit having the diagnostic capability of the present claims (remarks p. 10). Examiner notes that Whalen is cited in the new grounds of rejection as teaching a sterile saline syringe for inflating a catheter balloon (¶ [0070], The balloon 28 … is generally expandable … by the introduction of sterile or other physiologically compatible fluid into an inflation port 38 (e.g., a female luer fitting) using a syringe).
Applicant contends that neither Lark, Bolmsjo or Ajao disclose or suggest the recited indwelling catheter (remarks p. 10). Examiner replies that Bolmsjo is cited as teaching details of the catheter as discussed above.
Applicant submits that moreover, the cited prior art fails to disclose or suggest using the indwelling catheter in a prostatic diagnostic kit as recited by the Applicant (remarks p. 10). Examiner responds that Lark and Ajao are cited as teaching equipment and methods for measuring a patient’s bladder volume or diagnosing problems with a patient’s bladder. Bolmsjo is cited as teaching features of an indwelling catheter and Whalen is cited as teaching a sterile fluid syringe.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov.
Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Adam Marcetich/
Primary Examiner, Art Unit 3781