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 .
Applicant' s arguments, filed 10/27/25, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/27/25, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4-6, and 9-10 are the currently pending claims hereby under examination. Claims 3 and 7-8 have been canceled, and claims 1 and 9-10 having been amended.
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.
Claims 1-2, 4-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Newton (US 20070180928 A1), hereto referred as Newton, and further in view of Steer et al. (GB 2247626 A), hereto referred as Steer, and further in view of Laing et al. (US 20190365308 A1), hereto referred as Laing, and further in view of Moore et al. (US 20200121300 A1), hereto referred as Moore.
Regarding claim 1, Newton teaches that a urinary flow rate measurement device comprises: a vessel having an upper opening configured to receive a urinary input (Newton, Figs. 1–4, Abstract: “A peak flow measurement device comprises a hollow body (1) having an inlet”, ¶[0017]: “The upper end of the cylinder is flared to form a catchment funnel (8)”, shows that the vessel has an upper opening formed as a funnel to receive urinary input for rate measurement); the vessel being cup shaped and having a cross-sectional area that tapers and reduces from a top of the vessel toward a bottom of the vessel (Newton, Fig. 4; ¶[0017], “The upper end of the cylinder is flared to form a catchment funnel (8)”, shows a cup or funnel at the top that increases area toward the top such that the cross-sectional area reduces toward the bottom; ¶[0023], “At a height of 36 mm above the orifice (12) the diameter of the vessel expands to 20 mm, and at a further height of 46 mm (13) it expands again to 24 mm… Above the second step the vessel extends further, to a catchment funnel (8)”, teaches a geometry that widens upward and thus is tapered narrower toward the base; this overall flared and narrowing configuration reads on ‘cup-shaped…cross-sectional area that tapers…from top…toward a bottom’); a drainage aperture located at or near a base of the vessel (Newton, Fig. 1, Abstract: “an outlet”, ¶[0017]: “The closed end of the cylinder (2) is perforated by an orifice (3)”, shows the drainage aperture located at the base of the vessel); and a marker located on a wall of the vessel and configured to indicate if the volumetric flow rate of urinary input entering the vessel is above or below a predetermined threshold (Newton, Figs. 2–4, ¶[0018]: “The external surface of the cylinder has affixed a printed label (4)… red in its lower section (5), yellow in its mid section (6), and green in the upper section (7)… The boundary between the yellow (6), and green (7), sections corresponds with a fluid height… with a sustained flow of 15 ml per second”, teaches a marker that is labeled with both color and a diameter step (Fig. 4, ¶[0023]) indicating whether flow rate exceeds a threshold such as 15 ml/s); the marker being defined by a single horizontally extending step or band formed on an inner wall of the vessel such that if the urine level is below the marker the volumetric flowrate is insufficient, and if the urine level is at or above the marker, the volumetric flow rate is sufficient (Newton, Fig. 4; ¶[0023], “A further embodiment is shown in FIG. 4 which shows the diameter of the cylinder increasing step-wise, at specific measurement heights that relate to significant flow rates… As each step shoulder is immersed in urine, the subject may easily assess whether the height achieved by the urine surpasses the step”, teaches the use of an internal horizontal shoulder step (with respect to its longitudinal axis) as a band indicating whether the level surpasses a threshold; ¶[0018], “The boundary between the yellow (6), and green (7), sections corresponds with a fluid height in the cylinder appropriate to that achieved with a sustained flow of 15 ml per second of fluid introduced to the cylinder”, shows a defined threshold corresponding to sufficient flow; ¶[0020], “Other colours, and a greater or lesser number of sections may be used”, explicitly allows variation in the number of indicators, thereby encompassing a single threshold indicator; these disclosures collectively show that Newton teaches the claimed marker defined by a single horizontally extending step or band on the inner wall, where the urine level relative to that band indicates whether the flow rate is sufficient or insufficient).
Also regarding claim 1, Newton does not expressly teach that a urinary stream target is located on a wall of the vessel, an arcuate notch is formed in the upper opening of the vessel, and the arcuate notch is located on a generally opposing side of the vessel relative to the urinary stream target. (Note: BRI of “arcuate notch": Under the broadest reasonable interpretation, a “notch” encompasses any concavity or lowered cutout in the rim, and “arcuate” refers to a curved shape. The angled or tapered rim cuts depicted in Steer and Laing implicitly form such a curved low-side profile, while Moore defines an explicit spout or notch.) Rather, Newton teaches a urine flow measurement vessel and internal flow marker but does not teach a urinary stream target or anatomical alignment geometry with the notch being on an opposing side.
Steer establishes the presence of an aiming portion positioned on the highest wall of the vessel and implicitly defines an opposing lower arcuate region that functions as the anatomical placement area. (Steer, FIG. 1-3; p. 2, l. 12–15: “The vessel wall bears the legend 18 (‘AIM HERE’) on its internal surface diametrically opposed to the lower exit orifice 12. Above the legend 18, the vessel wall has a raised region 19 which is higher than any other region”, explicitly showing the high side where the stream target is located and the lower opposite wall forms a curved, lowered section that functions as an arcuate notch under the broadest reasonable interpretation, the configuration connoting the penis placement opposite the target wall within the lowered section; Fig. 1 and 3 of Steer shows the relative elevation difference between the high wall with the legend and the opposite lower rim, demonstrating this high/low configuration).
Laing corroborates this configuration through its depiction of a lowered curved front and higher rear wall that align the penis and urine stream (Laing, Fig. 2A–2H; ¶[0083]: “The funnel 206 may include features that orientate or align anatomy of a male patient relative to the voiding device 200 in order to facilitate directing or guiding the male patient's urine into the inlet 204a of the flow chamber 204”, illustrating a similar high and low wall arrangement that serves the same purpose of anatomical alignment and stream control).
Moore demonstrates a similar configuration, but explicitly defines a rim cutout or notch opposite the high wall and feature (handle), providing express evidence of the claimed notch structure (Moore, FIG. 1; ¶[0007], ¶[0031]–[0032]: “funnel body 12 further includes a spout 40… The location of spout 40 is near a top portion of at least one side or sloped sidewall 17… spout 40 is located opposite gripping area 16 about funnel body 12”, confirming an arcuate notch or spout at the rim positioned opposite the high wall and handle, thus explicitly disclosing a distinct notch feature corresponding to the structural and functional relationship depicted implicitly in Steer and Laing).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Newton in view of Steer, Laing, and Moore to include a urinary stream target on the high wall and an arcuate notch on the opposing low wall of the vessel. This modification aligns with known ergonomic configurations where the low side accommodates anatomical placement and the high side receives the urine stream. The combination is feasible because all references concern urine collection vessels with comparable rim geometries, and obvious because the high-side target and opposing low-side notch provide intuitive anatomical orientation and consistent stream alignment. The benefit of this combination is predictable: facilitating ergonomic use, ensuring the urine stream is properly directed toward the target, preventing splash over due to the high side, and improving repeatability of measurement without altering Newton’s measurement function.
Regarding claim 2, the modified Newton teaches that the predetermined threshold is about 15 millilitres per second (Newton, ¶[0018]: “The boundary between the yellow (6), and green (7), sections corresponds with a fluid height in the cylinder appropriate to that achieve with a sustained flow of 15 ml per second of fluid introduced to the cylinder”, shows the device includes a marker associated with a threshold of 15 millilitres per second).
Regarding claim 4, the modified Newton teaches that the marker includes text (Newton, ¶[0015]: “To assist such measurement, the outer surface of the cylinder may include an engraved or printed scale of a complexity appropriate to the application”, shows that the marker may include printed text for measurement purposes; ¶[0020]: “the label’s coloured sections are replaced with numbered sections”, shows that the marker includes numbers printed on the label, which constitute text used to indicate different measurement sections).
Regarding claim 5, the modified Newton teaches that the marker includes a region of different colour (Newton, ¶[0015]: "a simple scale consisting of three coloured bars is used", ¶[0018]: “The label is coloured red in its lower section (5), yellow in its mid section (6), and green in the upper section (7)”, shows that the marker includes multiple colored regions to visually indicate different flow rate thresholds).
Regarding claim 6, the modified Newton teaches that the marker includes a region of different texture (Newton, ¶[0023]: “To further enhance the visibility of the step, a series of pyramidal teeth (14) may optionally be incorporated into the rim of the step, which, under lateral illumination, renders even better visibility of their state of immersion in urine, to the observer”, shows that the marker includes raised pyramidal teeth that form a region of different texture).
Regarding claim 9, Newton teaches that a method of assessing a person's urinary volumetric flow rate comprises (Newton, Figs. 1–4, Abstract: “A peak flow measurement device comprises a hollow body (1) having an inlet… and an outlet”, shows that Newton teaches a urine flow measurement device which inherently supports a method of assessing urinary flow rate): the vessel being cup shaped and having a cross-sectional area that tapers and reduces from a top of the vessel toward a bottom of the vessel (Newton, Fig. 4; ¶[0017]: “The upper end of the cylinder is flared to form a catchment funnel (8)”, shows a cup or funnel at the top that increases area toward the top such that the cross-sectional area reduces toward the bottom; ¶[0023]: “At a height of 36 mm above the orifice (12) the diameter of the vessel expands to 20 mm, and at a further height of 46 mm (13) it expands again to 24 mm… Above the second step the vessel extends further, to a catchment funnel (8)”, teaches a geometry that widens upward and thus is tapered narrower toward the base; this overall flared and narrowing configuration reads on “cup-shaped… cross-sectional area that tapers… from top… toward a bottom”); the vessel having a drainage aperture located at or near a base of the vessel (Newton, Fig. 1, Abstract: “an outlet”, ¶[0017]: “The closed end of the cylinder (2) is perforated by an orifice (3)”, shows the drainage aperture located at the base of the vessel); and a marker located on a wall of the vessel and configured to indicate if the volumetric urinary flow rate entering the vessel is above or below a predetermined threshold (Newton, Figs. 2–4, ¶[0018]: “The external surface of the cylinder has affixed a printed label (4)… red in its lower section (5), yellow in its mid section (6), and green in the upper section (7)… The boundary between the yellow (6), and green (7), sections corresponds with a fluid height… with a sustained flow of 15 ml per second”, teaches a marker that is labeled with both color and a diameter step (Fig. 4, ¶[0023]) indicating whether flow rate exceeds a threshold such as 15 ml/s); monitoring a level of urine contained within the vessel to determine if the urine level reaches a height of the marker (Newton, ¶[0023]: “As each step shoulder is immersed in urine, the subject may easily assess whether the height achieved by the urine surpasses the step”, teaches monitoring the urine level relative to the marker height to assess whether the threshold has been met); the marker being defined by a single horizontally extending step or band formed on an inner wall of the vessel such that if the urine level is below the marker the volumetric urinary flow rate is insufficient, and if the urine level is at or above the marker, the volumetric urinary flow rate is sufficient (Newton, Fig. 4; ¶[0023]: “A further embodiment is shown in FIG. 4 which shows the diameter of the cylinder increasing step-wise, at specific measurement heights that relate to significant flow rates… As each step shoulder is immersed in urine, the subject may easily assess whether the height achieved by the urine surpasses the step”, teaches the use of an internal horizontal shoulder step (with respect to its longitudinal axis) as a band indicating whether the level surpasses a threshold; ¶[0018]: “The boundary between the yellow (6), and green (7), sections corresponds with a fluid height in the cylinder appropriate to that achieved with a sustained flow of 15 ml per second of fluid introduced to the cylinder”, shows a defined threshold corresponding to sufficient flow; ¶[0020]: “Other colours, and a greater or lesser number of sections may be used”, explicitly allows variation in the number of indicators, thereby encompassing a single threshold indicator; these disclosures collectively show that Newton teaches the claimed marker defined by a single horizontally extending step or band on the inner wall, where the urine level relative to that band indicates whether the flow rate is sufficient or insufficient).
Also regarding claim 9, Newton does not fully teach the method of encouraging the person to urinate into an upper opening of a vessel, by placing an underside of their penis into an arcuate notch formed in the upper opening of the vessel, a urinary stream target is located on a wall of the vessel which is opposite the arcuate notch. (Note: BRI of “arcuate notch.” Under the broadest reasonable interpretation, “notch” encompasses any concavity or lowered cutout in the rim, and “arcuate” refers to a curved shape. The angled or tapered rim cuts depicted in Steer and Laing inherently form such a curved low-side profile, while Moore defines an explicit spout or notch. Also, the instruction step, “placing an underside of their penis into an arcuate notch”, simply operationalizes the same structural arrangement (high-wall target and low-side arcuate notch) taught by Steer, Laing, and Moore, and therefore reads on the claimed method step.) Newton teaches a urine flow measurement vessel and internal flow marker but does not teach a urinary stream target or anatomical alignment geometry with the notch being on an opposing side.
Steer establishes the presence of an aiming portion positioned on the highest wall of the vessel and implicitly defines an opposing lower arcuate region that functions as the anatomical placement area. (Steer, FIG. 1-3; p. 2, l. 12–15: “The vessel wall bears the legend 18 (‘AIM HERE’) on its internal surface diametrically opposed to the lower exit orifice 12. Above the legend 18, the vessel wall has a raised region 19 which is higher than any other region”, explicitly showing the high side where the stream target is located and the lower opposite wall forms a curved, lowered section that functions as an arcuate notch under the broadest reasonable interpretation, the configuration connoting the penis placement opposite the target wall within the lowered section; Fig. 1 and 3 of Steer shows the relative elevation difference between the high wall with the legend and the opposite lower rim, demonstrating this high/low configuration).
Laing corroborates this configuration through its depiction of a lowered curved front and higher rear wall that align the penis and urine stream (Laing, Fig. 2A–2H; ¶[0083]: “The funnel 206 may include features that orientate or align anatomy of a male patient relative to the voiding device 200 in order to facilitate directing or guiding the male patient's urine into the inlet 204a of the flow chamber 204”, illustrating a similar high and low wall arrangement that serves the same purpose of anatomical alignment and stream control).
Moore demonstrates a similar configuration, but explicitly defines a rim cutout or notch opposite the high wall and feature (handle), providing express evidence of the claimed notch structure (Moore, FIG. 1; ¶[0007], ¶[0031]–[0032]: “funnel body 12 further includes a spout 40… The location of spout 40 is near a top portion of at least one side or sloped sidewall 17… spout 40 is located opposite gripping area 16 about funnel body 12...”, confirming an arcuate notch or spout at the rim positioned opposite a defining feature, the high wall and handle combination, thus explicitly disclosing a distinct notch feature corresponding to the structural and functional relationship depicted implicitly in Steer and Laing). Accordingly, when Steer’s wall-mounted target defines the high side and Moore’s rim notch is placed “opposite” the reference rim feature, the claimed limitation that “a urinary stream target [is] located on a wall of the vessel which is opposite the arcuate notch” is met (The Office does not rely on Moore’s outflow function; Moore is cited for the explicit rim-level arcuate cutout and its “opposite” placement, which is a structural notch meeting the claimed geometry).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Newton in view of Steer, Laing, and Moore to include a urinary stream target on the high wall and an arcuate notch on the opposing low wall of the vessel, and to encourage placement of the underside of the penis into the notch to direct the urine stream toward the target. This modification aligns with known ergonomic configurations where the low side accommodates anatomical placement and the high side receives the urine stream. The combination is feasible because each reference concerns a urine-collection vessel with comparable rim geometry and user-guidance features, and obvious because the high-side target and opposing low-side notch provide intuitive anatomical orientation and consistent stream alignment. The benefit of this combination is predictable: facilitating ergonomic use, ensuring the urine stream is properly directed toward the target, preventing splash over due to the high side, and improving repeatability of measurement without altering Newton’s measurement function.
Additionally, directing the user to place the underside of the penis over the low-side notch opposite the high wall target reflects the predictable manner in which such urine collection vessels are used. Common urinal and male urine-collection devices designs routinely employ a target region on a high splash guard wall opposite the lower arcuate front or notch that accommodates anatomical placement and directs the stream. Thus, the instruction merely operationalizes a well-known ergonomic configuration to achieve the expected benefits of aim consistency, splash reduction, and guides urine flow toward the drainage region for proper outflow, and does not add a non-obvious functional relationship beyond the combined structure.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Newton (US 20070180928 A1), hereto referred as Newton, and further in view of Steer et al. (GB 2247626 A), hereto referred as Steer, and further in view of Laing et al. (US 20190365308 A1), hereto referred as Laing, and further in view of Moore et al. (US 20200121300 A1), hereto referred as Moore, and further in view of Ciarico et al. (US 3871231 A), hereto referred as Ciarico.
Newton teaches claim 9 as described above.
Regarding claim 10, the modified Newton does not teach observing the volumetric urinary flow rate with the vessel on a plurality of separate occasions. Rather, the modified Newton teaches the method of using a urinary flow measurement device, as shown in claim 9 above, but does not teach using the device to observe flow rate across multiple separate occasions. Ciarico, however, teaches a device for the measurement of urine flow that is designed to be reused (Ciarico, Col. 4, ll. 24-28). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined Newton, Steer, Laing, and Moore in view of Ciarico to allow the urinary flow rate to be observed across a plurality of separate occasions. The combination would have been possible because both Newton and Ciarico describe fluid measurement devices with indicator components and user-facing structures. It would have been obvious to reuse Newton's device in the manner Ciarico describes in order to obtain a more comprehensive assessment of a user's urinary health over time. The benefit of the combination would be enabling ongoing monitoring with a single device to improve tracking of flow rate trends and changes over time.
Response to Arguments
Objections
Applicant's arguments filed 10/27/25, page 4, regarding the previous Objections of claims 1 and 9-10 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 10/27/25, page 4, regarding the previous 112(b) Rejections of claims 1-10 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §102
Applicant's arguments filed 10/27/25, pages 4-5, regarding the previous 102 Rejections of claims 1 and 9 and their dependents are persuasive and the 102 rejections have been withdrawn. However, claims 1 and 9 and their dependents are now rejected under §103 as shown above (with response to arguments shown below).
35 U.S.C. §103
Applicant's arguments filed 10/27/25, pages 5-9, regarding the previous 103 Rejections of claims 7-8 and 10 have been fully considered but are not persuasive as described below. Since the limitations to canceled claims 7 and 8 have been incorporated into claim 1, the arguments supporting these canceled claims are now relevant to claim 1 (and claim 9) and the responses below reflect this change.
A. Unsatisfactory for its intended purpose / teaching away
Applicant contends that incorporating Steer would render Newton unsatisfactory for its intended purpose and thus “teaches away.” The Office does not rely on Steer’s sample-dividing internals or fluid routing. In fact, the operation of the Newton device remains to be the same, but is also improved by the modification. Steer is cited for the teaching of a wall-mounted urinary stream target (e.g., a visible legend/raised region) on a high side of a urine collection vessel that facilitates user aim across the vessel. Adding a user-guidance feature to improve consistent aiming is a predictable, compatible improvement to a urine-collection vessel and does not alter Newton’s underlying measurement principle or defeat its operation. Accordingly, Applicant’s “unsatisfactory/teaches away” argument is not persuasive.
Obviousness rationale: It would have been prima facie obvious before the effective filing date to incorporate a simple, wall-mounted stream target (on a high wall side opposite a low wall side) in Newton to promote consistent aiming and reduce user-induced variability during use, yielding the predictable benefit of more repeatable measurements and reduced splash over.
B. Arcuate notch opposite the target
Applicant argues there is no reason to place the arcuate notch on a side generally opposite the stream target. The same art of record collectively demonstrates that urine-collection devices routinely employ opposing sides, a high-side / low-side geometry, around the opening or tother defining features. In each secondary reference, the lowered side is the user-facing entry region that accommodates the penis, while the higher opposite side receives or deflects the urinary stream to prevent splash back. This common geometry makes the claimed notch-and-target opposition a predictable design based on known ergonomic and functional considerations.
(Note: BRI of “arcuate notch": Under the broadest reasonable interpretation, a “notch” encompasses any concavity or lowered cutout in the rim, and “arcuate” refers to a curved shape. The angled or tapered rim cuts depicted in Steer and Laing implicitly form such a curved low-side profile, while Moore defines an explicit spout or notch.)
Steer explicitly positions its aiming portion on the highest wall region, opposite the lower side: “The vessel wall bears the legend 18 (‘AIM HERE’) on its internal surface diametrically opposed to the lower exit orifice 12. Above the legend 18, the vessel wall has a raised region 19 which is higher than any other region” (Steer, p. 2; FIG. 1). The configuration of the raised upper wall opposite the lower opening forms an angled or sloped rim profile. While not described as a ‘notch,’ the low side of this slope effectively produces an arcuate opening that functions as a shallow notch where the penis would be placed during use, opposite the high side bearing the aiming legend. Thus, Steer not only teaches the opposed high and low wall configuration but also depicts a geometry consistent with an arcuate notch opposite the high side.
Laing depicts a receptacle having a lower, arcuate front rim and a higher posterior rim joined by sidewalls. While the specification does not explicitly describe the function of the high and low sides, it explains that the funnel may include features that orient or align male anatomy relative to the device to guide urine into the inlet (Laing, FIG, 2A-H; [0083]). A person of ordinary skill in the art would understand from the figures that the lowered curved front would naturally accommodate the penis, and the higher opposite wall would receive the urine stream and reduce splash back. Even though Laing does not employ the word “notch,” its angled, curved rim cut functions as an arcuate notch, forming an opening contoured the low side opposite the higher splash-guard side. Thus, Laing corroborates Steer in depicting the same high/low geometry and its understood purpose.
Moore also adopts this configuration, but directly depicts a separate spout or notch (40) located opposite a higher rear wall with handle instead of just a lowered arched profile like Steer and Laing (Moore, FIG. 1-2). The spout defines a distinctly curved, concave cutout (an arcuate notch) that would facilitate user placement and functions as outflow on the low side while the higher opposite side would contain and direct the stream. Moore therefore reinforces that urine-collection vessels routinely feature opposed high and low sides, and explicitly defines a notch feature with a low arcuate opening or notch aligned opposite a high wall and handle with the connotation of user anatomy placement opposite the high side (especially in view of Steer's aiming target and one’s general knowledge).
Obviousness rationale (no new ground). In view of Steer’s explicit high/low geometry and opposed placement concerning the target, Laing’s depiction of a lowered, curved front and raised rear wall showing orientation for male use, and Moore’s concrete example of a spout-defined arcuate notch opposite a high rim and handle feature, it would have been prima facie obvious before the effective filing date to provide an arcuate notch positioned opposite the high side or other feature, consistent with Steer’s teaching that the aiming portion resides on the high wall of the vessel (implying the low wall is where the penis is positioned). Steer establishes the high/low relationship, Laing corroborates this arrangement with similar geometry and anatomical orientation, and Moore explicitly depicts an arcuate notch on the low side opposite the high side. Together these secondary references illustrate a consistent high-side/low-side configuration where the low side accommodates anatomical placement and the high side receives or contains the stream. This arrangement yields predictable ergonomic and functional benefits (proper anatomical orientation, improved aiming consistency, and splash prevention) without altering Newton’s measuring principle. These clarifications rely on the same references and motivations already of record and thus do not constitute a new ground of rejection.
B.1 Applicant’s argument regarding Moore’s spout
Applicant argues that the Office has misinterpreted Moore and Moore’s spout is only used for draining urine already collected in the funnel body and therefore cannot correspond to the claimed arcuate notch. However, Applicant’s position misreads the Office’s reliance on Moore. The Office does not equate the spout’s function as a drain with the claimed notch’s function for anatomical placement. Rather, the Office relies on Moore’s structural geometry, the spout (40) forms a concave, arcuate cutout at the rim, located opposite another feature (the handle on the high wall), which demonstrates that urine-collection vessels commonly include a lowered, curved rim portion opposite a reference wall. This physical configuration meets the structural requirement of an “arcuate notch” as claimed, irrespective of its outflow purpose. (Moore, ¶[0007], ¶[0031]–[0032]).
Accordingly, Applicant’s argument that Moore’s spout funnels collected urine and is unrelated to flow-rate monitoring is not persuasive. The Office does not rely on Moore for flow-rate measurement or sample-transfer functionality, but solely for its rim-level geometry defining a concave, arcuate notch located opposite a feature. The claimed relationship of a notch opposite a target is therefore fully supported by the structural disclosure of Moore in combination with the high-side targeting geometry of Steer and Laing. The Examiner’s interpretation of Moore is based on its express disclosure of the rim-level spout geometry opposite another feature, consistent with the overall combination rationale, and that this reading properly reflects the scope and content of Moore under MPEP § 2141.01(a).
C. Single horizontally extending step/band at ~15 ml/s
Applicant maintains that the claimed single step/band corresponding to ~15 ml/s is not taught or suggested. Newton expressly identifies threshold values (including ~15 ml/s) and illustrates step-wise internal bands/indicators and visible labels marking such thresholds (Newton, FIG. 4; [0015], [0020], [0023]). Selecting a single clinically significant threshold (e.g., ~15 ml/s) and implementing it as one horizontal band/step is a design choice squarely suggested by Newton, yielding a predictable result. Accordingly, the “single band at ~15 ml/s” limitation does not overcome the § 103 rejection.
D. Method Claim 9 – operational steps
Amended claim 9 recites steps of placing “the underside of [the] penis into an arcuate notch … generally opposite the target” and targeting the stream toward the target. Newton supports the overarching method framework (encourage voiding into a top opening; observe flow/threshold behavior). As detailed in Section B above, Steer, Laing, and Moore collectively demonstrate a consistent high-side/low-side geometry where the high side bears the aiming feature and the low side functions as an arcuate notch region for anatomical placement. In view of Steer (stream target located on the high side of the vessel, forming an implied notch on the low side), Laing (depicted high/low geometry corroborating Steer’s configuration and explicitly stating the design is for anatomical orientation), and Moore (explicitly defined arcuate notch opposite a handle on a high wall), operationalizing the structure by instructing the user to place the underside with respect to the notch and aim at the target would have been a predictable use of these known configurations to achieve the expected benefit of proper anatomical orientation, consistent aiming, and splash reduction. Applicant’s argument that these method steps render the combination inapplicable or non-combinable is unpersuasive, as Section B provides a detailed structural rationale demonstrating how these same references support the claimed arrangement.
Arguments Conclusion
Applicant’s remarks have been fully considered and are not persuasive. The amendments do not place the application in condition for allowance. A Final Office Action will issue maintaining the rejections as adjusted above. The Office remains amenable to considering further amendment that overcomes the cited teachings while preserving the application’s core objectives.
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.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791