DETAILED ACTION
Response to Amendment
The Amendment filed August 22, 2025 has been entered. Claims 1 – 9, 11 – 14 and 17 – 20 are pending in the application with claims 10, 15 and 16 being cancelled and claim 20 being newly added. The amendment made to the claims has overcome all of the claim objections set forth in the last Non-Final Action mailed May 22, 2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “the groove having a width that is less than the maximum width of the tube when the tube is compressed” in claim 20.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 recites the limitation “the groove having a width that is less than the maximum width of the tube when the tube is compressed”. The filed specification (see ¶46 and fig. 8) fails to provide support for the claimed relationship of groove’s width “is less than” the maximum width of the tube. ¶46 states “The groove 60 has a sufficient width (in the width dimension W) to accommodate a maximum width of the tube 12 when compressed between the rollers 44A-44D and roller bed 24, as shown in FIG. 8” and fig. 8 shows tube being compressed between a roller and a roller bed (i.e. compressed configuration of the tube). The phrase “sufficient width” in the filed disclosure fails to provide support for the claimed relationship between tube’s maximum width and groove’s width. Although fig. 8 appears to show the maximum width of the tube when compressed being greater than the groove’s width, Applicant has not shown that a width of πr + 2w will always result in the groove width being less than the maximum width of the compressed tube. Thus, the above limitation is a new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mou, Duen-Gang (US 8,128,384 – herein after Mou) in view of Baldwin, Brian E. (US 4,976,590 – herein after Baldwin).
In reference to claim 1, Mou teaches a pump (in fig. 1) for use with a tube (1) having an internal radius (r) and a wall thickness (w) (radius and thickness being inherent features of the tube), the pump comprising:
a rotor housing (5) including
a rotor (rotor assembly 2);
a first roller (21) and a second roller (21) that define an orbital path (circle traced by the outer surface of the rollers as the rotor rotates) about an axis of rotation (20) of the rotor;
a roller bed (3) including a surface (labelled “S” in top picture of fig. A below) having a groove (31), the groove comprising a circular arc segment that is symmetric about a plumb line axis (see fig. A below; plumb line axis = axis that is perpendicular to the rotor’s rotational axis) and has a circular curvature (this curvature being evident from fig. 5), the groove having a width that is no less than πr+2w [“πr+2w” is viewed as a maximum width of the tube when compressed; as evident from fig. 4, asserted groove 31 has the width that is greater than πr+2w], the roller bed (3) being disposed relative to the rotor housing (5) such that a separation distance (labelled “s.d.” in bottom picture of fig. A below) along the plumb line axis between the orbital path (point corresponding to orbital path is labelled “P1” in bottom picture of fig. A below) and the groove comprises a minimum separation distance (labelled “d” in bottom picture of fig. A below) between the orbital path and the surface (labelled “S” in fig. A below); and
an engagement member (36) that is configured to shift a position of the roller bed (3) from an open position (position shown in fig. 1) to a closed position (position shown in fig. 2/3).
PNG
media_image1.png
598
660
media_image1.png
Greyscale
PNG
media_image2.png
836
944
media_image2.png
Greyscale
PNG
media_image3.png
796
986
media_image3.png
Greyscale
Fig. A: Edited figs. 3-5 of Mou to show claim interpretation.
Mou does not teach the pump, wherein the surface has “the first roller and the second roller each including a recessed track having a width that is greater than a maximum width of the tube when the tube is compressed between the roller bed and the first roller or the second roller”.
However, Baldwin teaches a similar pump (11) wherein (see figs. 2 and 4 or fig. B below) each of the rollers (23) including a recessed track (23a+23b, see fig. 4 and col. 5, lines 7-14) having a width (labelled “w” in fig. B below) that is greater than a maximum width (labelled “m.w.” in fig. B below) of the tube when the tube is compressed between the roller bed and the first roller or the second roller (note that compressed tube 155 in width direction is accommodated within the width “w” of the recessed track 23b).
PNG
media_image4.png
812
1138
media_image4.png
Greyscale
Fig. B: Edited fig. 4 of Baldwin to show claim interpretation.
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the rollers in Mou’s pump for providing a recessed track and end flanges as taught by Baldwin to maintain the alignment of the tube on the rollers and prevent lateral displacement (‘walking’) of the tube during operation. Baldwin teaches (see col. 5, lines 7-14) that the flanges (23a) are ‘tube-retaining’ which would improve the reliability of Mou’s pump by ensuring the tube does not slip off the rollers during the peristaltic compression cycle, thus effecting improved rolling peristaltic squeezing of the tube.
In reference to claim 2, Mou teaches the pump, in which a separation distance between the rotor (2) and the roller bed (3) is minimized when the roller bed is in the closed position (in view of closed position seen in fig. 3: distance in ↔ direction between the rotor 2 and roller bed 3 is considered to be “a minimum separation distance”).
In reference to claim 3, Mou teaches the pump, in which the engagement member (36) extends behind the rotor (2) [in view of orientation shown in fig. 3: looking in → direction, engagement member 36 is considered to be behind the rotor 2].
In reference to claim 4, Mou teaches the pump, in which the engagement member (36) is connected to a mounting bracket (39) and a handle (37) is a connected to the mounting bracket (39).
In reference to claim 5, Mou teaches the pump, in which the mounting bracket (39) is coupled to an upper portion (in view of fig. 3: portion being on right portion) of the rotor housing (5).
In reference to claims 6 and 7, Mou, as modified by Baldwin, remains silent on the pump, in which a maximum depth of the groove (depth of Mou’s groove 31) ranges between about w/10 to about w/2, as in claim 6; and in which the maximum depth of the groove (depth of Mou’s groove 31) equals about one third of the tube width, as in claim 7.
Mou explicitly teaches (see col. 4, lines 60-67) that groove depth is a result-effective variable tied to wall thickness. Mou identifies that “depth of the groove” (32) as a “critical dimension” affecting “tubing protection”. As one of ordinary skill in the art would recognize, the groove depth should be held to a minimum that would ensure that the tube is effectively compressed. Ideally that depth would be zero thus, one of ordinary skill in the art would know to keep that depth as close to zero as possible. A skilled artisan would recognize that if the groove is too shallow, it fails to guide the tube (as taught by Baldwin’s retention motivation). If it is too deep, it interferes with the compression required for occlusion (as taught by Mou’s discussion of chamber clearance) and may result in the tube not being completely compressed, thus determining the optimal depth as a specific fraction of that thickness (e.g. between w/10 and w/2, or w/3) is a matter of routine engineering optimization. Further, expressing this depth range as a function of the wall thickness is an obvious matter of design choice since the groove depth, whatever it is, can always be expressed as a function of the tube wall thickness or in terms on numerical values.
In reference to claim 8, Mou teaches the pump, in which a separation distance between the rotor (2) and the roller bed (3) is a maximum separation distance when the roller bed is in the open position (in view of open position seen in fig. 1: distance in ↔ direction between the rotor 2 and roller bed 3 is considered to be “a maximum separation distance”).
Claims 9, 11 – 14 and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stemple et al. (US 2009/0129944 – herein after Stemple) in view of Baldwin, Brian E. (US 4,976,590 – herein after Baldwin).
In reference to claim 9, Stemple teaches a method of using a pump (10, in fig. 1) comprising (see fig. 1 and ¶23-¶25) a rotor housing (12) including a rotor (14), a first roller (52) and a second roller (52) that define an orbital path [orbital path is shown in fig. C below; orbital path = circle traced by the outer surface of the rollers as the rotor rotates; the circular motion of the rollers defines this claimed orbital path in circumferential direction that is about the rotational axis] about an axis of rotation (see fig. C below) of the rotor, a roller bed (20) including a surface (“surface” is labelled below in fig. C and is viewed as being formed by edges “e1” & “e2” and unshaded portions/surfaces “S1” & “S2”), and an engagement member (32) connecting (via 30 and 18, see fig. 4A) the roller bed (20) to a handle (handle on door 16, see fig. 1/3), the method comprising (figs. 2 and 4A-4C shows moving of door 16 from open to close position; however the opposite of this process teaches the below claimed method steps):
lifting the handle (handle) to lower the roller bed to an open position (in view of fig. 4A: lifting causes roller bed 20 to lower in ↑ direction);
positioning a tube (28) on the roller bed (see ¶24: “When the door 16 is opened, power is supplied, or the pump 10 is halted, a rotor sensor 27 orients the rotor assembly 14 to a predetermined rotational position, such as shown in FIG. 5 for example, in order to facilitate loading and unloading of flexible tubing 28 into and out of the pump 10”), the tube having an internal radius (r) and a wall thickness (w) (radius and thickness being inherent features of the tube);
lowering the handle to raise the roller bed toward the rotor (see ¶25: “The rack 32 and pinion 30 are configured such that as the door closes, the linear movement 34 of the rack 32 causes the occlusion bed 20 to move toward the rotor assembly 14”; in view of fig. 4A: lowering causes roller bed 20 to move in ↓ direction towards the rotor 14);
activating the pump to cause the rotor to rotate the first roller and the second roller (step being present because opening of the door halts the operation of the pump in view of disclosure in ¶24),
in which the roller bed (20) comprises the surface having a groove (see fig. C below: groove is shown as shaded portion) including (as evident from fig. C below) a circular arc segment that is symmetric about a plumb line axis (plumb line axis = axis that is perpendicular to the rotor’s rotational axis) and has a circular curvature, the groove having a width that is no less than πr+2w [“πr+2w” is viewed as a maximum width of the tube when compressed; as evident from fig. 4C (width being a dimension in horizontal direction), asserted groove has the width that is greater than πr+2w], the roller bed being disposed relative to the rotor housing such that a separation distance (labelled “s.d.” in fig. C below) along the plumb line axis between the orbital path and the groove comprises a minimum separation distance (labelled “d1” in fig. C below) between the orbital path and the surface.
PNG
media_image5.png
963
1240
media_image5.png
Greyscale
PNG
media_image6.png
844
1218
media_image6.png
Greyscale
PNG
media_image7.png
704
330
media_image7.png
Greyscale
Fig. C: Edited figs. 1 and 4C of Stemple to show claim interpretation.
Stemple does not teach the pump, wherein the surface has “the first roller and the second roller each including a recessed track having a width that is greater than a maximum width of the tube when the tube is compressed between the roller bed and the first roller or the second roller”.
However, Baldwin teaches a similar pump (11) wherein (see figs. 2 and 4 or fig. B above) each of the rollers (23) including a recessed track (23a+23b, see fig. 4 and col. 5, lines 7-14) having a width (labelled “w” in fig. B above) that is greater than a maximum width (labelled “m.w.” in fig. B above) of the tube when the tube is compressed between the roller bed and the first roller or the second roller (note that compressed tube 155 in width direction is accommodated within the width “w” of the recessed track 23b).
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the rollers in Stemple’s pump for providing a recessed track and end flanges as taught by Baldwin to maintain the alignment of the tube on the rollers and prevent lateral displacement (‘walking’) of the tube during operation. Baldwin teaches (see col. 5, lines 7-14) that the flanges (23a) are ‘tube-retaining’ which would improve the reliability of Mou’s pump by ensuring the tube does not slip off the rollers during the peristaltic compression cycle, thus effecting improved rolling peristaltic squeezing of the tube.
In reference to claim 11, Stemple teaches the method, in which the step of positioning the tube (28) on the roller bed (20) comprises positioning a center portion of the tube in the groove (this claimed step being part of a process wherein tubing 28 is placed between the rotor 14 and bed 20, see ¶26) [in view of fig. D below: “center portion of the tube” = curved portion (labelled “c.p.”) of the tube that is positioned in the groove].
PNG
media_image8.png
740
1010
media_image8.png
Greyscale
Fig. D: Edited fig. 2 of Stemple to show claim interpretation.
In reference to claim 12, Stemple teaches the method, further comprising clamping the tube to the roller bed (20) [clamping of the tube occurs in view of tube retention and clamping systems 36, 40 when door is closed (see ¶26, ¶28)].
In reference to claim 13, Stemple teaches the method, further comprising (see figs. C and D above) positioning a first lateral portion of the tube (labelled in fig. D above) in a suction port (suction port = port corresponding to suction side of the pump; any one of the ports “o1”, “o2” is considered to be the suction port).
In reference to claim 14, Stemple teaches the method, further comprising (see figs. C and D above) positioning a second lateral portion of the tube (labelled in fig. D above) in a discharge port (discharge port = port corresponding to discharge side of the pump; another of the ports “o1”, “o2” is considered to be the discharge port).
In reference to claim 17, Stemple teaches the method, in which the handle (in view of figs. 1/2) is connected to the engagement member (32) by a mounting bracket (bracket formed by door 16, shaft 18 and pinion 30; see fig. 4A and ¶24).
In reference to claims 18 and 19, Stemple, as modified by Baldwin, remains silent on the pump, in which a maximum depth of the groove (depth of Stemple’s groove) ranges between about w/10 to about w/2, as in claim 18; and in which the maximum depth of the groove (depth of Stemple’s groove) equals about one third of the tube width, as in claim 19.
The “depth of the groove” (32) as a “critical dimension” affecting “tubing protection”. As one of ordinary skill in the art would recognize, the groove depth should be held to a minimum that would ensure that the tube is effectively compressed. Ideally that depth would be zero thus, one of ordinary skill in the art would know to keep that depth as close to zero as possible. A skilled artisan would recognize that if the groove is too shallow, it fails to guide the tube. If it is too deep, it interferes with the compression required for occlusion and may result in the tube not being completely compressed, thus determining the optimal depth as a specific fraction of that thickness (e.g. between w/10 and w/2, or w/3) is a matter of routine engineering optimization. Further, expressing this depth range as a function of the wall thickness is an obvious matter of design choice since the groove depth, whatever it is, can always be expressed as a function of the tube wall thickness or in terms on numerical values.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mou, Duen-Gang (US 8,128,384 – herein after Mou) in view of Baldwin, Brian E. (US 4,976,590 – herein after Baldwin) and Takahashi et al. (US 2003/0071072 – herein after Takahashi).
Mou teaches a pump (in fig. 1) for use with a tube (1) having an internal radius (r) and a wall thickness (w) (radius and thickness being inherent features of the tube), the pump comprising:
a rotor housing (5) including
a rotor (rotor assembly 2);
a first roller (21) and a second roller (21) that define an orbital path (circle traced by the outer surface of the rollers as the rotor rotates) about an axis of rotation (20) of the rotor;
a roller bed (3) including a surface (labelled “S” in top picture of fig. A above) having a groove (31), the groove comprising a circular arc segment that is symmetric about a plumb line axis (see fig. A above; plumb line axis = axis that is perpendicular to the rotor’s rotational axis) and has a circular curvature (this curvature being evident from fig. 5), the roller bed (3) being disposed relative to the rotor housing (5) such that a separation distance (labelled “s.d.” in bottom picture of fig. A above) along the plumb line axis between the orbital path (point corresponding to orbital path is labelled “P1” in bottom picture of fig. A above) and the groove comprises a minimum separation distance (labelled “d” in bottom picture of fig. A above) between the orbital path and the surface (labelled “S” in fig. A above); and
an engagement member (36) that is configured to shift a position of the roller bed (3) from an open position (position shown in fig. 1) to a closed position (position shown in fig. 2/3).
Mou does not teach the pump, wherein the surface has “the first roller and the second roller each including a recessed track having a width that is greater than a maximum width of the tube when the tube is compressed between the roller bed and the first roller or the second roller”.
However, Baldwin teaches a similar pump (11) wherein (see figs. 2 and 4 or fig. B above) each of the rollers (23) including a recessed track (23a+23b, see fig. 4 and col. 5, lines 7-14) having a width (labelled “w” in fig. B above) that is greater than a maximum width (labelled “m.w.” in fig. B above) of the tube when the tube is compressed between the roller bed and the first roller or the second roller (note that compressed tube 155 in width direction is accommodated within the width “w” of the recessed track 23b).
Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the rollers in Mou’s pump for providing a recessed track and end flanges as taught by Baldwin to maintain the alignment of the tube on the rollers and prevent lateral displacement (‘walking’) of the tube during operation. Baldwin teaches (see col. 5, lines 7-14) that the flanges (23a) are ‘tube-retaining’ which would improve the reliability of Mou’s pump by ensuring the tube does not slip off the rollers during the peristaltic compression cycle, thus effecting improved rolling peristaltic squeezing of the tube.
Mou does not teach the pump, wherein the groove having a width that is less than the maximum width of the tube when the tube is compressed.
However, Takahashi teaches the pump that improves tube compression by modifying the geometry of the tube guide groove (roller bed). Takahashi teaches that using an arcuate groove (matching the curvature/profile of the pressing member) ensures that “the whole tube can be uniformly pressed” and that “it is possible to substantially completely squash the opening of the tube with a smaller force” (see ¶34). Thus, Takahashi teaches the pump, wherein the groove (for instance, groove viewed as 211 in fig. 3) having a width that is less than the maximum width of the tube (100 in fig. 3) when the tube is compressed [Takahashi teaches using an arcuate/recessed groove so that “when the tube is pressed, the tube is deformed along the shape of the tube guide groove” (see ¶32). By forcing the tube to conform to an arcuate (curved) cross-section (see ¶194), the groove physically constrains the tube from spreading flat. When a flexible tube is compressed into a curved shape, its linear width (chord length) is necessarily less than the maximum width the tube would occupy if it were compressed flat (where it would splash to its maximum dimension)].
While Takahashi uses “balls,” Takahashi explicitly relates the invention to the field of “tube pumps” and discusses conventional “cylindrical rollers” (see ¶7), making the teachings applicable to the rollers of Mou. Takahashi teaches that the “the cross-sectional shape of the tube-contacting surface defining the tube guide groove [should be] an arc shape formed concentrically with the ball or [roller]” (see ¶33), i.e. the groove’s shape is chosen to match the profile (i.e. shape) of corresponding surface of the tube’s pressing member. Takahashi explicitly critiques flat compression surfaces where the tube is allowed to spread out, noting that “both end portions of the tube are hardly pressed” (see ¶31). Thus, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the invention to modify the roller bed in Mou’s pump for providing a groove as taught by Takahashi for the purpose of achieving better occlusion with less mechanical force, as recognized by Takahashi (see ¶34). Note that, in the modified pump, “groove” provided using the teaching of Takahashi in the tube track 31 of Mou.
Response to Arguments
Applicant's arguments filed August 22, 2025, with respect to claims 1, 6 and 7, have been fully considered but they are not found to be persuasive. As a result, the rejections have been maintained.
Argument 1 (pages 2-5):
Applicant argues that Office failed to set forth a prima facie case of obviousness because the motivation to combine was conclusory.
The Examiner respectfully disagrees. Applicant attacks the generalized functional statement (“to effect rolling peristaltic squeezing”) while ignoring the specific structural benefit explicitly taught by the secondary reference. A “rational underpinning” requires that a person of ordinary skill in the art would have a reason to improve the primary reference using the teachings of the secondary reference. In this case, Mou (and Stemple) disclose rollers with smooth or undefined lateral surfaces. A known problem in tube mechanics is “walking” or lateral displacement, where the workpiece slips off the roller during operation. Baldwin explicitly teaches the solution to this problem. Baldwin describes (col. 5, lines 7-14) the flanges (23a) specifically as “tube-retaining end flanges”. Therefore, the motivation to modify Mou/Stemple with teachings from Baldwin is not merely to “squeeze the tube” (which Mou/Stemple does), but to improve the reliability of the squeezing operation by retaining the tube on the roller and preventing lateral displacement. It would have been obvious to the person of ordinary skill in the art to modify the rollers in Mou’s or Stemple’s pump for providing a recessed track as taught by Baldwin (i.e. for making “tube-retaining” flanged rollers) to ensure the tube remains centered on the roller path, protecting the tube from slipping off.
Applicant further argues that Baldwin’s figures 4 and 5 show that the end flanges (23a) do not compress the tube against the stator, and therefore the combination is somehow flawed regarding the compression function.
This argument actually supports the Examiner’s position. Claim 1 recites: “a recessed track having a width that is greater than a maximum width of the tube when the tube is compressed between the roller bed and the first roller or the second roller”. If the flanges (23a) compressed the tube, the track would be narrower than the tube. By pointing out that the flanges do not compress the tube (because the tube sits between them in the recess), the Applicant confirms that Baldwin’s track width is indeed greater than the compressed tube width, exactly as claimed. The structure of Baldwin (a central cylindrical surface 23b flanked by higher flanges 23a) creates a “recessed track”. The tube sits in this recess. The fact that the flanges stand outside the compression zone is precisely what defines the “recessed” nature of the track and allows it to accommodate the full width of the compressed tube without pinching the edges.
Argument 2(pages 5-7):
Applicant argues that Office failed to establish a prima facie case of obviousness because the Office did not articulate why the groove depth in a result-effective variable..
The Examiner respectfully disagrees. The Applicant’s argument overlooks the explicit teaching of the primary reference, Mou. To establish that a parameter is a “result-effective variable”, the prior art need only recognized that the variable affects a result (e.g., performance, fit, or function) [see MPEP 2144.05 II B]. In this case, Mou explicitly teaches (see col. 4, lines 60-67) that groove depth is a result-effective variable tied to wall thickness. Mou identifies that “depth of the groove” (32) as a “critical dimension” affecting “tubing protection”. This establishes groove depth as a result-effective variable. Mou expressly links this depth to the “tube wall thickness”. This provides the rational underpinning for why a skilled artisan would scale the groove depth relative to the wall thickness. Because, Mou recognizes that groove depth must be selected to accommodate and protect the tube wall thickness, determining the optimal depth as a specific fraction of that thickness (e.g. between w/10 and w/2, or preferably w/3) is a matter of routine engineering optimization. A skilled artisan would recognize that if the groove is too shallow, it fails to guide the tube (as taught by Baldwin’s retention motivation). If it is too deep, it interferes with the compression required for occlusion (as taught by Mou’s discussion of chamber clearance).
Regarding criticality: As the office has established a prima facie case that the groove depth is a result-effective variable (taught by Mou) and the claimed range is a matter of optimization, the burden shifts to the Applicant to show criticality. Furthermore, as noted in the previous Office Action, the Applicant’s own specification describes the range as merely “preferable” which suggests the range is not critical to the patentability of the invention.
Applicant's arguments filed August 22, 2025, with respect to newly added claim 20, have been fully considered but they are moot. As a result, the rejections have been maintained. The newly added claim 20 has a different scope from that of claim 1. As a result, the prior arts have been re-evaluated and re-applied this claim, in view of newly found reference of Takahashi.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHIRAG JARIWALA whose telephone number is (571)272-0467. The examiner can normally be reached M-F 8 AM-5 PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ESSAMA OMGBA can be reached at 469-295-9278. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/CHIRAG JARIWALA/ Examiner, Art Unit 3746
/ESSAMA OMGBA/ Supervisory Patent Examiner, Art Unit 3746
Prosecution Insights