DETAILED ACTION
Drawings
Replacement sheets (two) for Figs. 1 and 5 were received on December 17, 2025. These drawings are acceptable.
Applicant’s arguments, see pages 10-11, filed December 17, 2025, with respect to the Drawings have been fully considered and are persuasive. The Drawing Objection has been withdrawn.
Specification
Applicant’s arguments, see page 11, filed December 17, 2025, with respect to the Specification have been fully considered and are persuasive. The Specification Objection has been withdrawn.
Response to Arguments
Applicant’s arguments, see pages 12-13, filed December 17, 2025, with respect to the 35 USC 112(a) and 112(b) rejections of Claims 1-14 have been fully considered and are persuasive. The 35 USC 112(a) and 112(b) rejections of Claims 1-14 have been withdrawn.
Applicant’s arguments, see pages 13-14, filed December 17, 2025, with respect to the 35 USC 102(a)(1) rejection of Claims 1-4 have been fully considered but they are not persuasive:
Applicant has amended independent Claim 1 to recite “wherein three spatial coordinates of the ampoules with respect to the input apertures are changed from an initial position where the ampoules enter the input section to a new position where the ampoules exit the output section of the turning device”. Applicant argues that in Choumwong fails to discloses such an arrangement (see Applicant’s Response, page 13). The Examiner asserts that Choumwong’s insert (which is asserted to only be tray (102), as best shown in Figs. 1b-3b) does in fact cause three spatial coordinates of the object (i.e., the row bars (116)) being passed through insert (102) at the input apertures, to change from an initial position where they enter the input section to a new position where they exit the output section, as shown below:
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As seen from the above annotated view, it is clear that the spatial coordinates of the object located at the input section (i.e., the top of the far left row bar, as designated as X1, Y1, Z1 in annotated Fig. 1b above) is changed to a new, completely different spatial position (X2, Y2, Z2 as shown in annotated Fig. 3b above) after the insert (102) is rotated 180 degrees. As such it is maintained that Choumwong discloses the new limitation added to Claim 1.
Applicant further argues that “Choumwong emphasizes the necessity of aligning the channels in the different trays (first channel, transfer channel, and a second channel)” and that “[t]hese components are positioned on top of each other such that the channels are aligned with one another” (see Applicant’s Response, page 13). This argument fails because all that is being claimed is an “insert for a turning device”, and how Choumwong’s turning device in combination with trays and the insert works is irrelevant; the only structural features that Choumwong needs to teach is the insert (102, Figs. 1b-3b) having the input section/apertures (the portion adjacent (112), Figs. 1-3, having input apertures (118)), the output section (the portion adjacent (108) having a plurality of output apertures (122)), the transition section (the portion containing the row bar (116), as shown in Fig. 2b, and the plurality of guides (Fig. 2b)), wherein the input apertures and output apertures are arranged eccentrically and cause a change in spatial coordinates, which Choumwong teaches as described in the previous 35 USC 102 rejection and in the paragraph above. In addition, this argument seems disingenuous given that Applicant’s insert and the coordinating first and second nests/arrangement structures must be similarly aligned in the disclosed turning device as shown in Figs. 5 and 9, in order to achieve the claimed spatial coordinates change, i.e., the apertures in the first nest (11) must be aligned with the input apertures (4) in the insert (1), and the apertures in the second nest (12) must be aligned with the output apertures (6) in the insert (1) as best shown in Figs. 1, 5, and 9 when placing the insert and nests in the turning machine and turning the insert and nests, as shown in Fig. 9.
If Applicant is attempting to distinguish Choumwong’s insert from the claimed insert on the basis that Choumwong’s insert causes a different orientation of the object after passing through the insert and being rotated by the turning device ( i.e., in Choumwong, the object/row bar is rotated 90 degrees from a vertical orientation to a horizontal orientation, as compared to Applicant’s invention which maintains the vertical orientation of the medical ampoule), it is noted that this orientation difference is not claimed. Moreover, while Claim 1 recites that the claimed insert is “for a turning device for medical ampoules”, this limitation is an intended use limitation, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, there are no claimed limitations that require the insert to be sized for a medical ampoule as compared to the size of a row bar. In addition, a change in the size of a component is generally recognized as being within the level of ordinary skill in the art, and the ordinarily skilled artisan would be able to modify Choumwong’s insert to make it bigger to accommodate the larger medical ampoule using known methods and the modification would yield only predictable results.
For at least these reasons, the 35 USC 102(a)(1) rejection of Claims 1-4, as applied to amended Claim 1 is maintained. In addition, because Applicant did not address any of the 35 USC 103 rejections that also rely on Choumwong as the primary reference, these rejections are similarly maintained.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choumwong et al., US 8,545,164 (cited in the September 17, 2025 Non-Final Office Action).
With regard to Claim 1, Choumwong discloses an insert (102) for a turning device for elongated objects (100, FIGS.1-11, C3, L27- C6, L41; Note: Although Choumwong discloses an insert for a turning device for an elongated object, i.e., row bars, while the claimed invention is directed to an insert for a turning device for medical ampoules, the recitation of this insert for medical ampoules is an intended use of the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, a mere resizing of the apertures as disclosed in Choumwong would allow this device to reorient medical ampoules.), comprising
an input section (110, the portion adjacent 112, Figs. 1-3) which has a plurality of input apertures (118) for receiving a respective object (116), wherein the input apertures are provided in a first arrangement structure (112);
an output section (110, the portion adjacent 108) having a plurality of output apertures (122) for dispensing one object at a time, wherein the output apertures are provided in a second arrangement structure (108);
a transition section (110, the portion containing the row bar 116, as shown in Fig. 2b) which has a plurality of guides (Fig. 2b) the transition section being arranged and/or designed in such a way that objects/ampoules can pass from the input apertures through the plurality of guides to the output apertures (Figs. 1-3);
wherein the input apertures (118) and the output apertures (122) are arranged eccentrically relative to each other (Figs. 1-3); and
wherein three spatial coordinates of the ampoules/objects (116) with respect to the input apertures (118) are changed from an initial position where the ampoules/objects enter the input section (see annotated Fig. 1b above) to a new position where the ampoules/objects exit the output section of the turning device (see annotated Fig. 3b above).
With regard to Claim 2, Choumwong discloses wherein the input apertures (118) and the output apertures (122) are arranged offset relative to one another in a plan view of the insert (Figs. 1-3) .
With regard to Claim 3, Choumwong discloses wherein the input section, the output section and the transition section are integrally formed (Figs. 1-3).
With regard to Claim 4, Choumwong discloses wherein each guide comprises at least one braking portion configured to reduce a speed of movement of an ampoule when guiding from the input portion to the dispensing portion (Figs. 1-3, which show a similar angled transition section as shown in Fig. 1 of the present application).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Choumwong, as applied to Claim 1 above, in view of Wicks et al., US 2019/0344974 (cited in the September 17, 2025 Non-Final Office Action).
With regard to Claims 6-9 and 13, Choumwong discloses a turning device for turning elongated objects/medical ampoules (100), comprising:
an insert (102) according to Claim 1 (see the 35 USC 102 rejection of Claim 1 discussed above);
a holding device (104, 106, Figs. 1-3) for holding the insert (Figs. 1a-3a); and
at least one positioning aid (128, 130, 132, 134, 136, Fig. 10) configured to ensure a predetermined position of a nest/tray (108, 112) upon contact with the turning device (104, 106, 124, 126, Figs. 1a-3a);
wherein the holding device is configured to rotate the insert about a first axis (the axis that extends along shaft (124)).
However, Choumwong fails to teach that the holding device is configured to move the insert along a first direction. Wicks discloses a turning device (Figs. 1-6, [0029]-0078]) that includes an insert that holds the objects to be turned (104, Figs 2-3), a holding device for the insert (206) that is configured to rotate about a first axis (along the axis of shaft (208, Fig. 2) and along a second direction (X, Y, Fig. 2) that is orthogonal to the first axis (Fig. 2), an actuator configured to perform the movement in the first direction and the rotation about the first axis ([0045]-[0049], and a control unit having computing hardware configured to obtain an original position of the object to be turned and to determine a new position of the object after leaving the output apertures ([0039]-[0041]), and at least one positioning aid (115) configured to ensure a predetermined position of a nest upon contact of the nest with the turning device. It would have been obvious to one of ordinary skill in the art, before the effective filing date of Applicant’s invention, to modify Choumwong to include a holding device, actuator, controller, and positioning aid that collectively both rotate the insert and move the insert along a direction that is orthogonal to the first rotational axis because it would allow the insert to be repositioned above the initial location, inverted when there is sufficient clearance, and then returned to the same position after the objects have been turned/inverted, as shown by Wicks (Figs 4-5). This capability allows accurate repositioning of the insert in the same location post-turning, which could be desirable for many reasons, for example, reducing the horizontal footprint of the turning device.
With regard to Claim 10, Choumwong discloses wherein the holding device is configured to hold a first nest (112) with a plurality of object holding positions such that one object holding position is opposite one of the input apertures in each case (Fig. 1b).
With regard to Claim 11, Choumwong discloses wherein the holding device is configured to hold a second nest (108) with a plurality of object holding locations such that one object holding location is opposite one of the output apertures (Fig. 3b).
With regard to Claim 12, Choumwong discloses wherein the holding device is configured to hold a nest (112, 108) with a plurality of object holding locations such that one object holding location is opposite one of the output apertures (Figs. 1b, 3b).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Choumwong, as applied to Claim 1 above, in view of Rey, US 2022/0081179 (cited in the September 17, 2025 Non-Final Office Action). Although Choumwong discloses that the first and second arrangement structures/nests are made from plastic (C5, L37-39), Choumwong fails to teach specific plastics. Rey discloses an insert/arrangement structure/nest for containing ampoules (Figs 1-3, [0036]-[0070]) that is made from polyoxymethylene ([0045]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of Applicant’s invention, to modify Choumwong to make the insert from a specific type of plastic because plastic materials are well known and often used with medical ampoules because of their manufacturing low cost and ease capabilities, liquid-impermeable property, and anti-static characteristics, just to name a few of the advantages of plastics (see also US 3,380,636; US 5,601,128, US 5862,942, and US 2015/0266026; cited in the September 17, 2025 Non-Final Office Action). The ordinarily skilled artisan would be able to make this modification (of substituting any of the recited specific plastics) using known methods and the modification would yield only predictable results.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Choumwong in view of Wicks and DE 2913541 (“DE ‘541”; cited in the September 17, 2025 Non-Final Office Action). Choumwong discloses a method for turning elongated objects via an insert 100/110, FIGS.1-11, C3, L27- C6, L41, comprising:
providing an insert (110; see the 35 USC 102 rejection of Claim 1 above)
providing the plurality of elongated objects (116, Figs. 1-3) in a first arrangement structure (112);
guiding the elongated objects through a guide (the open spaces formed in insert (110)) from the input apertures (118) to the output apertures (122) of the insert; and
dispensing the elongated objects (116) from the output apertures (122) in a second arrangement structure (108).
However, Choumwong fails to teach a method directed to picking up medical ampoules. Wicks discloses a method (Figs. 4-5) in which objects (110) held by an insert/holder (104, 206) are picked up before they are rotated (Figs 4-6). DE ‘541 discloses a method (Figs 1-7, [0017]-[0030]) in which medical ampoules (1) are held by an insert/holder (2,3) and rotated (Figs 1-3, 7). It would have been obvious to one of ordinary skill in the art, before the effective filing date of Applicant’s invention, to modify Choumwong to pick up the objects before rotating the objects, as taught by Wicks (Figs. 1-7) because it would allow the objects to be returned to the same position after the objects have been turned/inverted, as shown by Wicks (Figs 4-5). It would have been obvious to one of ordinary skill in the art, before the effective filing date of Applicant’s invention, to modify the Choumwong/Wicks’ method to use this method with medical ampoules because it would allow the medical ampoules to be inspected, as taught by DE ‘541 ([0002]-[0015]). The ordinarily skilled artisan would recognize that Choumwong’s insert, first and second arrangement structures, and turning device would need to be scaled up to accommodate the larger medical ampoules, and would be able to make this modification using known methods and the modification would yield only predictable results.
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 LYNN E SCHWENNING whose telephone number is (313)446-4861. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm EST.
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/LYNN E SCHWENNING/Primary Examiner, Art Unit 3652